Human subjects research forms

• KU human research protocol (.docx)
  For projects involving and interactions with human subjects.
   
• Previously collected data/specimens protocol (.docx)
  Replace the Human Research Protocol with this document when you are only requesting approval for retrospective data analysis.
   
• Modification request form (.docx)
  Make changes to a study that has already been approved.

• Signed consent (.docx)
  Participants sign their name to verify consent for a project, and investigators provide a copy of the consent form to participants. For example, a signed consent form may be used to consent when identifying participants (i.e., audio or video recorded activities), sensitive topic information, clinical studies, etc.
   
• Tear-off consent (.docx)
  Signed consent for multiple participants: Participants sign their name to verify their consent; however, the certification information is detached from the study information. The project title should be included on the certification page of the consent form for document verification. There is not a legal problem with having the signer tear off the form and send in the signed form, so long as the researcher can show that the signed consent goes with the informational piece about the specific research study. Therefore, the tear-off or secondary certification part should identify the research study in the last paragraph that is sent to the researcher — so there is evidence that the signature of the signer was for that research study.
   
• Parent-guardian consent (.docx)
  Used when participants cannot legally sign consent for themselves (for example, research involving children or individuals with cognitive impairments).
   
• Assent templates (.docx)
  In research with children or other participants for whom the ability to give informed consent may be otherwise compromised, it is usually appropriate to obtain some form of agreement — or assent — to participation in the data-collection sessions. A prototype script of this procedure should be included with the IRB application. For example, even though children or individuals with developmental disabilities may not be able to provide informed consent for participation in research, a researcher still should describe the procedures in language that can be understood by the subjects, and obtain their verbal agreement to participate.
   
• Information statement (.docx)
  The information statement may be used instead of a consent form with anonymous surveys or questionnaires. Participants do not sign an information statement. This option would reduce your copies by half because participants would keep their copy and not sign one to give to you. This also would further protect anonymity of participants. However, you may decide to use a consent form for your own records.
   
• Oral consent (.docx)
  Oral consent may be most suitable in research where informality is the best way to set participants at ease and where documented consent is not required.
   
• Authorization for release of photographs, videos or written testimonials (.docx)
  Required for anticipated use in education and training or public relations and promotions.
   
• Debriefing template (.docx)
  The debriefing form is required for participants when deception is an approved part of the research procedures. Participants should be informed that deception took place, and should be appropriately informed as to why the deception was necessary to protect the integrity of the research. Participants also should be reminded of their right to withdraw from the study at the time of the debriefing.

The following guidelines are provided to assist in developing recruitment documents and to be in compliance with the Office of Human Research Protection (OHRP).

Recruitment information checklist

What you should avoid

• Do not emphasize monetary compensation.
• Do not use catchy words like “exciting” or “cutting-edge.”

What you may do

• Instead, make your ads eye-catching with fonts, color, photos, and other art.

• Protected Health Information (PHI) use statement (.docx)
   
• Combined signed consent and HIPAA authorization form (.docx)
   
• Request to review data pre-research (.pdf)
   
• Application for waiver of HIPAA privacy authorization requirement (.docx), e.g. medical records
   
• Waiver of patient authorization request (.pdf), e.g. interaction with individuals
   
• Request to review data pertaining to decedents for research (.pdf)
   
• Data use agreement for a limited data set (.docx)
   
• De-identification form (.pdf)
   
• Patient authorization form and checklist (.docx)

• IRB authorization agreement (.docx)
   
• Individual investigator agreement (.pdf)