Forms & Templates

IRB Applications

Use the eProtocol system to submit protocols to the UH IRB. For more guidance on submitting protocls through eProtocol go to Submit: eProtocol.

Study Closure Forms

COVID-19 Guidance and Required Forms

For guidance on the HSP’s response to COVID-19 and required forms, including the COVID-19 Safety Plan template, click on the link above.

Section 118 Designation

  • Undefined Research
  • Institutional (Infrastructure) Type or Training Grants

Section 118 Designation Application Form
APP 15 – Annual Report for Institutional Type Grants or Training Grants Form

Collaborative Research

For research in which two or more FWA-holding institutions are engaged in a research protocol/proposal, one IRB authority is investigators may request to have UH IRB be the relying IRB or cede IRB authority to another IRB. For more information, see SOP 120: Collaborative Research.

Ceding agreement – UH IRB reviewing the research

Step One: Download and complete the IRB Authorization Agreement form

Reviewing IAA Application

Information you will need:
  • Name of the Other Institution
  • The other institution’s IRB Registration Number (if relying on the another IRB) or FWA # (if using UH IRB as the relying IRB)
  • Project Name
  • Principal Investigator(s) of all Institutions listed in the IAA, with their respective institution’s name in brackets next to the name
  • Funding Source and Award Number, if applicable
  • Name of the Other Institution’s Institutional Official (IO)
  • Title of the Other Institution’s IO

Provide the Local Context Review Form to the relying institutions to complete, if they wish to input any local context consideration, administrative review.

Step Two: Submit the application

Submit the application to HSP via email or hardcopy. As part of your submission, provide a memorandum addressed to the Human Studies Program Director describing the justification for the reviewing request.

Include a copy of the Local Context Review Form, if any.

If you have not already obtained UH IRB approval, submit an IRB application for review. If you have an approval, and are adding a new collaborator or new site, you may need to submit a modification application to your project. Include the HSP number  for the project if available.

Ceding agreement – UH is RELYING on another IRB for oversight

Step One: Download and complete the IRB Authorization Agreement form

Ceding (Relying) IAA Application

Information you will need:
  • Name of the Other Institution
  • The other institution’s IRB Registration Number (if relying on the another IRB) or FWA # (if using UH IRB as the relying IRB)
  • Project Name
  • Principal Investigator(s) of all Institutions listed in the IAA, with their respective institution’s name in brackets next to the name
  • Funding Source and Award Number, if applicable
  • Name of the Other Institution’s Institutional Official (IO)
  • Title of the Other Institution’s IO
Step Two: Submit the application

Submit the application to HSP via email or hardcopy. As part of your submission, provide a memorandum addressed to the Human Studies Program Director describing the justification for ceding authority to another IRB.

Include a copy of the protocol, and informed consent, especially as relating to local participation

 

Smart IRB

UH is now a participant in an online reliance system, intended to help standardize and streamline this type of agreement, called Smart IRB. To use Smart IRB, both parties will need to be participants. You will need to check with your collaborator, or check the Smart IRB website to verify. If you do not have one already, you would need to create an account on the Smart IRB platform. You can access the request page at https://smartirb.org/reliance/. Once you have created your account, you can go ahead and start your reliance request on the platform.  You can contact us at the HSP office to have us assist you at that point, as well. Smart IRB may be the most efficient if there are multiple participating sites.

Alternative Forms

Alternatively, use the reliance agreement provided by the other institution. Typically, these agreements include much the same information, and we normally have no problems with using another institution’s agreement form.

Templates

UH Model Informed Consent and Recruitment Templates

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.

TMP 475 Model Recruitment Flyer

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
Mental Health and Suicide Prevention During Times of Crisis

Report a Protocol Violation or Unanticipated Problem

An UNANTICIPATED PROBLEM is any unfavorable incident, experience, or outcome that is unexpected, related or possibly related, and suggests that the research places participants or others at greater risk of harm than expected for this research.

A PROTOCOL VIOLATION is any deviation or departure from the IRB-approved protocol that does not have prior approval by the IRB.

  1. For protocols previously submitted and approved via eProtocol, use the eProtocol Protocol Violation form.
  2. For protocols that were not submitted and approved via eProtocol (originally approved prior to June 2016), and if your protocol was approved by the Cooperative IRB:
    • Reporting Form for Unanticipated Problems
      • An Unanticipated Problem Report may be submitted to the Human Studies Program by email at uhirb@hawaii.edu OR by hard-copy delivery to Human Studies Program, University of Hawai‘i at Mānoa, 2425 Campus Road, Sinclair 10, Honolulu, HI 96822
    • Reporting Form for Protocol Violations (rev. 12-28-2014)
      • Submit the Protocol Violation Report to the Human Studies Program via email at uhirb@hawaii.edu AND delivery of a hard-copy with original signature to Human Studies Program, University of Hawai‘i at Mānoa, 2425 Campus Road, Sinclair 10, Honolulu, HI 96822 

Further guidance on completing these forms can be found under SOPs 101 and 104 here.