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Human Subjects Review Board Policies
All research involving the use of human research subjects
(participants) must be reviewed and approved by the Hope College Human
Subjects Review Board (HSRB) before the research can be initiated. (Note:
Governmental agencies use the term IRB - Institutional Review Board -
instead of HSRB).
FUNCTION
Hope College is committed to the ethical treatment of all
human participants in research conducted by faculty, staff and students.
The Hope College Human Subjects Review Board (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:
VIOLATIONS
The Federal Wide Assurance under which Hope College operates requires
us to report to the 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, or any unanticipated adverse outcomes. If you are aware
of any violations of HSRB regulations, please contact the HSRB Chair
(hsrb@hope.edu) and the Provost (ray@hope.edu).
POLICIES GOVERNING HSRB REVIEW
- The process for reviewing HSRB proposals is explained in 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.
2013-14 Board
Karen Nordell Pearson, Chair
Barbara Vincensi, Nursing Department
Jonathan Hagood, Arts & Humanities Division
Kevin Cole, Social Sciences Division
Denise Bakker, Holland Community Hospital
Daryl Van Tongeren, Psychology Department
Lezlie Gruenler, Non-scientist staff member
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