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Templates

Model Informed Consents

For Social & Behavioral Science (SBS) Research

Research Involving Adult Participants
MIC 441 Interview 
MIC 442 Intervention 
MIC 443 Anonymous Survey (Online) 
MIC 444 Anonymous Survey (Direct Interaction) 
MIC 457 Adult Participant, Focus Group 
Research Involving Minors (under 18 years of age)
MIC 445 Parental Consent to Interview Minors 
MIC 446 Assent to Interview Minor (14-17)
MIC 447 Assent to Interview Minors (7-13)
MIC 448 Oral Assent to Interview Minors (under 7)
MIC 454 Assent, Curriculum Research on Minors (14-17)
MIC 455 Parental Consent, Curriculum Research on Minors  

For Biomedical Research

MIC 442 Intervention 
MIC 463 Assent, Genetic Study on Minors (7-13)

For Clinical Trials, start with the basic format provided in Model Consent Form (MCF) 442 above.  Because of the complexity of most clinical trials, it is important to focus on the process of informing individuals about the study in a way that is easy to understand.  A useful and thorough consent template addressing an array of clinical trial procedures is provided by the National Cancer Institute at https://ctep.cancer.gov/protocoldevelopment/informed_consent.htm.  While this template was developed for cancer trials, the sample language addressing complex medical procedures is useful for many types of clinical trials.

Other Consent Documentation

MIC 465 Deception Research, Debriefing Form
MIC 466 Adult Consent for Oral History
MIC 467 Short Form
MIC 468 Adult Consent, Future Use of Biospecimen

Regulatory Documents/ Investigator Toolkit

Normally used for clinical trials, but may be helpful for any large-scale research to help investigators manage their research

MIC 401 Adverse Event Tracking Log

To keep track of all unanticipated problems occurring while research is active, and its reporting

MIC 402 Delegation Log

To document the investigator's delegation of certain responsibilities to study personnel in order to conduct research

MIC 403 IRB Submission Log

To document all correspondence between the study site and IRB; includes notation of important dates (e.g., approval date, expiration date)

MIC 404 Note to File Template

Written to identify a discrepancy or problem in the conduct of a research study, note the source of the identified problem, identify corrective action taken to prevent recurrance of the issue,
and document that correction action has resolved the issue

MIC 405 Protocol Deviation Tracking Log

To keep track of all protocol deviations/ violations occurring while research is active, and its reporting

MIC 406 Screening and Enrollment Log

To document identification of potential participants and chronological enrollment of participants 

Other Useful Study Documentations

MIC 475 Model Recruitment Flyer
MIC 407 Endorsement Letter Template