Title 45 of the Code of Federal Regulations (CFR), Part 46, Protection of Human Subjects, defines a human subject as a living individual about whom an investigator conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information.
The CFR definition of research on a human subject specifically excludes 1) Research conducted in established educational settings, involving normal educational processes; 2) The use of educational tests, surveys, interviews, observations of public behavior, and; 3) The collection or study of existing publicly available data, so long as (i) subjects cannot be individually identified, and (ii) any disclosure of the human subjects responses outside the research could not reasonably place the subjects at risk of harm or liability. Public statements by responsible officials in the normal course of business are not subject to confidentiality restrictions. Performance evaluations and other work-related assessment tools, and investigations into alleged misconduct or malfeasance by responsible personnel are not human subject research for the purposes of this policy, but do come under federal and state guidelines for confidentiality.
- The college shall establish an Institutional Review Board (IRB) to review proposals determined by the IRB chair to be human subject research, in consultation, when necessary, with the membership of the IRB. The membership of the IRB consists of the dean of instruction, the director of institutional research, Kirtland’s FOIA officer, and Kirtland’s FERPA officer. If not already included, the dean of student services shall join when student subjects are requested, and the director of human resources shall join when employees are requested. The president shall designate the IRB chair and appoint other staff as may be appropriate to review a particular request.
- The IRB is authorized to review, recommend approval, request modifications, or recommend disapproval of research activities using human subjects. Requests for research activities are to be directed to the office of the president, who will inform the chair of the IRB in a timely manner when a request is received by the college. The chair will convene the IRB within 10 business days, and the IRB will provide a draft written response to send the requestor within 5 business days after that meeting. The IRB does not evaluate the soundness of the proposed study, the merits of the design, nor the potential contribution of the research. The recommendation of the IRB is based on whether a project meets requirements for such matters as informed consent, confidentiality, and any risk to the participants.
- When submitting a proposal for human subject research, researchers are advised to provide the following:
- Title of the study and summary of the research to be conducted,
- Purpose of the study (including the expected benefits obtained by doing the study and how risks are reasonable in relation to expected benefits),
- Subject inclusion/exclusion criteria (including scientific and ethical reasons for excluding subjects who might otherwise benefit from the research),
- Description of procedures to be performed,
- Provisions for managing adverse reactions,
- Circumstances surrounding consent procedure, including setting, subject autonomy concerns, language difficulties, vulnerable populations,
- Procedures for documentation of informed consent, including any procedures for obtaining assent from minors (‘minor’ is defined in Michigan as an individual under the age of 18), using legally authorized representatives, witnesses, translators and document storage,
- Remuneration to subjects for their participation and/or any compensation for injured research subjects,
- Provisions for protection of subject’s privacy,
- Extra costs to subjects for their participation in the study.
- Per the exclusions noted under CFR definitions of research, internal surveys or interviews on Kirtland-specific matters compiling aggregate data conducted under the direction of Kirtland faculty or staff for instructional, business or reporting purposes are not subject to these requirements. Interviews of agreeable Kirtland students and staff for the purposes of reporting news and opinion, and of staff on work-related matters within their areas of responsibility, or interviews in which the subjects are not personally identified, would not require a formal review. Simple data requests of Kirtland staff from outside sources that do not involve individual human subject research would likewise not require formal review. When in question, the IRB committee chair is authorized to determine whether a request constitutes a human subject research project requiring a formal review.
- Appeal of a decision can be made to the president of the college. The president’s decision is final.
To view the policy, go to POL 4.095 Human Subject Research at Kirtland Community College