Human Research Requiring a Protocol

This section of the Investigator Manual describes research that requires a standalone protocol, including clinical trials, more than minimal risk studies, registry and repository studies, studies requiring scientific review, and non-exempt multi-site studies. The section also provide protocol guidelines.

Studies that meet the federal definitions of human research require IRB review. For some of these studies, the IRB requires a standalone protocol that you will upload in the IRB application. This section of the Investigator Manual describes research that requires a standalone protocol.

The IRB may require a protocol for some other types of minimal risk research such as those studies involving multiple physical interventions, complex study design, or use of drugs, biologics, nutritional supplements, or devices. This determination would depend on several factors including the board that will review the study (MRR or HS), and the types/number of physical interventions.

All studies requiring a protocol should be submitted using the protocol-based application (for studies likely to be single site) or the single IRB application (for studies where the UW will be serving as the single IRB for multiple sites) in ARROW.

If a sponsor or a lead site has provided a protocol document for the study, upload that protocol in the IRB application.

When creating a protocol document for an investigator-initiated study, use a template appropriate to the type of research. See the “Protocol Templates” section for specific guidance, as well as general protocol guidelines.

• Protocol Templates
• Studies Requiring Review by the ICTR Scientific Review Committee (SRC)
• Non-Exempt Studies for Which UW-Madison Will Serve as the Reviewing IRB for Other Sites
• Protocol Guidelines

Protocol Templates

The following protocol templates are available to assist you in developing a standalone protocol:

• For biomedical clinical investigations evaluating drugs and/or devices, the following templates include guidance specific to the FDA requirements:
  • ICTR therapeutic clinical trial template
  • NIH protocol template
  • NCI protocol template
  • While these studies are likely to be minimal risk, they must include specific kinds of information to enable the IRB to make the relevant regulatory determinations. The IRB Toolkit’s registry and repository protocol template is the most efficient way for you to provide the information the IRB needs.

  You may use other templates to develop a protocol. When reviewing protocol documents, the IRB uses HRP-503-TEMPLATE PROTOCOL as a reference point for basic content that should be included. Including this basic content in your document (plus additional information if appropriate for your study) will help ensure the IRB has the information it will need for review.

  Studies Requiring Review by the ICTR Scientific Review Committee (SRC)

  All studies that require SRC review must have a standalone protocol to provide the level of detail required to evaluate the study’s scientific design. If you are designing an investigator-initiated study that requires SRC review, see the Protocol Template section for recommendations on the appropriate template to use.

  Per institutional policy, non-oncology-related applications for full initial IRB review require ICTR SRC unless they a) are otherwise reviewed and determined to be highly meritorious by an alternate internal or external scientific review or b) solely involve these procedures:

  • Collection of blood samples by finger stick, heel stick, ear stick or venipuncture, unless the purpose of the biospecimen collection is to perform large scale genetic analyses such as whole genome or whole exome sequencing
  • Prospective collection of biological specimens for research purposes by noninvasive means unless the purpose of the biospecimen collection is to perform large scale genetic analyses such as whole genome or whole exome sequencing
  • Use of materials (data, documents, records, images, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)
  • Collection of data from voice, video, digital, or image recordings made for research purposes
  • Surveys
  • Interviews, including focus groups
  • Wearable devices, such as accelerometers and fitbits, or tests that use external sensors that do not otherwise result in physical stimulation (e.g., EEGs)
  • Walking tests
  • Imaging (MRIs, ultrasounds) with FDA-approved devices (hardware and software) when the imaging is performed within the FDA indications and evaluation of the device is not the focus of the research. This does not include PET-MRI.

  If you are designing an investigator-initiated study and do not have an existing protocol template, you are encouraged to use the IRB-provided protocol template.

  For more information on scientific review requirements, see the SRC section.

  Non-Exempt Studies for Which UW-Madison Will Serve as the Reviewing IRB for Other Sites

  If UW-Madison will serve as the reviewing IRB for other sites, a standalone protocol is typically required.

  Exceptions include minimal risk studies involving only one other site that do not involve interventions with subjects or subject interventions are limited in nature.

  The IRB Toolkit’s HRP-503-TEMPLATE PROTOCOL -Biomedical and 503a-PROTOCOL TEMPLATE-Registries and Repositories include instructions for sections specifically addressing single IRB review requirement. Also see the Reliance Manual for guidance on multi-site research where UW-Madison is the reviewing IRB.

  Protocol Guidelines

  If you do not already have a protocol that addresses the relevant elements included in the protocol templates, use the appropriate protocol templates as a starting point. Each of these templates includes instructional text that describes information to include in the protocol. The IRB looks for this information when reviewing research. Here are some key points to remember when developing a protocol:

  • Use instructional text as guidance as guidance when writing your study-specific protocol document, but delete these instructions prior to submission.
  • When writing a protocol, always keep your own electronic copy. You will need to modify this copy when making changes to the protocol.
  • Note that, depending on the nature of your research, certain sections of the template may not be applicable to your study. Indicate this as appropriate. Retain the section heading and add “not applicable”, rather than deleting the section.
  • Upload the protocol to the IRB application in Word format, as this allows for reviewer edits and comments to be easily placed in the document.
  • If you plan to involve any individuals who are members of the populations listed below as participants in your research, you must indicate this in your protocol and address the regulatory requirements that need to be met for including these populations. You are encouraged to consult the checklists referenced below to assist you in addressing these regulatory requirements.
    • Individuals who are not yet adults (infants, children, teenagers) (HRP 416 – CHECKLIST – Children)
    • Adults unable to provide legally effective consent (HRP 417 – CHECKLIST – Adults with Impaired Decision-Making Capacity)
    • Pregnant persons (HRP 412 – CHECKLIST – Pregnant Persons)
    • Prisoners (HRP 415–CHECKLIST-Prisoners)