IRB BASICS: Issues in Ethics and Human Subject Protections Prepared by Ed Merrill Department of Psychology November 12, 2009

The IRB primary function is to ensure that the rights and welfare of human subjects involved in research are protected. The University of Alabama has one IRB designated for review of studies that use medical information and one for studies that do not (i.e., basic behavioral research). IRB Functions

Precipitating EventsOutcomes The Nazi ExperimentsNuremberg Code 1947 Tuskegee Syphilis Study National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research 1974 * Belmont Report 1978 * Common Rule 1991

The ethical principles of the Belmont Report govern all research supported by the U.S. Government are the basis for regulations that ensure protection of human subjects in research. The Belmont Report

1. Respect for Persons 2. Beneficence 3. Justice Three Basic Principles

Requires that researchers treat individuals as autonomous agents Provides for individuals to be given a choice about research participation Requires that extra protections be given to those with diminished autonomy (i.e., Prisoners, Children, Cognitively Impaired, etc.)

Researchers must first make sure they do no harm. Researchers are expected to maximize possible benefits and minimize risks.

Researcher must treat people fairly. Persons should share the burdens and benefits of the research EQUITABLY.

Respect Implementation of Informed Consent Process Development of Rules for Guarding Privacy and Confidentiality Beneficence Requirement of Adequately Designed Research Requirement of trained and competent investigators/researchers Requirement of Favorable Risk-Benefit Ratio Justice  Equitable Selection of Subjects  Equitable Distribution of Risks and Benefits

The “Common Rule” is the set of regulations developed by the Department of Health and Human Services to ensure compliance with the principles established by the Belmont Report. ALL UNIVERSITIES THAT ACCEPT FEDERAL FUNDING MUST COMPLY WITH THESE REGULATIONS. The Common Rule

Institutional assurances of compliance. Review of research by an IRB. Required informed consent of subjects. Established by The Common Rule

The University Does This. As a result – we are subject to Human Rights Audits by the Federal Government. A. Institutional Assurance

The Make-up of the Committee IRB includes researchers and nonresearchers. Must include persons who can review scientific merit. Must include persons who can review human rights issues. Must include someone who is NOT part of the Institution (a member of the community).

Special procedures are required for research involving prisoners. At least one member of the board must be a prisoner representative. Prisoners must receive no special benefits from the research that nonprisoners would not receive (e.g., favorable decisions about parole).

All research projects are categorized into one of four categories, reflecting the degree of scrutiny required, for the IRB review process. The IRB (not the researchers) make the final decision of which of the following categories that is assigned to a particular research project. 1. Full Board Review 2. Expedited 3. Exempt 4. Research Not Involving Human Subjects

At UA, one Committee member(s) is assigned to review the complete protocol. The Primary Reviewer summarizes the protocol for the Full Committee during a scheduled meeting and leads a discussion of the protocol. All other committee members are provided with ALL information, but only one reviewer is required to go over it in detail. All members vote on whether to approve each protocol and what revisions (if any) may be required.

Protocols that meet specific federal criteria qualify for an expedited review. Expedited protocols are typically reviewed by one qualified member of the committee (although a second reviewer may be asked to assist). Although often less time consuming that a full board review – these reviews may also require revisions on the part of the PI.

IRB review is not required for certain categories of research activities that involve little or no risk to human subjects. (Typically involves NO RISK and ANONYMOUS - not just confidential - Data) Only the IRB can make the determination of Exempt, this cannot be determined by researchers! Even if the research is determined to be exempt by IRB at a later date – by not consulting the IRB, the PI is in noncompliance and subject to disciplinary actions.

Research that involves coded private information or specimens that cannot be identified are classified as not involving human subjects and do not require IRB review (that they originated from human subjects is not relevant). Determinations of whether research involving coded private information or biological specimens is considered to be “human subjects research” must be made by the IRB, not the investigator.

Initial (New Protocol) Continuing Review (Renewal) – At least every year. Revisions – ANY CHANGE IN PROTOCOL MUST BE SUBMITTED AND APPROVED BY THE IRB BEFORE IMPLEMENTED OR CAN RESULT IN THE LOSS OF USE OF DATA. Monitoring of Safety Information or Unanticipated Problems to Subjects Noncompliance – Determining whether researchers have not followed approved procedures.

Risks are Minimized Risks are Reasonable in Relation to Benefits Selection of Subjects is Equitable Informed Consent will be Sought for Each Prospective Subject Informed Consent will Be Documented Provisions for Monitoring the Data Collected to Ensure Safety of the Subjects are adequate Provisons for Protecting the Privacy of Subjects and Confidentiality are Sufficient Additional safeguards are in place to protect the rights and welfare of vulnerable subjects.

Information – includes research procedure, purpose, risks, benefits, alternatives, etc. Comprehension – presentation of information must be adapted to the subject’s capacity Voluntary – participation conditions are free of coercion and undue influence C. Principles of Informed Consent

1. Statement that the study involves research 2. Description of Research 3. Description of Risks 4. Description of Benefits 5. Disclosure of Alternatives 6. Assurances of Confidentiality 7. Assurances of Voluntary Participation 8. Whom to Contact with Questions/Concerns AND WHEN GREATER THAN MINIMAL RISK IS INVOLVED 7. Compensation and/or medical treatment for complications is described

1.Number of subjects involved 2. Unforeseeable risks (that there is the potential for) 3. Early termination (reasons for) 4. Additional costs to subjects (if any) 5. Consequences of a subject's decision to withdraw from study participation 6. Disclosure new findings which may impact a subject's willingness to continue participation

Minimal Risk Alternatives are Clear Research could not be completed without waiver (it would be hard or time consuming is not enough). May also involve waiver of FULLY INFORMED consent (i.e., concealment and deception).

Information about EVERY contact with potential participants and organizations from which participants are recruited. Drafts of Letters. Drafts of Advertisements. Scripts of Phone Calls. Redundancy AND Consistency – Most things are repeated in the protocol AND the informed consent/contact information. Say it the same each time. If they approved it AND you follow it – you don’t get into trouble.