Skip Navigation Links

Infopath Questionnaire

OEP has developed a quick decision tool that should assist you with determining if your research involves human subjects, may be considered exempt from the Federal regulations or is not considered human subjects research. This tool should not be used as the sole determination of exemption. This tool should be used in conjunction with the instructions for preparing the Protection of Human Subjects section with your NIH application or proposal.

Please check which best describes your research:
Will this study involve any of the following (select all that apply):
Please check the most appropriate description regarding access to subject identifiers or the ability to link specimens or data to the identifiable information (including name, social security number, medical record, or address) of a living individual (select 1):
Please provide additional information regarding your study (select all that apply):

Your study is considered non-exempt human subjects research. In your NIH application, you should: Check “Yes” to Human Subjects. Check “No” to Exempt from Federal regulations. You must submit a complete Protection of Human Subjects section.

If your study involves a clinical trial you must include a Data and Safety Monitoring Plan (DSMP) commensurate with the risk of your study.

If your study involves an NIH-defined Phase III or multisite clinical trial your DSMP must include a Data and Safety Monitoring Board.

If funded, you will need:

  • certification of approval from your Institutional Review Board (IRB)
  • to provide your institution’s Federal wide Assurance (FWA) number
  • and, certification that all key personnel have received human subject's education.

If your research only involves the study of acceptable educational practices (such as testing a new in-class learning tool for teaching math or an e-Learning method of teaching anatomy) in a normal educational setting your study is most likely considered exempt from the human subjects regulations, category 1 (Exemption 1). In your NIH application you should: Check “Yes” to Human Subjects. Check “Yes” to Exempt from Federal regulations. Check “1” for which exemption. You will need to provide a detailed justification in the Protection of Human Subjects section that explains why your study is considered to be exempt from Federal regulations, category 1 (E1). If your study is funded, you will have to provide certification that all key personnel have received human subject's education.

Because you or someone on your study team has access to the subject identifiers linked to the specimens or data, your study is considered non-exempt human subjects research. In your NIH application, you should: Check “Yes” to Human Subjects. Check “No” to Exempt from Federal regulations. You must submit a complete Protection of Human Subjects section.

If funded, you will need:

  • certification of approval from your Institutional Review Board (IRB)
  • to provide your institution’s Federal wide Assurance (FWA) number
  • and, certification that all key personnel have received human subject's education.

Because the specimens or data were not collected specifically for your study and no one on your study team has access to the subject identifiers linked to the specimens or data, your study is not considered human subjects research. In your NIH application, you should: Check “No” to Human Subjects. You should include a Protection of Human Subjects section that clearly discusses the source of all human specimens and data and state whether or not anyone on the research team has the ability to link the specimens or data to subject identifiable information.

Your study is most likely considered exempt from the human subject's regulations, category 4 (Exemption 4). In your NIH application you should: Check “Yes” to Human Subjects. Check “Yes” to Exempt from Federal regulations. Check “4” for which exemption. You will need to provide a detailed justification in the Protection of Human Subjects section that explains why your study is considered to be exempt from Federal regulations, using category 4 (E4). If your study is funded, you will have to provide certification that all key personnel have received human subject's education.

If all of the specimens or data will come from cadavers or otherwise deceased individuals, your study is not considered human subjects research. In your NIH application, you should: Check “No” to Human Subjects. You should include a Protection of Human Subjects section that states that all specimens and data will be obtained from deceased individuals. There may be other local and state laws you must comply with. Please check your local authorities. **If your study will involve any specimens or data from living relatives then the study may be considered non-exempt human subjects research. Please return to the start of this questionnaire considering the specimens or data from living relatives.

Please contact the OEP-Human Subject's Team directly at oep-hs@mail.nih.gov.

Your study is most likely considered exempt from the human subject's regulations, category 2 (Exemption 2).

If your study involves only the observation of public behavior and none of the investigators participate in the activities being observed the study might be considered exempt from the human subject's regulations, category 2 (Exemption 2).

In your NIH application you should: Check “Yes” to Human Subjects. Check “Yes” to Exempt from Federal regulations. Check “2” for which exemption. You will need to provide a detailed justification in the Protection of Human Subjects section that explains why your study is considered to be exempt from Federal regulations, category 2 (E2). If your study is funded, you will have to provide certification that all key personnel have received human subject's education.

**Please note, if your study population includes children for any activity other than observation of public behavior, this study cannot be considered exempt.

You have selected that your study will involve children.

Unless your research only involves the observation of public behavior and the investigators are not involved in the behavior being observed, your study is considered non-exempt human subject's research. In your NIH application, you should: Check “Yes” to Human Subjects. Check “No” to Exempt from Federal regulations. You must submit a complete Protection of Human Subject's section.

Your study is considered non-exempt human subjec's research. In your NIH application, you should: Check “Yes” to Human Subjects. Check “No” to Exempt from Federal regulations. You must submit a complete Protection of Human Subject's section.

If your study involves a clinical trial you must include a Data and Safety Monitoring Plan (DSMP) commensurate with the risk of your study.

If your study involves an NIH-defined Phase III or multisite clinical trial your DSMP must include a Data and Safety Monitoring Board.

If funded, you will need:

  • certification of approval from your Institutional Review Board (IRB)
  • to provide your institution’s Federal wide Assurance (FWA) number
  • and, certification that all key personnel have received human subject's education.
Back to Top