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:
Assignment A
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 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:
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
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Vulnerable Populations …………………………………………………………………………………………………………. 20
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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.
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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.
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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.
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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
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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
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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.
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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.
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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.
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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.
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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
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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
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Federal statute(s) require(s) without exception that the confidentiality of the
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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
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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
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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
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•
•
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.
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5
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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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•
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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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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
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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
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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
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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
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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
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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…