ANY activity involvng humans as participants in research must gain approval
or exemption from the HSRB before the research may be undertaken.
To determine whether your project constitutes human research that requires
review, use the Hope HSRB Decision Tree.
The HSRB Committee reviews proposals as they are submitted.
- Research cannot commence before formal notification of approval
HSRB reviews protocols that are minimal risk
or below with an average turn-around time of two weeks.
- Studies that are deemed to include more than minimal risk are reviewed
at HSRB meetings, called by the HSRB chair. Turn-around time for these
proposals is generally four weeks.
Please note that turn-around time is dependent on the submission of
a complete and accurate proposal as well as the Primary
Investigator's responsiveness to the review requirements and requests.
Poorly written proposals are the largest source of delays and frustration
for applicants. Incomplete proposals will be returned to the investigator
GENERAL REVIEW PROCEDURES
The HSRB uses criteria 46.111 of the Federal
Code to evaluate research
and criteria 46.416 to evaluate Informed Consent forms.
Approval is typically granted for one year, but the Board may require
reports or reviews of the project at 3, 6, or 9 months.
The primary investigator of the project will be notified of the Board's
decision in writing. The investigator may be asked to file an amended
application reflecting any recommended changes with the HSRB by a stated
The Hope College administration may rescind an HSRB research approval,
but may not override an HSRB research denial.
REVIEW PROCEDURES FOR NEW RESEARCH
If the investigator indicates on the HSRB Application
for New Research Involving Human Subjects that the proposed project
involves no risk to participants, and if the chair of
the HSRB agrees with that assessment,
the chair will distribute copies of the plan of investigation to three
board members. If the three members provide the chair a written notice
of approval of the project, no meeting will be held, and the chair shall
give formal written HSRB approval of the project for up to one year.
may offer approval with the provision that minor procedural changes
be made in the protocol. If the suggestions appear to the chair to be
and the chair conveys them to the investigator, and the investigator
agrees to implement the suggestions, it will not be necessary to convene
the board to discuss them. The investigator will be asked to file an
amended application reflecting any recommended changes with the HSRB
by a stated deadline.
If at least one member of the board does
not want to approve the project without a meeting, or if the chair
believes that the suggestions offered by one or more board members should
discussed, then the chair shall schedule a meeting for a full review
If the investigator indicates on
the Application for New Research
Involving Human Subjects that the
proposed project involves putting the
participants at risk or if the HSRB chair disagrees
with the investigator's assessment that the project involves no risk
to participants, the chair
will distribute copies of the plan of investigation to each board
The chair will schedule a meeting to discuss the project. At the full
board review meeting, at least four members of the board must vote.
A majority of those voting must agree to one of the three following
- HSRB approval of project
- HSRB rejection of project
- HSRB approval of project with modifications
REVIEW PROCEDURE FOR MODIFICATION OF PRIOR-APPROVED RESEARCH
modifications are made to research procedures at any time during the
HSRB approval period (typically one year from approval date), a Modification
of Prior-Approved Research Application is required. Expedited review
by the HSRB chair or designated member is allowed if modifications
not change the initial risk assessment of a no-risk proposal. If the
initial proposal was classified as "at risk," modifications
may be brought before full board review, at the discretion of the HSRB
of modifications does not change the original HSRB approval expiration
date indicated in the original HSRB approval letter.
REVIEW PROCEDURE FOR CONTINUING RESEARCH
guidelines mandate that the HSRB assesses risks, potential benefits,
informed consent, and safeguards for human
subjects both at
the initial review and when researchers file a Continuing
Research Application. Initial
are good for up to one year. When conducting continuing review, the
HSRB needs to determine whether any new information has emerged, either
research itself or from other sources that could alter the HSRB’s
previous determinations, particularly with respect to risk to subjects.
any unanticipated problems involving risk to participants or others
that occurred since the previous HSRB review will also be relevant to
decision about continued approval.
Expedited Review of Continuing Research can
occur in two possible ways:
A) Expedited review by HSRB chair or designee
- If the initial study was minimal risk AND no additional risks are
- The research is permanently closed to the enrollment of new participants,
participants have completed all research interventions,
and the research is active only for long-term follow-up of participants,
- Continuing research activities are limited to data analysis.
B) Expedited review by three Board members
- If the continuing research has only minimal-risk.
Full HSRB Review of Continuing Research
If the initial procedures were more-than-minimal risk,
new risk issues emerged over the year, or the continuing research includes
additional risk issues, the review will be made by a quorum of the HSRB
at a convened HSRB meeting. The
attend this meeting to address questions.
REQUEST FOR EXEMPTION
Hope faculty who do exempt and nonexempt work with humans still
have an ethical responsibility to their participants and still
need to take the CITI
Research that qualifies as exempt must receive formal exemption from
the HSRB. The primary investigator should consult the exemption
guidelines for more details. A request
for exemption will be reviewed by the HSRB
chair. If the chair agrees, a formal exemption will be provided. If not,
the chair will request that the primary investigator submit a full application
for HSRB approval.
REQUEST FOR EXCLUSION
Oral history projects may,
if certain criteria are met, be excluded from HSRB review. Please see
our Oral History Projects page for a more complete discussion.