Investigator Documents

Application Form	KU Human Research Protocol (required for all new studies) For projects involving interventions and interactions with human subjects. New Study Checklist Previously Collected Data/Specimens Protocol Replace the Human Research Protocol with this document when you are ONLY requesting approval for retrospective data analysis. If your project involves interactions/interventions with subjects, use the above Human Research Protocol. Modification Request Form (make changes to an already approved study)
Consent Document(s)	Refer to Consent templates
Recruitment Materials	Flyers, emails, letters, ect. (see Recruitment Guidance)
Supporting Documents	If Applicable: Surveys, instruments Data collection sheets Subject instructions, diaries, etc. HIPAA documentation Etc.
Other Administrative Documents

Consent Templates NOTE: CONSENT TEMPLATES SHOULD ONLY BE USED FOR PROJECTS THAT RECEIVE KU HRPP APPROVAL. **The consent form templates have been edited to include additional consent requirements, effective January 21, 2018.	Comments
Signed Consent	Participants sign their name to verify the consent in a project and investigators provide a copy of the consent form for 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	(Multiple participants, signed consent): Participants sign their name to verify their consent; however, the certification information is de-attached 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 the signed form in, 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. For example, researchers using many participants for a study and providing a signed consent form.
Parent-Guardian Consent	Used when participants cannot legally sign consent for themselves (e.g., research involving children or cognitively-impaired individuals)..
Assent Procedures	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 of the "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 should still describe the procedures in language that can be understood by the subjects, and obtain their verbal "agreement" to participate.
Information Statement	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 one-half, since participants would keep their copy and not sign one to give to you. This would also further protect anonymity of participants. However, you may decide to use a consent form for your own records.
Oral Consent Procedure	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 Photograph, Video, or Written Testimonials	Required for anticipated use in education and training or public relations and promotions.
Debriefing Template	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 the actual purpose of the research, and the role of the deception in protecting the integrity of the research; that is, an explicit statement as to why the deception was necessary. Participants should also be reminded of their right to withdraw from the study at the time of the debriefing.