Sample Documents

I. Sample Consent Documents

Consent requirements are governed by federal statutes and guidance including…

• 45 CFR 46.116(a)&(b) Researchers should remember that consenting is a process and not an individual document.  Consent documents should be age appropriate and comprehension levels must be considered when preparing consent documents.
• Guidance for preparing consent documents (information letter and consent form) This document includes specifics for preparing a consent document. Review it prior to preparing consent documents.
• Informed Consent for Adults  This is a sample document that can be used as a guide to develop an Informed Consent specific to a research study. (Requires AU IRB approval stamp on all pages.) **IMPORTANT: Consent forms must have a concise summary table. The table should be placed at the beginning of the document.**
• Information Letter for Adults  This document can be used as a guide to develop an Information Letter or Information Sheet when it is determined by the IRB that the requirements for a signed consent form can be waived. (Requires AU IRB approval stamp on all pages.)
• On-line Information Letter for an Electronic Survey  An on-line Information Letter may be used for an anonymous, electronic survey when it is determined by the IRB that the requirements for a signed consent form can be waived. This sample may be used as a guide to develop an electronic Information Letter specific to the study.  (Requires AU IRB approval stamp on all pages.)
• Parental Permission/Minor Assent  This document can be used as a guide to develop a combined Parental Permission/Minor Assent to obtain a parent’s or guardian’s consent and minor’s assent for the minor to participate in research. (Requires AU IRB approval stamp on all pages.)
• Parental Permission This document can be used as a guide to develop a Parental/Guardian Permission for a minor to participate in research when the minor is too young to understand and sign their own name.  (Requires AU IRB approval stamp on all pages.)
• Minor Assent This document can be used as a guide to develop a Minor Assent to obtain a minor’s assent to participate in research.  (Requires AU IRB approval stamp on all pages.)

II. Recruitment Documents

• Recruitment Flyer (Requires AU IRB approval stamp on all pages.)
• FDA Recruiting Guidelines This is a sample document can be used to develop recruitment materials for specific studies.  Flyers and other recruitment materials should be submitted to the IRB for review and approval in the form in which they will be presented to participants.
• Recruitment Script This is a sample document can be used to develop recruitment materials for specific studies.  Scripts to be read by the researcher or other individuals assisting in the recruitment of participants should be submitted to the IRB for review and approval in the form in which they will be presented to participants.  (Requires AU IRB approval stamp on all pages.)
• Newspaper Advertisements This is a sample document can be used to develop recruitment materials for specific studies.  Newspaper advertisements should be submitted to the IRB for review and approval in the form in which they will be presented to participants.  (Requires AU IRB approval stamp on all pages.)
• E-Mail Invitation for On-Line Survey This sample document can be used to develop an e-mail invitation for an online survey. E-mails that will assist in the recruitment of participants should be submitted to the IRB for review and approval in the form in which they will be presented to participants.  (Requires AU IRB approval stamp on all pages.)
• E-Mail Invitation for Experiment This sample document can be used to develop an e-mail invitation for an experiment when the participant will be invited to go to a certain location (computer lab, exercise room, etc.) to participate. Invitation e-mails should be submitted to the IRB for review and approval in the form in which they will be presented to participants.  (Requires AU IRB approval stamp on all pages.)

III. Release of Information

These are sample documents that can be used if the researcher seeks permission from a participant for other uses of video/audio recordings or photos of the participant collected during the course of a research study. Permission to make a video/audio recording or take photos of the participant should be obtained during the consent process. Complete information about the video/audio/photo procedures must be included within the consent document. * Note: The age of majority is 19 in Alabama. (Requires AU IRB approval stamp on all pages.)

• Video Release (Adult) *
• Video Release (Minor)
• Audio Release (Adult) *
• Audio Release (Minor)
• Photo Release (Adult) *
• Photo Release (Minor)

IV. Site Authorizations

These sample documents can be used to develop site authorization/permission letters for individual studies. These letters give the investigator permission to conduct research at specific locations. Authorization letters may be required for contacting or recruiting participants and/or data collection which takes place on campus or outside of Auburn University.  E-mail messages will not be accepted. Letters must be on company letterhead with a valid signature. Letters can be faxed or scanned and sent by e-mail, followed by a mailed hard copy.

• General Guidelines for Letter for Site Cooperation or Authorization
• Site Authorization Letter - For research at schools
• Site Authorization Letter - For research on campus
• Site Authorization Letter - For research off campus

V. Precautions     

• Sample Referral  (04/07/22) This is a sample document that can be used to develop a referral for individual studies.  A Referral of this type can be provided to participants as a precaution to address risks of mental anguish.  The document should be appropriate for each study and the referrals should be specific to the location where the study is being conducted. This referral list of local mental health providers was shared with the AU IRB by Auburn University Psychological Services Center.
• Emergency Plan This is a sample document that can be used to develop an emergency plan as a precaution for studies to address reasonable risks associated with specific studies. Emergency Plans should be appropriate for each study and specific to the location and/or laboratory where the study is being conducted. 
• Debriefing Form  This is a sample document that can be used to develop a Debriefing Form for participants.  Debriefing Forms are most commonly required when a research study involves the risk of deception.  (Requires AU IRB approval stamp on all pages.)