What is the Institutional Review Board (IRB)
The IRB is an administrative body established to protect the rights and welfare of human research participants or subjects recruited to participate in research. An IRB is charged with the responsibility of reviewing, prior to study initiation, all research - whether funded or not - involving human participants.
Our researchers complete a human subjects protection training prior to beginning a study with human subjects. A copy of this certification is submitted to the Board and kept on file. For those who need to obtain certification, we suggest the NIH Office of Extramural Research PHRP Course. It is accessible on the PHRP NIH website: https://phrp.nihtraining.com.
If a study is considered to be research involving human subjects, it will undergo review at one of the three levels:
Full Board Review
Review times are based on several factors, including the number of studies that are in the queue at the time of the submission. It is important to ensure that the IRB protocol submission is complete and free from error.
For studies in collaboration with an institution of higher education, we advised our researchers to coordinate with the university's IRB.
For other studies, please contact Dr. Joshua Matacotta or Edith Gurrola for assistance.
IBHRI uses IntegReview IRB, an independent IRB that provides ethical review to approve and conduct periodic review of biomedical, medical device, social, educational, and behavioral research involving human subjects in the United States, Latin America, and Japan. IntegReview may collaborate with a Canadian-based IRB that conducts Canadian site review. We provide our researchers access to our online platform, IRB Manager, so that they may submit their materials and protocol for review.
Revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating any changes. For studies that are determined to be exempt, the following changes do not require IRB review:
Revising surveys or interview questions with minor edits, if such edits do not alter the nature of the questions asked (e.g., restating the same question for clarity, reordering questions, correcting grammatical errors)
Revising interview or focus group questions to include follow-up clarifying questions
Adding or removing study personnel who meet all of the following criteria: 1) Are affiliated with IBHRI or the PI's institution, 2) are not going to serve as the PI, 3) are not a student conducting the study for a thesis or dissertation
Note: The PI is responsible for ensuring that all study staff have completed the appropriate ethics training before they are added to the study team.
Revising recruitment materials, so long as the four required elements are still present and they conform to IBHRI policy.
Federal regulations allow for expedited review of minor changes to studies previously approved by the full IRB. A minor change is one that makes no substantial alteration in:
research design or methodology
number of subjects enrolled in the research (no more than 10% of the total requested)
the qualifications of the research team
the facilities available to support the safe conduct of the research, or
any other factor that warrants review of the proposed changes by the convened IRB or was used to initially evaluate the risk:benefit ratio, or any other criteria for approval.
A protocol exception is defined as a circumstance in which specific procedures called for in a protocol are not in the best interests of a participating subject. Exceptions may not increase risk or decrease the benefit, affect the participant's rights, safety, or welfare, or affect the integrity of the resultant data.