Institutional
Review Board (IRB)
Frequently asked questions
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
informed consent process
the degree to which the science of the research warrants the risk to human
subjects
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.
a. Does your project
involve human subjects? As an investigator,
will you interact with a human subject
or any identifiable private information on individuals? 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.
If yes, see b. below, if no, then no IRB review is required.
b. Is your project research as
defined under the Common Rule (45cfr46)? Is your project a systematic investigation designed to contribute to "generalizable" Knowledge? “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 either through a publication or an off
site presentation.
If yes, then your study involves human subject
research. The project must be reviewed by the IRB.
Yes, only the Division 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 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
Research Office, Division of Compliance. Proposals requiring full board review will be reviewed at the next
monthly meeting. Paper work must be
received by the Division of Compliance 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 training modules on the Responsible Conduct of Research
using Human Subjects will take about 2 hours to complete depending upon the
individual. Those people trying to
access the tutorial without using the URI dial-up must call the Office of Compliance in the Research Office for passwords.