The purpose of the Institutional Review Board (IRB) is to ensure appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research.
In the case of North Hennepin Community College, the IRB oversight extends to all of those on campus, including enrolled students, faculty, staff, and external parties wishing to include NHCC audiences in their research.
All proposals are submitted using an electronic form created and made secure by NHCC.
- Recommended Submission: 30 days prior to first day of data collection
- Board Review: 14 days (additional days may be required if request for modifications are requested)
Scope and Authority
According to the U.S. Food and Drug Administration (FDA), the IRB has the authority to approve, require modifications, or disapprove research. See below for details on the Department of Health and Human Services (DHHS) regulation to IRB decision-making capacities.
Each IRB shall have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
A quick overview of regulations pertaining to review of research in accordance with the DHHS can be seen below.
DHHS Office for Human Research Protections (OHRP) 46.109 IRB Review of Research
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under §46.104 for which limited IRB review is a condition of exemption (under 46.104 for which limited IRB review is a condision of exemption (under §46104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)).
(b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.
(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
(e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in §46.109(f).
(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:
(i) Research eligible for expedited review in accordance with §46.110;
(ii) Research reviewed by the IRB in accordance with the limited IRB review described in §46.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8);
(iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
(A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
(g) An IRB shall have authority to observe or have a third party observe the consent process and the research.