Do You Need IRB Review?
IRB Review is required if your project meets one of the following criteria.
- Does the project constitute research, based on the federal definition?
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
- Will findings from the project be disseminated outside of the university?
- Does the project involve a vulnerable population per 45 CFR 46 Subpart B, C or D ?
- Does the project involve any of the following:
- Violation of Privacy: Collection of data concerning at-risk or socially questionable behavior (for example, questions about substance use or sexual activity) is viewed by many individuals as violations of privacy.
- Legal Risks: Data concerning illegal behaviors may place individuals at risk of legal action, if (a) names can be linked to particular responses or observations and (b) the research has not received specific legal protection (e.g., by Certificate of Confidentiality).
- Psychosocial Stress and Related Risks: Procedures that raise sensitive issues may generate stress for participants. For example, questions about at-risk behaviors may cause students to feel stress related to their self-image or contribute to perceived peer pressure.
- Risks to Participants’ Social Relations: Because relevant questions often request information about the behavior, or relations with, family members, peers, or authorities, some procedures may pose a risk to those relations if confidentiality is not adequately safeguarded.
If the proposal includes any of the above, a review is required. If the proposal does not involve any of the above conditions, an IRB review is not required.
Projects without IRB approval may not be disseminated in written form or in public presentations outside of Endicott College.