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The New Crisis in Human Subject Protection: Is Accreditation the Answer


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Title: The New Crisis in Human Subject Protection: Is Accreditation the Answer

The New Crisis in Human Subject Protection Is
Accreditation the Answer?
  • Steven Smith
  • California Western School of Law
  • April 15, 2005

  • The use of human subjects in medical and social
    science research is critical to the advancement
    of medicine.
  • Continued support for this research is, however,
    threatened by the disclosure of research
  • The medical and higher education communities
    should take steps to maintain confidence in human
    studies, and to some extent are doing so.

The extent of the use of humans in research is
not known, but it is estimated that in the U.S.
  • More than 20 million people participate in human
    studies annually.
  • More than 60 billion is spent on biomedical
    research annually.
  • Perhaps 60,000 researchers conduct clinical
    trials in the U.S.
  • The number of clinical trials in the US may
    exceed 100,000 annually.
  • There are 3 to 5,000 IRBs
  • (I have no faith in most
    of these data)

Public Confidence
  • 83 of adults believe it is essential or very
    important to test new drugs or treatments on
    humans in clinical trials before they are
    approved for general use
  • Only 24 are very confident that patients in
    clinical trials are treated as patients and not
    guinea pigs
  • 25 are very confident they are told honestly of
    the risks
  • Only 20 are very confident that doctors and
    hospitals do not recruit them so they can make
    more money
  • Minority respondents were generally less
    confident in the legitimacy and safety of
    participating in human studies
  • From Harris Interactive Survey, 2002

Human experimentation has existed throughout
human history
  • God created man

So God caused a deep sleep to fall upon the man
and while he slept took one of his ribs and
closed up its lace with flesh and the rib he
made into a woman.
Traditional Control of Medical Experiments on
  • Tort Liability
  • Criminal Liability
  • License Discipline

Human Subject Protection Crisis I
"Permissible Medical Experiments." Trials of War
Criminals before the Nuremberg Military Tribunals
under Control Council Law No. 10. Nuremberg
October 1946 - April 1949, Washington. U.S.
Government Printing Office, vol. 2., pp. 181-182.
  • 1. The voluntary consent of the human subject is
    absolutely essential. This means that the person
    involved should have legal capacity to give
    consent should be situated as to be able to
    exercise free power of choice, without the
    intervention of any element of force, fraud,
    deceit, duress, over-reaching, or other ulterior
    form of constraint or coercion, and should have
    sufficient knowledge and comprehension of the
    elements of the subject matter involved as to
    enable him to make an understanding and
    enlightened decision. This latter element
    requires that before the acceptance of an
    affirmative decision by the experimental subject
    there should be made known to him the nature,
    duration, and purpose of the experiment the
    method and means by which it is to be conducted
    all inconveniences and hazards reasonably to be
    expected and the effects upon his health or
    person which may possibly come from his
    participation in the experiment.
  • The duty and responsibility for ascertaining the
    quality of the consent rests upon each individual
    who initiates, directs or engages in the
    experiment. It is a personal duty and
    responsibility which may not be delegated to
    another with impunity.

  • 2. The experiment should be such as to yield
    fruitful results for the good of society,
    unprocurable by other methods or means of study,
    and not random and unnecessary in nature.
  • 3. The experiment should be so designed and based
    on the results of animal experimentation and a
    knowledge of the natural history of the disease
    or other problem under study that the anticipated
    results will justify the performance of the
  • 4. The experiment should be so conducted as to
    avoid all unnecessary physical and mental
    suffering and injury.
  • 5. No experiment should be conducted where there
    is an a priori reason to believe that death or
    disabling injury will occur except, perhaps, in
    those experiments where the experimental
    physicians also serve as subjects.
  • 6. The degree of risk to be taken should never
    exceed that determined by the humanitarian
    importance of the problem to be solved by the

  • 7. Proper preparations should be made and
    adequate facilities provided to protect the
    experimental subject against even remote
    possibilities of injury disability or death.
  • 8. The experiment should be conducted only by
    scientifically qualified persons. The highest
    degree of skill and care should be required
    through all stages of the experiment of those who
    conduct or engage in the experiment.
  • 9. During the course of the experiment the human
    subject should be at liberty to bring the
    experiment to an end if he has reached the
    physical or mental state where continuation of
    the experiment seems to him to be impossible.
  • 10. During the course of the experiment the
    scientist in charge must be
  • prepared to terminate the experiment at any
    stage, if he has probable cause to believe, in
    the exercise of the good faith, superior skill
    and careful judgment required by him that a
    continuation of the experiment is likely to
    result in injury, disability, or death to the
    experimental subject.

  •   Ethical Principles for Medical Research
  • Involving Human Subjects
  • Adopted by the 18th WMA General Assembly,
    Helsinki, Finland, June 1964, and amended by
    the 29th WMA General Assembly, Tokyo, Japan,
    October 1975 35th WMA General Assembly, Venice,
    Italy, October 1983 41st WMA General Assembly,
    Hong Kong, September 1989 48th WMA General
    Assembly, Somerset West, Republic of South
    Africa, October 1996 and the 52nd WMA General
    Assembly, Edinburgh, Scotland, October 2000 Note
    of Clarification on Paragraph 29 added by the WMA
    General Assembly, Washington 2002 Note of
    Clarification on Paragraph 30 added by the WMA
    General Assembly, Tokyo 2004

  • The World Medical Association has developed the
    Declaration of Helsinki as a statement of ethical
    principles to provide guidance to physicians and
    other participants in medical research involving
    human subjects. Medical research involving human
    subjects includes research on identifiable human
    material or identifiable data.
  • It is the duty of the physician to promote and
    safeguard the health of the people. The
    physician's knowledge and conscience are
    dedicated to the fulfillment of this duty.
  • The Declaration of Geneva of the World Medical
    Association binds the physician with the words,
    "The health of my patient will be my first
    consideration," and the International Code of
    Medical Ethics declares that, "A physician shall
    act only in the patient's interest when providing
    medical care which might have the effect of
    weakening the physical and mental condition of
    the patient."
  • Medical progress is based on research which
    ultimately must rest in part on experimentation
    involving human subjects.
  • In medical research on human subjects,
    considerations related to the well-being of the
    human subject should take precedence over the
    interests of science and society.
  • The primary purpose of medical research involving
    human subjects is to improve prophylactic,
    diagnostic and therapeutic procedures and the
    understanding of the aetiology and pathogenesis
    of disease. Even the best proven prophylactic,
    diagnostic, and therapeutic methods must
    continuously be challenged through research for
    their effectiveness, efficiency, accessibility
    and quality.
  • In current medical practice and in medical
    research, most prophylactic, diagnostic and
    therapeutic procedures involve risks and burdens.
  • Medical research is subject to ethical standards
    that promote respect for all human beings and
    protect their health and rights. Some research
    populations are vulnerable and need special
    protection. The particular needs of the
    economically and medically disadvantaged must be
    recognized. Special attention is also required
    for those who cannot give or refuse consent for
    themselves, for those who may be subject to
    giving consent under duress, for those who will
    not benefit personally from the research and for
    those for whom the research is combined with
  • Research Investigators should be aware of the
    ethical, legal and regulatory requirements for
    research on human subjects in their own countries
    as well as applicable international requirements.
    No national ethical, legal or regulatory
    requirement should be allowed to reduce or
    eliminate any of the protections for human
    subjects set forth in this Declaration.

  • It is the duty of the physician in medical
    research to protect the life, health, privacy,
    and dignity of the human subject.
  • Medical research involving human subjects must
    conform to generally accepted scientific
    principles, be based on a thorough knowledge of
    the scientific literature, other relevant sources
    of information, and on adequate laboratory and,
    where appropriate, animal experimentation.
  • Appropriate caution must be exercised in the
    conduct of research which may affect the
    environment, and the welfare of animals used for
    research must be respected.
  • The design and performance of each experimental
    procedure involving human subjects should be
    clearly formulated in an experimental protocol.
    This protocol should be submitted for
    consideration, comment, guidance, and where
    appropriate, approval to a specially appointed
    ethical review committee, which must be
    independent of the investigator, the sponsor or
    any other kind of undue influence. This
    independent committee should be in conformity
    with the laws and regulations of the country in
    which the research experiment is performed. The
    committee has the right to monitor ongoing
    trials. The researcher has the obligation to
    provide monitoring information to the committee,
    especially any serious adverse events. The
    researcher should also submit to the committee,
    for review, information regarding funding,
    sponsors, institutional affiliations, other
    potential conflicts of interest and incentives
    for subjects.
  • The research protocol should always contain a
    statement of the ethical considerations involved
    and should indicate that there is compliance with
    the principles enunciated in this Declaration.
  • Medical research involving human subjects should
    be conducted only by scientifically qualified
    persons and under the supervision of a clinically
    competent medical person. The responsibility for
    the human subject must always rest with a
    medically qualified person and never rest on the
    subject of the research, even though the subject
    has given consent.
  • Every medical research project involving human
    subjects should be preceded by careful assessment
    of predictable risks and burdens in comparison
    with foreseeable benefits to the subject or to
    others. This does not preclude the participation
    of healthy volunteers in medical research. The
    design of all studies should be publicly
  • Physicians should abstain from engaging in
    research projects involving human subjects unless
    they are confident that the risks involved have
    been adequately assessed and can be
    satisfactorily managed. Physicians should cease
    any investigation if the risks are found to
    outweigh the potential benefits or if there is
    conclusive proof of positive and beneficial

  • Medical research involving human subjects should
    only be conducted if the importance of the
    objective outweighs the inherent risks and
    burdens to the subject. This is especially
    important when the human subjects are healthy
  • Medical research is only justified if there is a
    reasonable likelihood that the populations in
    which the research is carried out stand to
    benefit from the results of the research.
  • The subjects must be volunteers and informed
    participants in the research project.
  • The right of research subjects to safeguard their
    integrity must always be respected. Every
    precaution should be taken to respect the privacy
    of the subject, the confidentiality of the
    patient's information and to minimize the impact
    of the study on the subject's physical and mental
    integrity and on the personality of the
  • In any research on human beings, each potential
    subject must be adequately informed of the aims,
    methods, sources of funding, any possible
    conflicts of interest, institutional affiliations
    of the researcher, the anticipated benefits and
    potential risks of the study and the discomfort
    it may entail. The subject should be informed of
    the right to abstain from participation in the
    study or to withdraw consent to participate at
    any time without reprisal. After ensuring that
    the subject has understood the information, the
    physician should then obtain the subject's
    freely-given informed consent, preferably in
    writing. If the consent cannot be obtained in
    writing, the non-written consent must be formally
    documented and witnessed.
  • When obtaining informed consent for the research
    project the physician should be particularly
    cautious if the subject is in a dependent
    relationship with the physician or may consent
    under duress. In that case the informed consent
    should be obtained by a well-informed physician
    who is not engaged in the investigation and who
    is completely independent of this relationship.
  • For a research subject who is legally
    incompetent, physically or mentally incapable of
    giving consent or is a legally incompetent minor,
    the investigator must obtain informed consent
    from the legally authorized representative in
    accordance with applicable law. These groups
    should not be included in research unless the
    research is necessary to promote the health of
    the population represented and this research
    cannot instead be performed on legally competent
  • When a subject deemed legally incompetent, such
    as a minor child, is able to give assent to
    decisions about participation in research, the
    investigator must obtain that assent in addition
    to the consent of the legally authorized
  • Research on individuals from whom it is not
    possible to obtain consent, including proxy or
    advance consent, should be done only if the
    physical/mental condition that prevents obtaining
    informed consent is a necessary characteristic of
    the research population. The specific reasons for
    involving research subjects with a condition that
    renders them unable to give informed consent
    should be stated in the experimental protocol for
    consideration and approval of the review
    committee. The protocol should state that consent
    to remain in the research should be obtained as
    soon as possible from the individual or a legally
    authorized surrogate.
  • Both authors and publishers have ethical
    obligations. In publication of the results of
    research, the investigators are obliged to
    preserve the accuracy of the results. Negative as
    well as positive results should be published or
    otherwise publicly available. Sources of funding,
    institutional affiliations and any possible
    conflicts of interest should be declared in the
    publication. Reports of experimentation not in
    accordance with the principles laid down in this
    Declaration should not be accepted for

  • The physician may combine medical research with
    medical care, only to the extent that the
    research is justified by its potential
    prophylactic, diagnostic or therapeutic value.
    When medical research is combined with medical
    care, additional standards apply to protect the
    patients who are research subjects.
  • The benefits, risks, burdens and effectiveness of
    a new method should be tested against those of
    the best current prophylactic, diagnostic, and
    therapeutic methods. This does not exclude the
    use of placebo, or no treatment, in studies where
    no proven prophylactic, diagnostic or therapeutic
    method exists.
  • At the conclusion of the study, every patient
    entered into the study should be assured of
    access to the best proven prophylactic,
    diagnostic and therapeutic methods identified by
    the study.
  • The physician should fully inform the patient
    which aspects of the care are related to the
    research. The refusal of a patient to participate
    in a study must never interfere with the
    patient-physician relationship.
  • In the treatment of a patient, where proven
    prophylactic, diagnostic and therapeutic methods
    do not exist or have been ineffective, the
    physician, with informed consent from the
    patient, must be free to use unproven or new
    prophylactic, diagnostic and therapeutic
    measures, if in the physician's judgement it
    offers hope of saving life, re-establishing
    health or alleviating suffering. Where possible,
    these measures should be made the object of
    research, designed to evaluate their safety and
    efficacy. In all cases, new information should be
    recorded and, where appropriate, published. The
    other relevant guidelines of this Declaration
    should be followed

Crisis II Events
  • 1962-- Fetal abnormalities from Thalidomide
  • 1964-- Brooklyn Jewish Chronic Disease Hospital
  • 1966-- Beecher article in NEJM
  • 1971-- Willowbrook School for the Mentally
    Retarded Experiments
  • 1972-- Tuskegee Syphilis Study

Legal Response
  • National Research Act 1972
  • Belmont Report
  • HEW/FDA regulations establishing IRBs

Department of Health, Education, and Welfare
Office of the Secretary PROTECTION OF HUMAN
OF RESEARCH Report of the National Commission 
for the Protection of Human Subjects of
Biomedical and Behavioral Research
  • Table of Contents    
  • Summary
  • Members of the Commission
  • The Belmont Report An Introduction
  • Boundaries Between Practice and Research
  • Basic Ethical Principles
  • Respect for Persons
  • Beneficence
  • Justice
  • Applications
  • Informed Consent
  • Assessment of Risk and Benefits
  • Selection of Subjects      

The Age of the IRB
  • Decentralized decision-making
  • Community-based decisions reflecting the values
    of the community
  • Subject of Federal Guidelines, but little federal
  • The Common Rule
  • The FDA and HHS

Roles of the IRB
  • In reviewing proposed research involving human
    subjects, generally the IRB is to determine
  • (1) that risks to subjects are minimized through
    the use of a sound research design
  • (2) that risks are reasonable in relation to
    anticipated benefits
  • (3) that the selection of subjects is equitable
  • (4) that appropriate informed consent will be
    sought from each subject
  • (5) that the informed consent will be
    appropriately documented
  • (6) that if appropriate, the research plan will
    provide for monitoring of data and
  • (7) that if needed there are adequate provisions
    to protect subjects' privacy and maintain
    confidentiality of data.

A Third Crisis Develops
  • 1996--General Accounting Office - heavy
    workloads, lack of preparedness of IRB, limited
  • 1998--Office of Inspector General, DHHS - IRBs
    overwhelmed issued a warning signal
  • 1999--Jesse Gelsinger died in U. Pa. in gene
    therapy study
  • 2000--Suit filed in U. of Oklahoma melanoma
    vaccine study
  • 2001--Ellen Roche, a healthy volunteer, died in
    an asthma study at Hopkins

Potential Legal Controls
  • Civil Liability
  • Criminal Liability
  • License Discipline
  • Direct Regulation
  • Indirect Regulation (e.g., FDA)
  • Federal Funding

Suspensions of Federally Supported Research
  • March 1999 Greater Los Angeles Health Care
    System, West Los Angeles
  • May 1999 Duke University Medical Center
  • August 1999 University of Illinois, Chicago
  • January 2000 Virginia Commonwealth
  • June 2000 University of Oklahoma Health
    Sciences Center
  • July 2001 Johns Hopkins Medical

FDA warning letters to IRBs
52 Warning Letters were issued to IRBs from Jan
1997 to July 2004
Ref Bramstedt, A and Kassimatis, K. Clin
Invest Med 276 (Dec 2004) 316-323
  • Gelsinger v. Trustees of the Univ. of
  • Robertson v. McGee
  • Wright v. Hutchinson
  • Berman v. Hutchinson
  • Grimes v. Kennedy Krieger Inst.
  • Heinrich v. Sweet
  • Sexton v. United States
  • Whitlock v. Duke Univ.
  • Doe v. Ill. Masonic Med. Ctr.

Problems with the Current Approach to Subject
  • There are inherent problems with institutional
    reviews (inconsistency, pressure from local
  • Some research is not subject to any review (not
    subject to federal law or avoided illegally)
  • There is very little federal oversight of the
    operation of IRBs
  • There is no continuing, organized national system
    to address recurring issues and problems
  • There is an inadequate and excessively technical
    focus on informed consent

Problems with IRBs
  • Inadequate IRB resources and staffing
  • Inadequate training of IRB members and staffs
  • Inadequate review of implementation of IRB limits
    on approved studies
  • Inadequate continuing review
  • Inadequate reporting of adverse events
  • Increase in numbers and complexity of studies is
    outpacing IRBs ability to keep up

Problems Caused By Changing Conditions
  • Internationalization of research
  • Multicenter studies are poorly handled
  • Commercialization of research and conflicts of
    financial interest complicate matters
  • Inadequate mechanisms of compensating those
    injured in studies
  • Declining public confidence

Problems With Error Reduction
  • IRBs receive very little feedback of any kind
  • There is little systematic IRB collection of
    error data on which improvements could be based
  • There is no national recordkeeping of approved
    studies and the experience of IRBs
  • There is limited education of researchers and
    limited commitment to the highest ethical
    principles in research

Accreditation as a Partial Solution
  • The goal of accreditation is said to be to
    protect the rights and welfare of research
    participants by fostering and advancing the
    ethical and professional conduct of persons and
    organizations that engage in research with human
  • In fact, it may be to provide sufficient
    self-regulation to avoid more difficult outside

Association for the Accreditation of Human
Subject Protection Programs
  • Founding Members
  • Association of American Medical Colleges
  • Association of American Universities
  • Consortium of Social Science Associations
  • Federation of American Societies for Experimental
  • National Association of State Universities and
    Land-Grant Colleges
  • National Health Council
  • Public Responsibility in Medicine and Research

Accredited Organizations
  • Baylor College of Medicine
  • Baylor Research Institute
  • Catholic Medical Center
  • Cedars-Sinai Medical Center
  • Chesapeake Research Review, Inc.
  • Childrens Hospital Boston
  • Copernicus Group IRB
  • Dana Farber/Harvard Cancer Center
  • East Tennessee State University
  • Fox Chase Cancer Center
  • Hunter Holmes McGuire VAMC
  • Indiana University Purdue University,
    Indianapolis (IUPUI)
  • Iowa Health Des Moines
  • Johns Hopkins Medical Institutions
  • Massachusetts General Hospital and Brigham
    Womens Hospital as part of Partners Healthcare
  • Michigan State University

Accredited Institutions (2)
  • New England Institutional Review Board
  • Newton-Wellesley Hospital
  • Saint Francis Hospital and Medical Center
  • The University of Arizona
  • The University of Iowa
  • The University of New Mexico Health Sciences
  • The University of South Dakota
  • University of Arkansas for Medical Sciences
  • University of California, Irvine
  • University of California, San Francisco
  • University of Louisville
  • University of Maryland, Baltimore
  • University of Minnesota
  • University of Pittsburgh
  • Vanderbilt University
  • Washington University in St. Louis
  • Western Institutional Review Board

Accreditation standards
  • Human Research Protection Program
  • Domain 1 Organization
  • Domain 2 Research Review Unit (IRB)
  • Domain 3 Investigator
  • Domain 4 Sponsored Research
  • Domain 5 Participant Outreach

Benefits of accreditation For organizations
  • Improves overall quality of research program
    through better and more effective processes that
    are appropriate to volume and nature of research
    conducted by the organization
  • Promotes culture of responsible conduct of
  • Improves protections for research subjects
  • Ensures compliance with regulations
  • Better enrollment in clinical trials

Is There Salvation in Accreditation?
Where Do We Go From Here?
The Domains Organization
  • Organization The "Organization" is the entity
    that assumes responsibility for the Human
    Research Protection Program and applies for
    accreditation. The entity may be an academic
    institution, clinic, hospital, managed care
    organization, contract research organization, or
    a corporate entity, such as a pharmaceutical or
    biotechnology company, or an independent review
    board. Despite great dissimilarities in how such
    entities are structured, the Organization domain
    identifies those elements that must be evident,
    albeit in various different forms, in an entity
    that seeks accreditation for its Human Research
    Protection Program.

The Domains Research Unit
  • Research Review Unit The domain of Research
    Review Unit refers to the arrangements that the
    Organization has made for an independent review
    of ethical and scientific aspects of each
    research protocol involving human participants.
    Such activities are generally carried out by an
    institutional review board (IRB). Organizations
    with multiple IRBs might have a general oversight
    office or an individual with oversight
    responsibility. In these complex structures the
    functions and activities are split between the
    oversight office or individual with such
    responsibility and the IRBs. In recognition of
    these complex structures, the term Research
    Review Unit is used to describe the domain
    rather than IRB. The review and other activities
    of the IRB are concerned with protecting the
    rights and welfare of the participants. In the
    review process, IRBs must ensure that the
    scientific validity of a research protocol is
    considered as well as the risks and potential
    benefits to participants and benefits that might
    accrue to society. In addition, IRBs are
    responsible for reviewing research on an ongoing
    basis, monitoring reports of new information
    affecting risks and potential benefits, and
    assuring that the interests of research
    participants are protected.

Domains Investigator
  • Investigator The "Investigator" domain includes
    the various arrangements that the Organization
    has made for assuring that individuals who plan
    to conduct research whether as a principal
    investigator, co-investigator, or other member of
    a research team understand and fulfill their
    responsibilities. Fundamentally, these
    responsibilities stem from the fact that an
    individual conducting research enters into
    arrangements that may intentionally expose human
    participants to some degree of risk whether
    physical, psychological, economic, legal, or
    social for scientific purposes.

The Domains Sponsored Research
  • Sponsored Research The "Sponsored Research"
    domain includes the Organizations arrangements
    for structuring its relationships with those who
    fund or initiate research external to the
    Organization, such as federal agencies,
    foundations, individual donors, and corporations
    (e.g., pharmaceutical or biotechnology
    companies) usually referred to as sponsored
    research. The Organization seeking accreditation
    must apply its Human Research Protection Program
    to all sponsored research and address any special
    issues that might arise. These issues include,
    but are not limited to, the ethical conduct of
    research, dissemination of knowledge gained from
    research, and availability of health care to
    injured research participants.

The Domains Participant Outreach
  • Participant Outreach The "Participant Outreach"
    domain refers to the arrangements the
    Organization has made for understanding the
    social, psychological, and physical needs and
    concerns of research participants and their
    communities. Organizations and investigators who
    provide education to participants relevant to
    their participation in the research process
    should provide them with tools and resources to
    assume an active, responsible role in research.
    Participants might provide important feedback to
    investigators about their experience during the
    informed consent process and during the research
    itself, which can be helpful in design of future

Accreditation standards Research Review Unit,
including IRBs
  • Accreditation standards Research Review Unit,
    including IRBsThe following are AAHRPP
    accreditation standards related to the research
    review unit / IRB...STANDARD II-1 The structure
    and composition of the Research Review Unit are
    appropriate to the amount and nature of the
    research reviewed. ELEMENTSII.1.A. The Research
    Review Unit has and follows written policies and
    procedures requiring protocols to be reviewed by
    individuals with appropriate scientific or
    scholarly expertise. II.1.B. The IRB has a
    process for obtaining additional expertise when
    reviewing a specific protocol. II.1.C. The
    Research Review Unit has and follows written
    policies and procedures so that IRB members and
    consultants do not participate in the review of
    protocols in which they have a conflict of
    interest, except to provide information requested
    by the IRB. II.1.D. The IRB has a qualified IRB
    chair, members, and staff, whose membership and
    composition are periodically reviewed. The IRB
    administrator, staff, chair, and members have
    knowledge, skills, and abilities appropriate to
    their respective roles. II.1.E. The IRB
    membership roster includes sufficient information
    about members to permit appropriate
    representation at the meeting for each protocol
    under review. One or more unaffiliated members
    are represented on the IRB and one or more
    members can represent the general perspective of
    participants. II.1.F. The IRB meets regularly and
    members have sufficient time to review materials
    prior to meeting.

  • STANDARD II-2 The Research Review Unit
    systematically evaluates each research study to
    ensure the protection of participants.
  • II.2.A. The Research Review Unit has and follows
    written policies and procedures for conducting
    initial and continuing review, and procedures for
    handling modifications to research studies.
  • II.2.B. The Research Review Unit has and follows
    written policies and procedures to conduct
    reviews by the expedited procedure.
  • II.2.C. The Research Review Unit receives and
    reviews the relevant information to evaluate
    research studies during initial review.
  • II.2.D. The Research Review Unit receives and
    considers relevant information to conduct
    continuing reviews of research studies and, when
    appropriate, requests changes.
  • II.2.E. The Research Review Unit receives and
    considers the relevant information to evaluate
    proposed amendments to research studies.
  • STANDARD II-3 The Research Review Unit
    maintains documentation of its activities.
  • II.3.A. The Research Review Unit maintains a
    complete set of materials relevant to review of
    the research study in each protocol file.
  • II.3.B. The Research Review Unit retains required
    records for a period of time sufficient to meet
    federal, state, and local regulations, sponsor
    requirements, and organizational policies and
  • II.3.C. The IRB documents pertinent discussions
    and decisions on research studies and activities.

  • .
  • STANDARD II-4 The Research Review Unit
    systematically evaluates risks to participants
    and potential benefits as part of the initial
    review and ongoing review of research.
  • II.4.A. The Research Review Unit has and follows
    written policies and procedures for identifying
    and analyzing potential sources of risk and
    measures to minimize risk, including physical,
    psychological, social, legal, or economic risks.
    The analysis of risk includes a determination
    that the risks to participants are reasonable in
    relation to potential benefits to participants
    and to society.
  • II.4.B. The Research Review Unit reviews the plan
    for data and safety monitoring in research
    protocols, when applicable, and determines that
    the plan provides adequate protection for
  • II.4.C. The Research Review Unit has and follows
    written policies and procedures for determining
    the risks to vulnerable populations as defined in
    applicable federal regulations, and specifically
    for determining the required risk categories in
    protocols involving children and prisoners.
  • II.4.D. The Research Review Unit has and follows
    written policies and procedures for suspending or
    terminating previously approved research if
    warranted by findings in the continuing review or
    monitoring process.
  • STANDARD II-5 The Research Review Unit
    systematically evaluates recruitment and
    participant selection practices.
  • II.5.A. The Research Review Unit has and follows
    written policies and procedures to evaluate the
    equitable selection of participants from various
    populations and sub-populations, when applicable,
    and considers whether inclusion and exclusion
    criteria impose fair and equitable burdens and
  • II.5.B. The Research Review Unit reviews proposed
    participant recruitment methods, advertising
    materials, and participation payment
    arrangements, and permits them when fair, honest,
    and appropriate.

  • STANDARD II-6 The Research Review Unit
    systematically evaluates the protection of
    privacy interests of research participants and
    the confidentiality of data in proposed research.
  • II.6.A. The Research Review Unit has written
    policies and procedures to evaluate the proposed
    arrangements for protecting the privacy interests
    of research participants during and after their
    involvement in the research.
  • II.6.B. The Research Review Unit has written
    policies and procedures to evaluate proposed
    arrangements for protecting the confidentiality
    of identifiable data, when appropriate, during
    and after the conclusion of the investigation.
  • STANDARD II-7 The Research Review Unit has and
    follows written policies and procedures that
    require informed consent to be solicited from
    participants or their legally authorized
    representatives, and it verifies that this
    requirement is met.
  • II.7.A. The Research Review Unit evaluates
    compliance with policies and procedures on
    seeking informed consent from participants or
    their legally authorized representatives, and
    assent, when possible, from participants who
    cannot give consent.
  • II.7.B. The Research Review Unit has and follows
    written policies and procedures requiring that
    prospective participants whose decision-making
    capacity is in question be appropriately
  • II.7.C. The Research Review Unit reviews the
    content of the consent process, including the
    consent document, and the process through which
    informed consent is obtained from each
    participant, focusing on measures to improve
    participant understanding and voluntary
  • II.7.D. The Research Review Unit has and follows
    written policies and procedures requiring that
    the investigator has and follows a procedure for
    properly documenting informed consent.
  • II.7.E. The Research Review Unit has and follows
    written policies and procedures for approving
    waiver or alteration of the consent process and
    the waiver of consent documentation.
  • II.7.F. The Research Review Unit has and follows
    written policies and procedures for making
    exceptions to informed consent requirements in
    protocols for emergency situations, and
    appropriately reviews such protocols.
  • II.7.G. The Research Review Unit has procedures
    for observation of the informed consent process
    in ongoing research, when appropriate.

  • STANDARD II-8 The Research Review Unit has
    procedures for review and oversight of research
    conducted at multiple sites.
  • II.8.A. The Research Review Unit has and follows
    policies and procedures for communication among
    IRBs, when appropriate, for research conducted at
    multiple sites (e.g., multi-site clinical trials,
    epidemiology studies, or educational surveys).
  • II.8.B. The Research Review Unit has and follows
    policies and procedures for management of
    information obtained in multi-site research that
    may be relevant to the protection of research
    participants, such as reporting of unexpected
    problems or interim results.

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