FORM A. General Information Sheet Instructions
Most questions in the General Information Sheet (GIS) section are self-explanatory, however, for your convenience, further clarification for several of the questions has been provided below:
- For Question #5, HHS [45 CFR 46.102(f)] and FDA [21 CFR 56.102(i)] state that minimal risk in a normal subject population is where “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.” Minimal risk may be re-defined for vulnerable populations – see the forms under Section 5 of the IRB application for special populations (e.g., Form T thru Form W).
- Question #6 requests that you provide the dates you anticipate being able to begin your research, and when you anticipate being finished with your research. Note: These dates will not necessarily coincide with your IRB approval period. If during the course of your research, you realize that you will not be done by the anticipated ending date you provided to the IRB, you may either submit a request to modify the anticipated end date (referred to as an "extension" request), or adjust the date at Continuation Review time.
- Question #8 requests that you indicate which categories of subjects you intend to recruit for your study. Some of the subject categories will require that you seek other approvals, or complete a form for that subject population in order to ensure the IRB addresses the appropriate criteria for inclusion of that population in your study.
- Question #12 requests that you indicate which items apply to your research. Certain items may require that you complete and attach a form in order to ensure the IRB addresses the appropriate criteria for that component of your study. In addition, identifying which item(s) apply to your research enables accurate reporting through a database in the Office of Research Integrity (e.g., upon request, ORI may need to generate a report of all research involving deception, or placebo controlled trials).
- Question #13 requests that you indicate the type of funding you have obtained or plan to acquire in order to conduct the research. Note: NIH, CDC, HRSA, and SAMHSA, are all agencies of the Department of Health and Human Services (DHHS). If you are funded by NIH, CDC, HRSA, and/or SAMHSA, please checkmark the applicable funding agency and HHS.
- Question #16 requests that you specify whether your research falls under the purview of one or more of the committees listed. See Section 7 of the IRB application for details and instructions about additional materials required for IRB review if your research falls under the purview of one or more of the committees listed.
- Question #17 requests that you indicate all the sites at which your research will be conducted. If the research is being conducted at any non-UK facility, additional materials may be needed. See Section 4, Form N of the IRB application for details.
- Question #19 asks if you need additional certification. You may need the additional certification if your study is federally funded. If you answer "yes" to Question #19 the Office of Research Integrity will prepare the certification form and obtain the authorizing official's signature. The completed certification form is sent to the investigator, who is then responsible for submitting the form to the sponsor/agency.
- to be continued