University of Hawai‘i
Research Compliance

Templates and Forms

Model Informed Consents

For Social and Behavioral Science (SBS) Research

Research Involving Adult Participants

TMP 441 Interview
TMP 442 Intervention
TMP 443 Anonymous Survey (Online)
TMP 444 Anonymous Survey (Direct Interaction)
TMP 457 Adult Participant, Focus Group

Research Involving Minors (under 18 years of age)

TMP 445 Parental Consent to Interview Minors
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

For Biomedical Research

TMP 442 Intervention
TMP 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

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 recurrence 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