Frequently Asked Questions
The Basics
To Apply or Not to Apply
The Review Process
After Approval
Informed Consent
The Basics
What is the Human Subjects Review Board (HSRB)?
The HSRB is a group of scientific and non-scientific individuals
who conduct the initial and ongoing review of research studies in order
to
ensure the protection of the rights, safety, and well-being of human
subjects participating in those studies. The federal code of regulations
governs the composition and conduct of the HSRB (Title 45).
How is Hope College’s
HSRB different from an Institutional Review Board (IRB), an Independent
Ethics Committee (IEC), or an Ethical
Review
Board (ERB)?
It is not. Hope College’s HSRB fulfills the
same role as an IRB, an IEC, or an ERB at another institution.
Are "Human Research Participants" different from "Human
Subjects"?
The phrases "human subjects" and "human research participants" can
be used interchangeably. The disadvantage of using the term "human
subjects" is that it objectifies the people who have volunteered
to take part in the research.
What does CITI mean?
CITI refers to the Collaborative
Institutional Training Initiative (CITI)
the primary means by which researchers
receive training in the ethical treatment of human research participants.
Where do I get training in the ethical treatment of human research participants?
All Hope faculty who do exempt and nonexempt work with humans
still have an ethical responsibility to their participants, and are
required
to complete CITI (Collaborative
Institutional Training Initiative)
ethics training. Your CITI certification
is good
for 3 years, and is kept on file in the Frost Center. You must complete
your CITI training before submitting a request for exemption or a proposal
for HSRB review.
What is the Belmont Report?
The
Belmont Report is a report released in 1979 by the United States
Department of Health, Education, and Welfare (today's Department of Health
and Human Services,
or HHS) entitled “Ethical Principles and Guidelines for the Protection
of Human Subjects of Research.” The Belmont Report explains the
fundamental ethical principles for using any human research participants
that form the basis for the HHS human subject protection regulations
and are an essential reference for Hope College's HSRB and equivalent
institutional review boards.
How do I receive HSRB approval for a research study to be conducted
at Hope College or by faculty, students, or staff at Hope College?
Go to Submitting a Proposal to
complete and submit the required forms for HSRB review.
What happens if I involve human research participants without HSRB approval?
You
will be out of compliance with federal requirements for human subject
research. This can result in federal or Hope College actions that will
prevent you from conducting human subject research and can jeopardize
Hope College’s human research certification and federal funding.
To Apply or Not to Apply
How do I know if I need to apply for HSRB approval?
The
HSRB is only charged with reviewing research that involves people as
research participants. Refer to the Hope
HSRB Decision Tree to determine
if your research needs to be reviewed.
How do I determine if my research is exempt
from HSRB review?
The
federal guidelines have established criteria to determine what types
of research are exempt from HSRB review. Check the HSRB
Exemption Guidelines
to determine if your research is exempt. Studies involving vulnerable
populations including
pregnant women, fetuses, prisoners, minors/children (<18 years of
age) and persons with cognitive disabilities are ineligible for exempt
status.
Researchers must obtain approval from the HSRB chair that their research
is exempt from formal HSRB review. Complete and submit the HSRB
Request for Exemption Form. The HSRB chair will review your request
and respond to you within 7 business days.
Even if your research with human subjects is exempt, you still have
an ethical responsibility to your participants, and are therefore required
to complete CITI ethics tutorials.
If I submit a grant proposal, do
I need to acquire HSRB approval beforehand?
Yes, you can submit an HSRB application at the time you apply
for the grant. Depending on the sponsor, you may also wait until you
know if
you will receive the award. Please note that the Office
of Sponsored Research Programs will not release
the funding until there is an approved protocol.
Do students’ academic research projects require HSRB approval?
Student
research that involves human subjects, whether of a biomedical or social-scientific
nature, requires approval or granting of exemption
by the HSRB prior to initiation. Please note: Student researchers are
required to obtain a faculty sponsor for each project, and the sponsor
is responsible for working with the student to develop the HSRB application;
this should be in final form when submitted to HSRB. Hope College’s
HSRB cannot assume responsibility for teaching students how to design
or write up their research protocols. The decision
charts are useful in determining whether or not your student projects
require HSRB approval.
Do I need approval by Hope College’s HSRB if a review board
at another institution has already approved my study?
Yes, the
host institution, along with participating institutions must review and
approve the research activities. If the host institution is
unavailable, Hope College’s HSRB must review the activity, and
approval by Hope College’s HSRB will be the formal approval of
record for the research.
Do I need HSRB approval if I will conduct my research outside
of the campus or in another country?
Yes, to ensure that investigators
comply with federal and College regulations, it is important that the
College, through the HSRB, be aware of all research
conducted by employees and students of the college. This also includes
research conducted in other countries and research conducted at other
institutions. Formal approval must also be granted by the equivalent
of the College’s HRSB in the host institution or country. The HSRB
must receive and confirm this formal approval. If none is available,
approval by the College’s HSRB will be the formal approval of record
for the research.
My research does not involve human participants, but I must still
assess my research assistants and their experiences at the end. What
are my
ethical obligations?
If you are writing a recommendation letter for the student, use your
normal procedure. HSRB guidelines do not pertain to this situation.
If
a funding agency wants your assessment of many students who were in your
department's research labs, this assessment is likely
to be exempt
from formal HSRB review (see types of exemption at Federal
Code Part 46, specifically 46.101). Submit a Request
for Exemption.
ALL researchers who assess humans should complete the CITI tutorials.
Federal funding agencies (e.g., National Science Foundation) require
researchers who do any assessment with humans to know and follow the
Belmont Report and
the Code
of Federal Regulations. Violating those guidelines can
result
in money being revoked, financial penalties to Hope, hurt reputations,
and the federal government halting research.
I am going to apply for funding from a federal agency (e.g. NIH or NSF)
and my proposal will include surveying students, do I need HSRB approval?
If you are doing any kind of interaction with human subjects, federal
funding agencies require that you have either an exemption or approval
from an HSRB at the time the proposal is submitted. See the Decision
Tree to determine which is appropriate in your case.
The Review Process
May I begin my research before I receive HSRB approval?
No. The HSRB must approve research before it may be conducted.
Where
do I send my completed proposal?
Please send it to the HSRB Chair, Deirdre Johnston, PhD, at hsrb@hope.edu.
What are the levels of review?
The levels of HSRB review include exempt, expedited, and full.
The level of review depends on the risk to the human participants. To
determine
the level of risk to the human participants, use the risk assessment
flow chart. The same application procedures and forms
are used for all levels of review. For a detailed description of how
the review process varies by level of review, go to HSRB
Review Procedure.
- Exempt: Studies that meet the criteria for exemption
established by federal guidelines.
- Expedited: Studies that involve no or minimal risk
- Full Board Review: Studies that involve a greater than minimal
risk, deal with questions of a sensitive nature, or involve minors
or other
vulnerable participants.
As a researcher, is it my responsibility to assign a level of HSRB to
my project?
While completing the research application, the investigator
will be asked to propose a level of HSRB review. To determine
the level of review
required, consult the risk assessment flow chart [WHICH CHART?].
After Approval
If I make any changes in my protocol, am I required to re-apply
for HSRB review?
Yes, any changes to your protocol must be reviewed and approved
by the HSRB prior to the implementation of those changes. In most cases,
however,
this can be done quickly through an expedited review. Complete and submit
the Modification of Prior-Approved
Research Application.
Does
the HSRB continue to review projects once they have been approved?
Yes. By federal regulation, the HSRB is required to continually
review research. Approval is usually given for one year. An Application
for
Continuation of Research must be completed and submitted
prior to the end of the approval year.
How often do I need to update my training on the protection of human
research participants?
The training is valid for 3 years.
Do my co-primary investigators and
student research assistants need formal training on the protection
of human
research participants?
All primary investigators working on
an HSRB-approved research project need to receive and maintain current
CITI Certification. It is the responsibility
of the primary investigator to make sure that student research assistants
understand fundamental ethical principles for using any human research
participants.
Hope College’s
HSRB strongly recommends but does not require that student research assistants
obtain CITI Certification. In contrast, students who submit an application
to the HSRB as Primary Investigators MUST have current CITI Certification.
Informed Consent
Who can sign the consent form on behalf of a minor or other
participant incapable of giving consent?
Is an English consent document
OK when enrolling non-English-speaking participants?
How do you obtain
consent from someone who speaks and understands English but cannot read?
The
CITI Informed Consent training module outlines the signatures and
procedures required when working with minors, participants speaking
multiple languages,
and participants incapable of giving consent, and vulnerable populations.
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