аIJʿª½± Policy on Research Involving Human Subjects
I. Ìý POLICY STATEMENT.Ìý
Pursuant to federal regulations and College policy, all research involving human subjects mustÌýbe reviewed and approved by the College’s Human Subjects Research Review Committee.
II.Ìý APPLICABILITY.Ìý
This policy applies to all research involving human subjects conducted by any member of the College community.
III.Ìý DEFINITIONS.ÌýÌý
Human Subject - A living individual about whom an investigator conducting research obtainsÌý(1) data through intervention or interaction with the individual (e.g. “justÌýinterviewing" people) or (2) identifiable privateÌýinformation. This term should be interpreted broadly.
Minimal RiskÌý- A risk where the probability and magnitude of harm or discomfort anticipated in theÌýresearch are not greater in and of themselves than those ordinarily encountered in daily life orÌýduring the performance of routine physical or psychological examinations or tests.
Minors - Subjects under the age of 18.
Research - a systematic investigation, including research development, testing andÌýevaluation, designed to develop or contribute to generalizable knowledge. Examples of human subject research may include: experiments, interviews, surveys or questionnaires either on paper or electronic, observational studies, filming, and the collection and use of archival data.
Risk - A possible harm to a human subject. Researchers often conceive of risk as potential physical harm or discomfort. However, risk can also be social, psychological, physiological, as wellÌýas physical. Investigators should consider ways to minimize all forms of risk associated with their research.
IV.Ìý POLICY.
In accordance with the College’s Federal Wide Assurance (FWA) maintained with theÌýDepartment of Health and Human Services (DHHS), Office of Human Research ProtectionsÌý(OHRP), all research involving human subjects conducted by or under the auspices of аIJʿª½±ÌýCollege will be performed in accordance with (45ÌýCFR 46).Ìý
As mandated, the College designates and impanels the Human Subjects Research ReviewÌýCommittee (HSRRC) to protect the rights and welfare of human research subjects. The ResearchÌýCompliance Officer is also appointed to oversee the three Institutional Review Boards onÌýcampus: Human Subjects Research Review Committee (HSRRC), Institutional Animal Care andÌýUse Committee (IACUC), and Institutional Biosafety Committee (IBC), as well as to support theÌýinvestigators in their compliance.
A. HSRRC Review
All research involving human subjects mustÌýbe reviewed and approved by the HSRRC. As part of this process, the investigator must identify the possible risks for HSRRC review. HSRRC shallÌýevaluate whether such risks may be beyond the minimal risk.
See more about the review process on the IRB’s Human Subjects Page.
B. Informed Consent
Potential research subjects must be given all available information that might reasonably beÌýexpected for their voluntary participation in the research. Investigators need to help them toÌýunderstand fully the nature of the study being conducted, and the research risks and benefitsÌýassociated with it, so that they can make an informed decision on participation. This informationÌýshould be provided in a culturally appropriate manner and in language understandable to the subject or his/her authorized representative. Academic jargon and highly formal language should be avoided. The general recommendation is that informed consent forms be written at an eighth-grade reading level or lower, especially for studies targeting the general public.
ln addition, the informed consent materials shouldÌýbe free of any language that appears to be coercive, to waive any of the subject’s legal rights, orÌýto release the investigator and/or sponsor from liability for negligence.
Certain groups of human subjects require special consent considerations:
- Minors: require parental/ guardian consent.
- Mentally Disabled: subjects may or may not be capable of giving consent.
- Prisoners: availability as human research subjects is severely limited because their ability to give voluntary consent isÌýlimited by the nature of their incarceration.
C. Student Projects
All student-initiated research must be conducted under the supervision of a faculty member. Student research proposals must be submitted to the HSRRC by the faculty supervisor on behalf of the student. If aÌýstudent will work on a faculty member’s project that already has HSRRC approval, the facultyÌýinvestigator shall submit an amendment to the HSRRC to name the student as a research assistant.
D. Record Maintenance
The faculty principal investigator or the faculty supervisor shall maintain all documentsÌýpertaining to each research project. These documents, including all signed consent forms, and the signed consent forms must be keptÌýfor a minimum of three (3) years following termination of the study, and made available forÌýinternal reviews and external audits as necessary.
E. Noncompliance
Any research project involving human subjects that is carried out without HSRRC approval isÌýnoncompliant. Retroactive approval is not possible. All projects must receive HSRRC approval prior to recruitment and data collection.
For HSRRC-approved research projects, examples ofÌýnoncompliance include any significant deviation from the approved protocol (e.g. materials, procedures, researchers, participant groups) without prior approval of an amendment submitted to the HSRRC and failure to report any unanticipated problems involving risk to subjects or others.
All incidences of noncompliance shall be promptly reported to the Research Compliance Officer,Ìýand to the Dean of the College for possible referral to the Secretary of the Department of HealthÌýand Human Services and for other actions as necessary.
V.Ìý POLICY HISTORY.
Responsible Officer(s): HSRRC Chair
Last Revised Date: June 12, 2024
VI.Ìý RELATED POLICIES AND RESOURCES.