The Protection of Human Participants in Research A Brief Overview

Institutional Review Board Institutional Review Board (IRB): A campus-wide committee charged with the review of human participants research to assure adequate methods of informed consent and to determine acceptable balance of risk/benefit.

Why are IRBs mandated? Primarily for the protection of human participants in research Human Participants Research: An Human Participants Research: An investigation which involves the collection of data from or about living human beings. Human Participants: Living individuals Human Participants: Living individuals about whom an investigator obtains data or identifiable private information.

Research Abuse Examples The Tuskegee Study, conducted from The Tuskegee Study, conducted from 1932 to 1972, by the Public Health Service, examined the course of untreated syphilis in black American men. Participants were not told they had syphilis, nor was effective treatment offered. The Lead Paint Study, conducted by The Lead Paint Study, conducted by Johns Hopkins University in the 1990s, tested the effectiveness of housing repairs in reducing blood levels of lead in children in rental housing in Baltimore. Rental homes received differing levels of repairs. Landlords were asked to rent to families with young children. Children already in the houses remained, so their blood levels could be analyzed.

 Willowbrook Study through 1966 Studies were carried out at the Willowbrook School, a NY institution for “mentally defective persons”, to learn about infectious hepatitis and to test the effects of gamma globulin on the disease. The children were deliberately infected with hepatitis; either by being fed extracts of stools from infected individuals, or by receiving injections of more purified virus. Investigators defended these actions, saying that most children acquired the infection anyway at Willowbrook, and it would be better to be infected under research conditions. Research Abuse Examples

During the hepatitis studies, Willowbrook closed its doors to new inmates. However, because this program occupied its own space at the institution, it was able to continue to accept new patients. Thus parents were unable to admit their child unless the parents agreed that the child participate in the hepatitis studies. Research Abuse Examples

 The Milgram Study is an historical example of psychological risk possible with social and behavioral research. Stanley Milgram, who conducted this study and published the results in 1963, was interested in obedience and human response to authority. Researchers recruited volunteers by telling them the purpose was to study memory and learning. However, the real intent was to see how far the participant could be punished by complying with authority.

Participants punished “students” (who were actually confederates of the researcher) through administration of increasing levels of electric shock. Even though no shocks were actually administered, the “students” pretended to show severe pain. Experimenters pressured participants to continue to increase shock levels beyond the level marked “dangerous” and to complete the experiment. Issues: Research Abuse Examples Discovering unexpected personal weaknesses Shame or guilt feelings Deception

The determination of risk requires evaluating both the magnitude of potential harm to participants and the likelihood of the occurrence of that harm. Minimal Risk: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Research Risks

In order to approve research, the IRB must: Identify risks Determine that risks are minimized Determine that “risks to participants are reasonable in relation to anticipated benefits” Determine that participants are adequately informed about “any reasonably foreseeable risks or discomforts” Research Risks

Emotional distress Psychological Trauma Embarrassment Loss of employment – financial loss Social stigmatization Shame or guilt Invasion of privacy Breach of confidentiality More Research Risks In addition to the physical risks inherent in bio-medical research, social and behavioral research also may include risks such as:

Regulations The Code of Federal Regulations (45 CFR 46) The Code of Federal Regulations (45 CFR 46)Code of Federal RegulationsCode of Federal Regulations sets “minimum standards” of ethical conduct in human participants’ research. Federal-Wide Assurance with OHRP assures compliance with federal regulations and appropriate state laws The regulations contain three basic protections The regulations contain three basic protections for human participants: Institutional Assurances IRB Review Informed Consent

Ethical Codes & Principles The Belmont ReportThe Belmont Report – April 18, 1979 The Belmont Report identifies three basic ethical principles Underlying the conduct of research involving human participants: 1) Respect for persons 2) Beneficence 3) Justice

Ethical Codes & Principles Respect for persons: recognition of personal dignity and autonomy of individuals, with special protection for those with diminished autonomy. This is the basis for the informed consent process, and respect for privacy. Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing risks or harm. Justice: mandates that selection of participants be fair to all. Researchers should not place the burden of risk on one population with no anticipated benefit to that population, or unfairly target a specific population due to “easy access”. Use of good inclusion/exclusion criteria is essential.

The Nuremburg Code A set of standards developed in 1947, following the atrocities against humans during WWII by German researchers. Provided the first codification of ethical guidelines for the conduct of research involving human participants. Declaration of Helsinki Declaration of Helsinki Drafted by the World Medical Association, Revised 1975, 1983, 1989, 1996, Elaborated on the principles in the Nuremberg Code. Ethical Codes & Principles

Other Reasons for an IRB It may be difficult to be objective about your own work. People can underestimate the risks involved in things they are very familiar with. People sometimes overestimate the benefit of things that are important to them.

IRB Review Criteria for IRB Review: Criteria for IRB Review: For submission procedures, For submission procedures, read The Investigator’s Handbook read The Investigator’s Handbook and use The Investigator’s Checklist and use The Investigator’s Checklist Satisfactory risk/benefit ratio Equitable participant selection Satisfactory informed consent process Adequate privacy and confidentiality guarantees guarantees

Exempt Review Status: Certain categories of research projects involving human participants that meet the definition under the regulations are exempt from IRB review. Federal regulations permit the principal investigator to make a judgment as to whether the project is exempt; however only the IRB may determine that an exemption is appropriate. Exempt means here that a project is exempted from the Federal Department of Health and Human Services requirements spelled out in 45 CFR 46. IRB Review Types

To qualify as exempt, the research must fall within one of the specified regulatory categories and satisfy all Mitchell College institutional requirements. Only the IRB may determine when research is exempt or whether the research requires a full or expedited review. Therefore, researchers must submit an application to the Institutional Review Board to ensure that the research meets the criteria for exemption. IRB Review Types Exempt Review Status (continued):

IRB Review Types Expedited Review Status: Research that falls within the definition of minimal risk is covered by the expedited review category. Minimal risk is defined as "where the probability and magnitude of harm or discomfort anticipated in the proposed 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."

In reviewing the research, the Chair or her/his designee may exercise all of the authorities of the IRB, except that s/he may not disapprove the research. Disapproval requires action by the full Institutional Review Board. Expedited Review Status (continued): Expedited Review Status (continued): IRB Review Types

Full Review Status: The protocol is reviewed, discussed, and voted on by IRB members at a convened meeting of the IRB. The investigator (and faculty/staff advisor, if there is one) is invited to attend to the meeting of the IRB to discuss the protocol. The investigator may not be present, however, for the IRB’s deliberation or vote. All research involving human participants that is subject to the applicable government regulations falls in this category, unless it meets the criteria for the exceptions.

Consent Process During the consent process, investigators must be certain that all potential participants fully understand the information they are given, and that all potential risks are carefully explained. Participants must be able to understand the information presented. Legal surrogate consent must be obtained for those with reduced capacity. To maintain autonomy, participation must be freely given, without coercion or undue influence of others. Investigators must consider the possibility of obtaining consent from any “third parties” involved if personally identifiable, sensitive information is being obtained about them.

Required Reading and Certification The Belmont Report The Belmont Report The Nuremburg Report The Helsinki Report

CITI, Collaborative Institutional Training Initiative, an on-line course required for all IRB members and researchers IRB members and researchers Investigator’s Guide to Human Investigator’s Guide to Human Participants Research Participants Research Further Required Reading and Certification

Who must complete the training? All Principal Investigators and key personnel, compliance staff, institutional signatory officials, and institutional review board members When must the training be completed? Prior to conducting or reviewing research involving human participants. IRB Training

Mitchell College IRB Contact Information Daniel L. Kresge, Ph.D., A.T.,C. Chair, Mitchell College IRB Associate Professor, Dept. of Sport & Fitness Management Mitchell College 437 Pequot Avenue New London, CT (860)

Dr. Scott Horton, Behavioral Sciences Dr. Peter Love, Academic Success Center Dr. Kimberly Blake, Life Sciences Dr. Julie Liefeld, Health and Wellness Center IRB Development Committee Thank you to Dr. Mary Ellen Jukoski, Dr. Gil Maffeo, and the Mitchell College Board of Trustees