1. What is an IRB?
An IRB is a committee within the University that reviews research proposals that use human subjects as participants in research. The IRB reviews the proposals to determine if the research project follows the ethical principles for the protection of human subjects as required by federal and University regulations. The IRB has the authority to approve, disapprove, or require modifications of these projects.
2. The IRB looks specifically at:
Degree of risk to subjects vs. benefits, recruitment methods, and informed consent process.
3. Who serves on an IRB?
An IRB consists of at least five members of varying backgrounds. An IRB must have at least one scientist member and at least one member whose primary concerns are of a non-scientific nature. Additionally, there must be one member who is not affiliated with the institution (community member). The IRB should strive for cultural diversity and members should have the experience to provide appropriate scientific and ethical review.
4. How do I know if my project needs IRB review?
a. Does your project involve human subjects? As an investigator, will you interact with a human subject or any identifiable private information on individuals? Human Subject research studies may involve a variety of invasive or non-invasive procedures, including removal of body tissues or fluids such as blood, hair or saliva, administration of drugs, exposure to various forms of radiation, alteration of diet or environment, interviews, surveys, simple observation, administration of questionnaires, or review of records.
b. Is your project "Research"? "Research" is defined by the Department of Health and Human Services as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR46). This means the data will be made publicly available, usually either through a publication or an off site presentation.
If there is any question about whether a proposed project constitutes human subject research, email the Compliance Office at firstname.lastname@example.org
5. If I know my project is exempt, do I still have to submit an application for IRB review?
YES. Only the Director of Compliance or the IRB Chair may make the final decision as to the category of review assigned to a research project. EXEMPT DOES NOT MEAN IRB REVIEW IS NOT REQUIRED. At the University of Rhode Island, all research projects involving human subjects are reviewed to assure adherence to the ethical standards required by federal and University regulations. URI Policy requires review of all levels of research that involves human subjects, even projects that meet the federal definition of exempt.
6. How long will it take for my proposal to be reviewed?
It depends on the type of review required. Exempt and expedited reviews are done as they are received by the Compliance Office. Proposals requiring full board review will be reviewed at the next monthly meeting. Paperwork for a full board meeting must be received in the Compliance Office at least two weeks before the monthly meeting of the IRB. Incomplete paperwork will delay the process.
7. How long will the RCR web-based training modules take to complete?
The CITI course on the Responsible Conduct of Research using Human Subjects will probably take about 2 hours to complete, depending upon the individual.