Definitions

AAHRPP: Association for the Accreditation of Human Research Protection Programs. This accrediting body is governed by a consortium involving U.S. research institutions with the goal of standardizing and improving Human Research Protection Programs throughout higher education. Utah State University received full accreditation on March 27, 2009, and is valid for 3 years.  We are now in the process of re-applying for a 5-year re-accreditation and are preparing for site visitors in November, 2011.

Certificate of Confidentiality: The privacy of participants involved in research is protected through the COC. These certificates are issued by The National Institutes of Health (NIH) and various health and human service agencies; OHRP does not issue a COC. This certificate allows the researchers who have access to research records, to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. COC may be granted for studies collecting information that, if disclosed, could have adverse consequences for participants, such as damage to their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research participants, COC help to minimize risks to participants by adding an additional level of protection for maintaining confidentiality of private information.

Coercion and Undue Influence: Subject populations with circumstantial characteristics such as easy availability, compromised position, and susceptibility position, and susceptibility to manipulation make them susceptible to coercion and undue influence. Examples of such populations include students, employees of research institutions, prisoners, patients in mental institutions, patients with life-threatening conditions, and military personnel, all of whom may have subservient or dependent relationships of some kind to the investigator. Subjects may inappropriately be told that their jobs, promotions, or grades are contingent upon research participation. Additionally, if an investigator also serves as a patient’s primary care physician, the patient may feel obliged to participate in the research to please and express gratitude, or out of fear that declining to participate in the study will result in resentment or abandonment.

Conflict of Interest: Conflict of Interest is defined as, “a set of conditions in which an investigator’s judgment concerning a primary interest (e.g. subject’s welfare, integrity or research) may be biased by a secondary interest (e.g. personal gain). (Other sources of conflict of interest include: respect of peers, appointments, promotions, tenure, grants, fame, prizes, authorship on publications, equity holdings in commercial sponsors, consulting fees, royalties, patent rights and honoraria. Any of these may be problematic if linked to the sponsor of research or the product under study).” (Amdur and Bankert, 2002). The IRB is required to review conflict of interest.

Native American: Many tribal communities have their own IRB. The Navajo Nation established a Human Research Review Board in 1995. The Navajo Nation’s Council enacted a research code developed to protect the privacy and interests of their culture. All data resulting from research in the nation remains the property of the Navajo. They have a rigorous approval process requiring support from the community, progress reports, a final report, presentation at an annual conference and community feedback at the conclusion of the study and prior to publication. Publication of the research requires approval of the manuscript including required changes before publication. Contact the IRB if your research involves Native Americans.

Tissue Banking: Health Insurance Portability & Accountability Act (HIPAA) — In the course of conducting research, researchers may create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose HIPAA for research with individual authorization or without individual authorization under limited circumstances. Please contact the IRB Office for proper documentation, use and approval in your research.