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Templates

Model Informed Consents

Information in the consent document must be organized to facilitate comprehension. Consent documents should be written in plain language, generally at the 8th grade reading level. The reading level can be higher if the target population tends to have a higher literacy rate than the general population. For child assent documents, the reading level and complexity of the information provided should be appropriate for the age of the child. For more information on plain language go to http://www.plainlanguage.gov/.

For Social & Behavioral Science (SBS) Research

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

For Biomedical Research

TMP 442 Intervention revision indicator
TMP 460 Clinical Trial
TMP 463 Assent, Genetic Study on Minors (7-13)

Before you upload your consent document to the eProtocol application, please delete the cover page, any backslashes and brackets, and any highlighted text. The finished document should reflect what you will give to the subject.

Use a file name for each consent document that clearly identifies the type of consent and for which subjects it is intended (e.g. child assent, parental permission, adult consent, etc.)

Other Consent Documentation

TMP 465 Deception Research, Debriefing Form
TMP 466 Adult Consent for Oral History
TMP 467 Short Form
TMP 468 Adult Consent, Future Use of Biospecimen
TMP 470 Counseling Services Resource Information
TMP 471 HIPAA Privacy Rule Authorization

Regulatory Documents/ Investigator Toolkit

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

TMP 401 Adverse Event Tracking Log

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

TMP 402 Delegation Log

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

TMP 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)

TMP 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

TMP 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

TMP 475 Model Recruitment Flyer
TMP 407 Endorsement Letter Template
GUIDE 604 Guidelines for Developing a Clinical Research Protocol
GUIDE 605 Guide for a Social and Behavioral Sciences Research Protocol