Consent & Assent Templates
Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019. Learn more about the regulations.
Below you will find consent and asset templates to assist you in protocol creation.
Please contact your IRB Coordinators with any questions about these templates and which form of consent may be most
appropriate for your research.
|Informed Consent for Non-Exempt Research||Signed consent for Non-Exempt studies. Also includes required language for studies listed on: clinicaltrial.gov.|
|Signed consent, Audiotaped Interviews, non-federally funded, minimal risk||Does your study include an audiotaped interview? Please use this template for minimal risk, non-federally funded research|
|Layered Options||Suggested text for the layered portion of the signed consent form. Revise to meet your research requirements.|
|Undocumented, non-federally funded, minimal risk research||Study information file to provide your participants in non-federally funded, minimal risk research|
|Consent & Recruitment – Email||Online Anonymous Survey|
|Consent & Recruitment – Email||Online Survey with identifiers|
|Consent & Recruitment – Hard Copy||This template may be appropriate for paper copy surveys|
|Consent – Cover Letter||Multiple Uses – A cover letter (referred to as “alteration of consent” in eProtocol) can be used when the protocol fits the waiver of documented consent criteria listed in 117(c)(1) or 117(c)(2)|
|Consent & Recruitment – VERBAL||Anonymous – No identifiers collected|
|Consent & Recruitment – VERBAL||Data collected with identifiers|
|Study Summary||Study Information to Provide Participants recruited and consented with a Verbal Script|
|Assent for youth w/Parent Permission||Assent for youth ages 14-17 years old. Youth assent and parent consent can be obtained using the same form as long as the form is written at the level of the youngest (forms attached for federally funded and non-federally funded) Federally Funded Study – Assent for youth ages 14-17 years old. Youth assent and parent consent can be obtained using the same form as long as the form is written at the level of the youngest participant Non-Federally funded study – Assent for youth ages 14-17 years old. Youth assent and parent consent can be obtained using the same form as long as the form is written at the level of the youngest participant|
|Assent for children||Assent for children 7 to 14 years old. The assent should be simplified, brief, and in age-appropriate language. Parental consent will be obtained with a separate method.|
|Assent for younger children||Assent for children up to age 7 should be obtained verbally and using other signs that the child does or does not want to participate, such as crying.|
|Release Form For Use of Photograph/Videotape||If you will be taking still photographs or videos for CSU-related research projects (where the individual is visibly recognizable in the photograph) that you may wish to publish in your thesis, dissertation, or share in a presentation or publication, you must obtain consent from the participant to share the photo or video for research purposes. Approval can be obtained from the participant with the signed consent form (see the layered consent template) or with the use of this photo-release document.|
|Consent & Recruitment for mTurk population||Online surveys done via Amazon’s Mechanical Turk (mTurk)|
|Debriefing Deception||When using deception in research, it is required that participants are immediately notified of the use of deception and the justification for doing so. This is an ongoing consent procedure that is accepted in social, behavioral research. In addition, the Psychology Subject Pool requires that all research conducted with their pool provide some debriefing for all participants to further their education in participation in research. Please review: here for further guidance.|
|Parental Permission Template||Colorado State University Parental/Guardian Permission for Minor’s Participation in Research|