All About the Institution Review Board! Jennifer A. Jones, M.S. Jessica P Lauren E. Ewaniuk M.Ed ED 510 Fall 2011

What is an Institution Review Board? An internal review board (IRB) is an American committee whose primary function is to “protect the rights and welfare of research subjects” (Amdur & Bankert, 2010 p. 5). The IRB also serves as an ethical guide to researchers, defining what is right and wrong while conducting research with human subjects (Amdur & Bankert, 2010). IRBs can be found at all colleges and universities where research is conducted (Cotterelle & McKenzie, 2011). Though there is no law requiring independently funded research to be approved by the IRB, both the Department of Health and Human Services and the Food and Drug Administration require IRB approval to conduct research on human subjects (Amdur & Bankert, 2010). Gaining approval from an IRB ensures that research is being conducted in coherence with federal laws designed to maintain the safety of human subjects (Cotterelle & McKenzie, 2011).

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Who Comprises an IRB? An internal review board (IRB) is comprised of at least five members with diverse areas of study to create sufficiently representative opinions (Cotterelle & McKenzie, 2011). However, most IRB s are comprised of at least 10 members to meet the diversity requirements. An IRB must be comprised of persons with expertise to serve and knowledge of federal standards for research with human subjects (Cotterelle & McKenzie, 2011).

Members must also represent diverse groups. For example, an IRB must include men and women as well as members of various races and cultural backgrounds (Cotterelle & McKenzie, 2011).

Additionally, a member cannot be affiliated with the institution requesting approval (Cotterelle & McKenzie, 2011).

What are the general tasks of an IRB? The IRB must: - Identify the risks associated with the research - Determine that the risks will be minimized as much as possible - Identify the possible benefits from the research - Determine that the risks are reasonable in relation to be benefits to subjects, if any, and the importance of the knowledge to be gained - Assure that potential subjects will be provided with an accurate and fair description of the anticipated risks, discomforts, and/or benefits

Tasks of the IRB Continued - Conduct periodic review and determine that provisions are in place for monitoring the data collected - Check to ensure the researchers are protecting the privacy of the subjects and maintain the confidentiality of the data Provides guidance to investigators regarding how to best protect the rights of human participants by ensuring that the researcher follows research protocol and completes all consent forms Provides ethical guidelines the researchers must follow to protect their study’s participants Protect the rights and welfare of human research subjects involved in the research activities The IRB has the authority to approve, require modifications, or disapprove all research activities.

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What Are The IRB’s Greatest Concerns? The Institutional Review Board greatest concern is to assure protection, safety, and the welfare of human subjects to make sure that researchers are following the National Research Act of ethical and sound principles To ensure that the informed consent -clearly states all the risks to the subjects -provides full disclosure of what will be expected of the participant -Is not coercive

References Admur, R. J., & Bankert, E. A. (2010). Institutional Review Board: Member Handbook (3rd ed.). Sudbury, MA: Jones & Bartlett Publishers. Cottrell, R.R., & McKenzie, J.F. (2011). Health Promotion and Educational Research Methods (2nd ed.). Sudbury, MA: Jones and Bartlett Publishers. Widener University. (2011). Institutional Review Board. Retrieved from vost/irb vost/irb