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 investigation which involves the collection of data from or about living human beings. Human Participants: Living individuals about whom an investigator obtains data or identifiable private information.

Research Abuse Examples 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 in the 1990’s, tested the effectiveness of housing repairs in reducing blood levels of lead in children. 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.

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

Regulations The Code of Federal Regulations (45 CFR 46) sets “minimum standards” of ethical conduct in human participants’ research. Federal-Wide Assurance with OHRP assures compliance with federal regulations and appropriate state laws

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

Other Reasons for an IRB 1) It may be difficult to be objective about your own work. 2) People can underestimate the risks involved in things they are very familiar with. 3) People sometimes overestimate the benefit of things that are important to them.

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

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

IRB Training 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.

Mitchell College IRB Information Sources and Resources 1) Dedicated web page open to the public 2) Longer Power Point tutorial, on-line 3) Researcher’s Manual & appropriate web links 4) Members of the IRB and contact information

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