The following are some of the most Frequently Asked Questions (FAQs) by principal investigators contemplating using human subjects in their research projects:
1. Do I need to get approval from Human Subjects Review Board (HSRB) for my study?
There are several types of studies that do not need HSRB approval, although you may want to seek approval anyway, if it is required by a journal to which you plan to submit an article. To determine whether your study is exempt from needing HSRB approval, refer to the Guidelines.
If you are a faculty member teaching a course in which your students will be conducting individual or group research projects, they may qualify for delegated review.
2. Could my proposal qualify for an expedited review?
Certain projects may qualify for expedited review, wherein only the HSR Chairperson (or designee) and one or more other members of HSR review the request. Expedited review may be requested for research "involving no more than minimal risk, and for minor changes in approved research." A complete list of research activities that may qualify for expedited review is listed in Appendix C.
3. When are the submission deadlines for full proposals?
Generally, the HSRB meets every 3-4 weeks from early September through early May, and the deadline for submission of proposals is 7-10 days prior to each meeting. For a list of the current deadlines, go to the schedule.
4. What do I need to include in my HSRB proposal?
For a convened or expedited review, you need to include a cover page with abstract, a checklist, the 10-part proposal itself (see proposal template), and the appropriate appendices, which includes the subject recruitment statement or flyer, informed consent form, debriefing statements (if appropriate), and any instruments, questionnaires, protocols, etc. used in the study.
Do NOT include a resume or vita for the researcher(s), copies of related articles, a list of references, or anything that is not listed as part of the required appendices.
5. Do I need to use an informed consent form?
There are typically only three times when an informed consent form is not required (1) if the research solely involves observations, (2) if the subjects are only filling out an anonymous questionnaire, or (3) if the research is being conducted to assess the effectiveness of a curriculum unit that is part of the regular classroom curriculum and the unit and assessment are both taught or given primarily by the regular classroom teacher in such a way that it meets the curriculum needs and learning standards and does not take away from the instructional time devoted to regular class work, and has written approval from the teacher(s) and administrator(s), and the parents of the children in the class are generally informed about the process or activity through the regular channels of classroom communication.
6. What should an informed consent form look like, and what information should be included?
You must follow the format for informed consent forms included in the HSRB guidelines; a sample of an informed consent form is available.
7. What is the difference between anonymity and confidentiality?
The term "anonymous" should ONLY be used in situations where the researcher has no possible way to link the subject's responses to their name or physical person. This is typically accomplished by using an anonymous survey that the subject completes and drops into a "drop box." Face-to-face interviews cannot be anonymous. E-mail surveys typically cannot be anonymous, since the person receiving the e-mailed response would generally be able to determine the sender's e-mail address. For more information about anonymity and confidentiality, see guidelines.
8. Whose experience should be included under "Related Experience of the Researcher(s)"?
You should include the current position and previous research experience for all of the researchers listed on the proposal. In the case of student researchers, you should include any experience or training that the student(s) have had, as well as the current position and related research experience for the faculty supervisor of the project.
9. What information must go in the recruitment statement?
You must include a general description of what will happen in the study, how long participation will take, any serious risks for participation, who is eligible to participate (including the statement that participants must be at least 18 years old, unless parental
permission will be given), and how participants go about signing up to be in the study.
10. What if my study involves participants who are under the age of 18?
Written permission must be obtained from the child’s parent or guardian as well as the child himself/herself if over the age of 14 (unless the study is exempt from the need for an informed consent form, as outlined in Question 5 above). Those under 13 should have the project explained to them and assent should be indicated, although they are not required to sign the form.
11. How much technical terminology should I include in my proposal?
Your proposal should be written clearly in layman terms, since the members of the HSRB include individuals who are not researchers themselves or may not be familiar with specific apparatus, medical terms, etc. If you do need to include technical terms or will be using special equipment in your study, please define those terms in an appendix and/or attach a diagram or picture of the apparatus or equipment used.
12. What if I think there are no risks in this study?
There are always likely to be some risks, even if those risks are very minimal. Your phrasing in the proposal and the informed consent form can include reference to few, if any, risks for participating in the study or describing the risks as minimal. Risks for questionnaires, surveys and interviews might include some embarrassment or slight discomfort in answering the questions.
13. How many copies of the proposal do I need to submit?
You need to submit the original plus 10 copies for standard review, and the original plus 2 copies for an expedited review. Be sure that the original has been signed in blue ink by the researcher(s).
14. Where do I submit my proposal?
Submit the copies of the proposal to the Provost's Office on the third floor of the Peggy R. Williams Center. (607-274-3113)
15. How long will it take before I hear whether my proposal has been approved?
For a standard review, you will receive a letter from the Human Subjects Review Board within a few days following the HSRB meeting; see the meeting schedule.
16. How long do I have to keep records?
Records may be destroyed after 3 years. Data may be maintained indefinitely, but protected health information must be destroyed as soon as practical under the research design. Primary investigators are still responsible for keeping all informed consent forms (3 years). Any records that link individual subjects to subject identifiers or codes must be stored securely and should only be used when required by the research design.
17. I am applying for a grant, and may conduct research later on in relation to the grant. I am not sure yet (or am not sure yet just how) the research will be carried out. What do I do?
Granting agencies, particularly those associated with federal programs, may require proof of HSR review. In cases where research has yet to be designed, this letter should be submitted with the grant application. As soon as a protocol is reviewed and approved, the researcher should submit approval documentation from the HSR to the granting agency. Researchers can request a letter of acknowledgement for externally funded research. The letter will state that the Board has been made aware of the potential for the use of human subjects in the research, and will review the appropriate request for review when and if one is prepared.
18. What if I have another question about my proposal?
Contact any member of the Human Subjects Review Board.
