U-M Research & Compliance

Protocol Tools

Protocol Templates and Checklists

A study protocol acts as a work plan for the study and is a key resource for study teams, study sponsors, and research support units including the IRB and ancillary committees.  A protocol should comprise all the key information about the study conduct, including but not limited to the rationale and scientific background, plans for subject interaction/intervention from recruitment through long-term follow-up, how the study design fulfills applicable regulations, and how oversight is provided.

While having a stand-alone study protocol document is optional (excluding clinical trials and/or testing and FDA-regulated product), the HRPP encourages the use of a stand-alone protocol document for all human research studies as a best practice. A well-written stand-alone protocol document supports:

  • Efficiency and Compliance: Encourages efficient IRB review and supports regulatory compliance and facilitates study team education about human research protections.
  • Quality and Adherence: Minimizes deviations in study conduct, ensures best practices, and protects participants.
  • Scientific Rigor: Supports scientific rigor, reproducibility, and facilitates addressing primary aims.
  • Operational Effectiveness: Facilitates compliant conduct of the research.
  • Adaptability: Helps study teams navigate complex study designs and changes in research regulations.
  • Best Practice for Publication: Some scientific journals require a written protocol with submission of research articles.
  • Clinical Trial Requirements:  As part of the NIH clinical trial registration and results reporting regulations and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), a written protocol must be uploaded to the study’s registration record in ClinicalTrials.gov at the time of results submission.

To support study teams, the HRPP has developed the following protocol templates and checklists:

U-M Protocol Templates:

General Human Research Protocol Template 

Qualitative Human Research Protocol Template

Non-FDA Regulated Clinical Trials Protocol Template

FDA Regulated Clinical Trials Protocol Template (available through MICHR) 

Protocol Checklists:

Each protocol checklist listed below outlines the key information necessary for IRB review based on the type of research.  These checklists complement the corresponding U-M protocol templates. They can also be useful tools for researchers using an alternative protocol template or who already have a pre-existing protocol and are seeking to assess its comprehensiveness.

Questions and Input:

See the Protocol Tools FAQ for additional guidance.

Your input will assist the HRPP in refining the U-M protocol templates and checklists, developing additional guidance, and identifying process improvement opportunities. Complete the feedback form, or email your feedback to [email protected].

For Protocol Tools & Templates questions, contact [email protected].

For IRB process questions, contact your IRB Office.

Protocol Builder Pilot

The Protocol Builder Pilot is a short-term initiative, funded by a MICHR grant, designed to assess the usefulness of Protocol Builder – a third-party, web-based tool developed by BRANY – for the U-M human research community.

What is the Protocol Builder Pilot?

The pilot aims to determine how effectively Protocol Builder can help U-M study teams streamline and standardize the development of protocols for human research studies involving an interaction/intervention that is not classified as an FDA clinical trial.  

Why Participate?

  • Utilize Built-in Guidance: Protocol Builder navigates users through a protocol template with section-level guidance and sample text to help streamline the development of a protocol, saving time and reducing errors. 
  • Improve Quality & Compliance: Ensure your protocols meet U-M and regulatory requirements, supporting IRB reviews and strengthening research integrity.
  • Facilitate Collaboration:  Collaborate efficiently with multi-user drafting, built-in commenting features, and centralized storage. Shared access and version control enable seamless teamwork, making feedback and revisions simple and organized.
  • Shape U-M’s Future:
    • Be proactive. With the eResearch system replacement, U-M will require a stand-alone written protocol with IRB submission.  
    • Share your experience. Your feedback will influence decisions on the potential university-wide adoption of this tool.

Who Should Join?

We invite the following individuals to participate in the Protocol Builder Pilot:

  • Researchers (faculty, staff, students) developing a stand-alone, written study protocol document
  • Individuals interested in testing a protocol development tool 
  • Instructors or professors supervising students conducting human research
  • Department research administrators aiding faculty and students in developing protocols

How to Sign Up?

Complete the Pilot Interest & Intake Form.

FAQs

The HRPP protocol tools are a set of templates and checklists available to help U-M study teams efficiently design and conduct human research studies. They support regulatory review and compliance, minimize protocol deviations, and promote adherence to best practices.

A protocol template is a descriptive narrative of the study that communicates the science, methods, and operations of a study to the study team, IRB, publishers, etc.  

A protocol checklist is a tool that can be used with any protocol template and represents a list of required and recommended items that IRB reviewers look for during the review of an application.

Although having a written protocol is optional for U-M investigator-initiated human research studies, it is considered a best practice that facilitates the overall research design and conduct.

U-M protocol templates and checklists can be downloaded from the Protocol Tools page of the HRPP website. Look for the protocol template and checklist appropriate for your study

The HRPP protocol tools were developed by a working group that included research support staff from across the university and IRB administrators.

Their efforts involved:

  • Benchmarking existing protocol templates to identify common elements
  • Categorizing the essential elements based on the type of research and IRB review requirements
  • Drafting and refining the U-M protocol tools for various research designs for use when sponsor templates (e.g., from NIH or industry) are not applicable
Benefits of Using a Research Protocol

A research protocol offers numerous benefits:

  • Efficiency and Compliance: Encourages efficient IRB review and supports regulatory compliance, and facilitates study team education about human research protections.
  • Quality and Adherence: Minimizes protocol deviations, ensures best practices, and protects participants.
  • Scientific Rigor: Supports scientific rigor, reproducibility, and the ability to meet enrollment goals, and facilitates addressing primary aims.
  • Operational Effectiveness: Makes it easier for research staff to implement the study.
  • Adaptability: Helps study teams navigate complex study designs and changes in research regulations.
  • Best Practice for Publication: Some scientific journals require a written protocol with submission of research articles.
  • For clinical trials:  As part of the NIH clinical trial registration and results reporting regulations and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), a written protocol must be uploaded to the study’s registration record in ClinicalTrials.gov at the time of results submission.

A protocol allows the study team to provide more descriptive information about the study to an IRB reviewer, which enhances their understanding of the study and the protections needed for the participants.

Using the Protocol Tools

The following guidelines will help you select the most appropriate protocol template for your research project, ensuring it aligns with the specific methodologies and regulatory requirements of your study.

General Human Research Protocol Template:

  • Description: Suitable for studies involving quantitative research, which tests hypotheses using larger sample sizes and structured data collection methods like surveys.
  • Use When: Your study collects numerical data for statistical analysis or combines both qualitative and quantitative data to provide a comprehensive understanding of the research question.

General Qualitative Research Protocol Template:

  • Description: Designed for studies that collect and analyze non-numerical data to understand concepts, opinions, or experiences. Typically used in social sciences and humanities, qualitative research relies on data from interviews, written responses, historical texts, and observations.
  • Use When: Your study aims for the comprehension of human experiences, concepts, or opinions through non-numerical data, and usually involves smaller sample sizes that provide deep insight rather than broad generalizations.

Non-FDA Regulated Clinical Trials Protocol Template:

  • Description: Tailored for clinical trials not regulated by the FDA, focusing on various social/behavioral aspects of human health and behavior without requiring FDA oversight.
  • Use When: Your clinical trial involves human subjects but does not fall under FDA regulation, such as certain behavioral studies, health interventions, or pilot trials.

When submitting a written protocol, reference it by section title (e.g., “See protocol section, Study Population”) in the relevant HUM questions to reduce data entry duplication.

No, IRB reviews will not include a review of a completed protocol checklist.

Amendments to the protocol are needed whenever changes to the study make the protocol out-of-date or incorrect. This includes changes to the project scope, participants, study procedures, and other critical elements.

Implementation

Yes, IRB staff may compare the protocol text to HUM responses for consistency. If inconsistencies or missing information are found, the HUM/protocol may be returned for updating.

To reduce duplicate data entry and potential inconsistency between the protocol and the HUM, the IRB encourages study teams to reference the protocol section title in which the information can be located in the answer to related HUM questions.

If there are major regulatory or institutional changes requiring a template change, you may be asked to update specific sections rather than rewriting the entire document. This will be communicated clearly through the HRPP website and other official channels.

Where to Find More Information and Support

For non-regulatory questions about the protocol template or checklist forms, email [email protected]. For queries related to IRB requirements, human research regulations, or the eResearch application process, reach out to your U-M IRB.

CTR-Launch: Take advantage of free clinical trial Protocol Writing Support provided by CTR-Launch, a 4.5-year NIH-funded research project through MICHR.  Note: This service is limited to clinical trials and is limited to 40 hours over 12 weeks.

  • IRB Education Courses: IRB-HSBS and IRBMED offer educational courses to improve understanding of regulatory requirements, eResearch application completion, and special topics related to human participant research. 
  • U-M Human Research Protection Program (HRPP) Website: Check the HRPP website for guidance on regulatory requirements, links to IRB-specific guidance, and more.
Feedback

Your input will assist the HRPP in refining the U-M protocol templates and checklists, developing additional guidance, and identifying process improvement opportunities.

Questions?

For questions regarding the Protocol Tools email [email protected].

For questions regarding the Protocol Builder Pilot email [email protected]