Human Subject Protections in Experimentationby Thomas A. Gionis, MD JD MBA MHA FICS FRCS United...

Human Subject Protections in Experimentationbyby

Thomas A. Gionis, MD JD MBA MHA FICS FRCSThomas A. Gionis, MD JD MBA MHA FICS FRCS

United States Fulbright Scholar in LawUnited States Fulbright Scholar in Law

United States Fulbright Senior Specialist ProgramUnited States Fulbright Senior Specialist Program

Chairman, American Board of Healthcare Law and MedicineChairman, American Board of Healthcare Law and Medicine

Adjunct Professor of Law, St. Thomas University School of Adjunct Professor of Law, St. Thomas University School of

LawLaw

Human Subject Protections in Experimentation

WORLD MEDICAL ASSOCIATION (WMA)

DECLARATION OF HELSINKI

Ethical Principlesfor

Medical Research Involving Human Subjects


WORLD MEDICAL ASSOCIATION (WMA) DECLARATION OF HELSINKI

Ethical PrinciplesforMedical Research Involving Human Subjects

First Adopted; 18th WMA General Assembly, Helsinki, Finland, June 1964As Amended by:

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, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 Clarification; p. 29; added by WMA General Assembly, Washington 2002



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."



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



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.



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.



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.

The design of all studies should be publicly available.



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.

Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject.



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.



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.



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 persons.



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.


DECLARATION OF HELSINKI (p. 29)

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.

(See footnote*)



*FOOTNOTE:

Note of Clarification on Paragraph 29 of the WMA Declaration of Helsinki:

The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo controlled trial and that in general this methodology should only be used in the absence of existing proven therapy.

However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances:



*FOOTNOTE:

Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or

Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.

All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.



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.



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 judgment it offers hope of saving life, reestablishing 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.


Council for International Organizations of Medical Sciences

(WHO) (CIOMS)

International Ethical Guidelines for Biomedical Research

Involving Human Subjects


(CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects

Guideline 1: Ethical justification and scientific validity of biomedical research involving human

beings

Research can be ethically justifiable only if it is carried out in ways that respect and protect, and are fair to, the subjects of that research and are morally acceptable within the communities in which the research is carried out.



Guideline 2: Ethical review committees

All proposals to conduct research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees.



Guideline 2: Ethical review committees

The review committees must be independent of the research team, and any direct financial or other material benefit they may derive from the research should not be contingent on the outcome of their review.

The ethical review committee should conduct further reviews as necessary in the course of the research, including monitoring of the progress of the study.



Guideline 3: Ethical review of externally sponsored research

An external sponsoring organization and individual investigators should submit the research protocol for ethical and scientific review in the country of the sponsoring organization, and the ethical standards applied should be no less stringent than they would be for research carried out in that country.

The health authorities of the host country, as well as a national or local ethical review committee, should ensure that the proposed research is responsive to the health needs and priorities of the host country.



Guideline 4: Individual informed consent Guideline 7: Inducement to participate Guideline 8: Benefits and risks of study participation Guideline 9Guideline 9: : Special limitations on risk when research involves Special limitations on risk when research involves

individuals who are not capable of giving individuals who are not capable of giving informed informed consentconsent

Guideline 12Guideline 12: : Equitable distribution of burdens and benefits in Equitable distribution of burdens and benefits in the selection of groups of subjects in the selection of groups of subjects in

researchresearch Guideline 19Guideline 19: : Right of injured subjects to treatment and Right of injured subjects to treatment and

compensationcompensation



Guideline 13Guideline 13: : Research involving vulnerable personsResearch involving vulnerable persons

Special justificationSpecial justification is required for inviting is required for inviting vulnerablevulnerable individuals to serve as research subjects and, if individuals to serve as research subjects and, if

they are they are selected, the means of protecting their rights selected, the means of protecting their rights and and welfare must be strictly applied.welfare must be strictly applied.

Guideline 14Guideline 14:: Research involving childrenResearch involving children

the purpose of the research is to obtain knowledge the purpose of the research is to obtain knowledge relevant to the health needs of childrenrelevant to the health needs of children; ;



Guideline 15Guideline 15: : Research involving individuals who by reason Research involving individuals who by reason of of mental or behavioural disorders are not capable mental or behavioural disorders are not capable of of giving adequately informed consentgiving adequately informed consent

the investigator must ensure that:the investigator must ensure that:

such persons will not be subjects of research such persons will not be subjects of research that might equally that might equally well be carried outwell be carried out on persons whose capacity to give adequately on persons whose capacity to give adequately informed consent is not impaired;informed consent is not impaired;

the purpose of the research is to obtain knowledge relevant to the the purpose of the research is to obtain knowledge relevant to the particular health needsparticular health needs of persons with mental or behavioural of persons with mental or behavioural disorders;disorders;



Guideline 11Guideline 11: : Choice of control in clinical trialsChoice of control in clinical trials

As a general rule, research subjects in the As a general rule, research subjects in the control groupcontrol group of a trial of a trial of a diagnostic, therapeutic, or preventive intervention of a diagnostic, therapeutic, or preventive intervention should should receive an established effective interventionreceive an established effective intervention. In some . In some circumstances it may be ethically acceptable to use an alternative circumstances it may be ethically acceptable to use an alternative comparator, such as placebo or "no treatment".comparator, such as placebo or "no treatment".



Guideline 11Guideline 11: : Choice of control in clinical trialsChoice of control in clinical trials

Placebo may be used:Placebo may be used: when there is when there is no establishedno established effective intervention; effective intervention; when when withholdingwithholding an established effective intervention would an established effective intervention would

expose subjects to, at most, temporary discomfort or delay in expose subjects to, at most, temporary discomfort or delay in relief of symptoms;relief of symptoms;



Guideline 10Guideline 10:: Research in populations and communities with Research in populations and communities with limited resourceslimited resources

Before undertaking research in a population or community with Before undertaking research in a population or community with limited resourceslimited resources, the sponsor and the investigator must make , the sponsor and the investigator must make every effort to ensure that:every effort to ensure that:

the the researchresearch is is responsiveresponsive to the to the health needshealth needs and the priorities of and the priorities of the the population or communitypopulation or community in which it is to be carried out; and in which it is to be carried out; and

any intervention orany intervention or product developed, or knowledge generated, product developed, or knowledge generated, will be made will be made reasonably available for the benefit of that populationreasonably available for the benefit of that population or community. or community.



Guideline 20Guideline 20: : Strengthening capacity for ethical and scientific Strengthening capacity for ethical and scientific review and biomedical researchreview and biomedical research

Many countries lack the Many countries lack the capacity to assesscapacity to assess or ensure the or ensure the scientific scientific qualityquality or or ethical acceptabilityethical acceptability of biomedical research proposed or of biomedical research proposed or carried out in their jurisdictions. carried out in their jurisdictions.

In externally sponsored collaborative research, sponsors and In externally sponsored collaborative research, sponsors and investigators have an ethical obligation to ensure that biomedical investigators have an ethical obligation to ensure that biomedical research projects for which they are responsible in such countries research projects for which they are responsible in such countries contribute effectively to national or local capacitycontribute effectively to national or local capacity to to design and design and conduct biomedical research, and to provide scientific and ethical conduct biomedical research, and to provide scientific and ethical review and monitoring of such researchreview and monitoring of such research..



Guideline 20Guideline 20: : Strengthening capacity for ethical and scientific Strengthening capacity for ethical and scientific review and biomedical researchreview and biomedical research

Capacity-building may include, but is not limited to, the following Capacity-building may include, but is not limited to, the following

activities:activities:

establishing and strengthening independent and competent ethical establishing and strengthening independent and competent ethical review processes/ review processes/ committeescommittees

strengthening strengthening research capacityresearch capacity

developing developing technologiestechnologies appropriate to health-care and biomedical appropriate to health-care and biomedical researchresearch



Guideline 5Guideline 5: : Obtaining informed consent: Essential Obtaining informed consent: Essential information information for prospective research subjectsfor prospective research subjects

Before requesting an individual's consent to participate in research,Before requesting an individual's consent to participate in research,

the investigator the investigator must provide the following informationmust provide the following information, in language, in language

or another form of communication that the individual can or another form of communication that the individual can

understand:understand:

(1) – (26)(1) – (26)



Appendix 1 Appendix 1

Items to be included in a protocol (or associated documents) for Items to be included in a protocol (or associated documents) for

biomedical research involving humanbiomedical research involving human subjects.subjects.

(1) – (48)(1) – (48)


C.F.R.C.F.R.

Title 45, U. S. Title 45, U. S. Code of Federal RegulationsCode of Federal Regulations, Part , Part 4646

Protection of Human Subjects Protection of Human Subjects

Subpart ASubpart A


C.F.R.C.F.R.

Title 45, U. S. Title 45, U. S. Code of Federal RegulationsCode of Federal Regulations, Part , Part 4646

Protection of Human Subjects Protection of Human Subjects

Subpart ASubpart A


Title 45, U.S. CodeTitle 45, U.S. Code

§46.103§46.103 Assuring compliance with this policy -- Assuring compliance with this policy -- research research

conducted or supported by any Federal Department or conducted or supported by any Federal Department or

Agency.Agency.



§46.103§46.103

(2) (2) Designation Designation of one or more of one or more IRBs established in accordanceIRBs established in accordance with the requirements of this policy…with the requirements of this policy…

(3) A (3) A list of IRB memberslist of IRB members identified by name; earned degrees; identified by name; earned degrees; representative capacity; indications of experience such as board representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the employment or other relationship between each member and the institution;institution;

Change in IRB membershipChange in IRB membership shall be reported to the Office for shall be reported to the Office for Protection from Research Risks, National Institutes of Health, Protection from Research Risks, National Institutes of Health, DHHS.DHHS.



§46.103§46.103

(4) (4) Written proceduresWritten procedures which the IRB will follow which the IRB will follow

(i)(i) for conducting its for conducting its initial and continuing reviewinitial and continuing review of research and for of research and for reporting its findings and actions to the investigator and the reporting its findings and actions to the investigator and the institution; institution;

(ii) for determining (ii) for determining which projects require review more oftenwhich projects require review more often than than annually and which projects need verification from sources other annually and which projects need verification from sources other than the investigators that no material changes have occurred than the investigators that no material changes have occurred since previous IRB review; and since previous IRB review; and



§46.103§46.103

(4) (4) Written proceduresWritten procedures which the IRB will follow which the IRB will follow

(iii) (iii) for ensuring for ensuring prompt reportingprompt reporting to the IRB of to the IRB of proposed proposed changeschanges in a research activity, and for ensuring that such in a research activity, and for ensuring that such changes in changes in approved research, during the period for which IRB approved research, during the period for which IRB approval approval has already been given, may not be initiated without has already been given, may not be initiated without IRB review IRB review and approval except when necessary to eliminate and approval except when necessary to eliminate apparent apparent immediate hazards to the subject.immediate hazards to the subject.



§46.103§46.103

(5) (5) Written procedures for ensuring prompt reporting to the IRBWritten procedures for ensuring prompt reporting to the IRB, , appropriate institutional officials, and the Department or Agency appropriate institutional officials, and the Department or Agency head of head of

(i)(i) any any unanticipated problemsunanticipated problems involving risks to subjects or involving risks to subjects or others or any serious or continuing others or any serious or continuing noncompliancenoncompliance with this with this policy or the requirements or determinations of the IRB; and policy or the requirements or determinations of the IRB; and

(ii) (ii) any any suspensionsuspension or or terminationtermination of IRB approval. of IRB approval.



§46.107§46.107 IRB MembershipIRB Membership

(a) Each IRB shall have at least (a) Each IRB shall have at least five membersfive members, with varying , with varying backgrounds to promote complete and adequate review of backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. research activities commonly conducted by the institution.




The IRB shall be sufficiently qualified through the The IRB shall be sufficiently qualified through the experienceexperience and and expertiseexpertise of its members, and the diversity of the members, of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and respect for its advice and counsel in safeguarding the rights and welfare of human subjects. welfare of human subjects.

In addition to possessing the In addition to possessing the professional competenceprofessional competence necessary necessary to review to review specific research activitiesspecific research activities, the IRB shall be able to , the IRB shall be able to ascertain the acceptability of proposed research in terms of ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and institutional commitments and regulations, applicable law, and standards of professional conduct and practice. standards of professional conduct and practice.




The IRB shall therefore include persons knowledgeable in these The IRB shall therefore include persons knowledgeable in these areas. areas.

If an IRB regularly reviews research that involves a vulnerable If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in individuals who are knowledgeable about and experienced in working with these subjects.working with these subjects.




(b) Every (b) Every nondiscriminatorynondiscriminatory effort will be made to ensure that no IRB effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. long as no selection is made to the IRB on the basis of gender.

No IRB may consist entirely of members of No IRB may consist entirely of members of one professionone profession..




(c) Each IRB shall include at least (c) Each IRB shall include at least oneone member whose primary member whose primary concerns are in concerns are in scientific areasscientific areas and at least and at least oneone member whose member whose primary concerns are in primary concerns are in nonscientific areasnonscientific areas..

(d) Each IRB shall include at least (d) Each IRB shall include at least oneone member who is member who is notnot otherwise affiliatedotherwise affiliated with the institution and who is not part of the with the institution and who is not part of the immediate family of a person who is affiliated with the institution.immediate family of a person who is affiliated with the institution.

(e) No IRB may have a member participate in the IRB's initial or (e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a continuing review of any project in which the member has a conflicting interestconflicting interest, except to provide information requested by , except to provide information requested by the IRB.the IRB.




(f) An IRB may, in its discretion, (f) An IRB may, in its discretion, invite individualsinvite individuals with with competence in competence in special areasspecial areas to assist in the review of issues to assist in the review of issues which require expertise beyond or in addition to that available on which require expertise beyond or in addition to that available on the IRB. the IRB.

These individuals may not vote with the IRBThese individuals may not vote with the IRB


Compliance Oversight Branch Compliance Oversight Branch

Division of Human Subject Protections Division of Human Subject Protections

Office for Human Research Protections Office for Human Research Protections ((OHRPOHRP))

OHRP Compliance ActivitiesOHRP Compliance Activities: :

Common Findings and GuidanceCommon Findings and Guidance -7/10/2002 -7/10/2002


OHRP ComplianceOHRP Compliance; ; Common Findings and GuidanceCommon Findings and Guidance

INITIAL AND CONTINUING REVIEW INITIAL AND CONTINUING REVIEW Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(1).(1). Research Conducted without IRB Review Research Conducted without IRB Review (2).(2). Failure of IRB to Review HHS Grant Applications Failure of IRB to Review HHS Grant Applications (3).(3). IRB Lacks Sufficient Information to Make DeterminationsIRB Lacks Sufficient Information to Make Determinations(4).(4). Inadequate IRB Review at Convened Meetings Inadequate IRB Review at Convened Meetings (5).(5). Inadequate Continuing Review Inadequate Continuing Review (6).(6). Substantive Changes and no Additional Review by IRB Substantive Changes and no Additional Review by IRB (7).(7). Failure to Conduct Continuing Review at Least Once per Year Failure to Conduct Continuing Review at Least Once per Year (8).(8). IRB Meeting Convened without Quorum (Nonscientist Absent) IRB Meeting Convened without Quorum (Nonscientist Absent) (9).(9). IRB Meeting Convened without Quorum (Lack of a Majority) IRB Meeting Convened without Quorum (Lack of a Majority) (10).(10). IRB Members with Conflicting Interest Participated in IRBIRB Members with Conflicting Interest Participated in IRB



REPORTING OF UNANTICIPATED PROBLEMS AND IRB REPORTING OF UNANTICIPATED PROBLEMS AND IRB REVIEW REVIEW OF OF

PROTOCOL CHANGESPROTOCOL CHANGES Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(11).(11). Failure to Report Unanticipated Problems to IRB, Failure to Report Unanticipated Problems to IRB, Institutional Institutional Officials, and OHRP Officials, and OHRP

(12).(12). Failure of IRB to Review Protocol Changes Failure of IRB to Review Protocol Changes (13).(13). Inadequate IRB Review of Protocol ChangesInadequate IRB Review of Protocol Changes



INFORMED CONSENTINFORMED CONSENT Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(14).(14). Failure to Obtain Legally Effective Informed Consent Failure to Obtain Legally Effective Informed Consent (15).(15). Failure to Document Informed Consent Failure to Document Informed Consent (16).(16). Deficient Informed Consent Documents (ICDs) in General Deficient Informed Consent Documents (ICDs) in General (17).(17). Inadequate ICD for Specific Research/Lack of Required Inadequate ICD for Specific Research/Lack of Required

Elements Elements (18).(18). Inadequate ICD for Specific Research/Lack of Additional Inadequate ICD for Specific Research/Lack of Additional

Elements Elements (19).(19). ICD Language too Complex ICD Language too Complex (20).(20). Exculpatory Language in ICDs Exculpatory Language in ICDs



INFORMED CONSENTINFORMED CONSENT Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(21).(21). Standard Surgical Consent Documents Lack Required Standard Surgical Consent Documents Lack Required Elements Elements of Informed Consent of Informed Consent

(22).(22). Inappropriate Boiler Plate ICDs Inappropriate Boiler Plate ICDs (23).(23). Enrollment Procedures did not Minimize Possibility of Enrollment Procedures did not Minimize Possibility of

Coercion Coercion or Undue Influence or Undue Influence



IRB MEMBERSHIP, EXPERTISE, STAFF, SUPPORT, AND WORKLOADIRB MEMBERSHIP, EXPERTISE, STAFF, SUPPORT, AND WORKLOAD Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(24).(24). Lack of Diversity of IRB Membership Lack of Diversity of IRB Membership (25).(25). Lack of IRB Expertise Regarding Research Involving Children Lack of IRB Expertise Regarding Research Involving Children (26).(26). Lack of Prisoner/Prisoner Representative for IRB Review of Lack of Prisoner/Prisoner Representative for IRB Review of

Research Involving Prisoners Research Involving Prisoners (27).(27). Conflict Resulting from Office of Research Support Conflict Resulting from Office of Research Support

(Sponsored (Sponsored Programs) Serving as a Voting Member of the IRB Programs) Serving as a Voting Member of the IRB (28).(28). IRB Chair and Members Lack Sufficient Understanding of HHSIRB Chair and Members Lack Sufficient Understanding of HHS

Regulations Regulations



IRB MEMBERSHIP, EXPERTISE, STAFF, SUPPORT, AND WORKLOADIRB MEMBERSHIP, EXPERTISE, STAFF, SUPPORT, AND WORKLOAD Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(29).(29). Designation of an Additional IRB under an MPA without Prior Designation of an Additional IRB under an MPA without Prior OHRP Approval OHRP Approval

(30).(30). Inadequate IRB Resources Inadequate IRB Resources (31).(31). Overburdened IRBOverburdened IRB



DOCUMENTATION OF IRB ACTIVITIES, FINDINGS, AND DOCUMENTATION OF IRB ACTIVITIES, FINDINGS, AND PROCEDURESPROCEDURES

Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(32).(32). Inadequate IRB Records Inadequate IRB Records (33).(33). Inadequate IRB Minutes Inadequate IRB Minutes (34).(34). Poorly Maintained IRB Files Poorly Maintained IRB Files (35).(35). Failure of IRB to Determine That Criteria for IRB Approval Failure of IRB to Determine That Criteria for IRB Approval

Are Are Satisfied Satisfied (36).(36). Failure of IRB to Document Consideration of Additional Failure of IRB to Document Consideration of Additional

Safeguards for Vulnerable Subjects Safeguards for Vulnerable Subjects (37).(37). Failure of IRB to Make Required Findings When Reviewing Failure of IRB to Make Required Findings When Reviewing

Research Involving Children Research Involving Children (38).(38). Failure of IRB to Make Required Findings When Reviewing Failure of IRB to Make Required Findings When Reviewing

Research Involving Prisoners Research Involving Prisoners



DOCUMENTATION OF IRB ACTIVITIES, FINDINGS, AND PROCEDURESDOCUMENTATION OF IRB ACTIVITIES, FINDINGS, AND PROCEDURES Common OHRP Findings of NoncomplianceCommon OHRP Findings of Noncompliance

(39).(39). Failure of IRB to Make and Document Required Findings for Failure of IRB to Make and Document Required Findings for Waiver of Informed Consent Waiver of Informed Consent

(40).(40). Failure to Make Required Findings for IRB Waiver of a Signed Failure to Make Required Findings for IRB Waiver of a Signed Informed Consent Document Informed Consent Document

(41).(41). Lack of Appropriate Written IRB Policies and Procedures Lack of Appropriate Written IRB Policies and Procedures (42).(42). Inadequate Procedures for Oversight of Repository Activities Inadequate Procedures for Oversight of Repository Activities (43).(43). Inadequate Procedure for Reporting and Review of Inadequate Procedure for Reporting and Review of

Unanticipated Unanticipated ProblemsProblems


International Health Law and Human RightsInternational Health Law and Human Rights

The EndThe End

Many Thanks to All! ! ! ! ! Many Thanks to All! ! ! ! !

Good Luck, Good Luck, Much respect,Much respect,

God be with you,God be with you,

Professor Tom GionisProfessor Tom Gionis

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