Sample Documents


The following are sample documents that can be used by investigators to develop documents specific to their research studies.  Not all documents are applicable to every research study.

 


I. Sample Consent Documents

Consent requirements are governed by federal statues 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.
  • Informed Consent for Adults  This is a sample document which can be used as a guide to develop an Informed Consent specific to a research study.  *Note: The age of majority is 19 in Alabama.
  • 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. *Note: The age of majority is 19 in Alabama.
  • 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.
  • 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.  In the State of Alabama the age of majority is 19 and parental permission and minor assent must be obtained for participants under the age of 19.
  • 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. In the State of Alabama the age of majority is 19 and parental permission must be obtained for participants under the age of 19.        
  • 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.  In the State of Alabama the age of majority is 19 and parental consent and minor assent must be obtained for participants under the age of 19.

 


II. Recruitment Documents

  • Recruitment Flyer
  • 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.
  • 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.
  • E-Mail Invitation for On-Line Survey This sample document can be used to develop an e-mail invitation for an on-line survey. E-mails which will assist in the recruitment of participants should be submitted to the IRB for review and approval inthe form in which they will be presented to participants.
  • 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.

 


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. 

 


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.

 


V. Precautions     

  • Sample Referral  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.
  • 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.

 

Last Updated: 1/13/2014