- If you are conducting “research" and
- If human subjects are involved, either directly or through the use of identifiable data about them.
If you are conducting research with humans as defined in the context of the IRB, you MUST apply for IRB approval before beginning your research. Still not sure?
- Consult a decision chart of what needs IRB approval
- Review the BHCC IRB Handbook
- Consult the IRB Chair
If I do need IRB approval, how do I apply?
Please note the IRB has the authority to approve or deny approval to research projects involving human participants when conducted by or under the direction of any employee, student, or agent of BHCC in connection with their institutional responsibilities or using any institutional property or facility. Also, the IRB reviews research protocols of non-BHCC investigators when BHCC faculty, staff, or students are involved. The IRB has statutory authority to take any action necessary to protect the rights and welfare of human subjects participating in research.
Principal Investigators who wish to conduct IRB approved research involving BHCC faculty, staff or students must also get permission from the College. Please contact the Provost’s Office regarding these requests. BHCC reserves the right to decline to participate in IRB approved research project
- IRB Application Checklist 2019 Common Rule
- IRB Consent Form Checklist 2019 Common Rule
- IRB Recruitment Checklist 2019 Common Rule
Policies and Procedures
- Applications will not be reviewed if they do not have all of the required elements, as detailed in the checklists linked below. Broadly, the application must make clear to the reviewers that the elements of the proposed research project conform to accepted ethical standards; that the investigators are trained in appropriate research protocol; that the goals of the project justify the proposed procedures; and, above all, that the participants' well-being will be prioritized.
- Applicants external to BHCC may apply only under the aegis of a sponsoring institution (academic or otherwise), and only with the contact information and proof of approval from the sponsoring institution. Any project proposed as part of an undergraduate or graduate degree program must be submitted with the faculty research supervisor listed as principal investigator; and must include the contact information for the department Chair, where applicable.
- The determination of Exempt status is strictly the prerogative of the BHCC IRB. Proposals from external applicants, even when granted Exempt status by the IRB at the applicant’s home institution, will at minimum require a limited review.
- Funding sources for any proposed financial incentives to participants must be secure at the time of application to the BHCC IRB, and specified in the application.
- Regardless of proposal status, both IRB approval and site use permission must be granted before any recruitment or other research activities may begin.
- Any member of the College community may contact the IRB if they have concerns about recruitment materials and/or the administration of an already-approved research project. However, in the event that a proposal is denied IRB approval, only the investigators named on the original proposal may contact the IRB for further discussion. Any denial of site use permission is binding. Under no circumstances may anyone not named on a proposal contact the IRB to lobby for approval or for site use permission.
BHCC Institutional Review Board Exemption Application
The 2018 revision of the Common Rule expanded the types of research eligible for “Exempt” status. Because these officially require, at most, a limited review, researchers are invited to submit an overview of their proposed project in lieu of BHCC's full application if it is likely to fall into one of the exemption categories (see 45 CFR 46.104 for details). Examples of these include:
- Normal classroom/educational activities
- Educational tests, surveys, or interviews
- Benign behavioral interventions
Please note that applications from external researchers will be given limited review of their application even if this would not be strictly required under the Revised Common Rule. Under all circumstances, a proposal must obtain both BHCC IRB approval and site use permission before recruitment for research activities may begin.
In order to apply under potential Exempt status, please submit a brief summary of the proposed research, including information on how participants will be recruited, how consent will be obtained, and how data will be anonymized/protected/accessed/stored. If you are not a BHCC affiliate, please include a copy of your application and approval letter from the IRB of your sponsoring institution.
Feel free to contact Karen Atkinson, BHCC IRB Chair, with any questions at firstname.lastname@example.org