Human Subjects Checklist

This checklist may be used to determine if human subjects are involved in your evaluation, and if the research does involve human subjects, whether it may be exempt under current Department of Commerce regulations on the protection of human subjects (15 CFR Part 27).

  1. Is there an intervention or an interaction with a living person that would not be occurring but for this research? Examples: video taping people, observing children using new software, surveying personnel regarding a new delivery of service to a client, etc.

    1. Will data/information/specimens collected originally from people or data/information/specimens about people be used in this research? Examples: broadcast video, web use logs, medical information, survey questions.

      • Yes - Identifiable Human Subjects may be involved. Go to Question 2.b.

      • No. It appears that human subjects may not be involved in the project. However, an exemption determination may be required. Please review Question 3 for additional information about research that may require an exemption determination.

    2. Does that information contain private information in a form in which the identity of the subject is or may readily be ascertained from the information? Examples: medical records, donor name or address, sales transaction records.

      • Yes - Identifiable Human Subjects are involved. Go to Question 3 to see if an exemption may apply. If you know that an exemption does not apply proceed to Question 5.

      • No - Go to Question 3. The research may not be within the scope of 15 CFR Part 27, however, it may require an exemption determination to be made due to the use of data, recordings, or specimens that could be linked to humans without appropriate safeguards.

  3. Do you think the research is outside the scope of 15 CFR Part 27 or qualify for an exemption under 15 CFR 27.101 (b)? The following questions will help you evaluate whether an exemption is applicable.

    1. Will the task involving human subjects only use existing data, recordings (audio or visual), or specimens? Examples: patient records, a company's customer data, web use logs.

      • Yes - Go to 3.d.

      • No - Go to 3.b.

    2. Will the evaluation involve normal educational practices such as instructional strategies or comparison of instructional techniques, curricula, or classroom management methods? Examples: observation of student-teacher interactions, video of instruction.

      • Yes - Go to 3.d.

      • No - Go to 3.c.

    3. Will the evaluation involve educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior? Examples: user satisfaction surveys, observation of staff usage.

      • Yes - Go to 3.d.

      • No - Go to 3.d.

    4. Do any of the data, recordings, or practices/procedures involve a protected class? Protected classes currently include all prisoners.

      • Yes - Go to 5, this research is probably not exempt and will need an Institutional Review Board (IRB) review.

      • No - Go to 3.e.

    5. Do any of the data, recordings, or practices/procedures involve a "vulnerable" class? "Vulnerable" classes include: children under the age of 18, people with disabilities, elderly persons, etc. Examples: testing educational software with children, surveys of elderly patients.

      • Yes - Go to 3.f, this research is probably exempt, but you may need to develop informed consent procedures.

      • No - Go to 3.f.

    6. Are the data or recordings (audio or visual) publicly available? Note: Publicly available may include items for sale, items that are freely available to the public, or items that reside in the public domain. Examples: customer data sets, donations of pathological specimens, shareware.

      • Yes - Go to 4, this research may be exempt under 15 CFR 27.101(b).

      • No - Go to 3.g.

    7. Will the data or recordings (audio or visual) be stripped of all identifiable data and information that could be linked to a human subject prior to being received by the investigator?

      • Yes - Go to 4, this research may be exempt under 15 CFR 27.101(b).

      • No - Go to 3.h.

    8. Will the information be recorded by the investigator in such a way that it can be linked to the human subject? Examples: web use logs tied to email addresses, patient records that include patient identifiers.

      • Yes - Go to 5, this research is probably not exempt and will need an Institutional Review Board (IRB) review.

      • No - Go to 4, this research may be exempt under 15 CFR 27.101(b).

  4. An exemption MAY apply to the proposed research or evaluation. 15 CFR 27.101(b), available at

    http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

    allows exemptions for certain types of research. Prepare an exemption request.

  5. An exemption PROBABLY DOES NOT apply to the proposed research or evaluation. You will need to have an IRB review and approve your research or evaluation. Prepare an IRB approval request. Please note that some exemptions apply for vulnerable groups, including children and individuals with disabilities. However, if your research involves prisoners, no exemptions apply.