- 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 Collaborative Institutional Training Initiative (CITI) ethics training. Your CITI certification is good for three years. 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 seven 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 Hope College 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 Hope HSRB 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 your proposal to the HSRB chair at firstname.lastname@example.org.
- What are the levels of review?
The levels of HSRB review include:
- Exempt: Studies that meet the criteria for exemption established by federal guidelines
- Expedited: Studies that involve no or minimal risk
- Full: Studies that involve a greater than minimal risk, deal with questions of a sensitive nature, or involve minors or other vulnerable participants
The level of review depends on the risk to the human participants. Full review is required for research that contains “at risk” procedures. Participants are “at risk” when researchers ask them to do procedures that involve more social, emotional and/or physical harm than they experience in their everyday lives. 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.
- As a researcher, is it my responsibility to assign a level of HSRB review to my project?
- While completing the research application, the investigator will be asked to propose a level of HSRB review. Level of review is closely tied to level of risk participants experience. See the “What are the levels of review?” answer above.
- If I make 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 three 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.
- Who can sign the consent form on behalf of a minor or other participant incapable of giving consent?
- Is an English consent document acceptable 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, participants incapable of giving consent and vulnerable populations.
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