Maricopa Community Colleges Health & Medical Paper

Early in 2019, the Common Rule was updated to include some major changes. (Keep in mind that the Common Rule is found in 45 CFR 46 and relates to government-funded studies.) Many colleges and universities will be updating their standard operating procedures to include the changes in the Common Rule because some of the changes will have a major impact on how research is conducted within their organizations. Also, remember that Title 45 requires IRBs to have operating procedures.

Your assignment:

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  • As part of your responsibilities in the Suffolk Community College system research department, you have been asked to review the IRB processes and procedures to identify changes that should be made in it to be compliant with the new Common Rule. This will involve your review of the Common Rule changes and comparison with the rules and processes within the Community College Standard processes. You will be presenting this information to the Community College Advisory Board.
  • Assignment A

  • You will create a fully developed written script to be used as a voice-over narration to the Assignment B PowerPoint presentation. The scripted narration should be a minimum of 3 minutes, not to exceed 5 minutes in length. It should include responses to the Community College Board explaining the following:
  • Introduction of the purpose of the Common Rule and its applicability to research funded by the federal government. (2 paragraphs)

    Why the Common Rule was updated (1 paragraph)

    Why the Community College should/should not update its procedures (2 paragraphs)

    References should be included and should be on a separate 2nd page.

    Assignment B

    You will create a PowerPoint presentation with 10-12 slides that outline the changes, or lack of changes,  to the standard procedures that you will be presenting to the Community College Board. Keep in mind that if you do not think there should be changes to the standard procedures, you will need to explain why in the PowerPoint and scripted document.

    Assignment C

    The community college has asked you to investigate the major elements of implementing animal research at the college.

    In  two pages (double-spaced) explain to them the salient federal regulations and the role of the IACUC

    (references should be on another page).

    Additional Resources

    IRB operations:

  • Please review 45 CFR 46 (Links to an external site.) and 21 CFR 56 (Links to an external site.), are operational procedures a requirement? Why do you think they are required?
  • Please look at the Standard Operating Procedures from these two institutions – are there similarities, differences? Do they seem to address the rules and regulations?

    Suffolk County Community College IRB

    Columbia University (Links to an external site.)

    Actions

    IACUC operations:

  • Please review the “Blue Book (Links to an external site.)” – what is its purpose? What government agency (Links to an external site.) publishes this book? Why do you think this agency is appropriate for oversight?
  • Please look at the IACUC rules on page 32 of the Blue Book – are there similarities or differences between these regulations and IRB regulations?
  • Cornell University (Links to an external site.) has a website with IACUC procedures – check it out.
  • Biosafety Committees and Operations:
  • The National Institutes of Health is highly involved in the oversight of Biosafety and Biosafety Committees from a national perspective, please read the NIH’s

    powerpoint(Links to an External Site) (Links to an external site.)

    what other agencies are involved in the oversight of biosafety concerns? What is all the fuss about biosafety, how should it concern us in research?

    Radiation Safety Committees:

    Radiation Safety Committees are a little different from other committees because they are overseen by several state and federal entities, depending on the type of committee (university, research, hospital, etc.) In most cases, radiation safety committees are overseen by state radiation safety or radiologic health departments which issue licenses for the use of radioactive materials. The state is active in monitoring any kind of safety concern regarding spills, human exposure to radiation, and other safety issues. At the federal level, the Occupational Safety and Health Administration and the Environmental Protection Agency also have oversight of various aspects of radiation exposure, use, or research.

    Institutional Review Board (IRB) Policy and
    Standard Operating Procedures Manual
    August, 2014
    Institutional Review Board #IORG0006694, Suffolk County Community College
    Table of Contents
    LETTER FROM THE VICE-PRESIDENT ………………………………………………………………………………………….. 3
    INTRODUCTION …………………………………………………………………………………………………………………………. 4
    Importance of the IRB ……………………………………………………………………………………………………………. 4
    IRB Purpose and Principles …………………………………………………………………………………………………….. 5
    IRB Policy ……………………………………………………………………………………………………………………………… 6
    Authorization and Registration of the IRB ………………………………………………………………………………. 6
    ROLE OF THE IRB ………………………………………………………………………………………………………………………. 6
    Operations ……………………………………………………………………………………………………………………………… 6
    Meetings ………………………………………………………………………………………………………………………………. 6
    Membership………………………………………………………………………………………………………………………….. 7
    Management ………………………………………………………………………………………………………………………… 8
    Voting …………………………………………………………………………………………………………………………………. 8
    Conflict of Interest ………………………………………………………………………………………………………………….. 9
    PROCEDURES …………………………………………………………………………………………………………………………….. 9
    Approval of Projects ……………………………………………………………………………………………………………….. 9
    Project Authorization……………………………………………………………………………………………………………… 9
    IRB Review ……………………………………………………………………………………………………………………………. 9
    Exempt Activities …………………………………………………………………………………………………………………. 10
    Expedited Review ………………………………………………………………………………………………………………… 11
    Full Review ………………………………………………………………………………………………………………………… 13
    IRB Actions …………………………………………………………………………………………………………………………. 14
    Initial Review ……………………………………………………………………………………………………………………… 14
    Continuing Review ………………………………………………………………………………………………………………. 15
    Documentation …………………………………………………………………………………………………………………….. 16
    Appeals ………………………………………………………………………………………………………………………………… 17
    Adverse Events …………………………………………………………………………………………………………………….. 18
    Policy Violations ………………………………………………………………………………………………………………….. 18
    RESEARCH GUIDELINES …………………………………………………………………………………………………………… 19
    Belmont Report ……………………………………………………………………………………………………………………. 19
    APPENDICES
    Page
    Vulnerable Populations …………………………………………………………………………………………………………. 20
    2
    Informed Consent…………………………………………………………………………………………………………………. 19
    LETTER FROM THE VICE-PRESIDENT
    As an institution of higher education, Suffolk County Community understands the value of research
    performed for a variety of purposes. Suffolk County Community College also is committed to
    safeguarding the welfare, rights, and privacy of all persons who participate as subjects in research
    projects conducted under its auspices, and to ensuring that the subjects of such research are aware of
    their rights and the protections available to them. In compliance with federal regulations, Suffolk
    maintains an Institutional Review Board (IRB) to review all research requests to make sure they
    conform to human subject protection standards. These safeguards derive from the ethical principles,
    which were first articulated in the Belmont Report issued by the National Commission for the
    Protection of Human Subjects of Biomedical and Behavioral Research in 1979, which are described
    later in this document.
    This manual provides the College’s policies, procedures and review guidelines for research involving
    human subjects as well as the process for obtaining approval from Suffolk’s IRB. Any person
    conducting a research project using human subjects will need to obtain approval of the IRB prior to
    collecting data. The purpose of this policy is to provide a single, comprehensive standard of
    protection for human subjects of research conducted by students, staff, faculty, or visiting researchers
    at Suffolk County Community College. The intent is to assure that researchers do not unduly put at
    risk or harm the subjects of research, and that the subjects of such research are aware of their rights
    as defined in Title 45, part 46 of the Code of Federal Regulations. IRB approval must precede
    commencement of any work involving human subjects.
    Suffolk County Community College receives many requests for permission to perform research
    studies. Our IRB policy has been developed to encourage research while maintaining protections for
    those who take part in any research activities.
    Page
    3
    Jeffrey M. Pedersen, Ed. D.
    Vice President for Planning and Institutional Effectiveness
    INTRODUCTION
    Importance of the IRB 1
    Suffolk County Community College, as a comprehensive, public community college, not only
    provides a quality education to its students, enhances local economic development, and engages in
    community outreach, but also supports faculty, staff, students, and administrators in conducting
    research and engaging in educational projects. Additionally, where appropriate, the College allows
    external constituents to conduct appropriate and beneficial research at one of the three campuses or
    two off-campus centers. While these efforts are supported, the College is, first and foremost,
    concerned with and dedicated to the protection of its faculty, staff, and students.
    For practical and legal, but primarily ethical reasons, the College is committed to protecting the
    rights of all individuals involved with either research or educational projects that depend upon
    interaction with members of the college community. To ensure institutional accountability,
    responsibility, and oversight over research efforts, the Institutional Review Board (IRB) was
    established and operates as the institutional board charged with assurance of human subjects’
    protection. This board is responsible for ensuring that all research projects protect the rights and
    well-being of individuals involved in the studies, that informed consent is provided, that risks have
    been minimized, and that participants understand the voluntary nature of the activities. The body
    ensures these protections through a thorough review of protocols to determine if they meet the
    criteria for research, are eligible for exemption or expedited review, or whether a full review is
    necessary. At its core, the IRB exists to ensure that individuals are treated ethically, with respect,
    and in accordance with the mission and vision of the College. Given the technical nature of this
    document, a list of acronyms (Appendix A) and a glossary of terms (Appendix B) is included.
    In discussing the importance of the IRB, it is important to speak to two issues that are not addressed
    by the review board. First, there are a number of activities that occur at the College as a part of the
    “normal educational practices” of the institution and are not subject to review by the board. These
    areas are explained in detail later, however, they include regular assessment of student learning and
    the support of student learning, institutional reporting, and faculty projects not designed to expand
    generalizable knowledge. Secondly, it is not the policy of the SCCC IRB to review the soundness of
    the research studies. Through the College’s IRB Policy (Appendix C), a process has been
    established to approve research studies. After approval, the IRB reviews the protocol and proposal
    to ensure human subject’s protection, review other institutional IRB approvals, and authorize the
    study.
    Page
    Three documents were very helpful in the development of this manual and include The American
    Psychological Association’s The Institutional Review Board (IRB);A Community College Planning Guide, Columbus
    State Community College’s Institutional Review Board Standard Operating Procedures, and Maricopa County
    Community College District’s Institutional Review Board Handbook: Standard Procedures of Operation.
    4
    1
    IRB Purpose and Principles
    The IRB exists for one primary reason – to ensure that research participants are treated ethically,
    protected from undo risk, and informed of their rights which includes the right to withdraw without
    any penalties. This purpose, as well as the guiding principles for ensuring human subjects
    protection, is found within the 1979 Belmont Report (Appendix D). This report summarized the
    findings from the National Commission for the Protection of Human Subjects of Biomedical and
    Behavioral Research; a group tasked with establishing national standards designed to protect
    research participants.
    As a result of the Commission’s work, three basic ethical principles emerged. These include:
    1. Respect for Persons – The report calls for researchers to respect individuals and to treat
    them as “autonomous agents” and for those unable to act with full autonomy (vulnerable
    subjects), it requires that special review be put in place to ensure that they are not subjected
    to situations which they cannot fully comprehend
    2. Beneficence – Rather than focusing on “kindness” the report requires researchers to treat
    individuals with dignity, respect, and in an ethical manner that protects subjects from harm
    while also seeking to “secure their well-being.” Even when benefits may not be readily or
    ever apparent to participants, studies should seek to “maximize possible benefits and
    minimize possible harms.”
    3. Justice – For the purposes of behavioral research, the commission implores researchers to
    ensure a “fairness of distribution” in regards to the selection of participants, especially where
    benefits are direct and readily apparent.
    The report also explores the boundaries between practice and research and applications. This
    information is summarized into the following series of principles to ensure human subject
    protection 2:
    1. Subjects’ legal rights will be respected; their rights to privacy, dignity, and comfort
    will also be considered in approving proposed research,
    2. Risks to subjects must be reasonable in relation to anticipated benefits, if any, to
    subjects, and the importance of the knowledge that may reasonably be expected to
    result,
    3. Adequate provision(s) must be made for all facilities, procedures, and professional
    attention necessary for the protection of the individual as a research subject,
    2
    This summation was taken from both Columbus State Community College and the Maricopa County
    Community College District IRB Handbooks
    Page
    5
    4. Adequate provisions should be made for recruiting a subject population that is
    representative of the population base in terms of gender and minority representation, unless
    the nature of the study justifies a specific subject population,
    5. Research involving human subjects must be supervised by qualified persons,
    6. Participation of a human subject in research must be voluntary, and the right to
    withdraw at any time must be provided. Information provided to gain subject
    consent must be adequate, appropriate, and presented in lay language appropriate
    to the subject population.
    IRB Policy
    The College’s most recent IRB Policy was approved by the Board of Trustees on 8/21/2014 and is
    the basis for this manual. The full policy can be found in both appendix C and on the Legal Affairs
    webpage
    Authorization and Registration of the IRB
    Suffolk County Community College is registered with and authorized by the U.S. Department of
    Health and Human Services (HHS) to operate and institutional review board. The purpose of the
    board is to review “research involving human subjects conducted or supported by the Department of
    Health and Human Services, or other federal departments or agencies that apply the Federal Policy
    for the Protection of Human Subjects to such research…” Accordingly, the board is empowered to
    make decisions regarding what projects are considered research and whether the rights and safety of
    human subjects are adequately protected along with other responsibilities stated in the IRB
    responsibilities section. The College has one committee registered with HHS and the official
    institution/organization number is IORG0006694.
    ROLE OF THE IRB
    Operations
    Meetings
    Page
    6
    IRB meetings are scheduled once in the fall and once in the spring semesters. If an emergency
    meeting is required (e.g. violation of policy, urgent request), members will be given ten days’ notice.
    Agendas and all paperwork associated with current IRB requests will be provide at least five business
    days prior to meetings, either regularly scheduled or emergency, and sign-in sheets will be
    distributed at each meeting.
    Membership
    The membership of the review board includes the following:

    IRB Chairperson (Representative from the Office of Planning and Institutional
    Effectiveness);

    An instructional faculty member from each campus (selected by Campus Governance
    representatives);

    A faculty or staff member selected by the President;

    A faculty or staff member selected by the Office of Planning and Institutional Effectiveness;
    and

    One external representative.
    In addition to this membership, one representative from the Office of Grants Development, Legal
    Affairs, Academic Affairs, and Student Affairs will serve as ex-officio members. In accordance with
    federal guidelines, membership of the IRB is chosen to ensure:
    1.
    2.
    3.
    4.
    Diversity of research expertise
    Diversity of representation
    Diversity of gender
    Diversity of profession
    To ensure a membership with the education, experience, and expertise to evaluate research projects,
    the following criteria must be adhered to:

    Instructional faculty representatives are selected from either a physical or social science
    and, where possible, should have human subjects research experience and a terminal
    degree;

    The Chair and appointed members should have human subjects research experience, when
    possible; and

    The external representative is not related to any employee of the College but represents
    community interest, the population from which human subjects are commonly drawn,
    and/or has a background in ethics or human rights advocacy.
    Page
    a. Confidentiality agreement
    b. Conflict of interest form
    c. Belmont report agreement form
    7
    Prior to serving on the College’s IRB, all members must submit the following documentation
    Management
    Given the role of the IRB, the College has determined that oversight and accountability are the
    responsibility of the Office of Planning and Institutional Effectiveness (OPIE). In his/her role as the
    Vice-President of OPIE, he/she recommends both a Chairperson and Vice-chairperson of the IRB to
    the President for approval. The chairperson will be a staff member from OPIE while the Vice-chair
    will represent another office and will be selected from the current membership. In the absence of the
    Chairperson, the Vice-chair will conduct business during regularly scheduled meetings. If a change
    in Chair is required, the Vice-President will name a replacement and ensure that accurate
    information is sent to HHS.
    Faculty membership is important to the board and given the three-campus structure of the College,
    one faculty member, appointed by the campus governance representatives, from each campus will
    serve on the board. These individuals should have a physical science/hard science degree and
    experience with social science research at the graduate level. Ideally, these individuals will possess
    terminal degrees.
    To ensure diversity of experiences, positions, and research experience, the President and the VicePresident of OPIE will each appoint one member to serve on the IRB. These individuals can
    represent faculty, staff, students, or administrators, however, it is important that the membership not
    be overly represented by administrators.
    In accordance with guidance from HHS, the College selects one external member to serve as a
    voting member of the IRB. This individual will, ideally, have an advanced degree in a research field,
    will have a background in ethics or advocacy, and will have a demonstrated research record.
    Additionally, this individual must not be related to any College employee given that their task is to
    represent the community interest.
    With the exception of the Chair, internal members are appointed on a two-year basis. The external
    member, in contrast, serves for a three-year period.
    Page
    In order to conduct business during a regularly scheduled or emergency meeting, the IRB must
    convene a quorum of its membership (a simple majority). In the case of either exempting a study
    from IRB review or granting an expedited review, a formal board vote is not required as stated in 45
    CFR 46.110. In these cases, paperwork accompanying the decision will be sent forward to the
    remainder of the board for review. Should a majority of members vote during the next regularly
    scheduled meeting that a full review is necessary (as opposed to the expedited review), the decision
    by the full body will supersede the original decision. Additional information and formal procedures
    are provided later in the document. In the case of approval for a study requiring a full review,
    authorization can only be granted by majority vote from those present at the meeting.
    8
    Voting
    The IRB meetings are open to the public and operate as a forum where additional information can
    be provided on the projects. This can include presentations from the Project Directors, Primary
    Investigators, or other concerned parties. If an IRB member wishes to offer information, they must
    assure the board that their presence as a voting member on the study does not represent a conflict of
    interest. If the membership determines that sensitive matters need to be discussed, the Chair will call
    the meeting into an executive session and will close the meeting to the public.
    Conflict of Interest
    Under no circumstance should any member of the IRB be involved with the initial review nor
    continuing review of a study in which they are directly or indirectly connected. They may offer
    information and respond to questions from the remainder of the body, however, they must recuse
    themselves from the formal voting process.
    PROCEDURES
    Approval of Projects
    The IRB does not provide approval for research projects, but rather authorizes that approved
    projects can be conducted based on exemption or acceptance of the research protocol. Upon receipt
    of a proposal, the information will be forwarded to the Office of Academic Affairs or the Office of
    Student Affairs, depending upon the content. When necessary, these offices will confer with the
    Office of Legal Affairs. After approval from the appropriate administrator, the IRB Chair is
    permitted, if necessary, to submit a letter of support to the requestor. The approval process takes
    between 3 and 4 weeks.
    Project Authorization
    The IRB does not provide approval for research projects, but rather authorizes that approved
    projects can be conducted either through exemption or as a result of an expedited or full review. The
    IRB is not a committee, but rather a board and is empowered by HHS, the College, and this
    operational manual to either authorize or reject research projects that impact the faculty, students,
    staff, and administrators at the College. Authorization times vary by type of review with exemption
    and expedition of the projects taking 2-3 weeks after approval and authorization from a full review
    coming 2-3 weeks after the IRB’s regularly scheduled meetings. The IRB application for
    authorization can be found in Appendix E.
    the study or project from review, expediting the review, or requiring a full review.
    Page
    The IRB exists to review approved projects to ensure that human subjects are protected from
    unnecessary risk or harm. There are three decisions that can be made regarding review: exempting
    9
    IRB Review
    Exempt Activities
    The majority of the data collected within a college does not meet the definition of research
    and therefore does not require an IRB review. If an activity uses human subjects data that is
    regularly and routinely gathered at the institution, does not require new, additional, or
    significantly altered data gathering procedures, or if the activity is not sponsored by an
    external agency or does not test a hypothesis, it probably is not research (e.g. assessment of
    student learning). Specifically, the following activities at Suffolk County Community College
    are always exempt from IRB review even though they involve human subjects:

    Assessment of student learning at the classroom or program level;

    Analysis of existing data sets when 1) all identifiable information has been removed
    or 2) the activity does not meet the criteria for research;

    Collection of data to fulfill county, state, federal, or system requirements; or

    Institutional analyses
    These activities do not require an IRB review and are, instead, subject to the official, formal
    approval and authorization protocols. In addition to these common data collection activities,
    numerous other projects are eligible for exemption. According to HHS 3, the following
    scenarios represent activities that are exempt
    1. Research conducted in established or commonly accepted educational settings,
    involving normal educational practices, such as (i) research on regular and special
    education instructional strategies, or (ii) research on the effectiveness of or the
    comparison among instructional techniques, curricula, or classroom management
    methods.
    2. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
    achievement), survey procedures, interview procedures or observation of public
    behavior, unless: (i) information obtained is recorded in such a manner that human
    subjects can be identified, directly or through identifiers linked to the subjects; and
    (ii) any disclosure of the human subjects’ responses outside the research could
    reasonably place the subjects at risk of criminal or civil liability or be damaging to the
    subjects’ financial standing, employability, or reputation.
    3
    www.hhs.gov/ohrp/humansubjects/guidance/hsdc95-02.htm
    Page
    Federal statute(s) require(s) without exception that the confidentiality of the
    10
    3. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
    achievement), survey procedures, interview procedures, or observation of public
    behavior that is not exempt under paragraph (2) of this section, if: (i) the human
    subjects are elected or appointed public officials or candidates for public office; or (ii)
    personally identifiable information will be maintained throughout the research and
    thereafter.
    4. Research involving the collection or study of existing data, documents, records,
    pathological specimens, or diagnostic specimens, if these sources are publicly
    available or if the information is recorded by the investigator in such a manner that
    subjects cannot be identified, directly or through identifiers linked to the subjects.
    5. Research and demonstration projects which are conducted by or subject to the
    approval of Department or Agency heads, and which are designed to study, evaluate,
    or otherwise examine: (i) Public benefit or service programs; (ii) procedures for
    obtaining benefits or services under those programs; (iii) possible changes in or
    alternatives to those programs or procedures; or (iv) possible changes in methods or
    levels of payment for benefits or services under those programs.
    6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome
    foods without additives are consumed or (ii) if a food is consumed that contains a
    food ingredient at or below the level and for a use found to be safe, or agricultural
    chemical or environmental contaminant at or below the level found to be safe, by the
    Food and Drug Administration or approved by the Environmental
    The decision chart provided by HHS and utilized by the IRB to render decisions about
    exempt status can be found in Appendix F. When in doubt, the primary investigator should
    contact the IRB chair to determine if the project is exempt. Under three conditions, however,
    the primary investigator is required to complete an exemption form (Appendix E) which can
    be found on the OPIE website. The conditions are:

    The study is being conducted by a party external to the college

    Research is being conducted as part of a dissertation

    A previously exempted study has undergone a change to the protocol.
    In accordance with CFR 45, the decision to exempt a study falls under the purview of the
    IRB Chair. All documentation associated with the decision will be shared via e-mail with all
    members of the board and will be up for discussion at the subsequent, regularly scheduled
    meeting. If a project is authorized as exempt, the Primary Investigator or Project Director
    should still expect to wait between 4 and 6 weeks for formal approval by the appropriate
    College administrator and subsequent authorization by the IRB.
    of the IRB chair. The IRB is committed to providing responses to the Primary Investigators
    Page
    When the educational activity is designated as research and does not meet any of the
    exemptions identified by HHS, the study may undergo an expedited review at the discretion
    11
    Expedited Review
    or Project Directors in a reasonable time frame and, where possible, seeks to expedite the
    review. As was the case with exempting studies, the decision to expedite the review is
    handled by the IRB Chair. HHS provides a listing of the criteria that allow for an expedited
    review and these include 4:

    Research activities that (1) present no more than minimal risk to human subjects,
    and (2) involve only procedures listed in one or more of the following categories
    [listed below], may be reviewed by the IRB through the expedited review procedure
    authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be
    deemed to be of minimal risk simply because they are included on this list. Inclusion
    on this list merely means that the activity is eligible for review through the expedited
    review procedure when the specific circumstances of the proposed research involve
    no more than minimal risk to human subjects

    Collection of data through noninvasive procedures (not involving general anesthesia
    or sedation) routinely employed in clinical practice, excluding procedures involving
    x-rays or microwaves. Where medical devices are employed, they must be
    cleared/approved for marketing. (Studies intended to evaluate the safety and
    effectiveness of the medical device are not generally eligible for expedited review,
    including studies of cleared medical devices for new indications.)
    Examples: (a) physical sensors that are applied either to the surface of the body or at
    a distance and do not involve input of significant amounts of energy into the subject
    or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c)
    magnetic resonance imaging; (d) electrocardiography, electroencephalography,
    thermography, detection of naturally occurring radioactivity, electroretinography,
    ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
    (e) moderate exercise, muscular strength testing, body composition assessment, and
    flexibility testing where appropriate given the age, weight, and health of the
    individual.
    Research involving materials (data, documents, records, or specimens) that have
    been collected, or will be collected solely for nonresearch purposes (such as medical
    treatment or diagnosis). (NOTE: Some research in this category may be exempt from
    the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This
    listing refers only to research that is not exempt.)
    4
    www.hhs.gov/ohrp/policy/expedited98.html
    Page
    12


    Collection of data from voice, video, digital, or image recordings made for research
    purposes.

    Research on individual or group characteristics or behavior (including, but not
    limited to, research on perception, cognition, motivation, identity, language,
    communication, cultural beliefs or practices, and social behavior) or research
    employing survey, interview, oral history, focus group, program evaluation, human
    factors evaluation, or quality assurance methodologies. (NOTE: Some research in
    this category may be exempt from the HHS regulations for the protection of human
    subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is
    not exempt.)

    Continuing review of research previously approved by the convened IRB as follows:
    where (i) the research is permanently closed to the enrollment of new subjects; (ii) all
    subjects have completed all research-related interventions; and (iii) the research
    remains active only for long-term follow-up of subjects; or where no subjects have
    been enrolled and no additional risks have been identified; or where the remaining
    research activities are limited to data analysis.
    There are numerous other categories of research listed on the site, however, per the College’s
    IRB policy, research involving clinical trials, drug trials, or testing of medical equipment are
    not permitted and will not be authorized. As a result, these categories were not included
    within this manual.
    Full Review
    In the event that a proposal is approved, but is not eligible for either exemption or an
    expedited review, it will be sent to the full membership for review. The full review meeting is
    a working meeting that is open to the public with the exception of an executive session if
    necessary 5. The Primary Investigator or Project Director will be alerted as to the date of the
    next IRB meeting and should expect to wait for two weeks after the meeting date to receive a
    final decision on authorization.
    Completion of the IRB authorization process is highly recommended if there is any
    question or doubt about whether a project or study involving human subjects or the
    analysis of potentially sensitive requires IRB authorization. Should the IRB be made
    aware of a project that should have been authorized before initiation, a letter will be sent
    from the IRB noting that the project or study must be halted while a review is conducted.
    Should the board need to discuss sensitive information regarding a project under review, the Chair will call an
    executive session which closes that portion of the meeting to the public.
    Page
    5
    13
    While the project is halted, it will undergo the full approval and authorization process
    and if approved, the IRB chair will determine if the project meets the exempt or
    expedited criteria.
    IRB Actions
    Initial Review
    Upon receiving a completed IRB application for authorization form, the IRB Chair sends the
    form to either Academic or Student Affairs for review and approval. After approval from the
    appropriate administrator, the request is sent back to the IRB (within 2-3 weeks of receipt). If
    the project is deemed to be either exempt or eligible for an expedited review, the Chair of the
    IRB will send an authorization letter to the Primary Investigator or Project Director. This
    letter will only be sent, however, if appropriate documentation has been sent along with the
    application form. As noted on the form, this includes a copy of the home institution’s IRB
    approval, the research protocol, and, if appropriate, the consent form. Should a letter of
    support be required, the letter will be sent for either exempt or expedited projects in lieu of
    the authorization letter. The authorization letter, which is also sent to members of the IRB
    and filed in the Office of Planning and Institutional Effectiveness, can only be sent after the
    form is completed and all documentation is included.
    In the event that a full review is necessary, applicants must follow these same steps:

    Submission of the authorization form and documentation

    Obtain approval from Academic or Student Affairs

    Obtain a letter of authorization from the IRB
    Although the process is different, a letter of support can still be sent with the same,
    aforementioned caveats. If a project is subject to full review, the following questions have not
    been sufficiently addressed:

    The extent to which individuals participating in the study are protected from
    unnecessary risks and harm

    The extent to which the protocol explicitly addresses the protection of participant
    rights

    The extent to which the protocol explicitly addresses the ethical treatment of the
    The degree to which confidentiality of participation and the protection and security
    of data is addressed
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    14
    human subjects

    The degree to which the potential benefits to the participants and/or contribution to
    greater generalized knowledge outweighs the potential risks to the subject or the
    college

    Rationale for why informed consent is being withheld (per regulations in 45 CFR 46)
    or insufficiency of the informed consent documentation

    The adequacy of facilities and resources necessary for conducting the study
    Only after any and all concerns are adequately addressed with the IRB authorize a research
    study.
    Should a full review be required, the Primary Investigator, Project Director, or members of
    the research team are invited to attend the meeting to discuss their proposal and to respond
    to questions from the board. After the board is satisfied that all concerns have been
    addressed, they will authorize the study.
    In the event that additional or revised documentation is required (minor revision), the board
    will authorize the study with restrictions. Under this condition, the study can only start after
    submission of any new documentation and a letter of authorization from the IRB Chair.
    Should the IRB deem that the required changes are “substantial”, but that the project is
    viable with the Primary Investigator or Project Director will be required to resubmit the
    entire project for a new review. Under this scenario, discussion about the project is tabled
    until resubmission and discussion at the next, regularly scheduled IRB meeting.
    In the event that substantial questions remain regarding the project and the board determines
    that a complete resubmission of all materials is required (significant revision), the project will
    be disapproved. As with projects deemed to require substantial change, the Primary
    Investigator or Project Director can resubmit the entire application packet and submit the
    proposal for a full IRB review.
    Continuing Review
    Exempt – Projects or studies deemed to be exempt from IRB review are authorized
    without a predetermined review date. Should changes to the protocol or study occur,
    however, the Primary Investigator or Project Director must resubmit the proposal
    and based on changes, an official continuing review date may be established.
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    15
    In accordance with guidelines provided by HHS, the College maintains a systematic
    approach to the IRB’s authorization period. It is the responsibility of the board to ensure that
    research projects are reviewed and reauthorized to ensure the continued protection of both
    human subjects’ safety and rights. Regardless of the type of review conducted by the IRB, all
    projects are subject to continuing review. The timelines are as follows:

    Expedited – If a study is authorized with an expedited review, the review date is
    established as one calendar year from the official authorization act. Should changes
    to the protocol or study occur, however, the Primary Investigator or Project Director
    is expected to immediately resubmit the proposal for review. If the proposal is
    accepted on an expedited basis, the review date is extended one year from the date
    of the reauthorization letter. If the study is required to go through a full review, the
    new review date is one year from authorization by the full board.

    Full Review – If a study is authorized under a full review, the review date is
    established as one calendar year from the official authorization act. Should changes
    to the protocol or study occur, however, the Primary Investigator or Project Director
    is expected to immediately resubmit the proposal for review. If the proposal is
    accepted on an expedited basis (based on limited adjustments to a previous
    authorization by the full board), the review date is extended one year from the date
    of the reauthorization letter. If the study is required to go through a full review, the
    new review date is one year from authorization by the full board.
    Documentation
    The Primary Investigator or Project Director is expected to complete the Application for IRB
    Approval which is located on the College’s Office of Planning and Institutional Effectiveness site.
    This document includes information about the researchers, the study and its procedures, and
    requires the inclusion of documentation of IRB approval from the home institution, the research
    protocol, the informed consent form, and any additional information that the submitter believes will
    help the board make an informed decision.
    The IRB is also responsible for providing and maintaining documentation for each individual
    request. After project or study approval, an IRB number is assigned regardless of the type of review
    required. The following information is provided for each type of review:

    Exempt – The submitter will receive an official authorization letter with the
    College’s expectations (i.e. notification of change), an IRB number, a review date
    (marked as N/A), and the College’s IORG number. In addition, a signed copy of
    the Application for IRB approval will be sent. Should a letter of support be required
    after the project or study is approved by appropriate College administrators, a letter
    will be sent that indicates that the study will be authorized subsequent to approval
    from the home institutions’ IRB. All correspondence will be sent electronically and
    Expedited – The submitter will receive an official authorization letter with the
    College’s expectations (i.e. notification of change), an IRB number, a review date
    (one year from the date of the letter), and the College’s IORG number. In addition, a
    Page

    16
    in hard copy.
    signed copy of the Application for IRB approval will be sent. Should a letter of
    support be required after the project or study is approved by appropriate College
    administrators, a letter will be sent that indicates that the study will be authorized
    subsequent to approval from the home institutions’ IRB. All correspondence will be
    sent electronically and in hard copy.

    Full Review – After a meeting of the full board, the submitter will receive an official
    authorization letter with the College’s expectations (i.e. notification of change), an
    IRB number, a review date (one year from the date of the letter), and the College’s
    IORG number. In addition, a signed copy of the Application for IRB approval will
    be sent. Should a letter of support be required after the project or study is approved
    by appropriate College administrators, a letter will be sent that indicates that the
    study will be authorized subsequent to approval from the home institutions’ IRB. All
    correspondence will be sent electronically and in hard copy.
    In addition to the aforementioned documentation, the IRB is responsible for maintaining complete
    records for each of the projects that go through review. These records include the following:

    All correspondence identified above (including e-mail correspondence with the IRB Chair)

    Agendas, minutes (including approval of previous minutes), and sign-in sheets

    Statements of significant changes along with amended Application for IRB forms

    Updated documents (protocols, consent forms, etc.)

    Adverse event or policy violation reports

    If applicable, information regarding appeals

    Materials provided to research participants
    Appeals
    If a Primary Investigator or Project Director is dissatisfied with the IRB’s decision to either authorize
    a project with restrictions or to disapprove a study, he/she may formally appeal the decision. The
    first step in the process is to seek mutual agreement during the IRB meeting in which the project is
    under discussion. Should this opportunity fail to lead to an acceptable alternative, the decision can
    be appealed in writing. This appeal letter is to be sent to the IRB Chair who will convene a special ad
    hoc committee to review the appeal. The process of committee review will take between 4 and 6
    weeks after official receipt of the letter and the findings will be presented to the full board at the next
    regularly scheduled meeting. At that meeting, the IRB will make a final determination regarding the
    appeal and in accordance with federal regulations, the final decision by the IRB is official and
    Page
    17
    cannot be appealed further.
    Adverse Events
    Two federal regulations (21 CFR 56.108 and 45 CFR 46.103) charge the IRB with accountability,
    responsibility, and oversight regarding adverse events that occur during a study. While some of this
    responsibility is subsumed under the standard continuing review cycle, there are instances that may
    occur during an authorization period that requires investigation and, potentially, intervention by the
    board.
    An adverse event is any instance which places participants at risk or at a level or degree of potential
    harm outside of those indicated within the initial protocol. Should such an event occur, the College
    IRB must be notified within 48 hours of the event. This information will be forwarded to the Vice
    President for Planning and Institutional Effectiveness as well as to the Office for Human Research
    Protection.
    Upon receipt of the adverse event report, the Chair of the IRB, in consultation with other members
    and administrators as appropriate, will require immediate suspension of the activity prior to review
    by the full membership. The body will then review the situation at an emergency meeting to
    determine if additional information or further investigation is required and to provide official
    correspondence that study must be halted until corrective action is taken. Affected supervising
    administrator(s) will be copied on all correspondence between the review board and the involved
    parties.
    Policy Violations
    As the institutional body charged with assurance of human subject safety, the IRB is also tasked with
    ensuring that research conducted at the College is conducted ethically in accordance with the
    principles outlined in the Belmont Report. Accordingly, the IRB is responsible for ensuring adherence
    to this policy and to the procedures and processes outlined in the IRB Manual. All projects
    authorized by the IRB must meet strict ethical standards in line with accepted best practices, and
    violations of this policy, regardless of the reason, are taken seriously and will be dealt with by the
    review board.
    Should any violations of this policy occur, the information will be brought before the IRB at a
    convened meeting. The body will review the reported violation and determine if additional
    information or further investigation is required. Affected supervising administrator(s) will be copied
    on all correspondence between the review board and the involved parties. If it is determined that a
    Page
    In situations where participant safety is compromised, and/or the violations are apparent, the Chair
    of the IRB, in consultation with other members and administrators as appropriate, will require
    18
    violation of this policy has occurred, the IRB will require that the activity in question be halted until
    corrective action is taken.
    immediate suspension of the activity prior to review by the full membership. If the IRB determines
    that the violation involves possible scholarly or scientific misconduct that doesn’t impact human
    subjects protection, the Vice President for Academic and Student Affairs and the Vice President for
    Planning and Institutional Effectiveness will be notified by the board. While the IRB can and will
    assist in the investigation, the review board will adhere to the decisions made by the Vice-Presidents
    regarding continued institutional approval of the project. It is expected that the College
    administrators will determine which direction to take in accordance with established College
    assurances, policies, and procedures.
    RESEARCH GUIDELINES
    Belmont Report
    The Belmont Report is considered the seminal federal document associated with the protection of
    human subjects and is the document most connected with 45 CFR 46 (Human Subjects Research).
    This document is required reading for all members of the IRB and is provided in totality in
    Appendix D. According to HHS, 6
    On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by
    creating the National Commission for the Protection of Human Subjects of Biomedical and
    Behavioral Research. One of the charges to the Commission was to identify the basic ethical
    principles that should underlie the conduct of biomedical and behavioral research involving human
    subjects and to develop guidelines which should be followed to assure that such research is
    conducted in accordance with those principles…The Belmont Report attempts to summarize the
    basic ethical principles identified by the Commission in the course of its deliberations… It is a
    statement of basic ethical principles and guidelines that should assist in resolving the ethical
    problems that surround the conduct of research with human subjects.
    Informed Consent
    With the exception of therapeutic or diagnostic research, human subjects involved in a research
    study are entitled to informed consent. Given the scope of research reviewed by the IRB and
    authorized at the College, all studies must provide either direct or implied consent. Based on 45
    CFR 46.116 (45 CFR 46 is found in Appendix G), informed consent must include the following7

    A statement that the study involves research, an explanation of the purposes of the
    7
    www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
    Page
    6
    19
    research and the expected duration of the subject’s participation, a description of the
    procedures to be followed, and identification of any procedures which are
    experimental;

    A description of any reasonably foreseeable risks or discomforts to the subject;

    A description of any benefits to the subject or to others which may reasonably be
    expected from the research;

    A disclosure of appropriate alternative procedures or courses of treatment, if any,
    that might be advantageous to the subject;

    A statement describing the extent, if any, to which confidentiality of records
    identifying the subject will be maintained;

    For research involving more than minimal risk, an explanation as to whether any
    compensation and an explanation as to whether any medical treatments are available
    if injury occurs and, if so, what they consist of, or where further information may be
    obtained;

    An explanation of whom to contact for answers to pertinent questions about the
    research and research subjects’ rights, and whom to contact in the event of a
    research-related injury to the subject; and

    A statement that participation is voluntary, refusal to participate will involve no
    penalty or loss of benefits to which the subject is otherwise entitled, and the subject
    may discontinue participation at any time without penalty or loss of benefits to
    which the subject is otherwise entitled.
    Full documentation as well as a checklist that can be used to guide the development of the
    informed consent form can be found in Appendix H.
    Vulnerable Populations
    Page
    20
    In the event where a study will be conducting research on populations identified by HHS as either
    special or vulnerable, a full review by the IRB will be required. The board will place extra scrutiny
    on the protocol, consent form, and any risks or potential for harm. Given the scope of the research
    approved by the College, only children under 18 are identified as part of a special population.
    APPENDIX A: Acronyms
    IRB – Institutional Review Board
    BOT – Board of Trustees
    HHS – U.S. Department of Health and Human Services
    IORG – Institutional or Organizational Number
    OHRP – Office of Human Research Protection
    OPIE – Office of Planning and Institutional Effectiveness
    CFR – Code of Federal Regulations
    APPENDIX B: Definition of Terms
    Adverse event – An unintended and unwanted consequence resulting in the course of research that
    must be reported immediately and may lead to a suspension of the project
    Approval – Permission to conduct a study that is granted by College administration
    Authorization – Certification by the IRB that human subjects will be treated ethically, informed,
    and protected from unnecessary risk
    Anticipated benefits – Benefits that are accrued to some combination of the participants, researcher,
    or to general knowledge and understandings
    Belmont Report – A report emanating from the National Commission for the Protection of Human
    Subjects in 1979 and seen as the seminal document offering guidelines on the ethical treatment of
    human subjects
    Confidentiality – Assurance that the information gathered during the course of a research project
    will not be connected back to participants and that provisions are in place to safeguard individual
    records
    Commonly accepted educational settings – These include spaces and facilities in which educational
    activities commonly occur (i.e. classroom, library, etc.)
    Continuing Review – A status assigned to expedited or full review which require the researchers to
    submit progress reports and reapply for IRB authorization at a given time or a process that is
    initiated after a significant change in the research protocol
    Educational projects – Activities that gather and analyze information, but which do not meet the
    definition of research
    Ethical principles – A set of values documented in the Belmont Report designed to ensure that human
    subjects are treated equitably, ethically, and with dignity
    Exempt – Educational projects that don’t meet the criteria for research and which meet the standard
    for normal educational practices in commonly accepted educational setting and either never need to
    be reviewed per guidance in this manual or which are reviewed and a determination is made that
    further review, apart from significant protocol changes, is not necessary
    Expedited review – Activities meeting the definition of research, but which include no more than
    minimal risk and meet one of the criteria illustrated in the Human Subjects Regulations Decision
    Charts for expedited review
    Full review – Activities meeting the definition of research and that include more than minimal risk
    and/or do not meet any of the criteria illustrated in the Human Subjects Regulations Decision
    Charts for expedited review
    Human subjects – By HHS definition these are “Living individual(s) about whom an investigator
    (whether professional or student) conducting research obtains (1) data through intervention or
    interaction with an individual, or (2) identifiable private information”
    Informed consent – Assurance that participants in a study are doing so voluntarily and based upon
    an appropriate level of knowledge about the purpose, risks, and benefits of a stud
    Institutional Review Board – An institutional board charged with authorizing research projects
    based on the degree to which the rights are protected for human subjects
    IRB policy – The policy document approved by the Suffolk County Community College Board of
    Trustees that enables the IRB to authorize research studies and provides the framework for the IRB
    Operating Procedures Manual
    Normal educational practices – Activities that take place on a routine and regular basis as part of
    the educational process and can include, but is not limited to, testing of student knowledge,
    measuring the effectiveness of pedagogical interventions, or assessing the impact of curricular
    change
    Protocol – The document provided to the IRB that identifies the research design and includes the
    rationale, methodology, methods, and other information pertinent to the study
    Research – By HHS definition it is “a systematic investigation, including research development,
    testing, and evaluation, designed to develop or contribute to generalizable knowledge”
    Restrictions – In reference to authorization of a study, restrictions indicate that a study is only
    authorized after the identified issues have been addressed and revisions have been submitted to the
    IRB
    Risks – The likelihood that harm or injury (physical, psychological, reputational, or financial) will
    occur to a participant of a research study and may range from minimal to significant
    Voluntary – Maintaining the choice to participate or not without the use of coercion or pressure and
    without fear of retribution or reprisal
    Vulnerable populations – Individuals who for one reason or another are not of sound mind, able the
    exercise autonomy or sound judgment, are subject to special risks, or who are not empowered to
    make their own decisions and includes children (under age 18), prisoners, pregnant woman
    (depending upon the research) and other classes identified by HHS
    Appendix C: Final Board Approved Policy
    Policy on Institutional Review Board and Human Subjects’ Protection
    I.
    Introduction
    Suffolk County Community College (the College) is committed to the protection of students,
    employees, and others who may conduct or participate in research or externally-funded educational
    projects involving human subjects, which are sponsored by, or associated with, the College. In
    accordance with the regulations of the United States Department of Health and Human Services,
    Office for Human Research Protections (OHRP), and requirements of federal grant agencies and the
    State of New York, the College’s Institutional Review Board (IRB) is charged with ensuring this
    protection and rendering decisions regarding research and educational projects that impact the
    College community. The primary role of the IRB is to ensure that the College’s students, faculty,
    staff, and administrators, as well as individuals involved in College-approved and sanctioned
    research or educational projects, are protected from unnecessary harm and risk.
    II.
    Definitions
    Human Subjects. Living individual(s) about whom an investigator (whether
    A.
    professional or student) conducting research obtains (1) data through intervention or interaction with
    an individual, or (2) identifiable private information (45 CFR 46.102[d]).
    B.
    Research. A systematic investigation, including research development, testing, and
    evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102[d]) If
    the activity meets this standard, it is defined as research (e.g. dissertation research). If an activity
    uses human subjects data that is regularly and routinely gathered at the institution, does not require
    new, additional, or significantly altered data gathering procedures, or if the activity is not sponsored
    by an external agency or does not test a hypothesis, it likely does not constitute research (e.g.
    assessment of student learning).
    III.
    Policy and Duties of the IRB
    A.
    All proposed research or educational projects involving human subjects will be
    reviewed by the IRB to ensure compliance with all applicable law, rules and regulations.
    B.
    This policy applies to the following:
    1.
    All College faculty, staff, and students using College facilities or the facilities
    of an off-campus site for the purpose of conducting research or for externally funded projects
    involving human subjects;
    1
    2. Persons who are not College employees or students who wish to use College
    facilities for such projects; and
    3. Persons who wish to conduct projects with College employees or students as
    subjects, regardless of the project’s location.
    C.
    The IRB shall be empowered and responsible to:
    1. Determine whether proposed research or educational projects constitute
    ”research.” In the case of any such research project, the IRB will meet to approve, request
    revision, or deny approval of the research activity’s protection protocol for human subjects.
    2. Determine if research activities are exempt from IRB oversight.
    3. Provide oversight of human subject protection for ongoing research involving
    human subjects.
    4. Ensure adherence to this policy and to the procedures and processes outlined in
    the IRB Manual (manual is located on the OPIE section of the SCCC website).
    5. Ensure that research conducted at the College is conducted ethically, in
    accordance with the principles outlined in the Belmont Report (see the IRB procedures manual
    on the SCCC website).
    IV.
    Membership of the Institutional Review Board
    A.
    The membership of the institutional review board shall include the following:
    1.
    IRB Chairperson (Representative from the Office of Planning and
    Institutional Effectiveness);
    2.
    An instructional faculty member from each campus (selected by Campus
    Governance representatives);
    3.
    A faculty or staff member selected by the President;
    4.
    A faculty or staff member selected by the Office of Planning and
    Institutional Effectiveness; and
    5.
    One external representative
    B.
    In addition to this membership, a representative from the Offices of Grants
    Development, Legal Affairs, Academic Affairs, and Student Affairs will serve as ex-officio
    members.
    2
    C.
    To ensure an IRB membership with the education, experience, and expertise to
    evaluate research projects, the following criteria must be adhered to:
    1.
    Instructional faculty representatives are to be selected from either a physical
    or social science and, where possible, should have human subjects research
    experience and a terminal degree;
    2.
    The Chair and appointed members should have human subjects research
    experience, when possible; and
    3.
    The external representative may not be related to any officer or employee of
    the College. Such representative should represent a community interest, and/or
    have a background in ethics or human rights advocacy.
    V.
    Mandatory Training
    All members of the IRB, as well as persons who conduct research directly or indirectly with
    human subjects, must undergo training on the protection of human subjects. Given the limited scope
    of research conducted at the College, this requirement is fulfilled through mandatory review of the
    Belmont Report by the membership of the IRB.
    VI.
    Prohibited Research
    In adherence to the College’s mission, the College will not engage in, nor support, research
    projects involving students, faculty, administration, or staff that require clinical trials, drug trials or
    medical device research.
    VII. Policy Violations
    A.
    Should any alleged violations of this policy occur, the allegations will be brought
    before the IRB at a convened meeting. The body will review the reported violation and determine if
    additional information or further investigation is required. Affected supervising administrator(s) will
    be copied on all correspondence between the review board and the involved parties. If it is
    determined that a violation of this policy has occurred, the IRB will require that the activity in
    question be halted until corrective action is taken.
    B.
    In situations where participant safety is compromised, and/or the violations are
    apparent, the Chair of the IRB, in consultation with other members and administrators, as
    appropriate, will require immediate suspension of the activity prior to review by the full membership.
    If the IRB determines that the violation involves possible scholarly or scientific misconduct, the Vice
    President for Academic and Student Affairs and the Vice President for Planning and Institutional
    Effectiveness will be notified. While the IRB can and will assist in the investigation, the review
    board will adhere to the decisions made by the Vice-Presidents which must consider all appropriate
    actions in light of established College assurances, policies, and procedures.
    3
    VIII.
    Policy Review
    A.
    Annual Review. This policy shall be reviewed on an annual basis.
    B.
    Comprehensive Review. This policy shall be reviewed five (5) years from the
    effective date or one year from a change in CFR 45, Part 46.
    IX.
    Effective Date
    This policy shall be effective as of August 21, 2014.
    4
    Appendix D: The Belmont Report
    The Belmont Report
    Office of the Secretary
    Ethical Principles and Guidelines for the Protection of Human
    Subjects of Research
    The National Commission for the Protection of Human Subjects
    of Biomedical and Behavioral Research
    April 18, 1979
    AGENCY: Department of Health, Education, and Welfare.
    ACTION: Notice of Report for Public Comment.
    SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into
    law, there-by creating the National Commission for the Protection of Human Subjects of
    Biomedical and Behavioral Research. One of the charges to the Commission was to identify the
    basic ethical principles that should underlie the conduct of biomedical and behavioral research
    involving human subjects and to develop guidelines which should be followed to assure that such
    research is conducted in accordance with those principles. In carrying out the above, the
    Commission was directed to consider: (i) the boundaries between biomedical and behavioral
    research and the accepted and routine practice of medicine, (ii) the role of assessment of riskbenefit criteria in the determination of the appropriateness of research involving human subjects,
    (iii) appropriate guidelines for the selection of human subjects for participation in such research
    and (iv) the nature and definition of informed consent in various research settings.
    Page
    1
    The Belmont Report attempts to summarize the basic ethical principles identified by the
    Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period
    of discussions that were held in February 1976 at the Smithsonian Institution’s Belmont
    Conference Center supplemented by the monthly deliberations of the Commission that were held
    over a period of nearly four years. It is a statement of basic ethical principles and guidelines that
    should assist in resolving the ethical problems that surround the conduct of research with human
    subjects. By publishing the Report in the Federal Register, and providing reprints upon request,
    the Secretary intends that it may be made readily available to scientists, members of Institutional
    Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy
    reports of experts and specialists who assisted the Commission in fulfilling this part of its charge,
    is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the
    Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Unlike most other reports of the Commission, the Belmont Report does not make specific
    recommendations for administrative action by the Secretary of Health, Education, and Welfare.
    Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a
    statement of the Department’s policy. The Department requests public comment on this
    recommendation.
    National Commission for the Protection of Human Subjects
    of Biomedical and Behavioral Research
    Members of the Commission
    Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women.
    Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University.
    Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
    Dorothy I. Height, President, National Council of Negro Women, Inc.
    Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San
    Francisco.
    Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.
    Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of
    Religion.
    *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley.
    Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine,
    University of Texas at Dallas.
    ***Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological
    Psychology, University of Pennsylvania.
    *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle,
    Washington, D.C.
    ***Deceased.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Page
    Ethical Principles and Guidelines for Research Involving Human Subjects
    A. Boundaries Between Practice and Research
    B. Basic Ethical Principles
    1. Respect for Persons
    2. Beneficence
    3. Justice
    C. Applications
    1. Informed Consent
    2. Assessment of Risk and Benefits
    3. Selection of Subjects
    2
    Table of Contents
    Ethical Principles & Guidelines for Research Involving Human Subjects
    Scientific research has produced substantial social benefits. It has also posed some troubling
    ethical questions. Public attention was drawn to these questions by reported abuses of human
    subjects in biomedical experiments, especially during the Second World War. During the
    Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging
    physicians and scientists who had conducted biomedical experiments on concentration camp
    prisoners. This code became the prototype of many later codes(1) intended to assure that
    research involving human subjects would be carried out in an ethical manner.
    The codes consist of rules, some general, others specific, that guide the investigators or the
    reviewers of research in their work. Such rules often are inadequate to cover complex situations;
    at times they come into conflict, and they are frequently difficult to interpret or apply. Broader
    ethical principles will provide a basis on which specific rules may be formulated, criticized and
    interpreted.
    Three principles, or general prescriptive judgments, that are relevant to research involving
    human subjects are identified in this statement. Other principles may also be relevant. These
    three are comprehensive, however, and are stated at a level of generalization that should assist
    scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in
    research involving human subjects. These principles cannot always be applied so as to resolve
    beyond dispute particular ethical problems. The objective is to provide an analytical framework
    that will guide the resolution of ethical problems arising from research involving human subjects.
    This statement consists of a distinction between research and practice, a discussion of the three
    basic ethical principles, and remarks about the application of these principles.
    [RETURN TO TABLE OF CONTENTS]
    Part A: Boundaries Between Practice & Research
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Page
    It is important to distinguish between biomedical and behavioral research, on the one hand, and
    the practice of accepted therapy on the other, in order to know what activities ought to undergo
    review for the protection of human subjects of research. The distinction between research and
    practice is blurred partly because both often occur together (as in research designed to evaluate a
    therapy) and partly because notable departures from standard practice are often called
    “experimental” when the terms “experimental” and “research” are not carefully defined.
    3
    A. Boundaries Between Practice and Research
    For the most part, the term “practice” refers to interventions that are designed solely to enhance
    the well-being of an individual patient or client and that have a reasonable expectation of
    success. The purpose of medical or behavioral practice is to provide diagnosis, preventive
    treatment or therapy to particular individuals.(2) By contrast, the term “research’ designates an
    activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or
    contribute to generalizable knowledge (expressed, for example, in theories, principles, and
    statements of relationships). Research is usually described in a formal protocol that sets forth an
    objective and a set of procedures designed to reach that objective.
    When a clinician departs in a significant way from standard or accepted practice, the innovation
    does not, in and of itself, constitute research. The fact that a procedure is “experimental,” in the
    sense of new, untested or different, does not automatically place it in the category of research.
    Radically new procedures of this description should, however, be made the object of formal
    research at an early stage in order to determine whether they are safe and effective. Thus, it is the
    responsibility of medical practice committees, for example, to insist that a major innovation be
    incorporated into a formal research project.(3)
    Research and practice may be carried on together when research is designed to evaluate the
    safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the
    activity requires review; the general rule is that if there is any element of research in an activity,
    that activity should undergo review for the protection of human subjects.
    Part B: Basic Ethical Principles
    B. Basic Ethical Principles
    The expression “basic ethical principles” refers to those general judgments that serve as a basic
    justification for the many particular ethical prescriptions and evaluations of human actions.
    Three basic principles, among those generally accepted in our cultural tradition, are particularly
    relevant to the ethics of research involving human subjects: the principles of respect of persons,
    beneficence and justice.
    Page
    An autonomous person is an individual capable of deliberation about personal goals and of
    acting under the direction of such deliberation. To respect autonomy is to give weight to
    autonomous persons’ considered opinions and choices while refraining from obstructing their
    actions unless they are clearly detrimental to others. To show lack of respect for an autonomous
    agent is to repudiate that person’s considered judgments, to deny an individual the freedom to act
    4
    1. Respect for Persons. — Respect for persons incorporates at least two ethical convictions: first,
    that individuals should be treated as autonomous agents, and second, that persons with
    diminished autonomy are entitled to protection. The principle of respect for persons thus divides
    into two separate moral requirements: the requirement to acknowledge autonomy and the
    requirement to protect those with diminished autonomy.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    on those considered judgments, or to withhold information necessary to make a considered
    judgment, when there are no compelling reasons to do so.
    However, not every human being is capable of self-determination. The capacity for selfdetermination matures during an individual’s life, and some individuals lose this capacity wholly
    or in part because of illness, mental disability, or circumstances that severely restrict liberty.
    Respect for the immature and the incapacitated may require protecting them as they mature or
    while they are incapacitated.
    Some persons are in need of extensive protection, even to the point of excluding them from
    activities which may harm them; other persons require little protection beyond making sure they
    undertake activities freely and with awareness of possible adverse consequence. The extent of
    protection afforded should depend upon the risk of harm and the likelihood of benefit. The
    judgment that any individual lacks autonomy should be periodically reevaluated and will vary in
    different situations.
    In most cases of research involving human subjects, respect for persons demands that subjects
    enter into the research voluntarily and with adequate information. In some situations, however,
    application of the principle is not obvious. The involvement of prisoners as subjects of research
    provides an instructive example. On the one hand, it would seem that the principle of respect for
    persons requires that prisoners not be deprived of the opportunity to volunteer for research. On
    the other hand, under prison conditions they may be subtly coerced or unduly influenced to
    engage in research activities for which they would not otherwise volunteer. Respect for persons
    would then dictate that prisoners be protected. Whether to allow prisoners to “volunteer” or to
    “protect” them presents a dilemma. Respecting persons, in most hard cases, is often a matter of
    balancing competing claims urged by the principle of respect itself.
    2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions
    and protecting them from harm, but also by making efforts to secure their well-being. Such
    treatment falls under the principle of beneficence. The term “beneficence” is often understood to
    cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence
    is understood in a stronger sense, as an obligation. Two general rules have been formulated as
    complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize
    possible benefits and minimize possible harms.
    Page
    5
    The Hippocratic maxim “do no harm” has long been a fundamental principle of medical ethics.
    Claude Bernard extended it to the realm of research, saying that one should not injure one person
    regardless of the benefits that might come to others. However, even avoiding harm requires
    learning what is harmful; and, in the process of obtaining this information, persons may be
    exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their
    patients “according to their best judgment.” Learning what will in fact benefit may require
    exposing persons to risk. The problem posed by these imperatives is to decide when it is
    justifiable to seek certain benefits despite the risks involved, and when the benefits should be
    foregone because of the risks.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    The obligations of beneficence affect both individual investigators and society at large, because
    they extend both to particular research projects and to the entire enterprise of research. In the
    case of particular projects, investigators and members of their institutions are obliged to give
    forethought to the maximization of benefits and the reduction of risk that might occur from the
    research investigation. In the case of scientific research in general, members of the larger society
    are obliged to recognize the longer term benefits and risks that may result from the improvement
    of knowledge and from the development of novel medical, psychotherapeutic, and social
    procedures.
    The principle of beneficence often occupies a well-defined justifying role in many areas of
    research involving human subjects. An example is found in research involving children.
    Effective ways of treating childhood diseases and fostering healthy development are benefits that
    serve to justify research involving children — even when individual research subjects are not
    direct beneficiaries. Research also makes it possible to avoid the harm that may result from the
    application of previously accepted routine practices that on closer investigation turn out to be
    dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult
    ethical problem remains, for example, about research that presents more than minimal risk
    without immediate prospect of direct benefit to the children involved. Some have argued that
    such research is inadmissible, while others have pointed out that this limit would rule out much
    research promising great benefit to children in the future. Here again, as with all hard cases, the
    different claims covered by the principle of beneficence may come into conflict and force
    difficult choices.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Page
    Questions of justice have long been associated with social practices such as punishment, taxation
    and political representation. Until recently these questions have not generally been associated
    with scientific research. However, they are foreshadowed even in the earliest reflections on the
    ethics of research involving human subjects. For example, during the 19th and early 20th
    centuries the burdens of serving as research subjects fell largely upon poor ward patients, while
    the benefits of improved medical care flowed primarily to private patients. Subsequently, the
    exploitation of unwilling prisoners as research subjects in Nazi concentration camps was
    condemned as a particularly flagrant injustice. In this country, in the 1940’s, the Tuskegee
    6
    3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a
    question of justice, in the sense of “fairness in distribution” or “what is deserved.” An injustice
    occurs when some benefit to which a person is entitled is denied without good reason or when
    some burden is imposed unduly. Another way of conceiving the principle of justice is that equals
    ought to be treated equally. However, this statement requires explication. Who is equal and who
    is unequal? What considerations justify departure from equal distribution? Almost all
    commentators allow that distinctions based on experience, age, deprivation, competence, merit
    and position do sometimes constitute criteria justifying differential treatment for certain
    purposes. It is necessary, then, to explain in what respects people should be treated equally.
    There are several widely accepted formulations of just ways to distribute burdens and benefits.
    Each formulation mentions some relevant property on the basis of which burdens and benefits
    should be distributed. These formulations are (1) to each person an equal share, (2) to each
    person according to individual need, (3) to each person according to individual effort, (4) to each
    person according to societal contribution, and (5) to each person according to merit.
    syphilis study used disadvantaged, rural black men to study the untreated course of a disease that
    is by no means confined to that population. These subjects were deprived of demonstrably
    effective treatment in order not to interrupt the project, long after such treatment became
    generally available.
    Against this historical background, it can be seen how conceptions of justice are relevant to
    research involving human subjects. For example, the selection of research subjects needs to be
    scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial
    and ethnic minorities, or persons confined to institutions) are being systematically selected
    simply because of their easy availability, their compromised position, or their manipulability,
    rather than for reasons directly related to the problem being studied. Finally, whenever research
    supported by public funds leads to the development of therapeutic devices and procedures,
    justice demands both that these not provide advantages only to those who can afford them and
    that such research should not unduly involve persons from groups unlikely to be among the
    beneficiaries of subsequent applications of the research.
    Part C: Applications
    C. Applications
    Applications of the general principles to the conduct of research leads to consideration of the
    following requirements: informed consent, risk/benefit assessment, and the selection of subjects
    of research.
    1. Informed Consent. — Respect for persons requires that subjects, to the degree that they are
    capable, be given the opportunity to choose what shall or shall not happen to them. This
    opportunity is provided when adequate standards for informed consent are satisfied.
    While the importance of informed consent is unquestioned, controversy prevails over the nature
    and possibility of an informed consent. Nonetheless, there is widespread agreement that the
    consent process can be analyzed as containing three elements: information, comprehension and
    voluntariness.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Page
    However, a simple listing of items does not answer the question of what the standard should be
    for judging how much and what sort of information should be provided. One standard frequently
    invoked in medical practice, namely the information commonly provided by practitioners in the
    field or in the locale, is inadequate since research takes place precisely when a common
    7
    Information. Most codes of research establish specific items for disclosure intended to assure
    that subjects are given sufficient information. These items generally include: the research
    procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is
    involved), and a statement offering the subject the opportunity to ask questions and to withdraw
    at any time from the research. Additional items have been proposed, including how subjects are
    selected, the person responsible for the research, etc.
    understanding does not exist. Another standard, currently popular in malpractice law, requires
    the practitioner to reveal the information that reasonable persons would wish to know in order to
    make a decision regarding their care. This, too, seems insufficient since the research subject,
    being in essence a volunteer, may wish to know considerably more about risks gratuitously
    undertaken than do patients who deliver themselves into the hand of a clinician for needed care.
    It may be that a standard of “the reasonable volunteer” should be proposed: the extent and nature
    of information should be such that persons, knowing that the procedure is neither necessary for
    their care nor perhaps fully understood, can decide whether they wish to participate in the
    furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects
    should understand clearly the range of risk and the voluntary nature of participation.
    A special problem of consent arises where informing subjects of some pertinent aspect of the
    research is likely to impair the validity of the research. In many cases, it is sufficient to indicate
    to subjects that they are being invited to participate in research of which some features will not
    be revealed until the research is concluded. In all cases of research involving incomplete
    disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly
    necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects
    that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when
    appropriate, and for dissemination of research results to them. Information about risks should
    never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers
    should always be given to direct questions about the research. Care should be taken to
    distinguish cases in which disclosure would destroy or invalidate the research from cases in
    which disclosure would simply inconvenience the investigator.
    Comprehension. The manner and context in which information is conveyed is as important as
    the information itself. For example, presenting information in a disorganized and rapid fashion,
    allowing too little time for consideration or curtailing opportunities for questioning, all may
    adversely affect a subject’s ability to make an informed choice.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Page
    Special provision may need to be made when comprehension is severely limited — for example,
    by conditions of immaturity or mental disability. Each class of subjects that one might consider
    as incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and
    the comatose) should be considered on its own terms. Even for these persons, however, respect
    requires giving them the opportunity to choose to the extent they are able, whether or not to
    participate in research. The objections of these subjects to involvement should be honored,
    unless the research entails providing them a therapy unavailable elsewhere. Respect for persons
    also requires seeking the permission of other parties in order to protect the subjects from harm.
    Such persons are thus respected both by acknowledging their own wishes and by the use of third
    parties to protect them from harm.
    8
    Because the subject’s ability to understand is a function of intelligence, rationality, maturity and
    language, it is necessary to adapt the presentation of the information to the subject’s capacities.
    Investigators are responsible for ascertaining that the subject has comprehended the information.
    While there is always an obligation to ascertain that the information about risk to subjects is
    complete and adequately comprehended, when the risks are more serious, that obligation
    increases. On occasion, it may be suitable to give some oral or written tests of comprehension.
    The third parties chosen should be those who are most likely to understand the incompetent
    subject’s situation and to act in that person’s best interest. The person authorized to act on behalf
    of the subject should be given an opportunity to observe the research as it proceeds in order to be
    able to withdraw the subject from the research, if such action appears in the subject’s best
    interest.
    Voluntariness. An agreement to participate in research constitutes a valid consent only if
    voluntarily given. This element of informed consent requires conditions free of coercion and
    undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one
    person to another in order to obtain compliance. Undue influence, by contrast, occurs through an
    offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order
    to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue
    influences if the subject is especially vulnerable.
    Unjustifiable pressures usually occur when persons in positions of authority or commanding
    influence — especially where possible sanctions are involved — urge a course of action for a
    subject. A continuum of such influencing factors exists, however, and it is impossible to state
    precisely where justifiable persuasion ends and undue influence begins. But undue influence
    would include actions such as manipulating a person’s choice through the controlling influence
    of a close relative and threatening to withdraw health services to which an individual would
    otherwise be entitle.
    2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful
    arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits
    sought in the research. Thus, the assessment presents both an opportunity and a responsibility to
    gather systematic and comprehensive information about proposed research. For the investigator,
    it is a means to examine whether the proposed research is properly designed. For a review
    committee, it is a method for determining whether the risks that will be presented to subjects are
    justified. For prospective subjects, the assessment will assist the determination whether or not to
    participate.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Page
    The term “benefit” is used in the research context to refer to something of positive value related
    to health or welfare. Unlike, “risk,” “benefit” is not a term that expresses probabilities. Risk is
    properly contrasted to probability of benefits, and benefits are properly contrasted with harms
    rather than risks of harm. Accordingly, so-called risk/benefit assessments are concerned with the
    probabilities and magnitudes of possible harm and anticipated benefits. Many kinds of possible
    harms and benefits need to be taken into account. There are, for example, risks of psychological
    harm, physical harm, legal harm, social harm and economic harm and the corresponding
    9
    The Nature and Scope of Risks and Benefits. The requirement that research be justified on the
    basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence,
    just as the moral requirement that informed consent be obtained is derived primarily from the
    principle of respect for persons. The term “risk” refers to a possibility that harm may occur.
    However, when expressions such as “small risk” or “high risk” are used, they usually refer (often
    ambiguously) both to the chance (probability) of experiencing a harm and the severity
    (magnitude) of the envisioned harm.
    benefits. While the most likely types of harms to research subjects are those of psychological or
    physical pain or injury, other possible kinds should not be overlooked.
    Risks and benefits of research may affect the individual subjects, the families of the individual
    subjects, and society at large (or special groups of subjects in society). Previous codes and
    Federal regulations have required that risks to subjects be outweighed by the sum of both the
    anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of
    knowledge to be gained from the research. In balancing these different elements, the risks and
    benefits affecting the immediate research subject will normally carry special weight. On the
    other hand, interests other than those of the subject may on some occasions be sufficient by
    themselves to justify the risks involved in the research, so long as the subjects’ rights have been
    protected. Beneficence thus requires that we protect against risk of harm to subjects and also that
    we be concerned about the loss of the substantial benefits that might be gained from research.
    Page
    Finally, assessment of the justifiability of research should reflect at least the following
    considerations: (i) Brutal or inhumane treatment of human subjects is never morally justified. (ii)
    Risks should be reduced to those necessary to achieve the research objective. It should be
    determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be
    entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (iii)
    When research involves significant risk of serious impairment, review committees should be
    extraordinarily insistent on the justification of the risk (looking usually to the likelihood of
    benefit to the subject — or, in some rare cases, to the manifest voluntariness of the participation).
    (iv) When vulnerable populations are involved in research, the appropriateness of involving them
    should itself be demonstrated. A number of variables go into such judgments, including the
    nature and degree of risk, the condition of the particular population involved, and the nature and
    level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in
    documents and procedures used in the informed consent process.
    10
    The Systematic Assessment of Risks and Benefits. It is commonly said that benefits and risks
    must be “balanced” and shown to be “in a favorable ratio.” The metaphorical character of these
    terms draws attention to the difficulty of making precise judgments. Only on rare occasions will
    quantitative techniques be available for the scrutiny of research protocols. However, the idea of
    systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible.
    This ideal requires those making decisions about the justifiability of research to be thorough in
    the accumulation and assessment of information about all aspects of the research, and to consider
    alternatives systematically. This procedure renders the assessment of research more rigorous and
    precise, while making communication between review board members and investigators less
    subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first
    be a determination of the validity of the presuppositions of the research; then the nature,
    probability and magnitude of risk should be distinguished with as much clarity as possible. The
    method of ascertaining risks should be explicit, especially where there is no alternative to the use
    of such vague categories as small or slight risk. It should also be determined whether an
    investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known
    facts or other available studies.
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the
    requirements for consent, and the principle of beneficence in risk/benefit assessment, the
    principle of justice gives rise to moral requirements that there be fair procedures and outcomes in
    the selection of research subjects.
    Justice is relevant to the selection of subjects of research at two levels: the social and the
    individual. Individual justice in the selection of subjects would require that researchers exhibit
    fairness: thus, they should not offer potentially beneficial research only to some patients who are
    in their favor or select only “undesirable” persons for risky research. Social justice requires that
    distinction be drawn between classes of subjects that ought, and ought not, to participate in any
    particular kind of research, based on the ability of members of that class to bear burdens and on
    the appropriateness of placing further burdens on already burdened persons. Thus, it can be
    considered a matter of social justice that there is an order of preference in the selection of classes
    of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the
    institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only
    on certain conditions.
    Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by
    investigators and treated fairly in the course of research. Thus injustice arises from social, racial,
    sexual and cultural biases institutionalized in society. Thus, even if individual researchers are
    treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are
    selected fairly within a particular institution, unjust social patterns may nevertheless appear in
    the overall distribution of the burdens and benefits of research. Although individual institutions
    or investigators may not be able to resolve a problem that is pervasive in their social setting, they
    can consider distributive justice in selecting research subjects.
    Some populations, especially institutionalized ones, are already burdened in many ways by their
    infirmities and environments. When research is proposed that involves risks and does not include
    a therapeutic component, other less burdened classes of persons should be called upon first to
    accept these risks of research, except where the research is directly related to the specific
    conditions of the class involved. Also, even though public funds for research may often flow in
    the same directions as public funds for health care, it seems unfair that populations dependent on
    public health care constitute a pool of preferred research subjects if more advantaged populations
    are likely to be the recipients of the benefits.
    (1) Since 1945, various codes for the proper and responsible conduct of human experimentation
    in medical research have been adopted by different organizations. The best known of these codes
    http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
    Page
    11
    One special instance of injustice results from the involvement of vulnerable subjects. Certain
    groups, such as racial minorities, the economically disadvantaged, the very sick, and the
    institutionalized may continually be sought as research subjects, owing to their ready availability
    in settings where research is conducted. Given their dependent status and their frequently
    compromised capacity for free consent, they should be protected against the danger of being
    involved in research solely for administrative convenience, or because they are easy to
    manipulate as a result of their illness or socioeconomic condition.
    are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the
    1971 Guidelines (codified into Federal Regulations in 1974) issued by the U.S. Department of
    Health, Education, and Welfare Codes for the conduct of social and behavioral research have
    also been adopted, the best known being that of the American Psychological Association,
    published in 1973.
    (2) Although practice usually involves interventions designed solely to enhance the well-being
    of a particular individual, interventions are sometimes applied to one individual for the
    enhancement of the well-being of another (e.g., blood donation, skin grafts, organ transplants) or
    an intervention may have the dual purpose of enhancing the well-being of a particular individual,
    and, at the same time, providing some benefit to others (e.g., vaccination, which protects both the
    person who is vaccinated and society generally). The fact that some forms of practice have
    elements other than immediate benefit to the individual receiving an intervention, however,
    should not confuse the general distinction between research and practice. Even when a procedur…

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