All research involving the use of human research subjects (participants) must be reviewed and approved by the Hope College Human Subjects Review Board before the research can be initiated.
Governmental agencies use the term IRB – Institutional Review Board – instead of Human Subjects Review Board (HSRB).
Hope College is committed to the ethical treatment of all human participants in research conducted by faculty, staff and students. The HSRB is responsible for reviewing all research involving human participants done under the auspices of the college to ensure that human participants are treated in a just and ethical manner.
The HSRB has the authority to approve, require modification or disapprove research involving human participants. Hope College administration may override an HSRB approval, but may not override an HSRB denial.
The HSRB is responsible for auditing on-going human participant research on campus. Research projects may be randomly selected for auditing, or a decision to audit may be made by the HSRB based on the complexity of the project, potential risk to participants or a history of non-compliance with HSRB regulations.
FEDERAL GUIDELINES FOR TREATMENT OF HUMAN PARTICIPANTS IN RESEARCH
Hope College complies with the regulations of the:
- United States Department of Health and Human Services for the Protection of Human Research Subjects (Part 46 of Title 45 of the Code of Federal Regulations, as amended), and
- Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (also known as the Belmont Report)
The Federal Wide Assurance under which Hope College operates requires us to report to the Office for Human Research Protections (OHRP) any violations, including:
- Research conducted without prior HSRB approval
- Research conducted without informed consent
- More than minor change in research protocol without HSRB notification and approval
- Any unanticipated adverse outcomes
POLICIES GOVERNING HSRB REVIEW
- The process for reviewing HSRB proposals is explained in review procedures. For additional detail on review procedures, meetings, notifications, audits and reporting research violations, please refer to the Federal Wide Assurance for Hope College.
- HSRB decisions will be reported in writing to the investigator and to the college. Electronic records of all proposals submitted, correspondence with investigators and HSRB decisions will be archived. All records shall be retained for at least three years.
- HSRB approval must be renewed annually, and renewal may be required more frequently than once a year if the project involves participant risk.
- Informed consent should be acquired and documented for all research participants or the participants’ legal representative, unless explicitly waived by the HSRB.
- No changes in research protocol and procedures may be made following HSRB approval unless change is to prevent immediate hazard to research participants. All other changes must be submitted and approved by HSRB prior to implementation.
- Research investigators must complete the CITI ethical tutorials prior to submitting to HSRB. Faculty are encouraged to require student researchers to complete all or part of the CITI tutorials as well. Faculty are responsible for training students under their supervision in research ethics.
MEMBERSHIP OF HUMAN SUBJECTS REVIEW BOARD
The board shall have at least six members, including at least one faculty member from each Academic Division, at least one member with an advanced degree in a health-related profession, and at least one community member who is not affiliated with Hope College and has no immediate family member affiliated with Hope College. At least one of the HSRB members must be a non-scientist who represents the interests of those who have no experience in science or research.
- William Polik, Natural Sciences Division
- Liz Cambier (Holland Hospital), Community Member
- Milly Hudgins, Non-scientist
- Katelyn Poelker, Social Sciences Division
- Brian Rider, Social Sciences Division
- Barb Vincensi, Health Professions
- Daniel Woolsey, Arts & Humanities Divisions
A. Paul Schaap Science Center35 East 12th StreetRoom 3107Holland, MI 49423