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Protection of Human Subjects in Research

Bentley College

Institutional Review Board (IRB)

Principal Investigator Training

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Revised 10/12/04

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Composition of Bentley IRB• Institutional Official: Robert Galliers, Provost & Academic

Vice President

• IRB Administrator: Mary Louise Pauli, Director of Sponsored Programs

• IRB Chair, Anthony F. Buono, Professor of Management & Sociology, Coordinator, Bentley Alliance for Ethics & Social Responsibility

Federal regulations require a minimum of five members• Bentley’s IRB has 10 Members:

– 7 senior full-time faculty from the various Business and A&S Departments

– 2 Staff members– One community member

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Bentley’s Mission

“We educate students to be leaders in business and related professions… [in ways that] inspire students to be literate, articulate, ethical, creative and broad-minded… [with] a rich campus life infused with intellectual, social and cultural diversity, community spirit, and a sense of civic responsibility … valu[ing] excellence in both scholarship and the classroom … [and] achieving best practice in [our] respective fields.”

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The Beginning: Nuremberg

• Nuremberg War Crimes Trials of Nazi doctors– “Medical experiments” were performed on thousands of

concentration camp prisoners

– In 1946, 23 physicians and administrators, many of whom were leading members of the German medical hierarchy, were indicted for “crimes against humanity.”

• 16 were found guilty and imprisoned, and 7 were sentenced to death

• A result was the Nuremberg Code (1947)– Ten principles that form the basis for ethics codes

internationally

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Nuremberg Code: Key Tenets• Voluntary consent of human subjects is absolutely

essential.• Animal experimentation should precede human

experimentation.• All unnecessary physical and mental suffering and

injury should be avoided• The degree of risk to participants should never exceed

the "humanitarian importance of the problem." • All risk should be minimized through "proper

preparations.“ • Participants should always be at liberty to withdraw

from experiments.

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Controversial Studies• Jewish Chronic Disease Hospital (1963)

– Patients with chronic debilitating diseases were injected with live cancer cells without their knowledge.

– The researchers were found guilty of fraud, deceit, and unprofessional conduct.

• U.S. Public Health Service Tuskegee Syphilis Study (1934-1972) – Study began in 1934 as an examination of the natural history of

untreated syphilis. – 400 black males participated without informed consent and were

misinformed about procedures “in the interest of research.”– Although penicillin was found to be effective in treating syphilis in

the 1940s, the study continued and the men were neither informed nor treated with the antibiotic.

– Publication of study results in 1972 prompted public outrage, leading to a mandate to regulate all federally supported research involving human subjects.

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• Willowbrook State School Study (1963-66)– At the NY State institution for “mentally defective” children, new

entrants were deliberately injected with the hepatitis virus to examine the natural history of infectious hepatitis.

– Researchers defended the study arguing that is was likely the children would have contacted the disease anyway due to the crowded and unsanitary conditions at the school.

• Milgram Obedience to Authority Studies (1960s)– Being told that they were volunteering for a study to test the effect of

negative reinforcement (punishment) on learning behavior, the volunteer “teachers” were unknowingly the subjects of the experiment

– The “teachers” gave increasing electric shocks to “learners” – who were confederates in the research study

– Study raised significant questions about the ethics of creating psychological stress and tension in human subjects and the extent to which the search for knowledge should justify such “costs” to the participants.

Controversial Studies - 2

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Ethical Conduct of Research: Background

• 1962 - FDA legislation required formal consent• 1964 - Declaration of Helsinki focused on guidelines

for medical research • 1965/6 - NIH Advisory Committee developed

guidelines for ethical review of all NIH-funded research protocols by peers plus others at institution before experiment could begin– Included requirement for informed consent and assessment

of risks and benefits– Start of Institutional Review Boards (IRBs)

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• National Research Act (1974)

– Creation of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

• Commission delivers the “Belmont Report” (1979)

• Recommendations implemented in the federal regulations known as the “Common Rule” (1981)

Ethical Conduct of Research

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Principles of the Belmont Report• Respect for persons

– obligation to treat individuals as autonomous agents able to chose for themselves

– obligation to protect those with diminished capacity

• Beneficence– obligation to not harm

– obligation to maximize benefits and reduce harms

• Justice– obligation to be fair and equitable

– obligation to distribute benefits and burdens fairly

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Implementing the Principles of the Belmont Report: The “Common Rule”

• Respect for persons– Informed consent

• Beneficence– Minimization of possible risks, assessment of

risks and benefits

• Justice– Scrutiny of subject selection

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The Common Rule for Department of Health and Human Services –

45 CFR 46

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Bentley College Institutional Review Board Policies and Procedures

(July 2001; Revised January 2003)

Overview

The following policies and procedures are adopted by Bentley College for oversight of research by the College’s Institutional Review Board (IRB). They have been formulated in response to consideration of 45 CFR 690, the federal requirements known as the “Common Rule” that may be examined in its entirety at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

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Definitions: Research

Research “means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

~ 45 CFR 46.102d

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Definitions: Human Subject

“A living individual about whom an investigator (whether professional or student) conducting research obtains:

1. data through intervention or interaction with the individual, or

2. identifiable private information”

~ 45 CFR 46.102f

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Definition: Minimal Risk

“…means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

~ 45 CFR 46.102i

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General Considerations

• Know, understand, and follow the relevant principles, regulations, policies and guidelines

• Plan your research – well before you start• Keep your obligations to human subjects in mind

during the research• Anticipate and be empathic

– Anticipate possible problems and/or complications– Try to put yourself in the participants’ place

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• Design your study to minimize risks and maximize benefits– Consider psychological, financial, social, employment, and

educational risks – Don’t ask more than you need to know– Design for confidentiality

• Don’t promise more than you can deliver

– Have plans to deal with possible participant distress or injury– Maximize any direct benefits to the participants

General Considerations -2

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General Considerations -3

• Consider participant recruitment procedures– Is the process free of coercion?

• Role conflicts? Power inequities?

– Have you selected the best population with which to investigate your question (vs. the most convenient)?

• Vulnerable population? Population that may benefit?

– Is the design inclusive? Equitable?– Are inclusion and exclusion criteria clear and

appropriate?

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General Considerations -4

• Consider informed consent procedures– Have subjects been fully informed of all relevant

information and planned procedures?• Use of data? Who has access? Video or audio tapes?

– Has the information been understood?• Presented appropriately? Ability to ask questions?

– Are subjects able to give consent?• Cogently impaired? Underage? English-speaking?

– Who will inform and witness the consent?

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Remember Your Obligations

• Informed consent is a process– Are there means to contact the researcher?

Have you allowed for continuing exchange of information and questions?

• Monitor for problems, adverse events• File with the IRB any necessary reports,

requests for amendments, adverse events• Above all, respect those who volunteer to

participate in your research study

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Levels of IRB Review

• Exempt status

• Expedited review

• Full review

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Research that Qualifies for “Exempt Status”

• No more than minimal risk

• No identifiers: Identities of subjects cannot be linked with the data or publicly available data

• No medical treatments are involved

• The research falls into one of the following categories:– Educational settings, involving normal educational practices

– Educational testing, surveys, interviews or observation of public behavior

– Research involving public officials

– Use of Existing data (no additional data to be gathered)

– Demonstration projects (public benefit or service projects)

– Taste and food quality evaluation and consumer acceptance

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Exempt Review Categories

Detailed descriptions of exempt review categories are available at:

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.101

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If Exempt Status Applies…

• Request “Exempt” status on the Research Review Form, explaining why and citing appropriate regulatory details.

• Exempt status will be confirmed if research fulfills the exemption criteria

• While there is no further review for “exempt status,” the researcher should still follow the Belmont principles and Common Rule as appropriate

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Research that Qualifies for “Expedited Review”

• If no more than minimal risk is involved• If research activity falls solely within one or more of the

following categories:– Voice, video, digital or image recordings

– Group of behavior characteristics

– Previously approved research (continuing review)

– Certain medical studies, including clinical studies of drugs and medical devices, blood samples, routine noninvasive procedures and prospective specimen collections (which are unlikely at Bentley) .

• If there are minor changes (amendments) in previously approved research (during period approved)

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Expedited Review Categories

Detailed descriptions of expedited review categories are available at:

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm

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Criteria for IRB Full Review &Approval of Research (45 CFR 46.111)

• Risks to subjects are minimized• Risks to subjects are reasonable relative to anticipated benefits• Selection of subjects is equitable• Informed consent will be sought and documented• Provisions for data monitoring for subjects’ safety• Provisions to protect privacy and maintain confidentiality• Additional safeguards are provided as appropriate if vulnerable subjects are involved

The Bentley IRB Application asks that the information outlined above be provided by the Principal Investigator.

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Valid Informed Consent

• Fully informed

• Information understood

• Voluntary, free of coercion

• Given by competent adult

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For children and others not legally able to consent:

• Permission from parent, guardian, or legal representative, and

• Assent from the individual

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Basic Elements of Informed Consent (45 CFR 46.116)

• The subject is competent and can fully comprehend the information

• Statement of the research - purpose, duration, procedures• Reasonably foreseeable risks or discomforts• Reasonably expected benefits to subject or others• Extent to which confidentiality will be maintained• Whom to contact if subject has questions • Statement that participation is voluntary; no penalty or loss of

benefits if decline to participate; can withdraw at any time

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Possible additional elements of informed consent

• Risks not currently foreseeable

• Circumstances under which subject’s participation may be terminated by researcher

• Any additional costs to subjects

• Consequences of early withdrawal

• Statement that researcher will tell subject of significant new findings discovered during course of study

• Approximate number of subjects

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Vulnerable Populations

“Subjects likely to be vulnerable to coercion or undue influence”• Children• Prisoners• Pregnant women• Mentally disabled persons• Economically or educationally disadvantaged persons• Employees? Students? Clients?

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Research with Children

• Subpart D: 45 CFR 46.401-409 applies to research with children

• "Assent" means a child's affirmative agreement to participate in research. Failure to object should not, absent affirmative agreement, be construed as assent. (45 CFR46.402b)

• Risk/benefit determination

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Risk/Benefit Categories for Research with Children

• Research not involving greater than minimal risk.• Research involving greater than minimal risk but presenting

the prospect of direct benefit to the individual subjects.• Research involving greater than minimal risk and no prospect

of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.

• Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

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Dual Role Issues

• Individual as researcher and teacher/principal• Important to reduce potential for coercion of

participants who are students or employees• Consider who will recruit students/employees• Will they be given an opportunity to decline?• If they choose not to participate, will their peers

know? (e.g., If students do not participate, will they be given other tasks to complete while their peers are participating in the research?)

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HIPAA Information(Health Insurance Portability and

Accountability Act)

• Bentley is not a covered entity under HIPAA

• Bentley researchers, however, may work with covered entities

• PIs who work with health information need to complete the “Statement on HIPAA PHI Use” form – see Mary Louise Pauli, IRB Administrator, for further information

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For Additional IRB Information

• Tony Buono, IRB Chair – AAC315; 781-891-2529 – abuono@bentley.edu

• Mary Louise Pauli, IRB Administrator– LCC 270; 781-891-2660– mpauli@bentley.edu