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National Center for Mental Health Promotion and Youth Violence Prevention

Protection of Human Subjects

When you submitted your SS/HS application, you were required to indicate whether you were conducting any research activities involving human subjects. Research was defined as activities

  1. designed to contribute to generalizable knowledge; or
  2. in which information about a living person is obtained by manipulating that person or that person’s environment, as might occur when a new instructional technique is tested, or by communicating or interacting with the individual, as occurs with surveys and interviews, the definition of human subjects is met; or
  3. in which private information about a living person is obtained in such a way that the information can be linked to that individual (the identity of the subject is or may be readily determined by the investigator or associated with the information), the definition of human subject is met.

If you indicated that your project was conducting research activities involving human subjects, you were asked to indicate whether or not these activities were exempt from the regulations under any of six categories of exemptions. If you indicated on the cover page of your grant application that you were not exempt from these human subject requirements, you will need to do four things:

  1. Identify a registered Institutional Review Board (IRB) to review your project. If your evaluator is University-affiliated, they will often have an IRB at their disposal. If not, you can search for registered IRBs with Federal Assurances on the U.S. Department of Health and Human Services Web site http://www.hhs.gov/ohrp/assurances/
  2. Have the IRB review and approve your research activities.
  3. Obtain informed consent and assent and/or parental permission from the subjects involved in your project unless this requirement is waived or altered by the IRB. For SS/HS projects, these subjects are usually students, but could also include out-of-school youth, the parents of students, or school staff.

If you indicated that your project was not conducting research activities involving human subjects, or that you were conducting research activities involving human subjects, but that the research activities were exempt from the regulations under one or more of the of six categories of exemptions, you do not need to go through the four steps outlined above.

To learn more about what kinds of human subjects research are exempt and regulations related to Institutional Review Boards, please see: