Tips for developing a data-only protocol

A well-written protocol is crucial to the success of any research study — this includes data-only studies that exclusively use existing data and involve no participant interaction.

In this article, we’re sharing practical tips to help you develop a complete, IRB-ready, data-only protocol for your University of Minnesota study using a four-part framework: Plan, connect, submit, and conduct:

• Plan your project
• Connect with research experts
• Submit your protocol
• Conduct your study

Plan your project: Steps to take before writing your protocol

A good plan goes beyond having a good study idea, and will set your project up for success.

• Understand the rules and responsibilities — This applies to both the Principal Investigator (PI) and study team members. Students must work with a mentor who will serve as PI. Students and study coordinators can create a study in ETHOS (a web-based platform for IRB submissions), but only an eligible PI can submit the IRB application and any subsequent changes or protocol modifications. Make sure to designate a PI and form this relationship inside your specific department or division ahead of time to avoid delays in the submission and review process.
• Use the appropriate protocol template, in the most updated version — We recommend downloading the protocol template from the UMN IRB every time you start a new protocol, rather than starting with a copy of a previous protocol or template saved on your computer. That way, if the IRB has released an updated version, you don’t have to spend time transferring everything to a new template.
• Secure (or renew) NERS approval — If you need to access electronic health record (EHR) data using Epic, you will need Non-Fairview Employed Research Staff (NERS) Epic access. Epic is the electronic health record platform used by M Health Fairview. Study staff should submit an application and other supplemental documentation, which will be reviewed by Fairview. NERS approval must be renewed annually.
• Ensure the study team has sufficient resources to complete the project — This includes:
  • Time. Do all study team members have enough time to successfully complete the study? If you have project deadlines, are they reasonable?
  • Departmental support. If you are in the Medical School, you will need to complete the Departmental Research Resource Review.
  • Study team expertise. Ensure the PI and study team have the relevant scientific and/or clinical background to successfully execute the protocol.
  • Technology devices and systems. Ensure you have the appropriate devices, including Health Sciences Technology (HST) managed devices when needed, to stay compliant with requirements for secure data collection and storage. 

Connect with research experts

There are many resources available to help develop your protocol! One of the most popular options for University of Minnesota researchers is the Clinical Research Support Center (CRSC).

The CRSC brings together experts from more than 20 specialized teams to provide comprehensive support to help study teams navigate the complex research process and set their projects up for success.

Established in 2018, the CRSC supports on average 1,500 studies per year, across numerous UMN departments and schools. The Clinical and Translational Science Institute (CTSI) is one of the many collaborators behind the CRSC and leads its day-to-day operations. 

Services for data-only studies

Several services are available for data-only studies:

• Protocol development support: Meets with study teams to provide guidance and answer questions about research and/or the protocol. Once a study team sends a protocol draft, CRSC experts review the draft and provide specific feedback and example text. They also give researchers a single point of contact during the study’s critical planning and activation stages. All support is free of charge.
• Data access and informatics support: Provides study teams with access to high-quality data for their research from a variety of data sources. During the initial consultation, you may discover that they can pull the data you need — saving you time and reducing coding errors. If your study is retrospective and all data is made available to you, you may be able to complete an abbreviated review. A consultation with the informatics team is required for the abbreviated process — eligibility will be determined at that time and the IRB will require a report from the consultation. If it’s determined that your study is eligible for the abbreviated process, you will only need to complete up to section 3.2 of the study protocol, and Fairview and UMN Health Information Privacy & Compliance Office (HIPCO) ancillary reviews are waived.
• Regulatory support: Regulatory specialists help study teams navigate the IRB submission process, maintain electronic regulatory binders, and guide the study team on Good Clinical Practice (GCP) guidelines. 

These are just a few of the many CRSC services available to help your study — there’s also biostatistical support, REDCap support, and more!  All initial consultations and office hours are free, although there may be a fee for some services.

Submit your protocol

Once your protocol is finalized, submit the study protocol and any relevant study materials, such as data collection instruments (i.e., questionnaires), to the UMN IRB using the ETHOS platform.

Tips for the IRB submission process

• Don’t forget about the ancillary review step — Ancillary reviews are reviews of human research projects by compliance groups in addition to the IRB review. For example, HIPCO is an ancillary reviewer for all studies submitted to ETHOS that involve individual health information. The IRB typically assigns ancillary reviews once the submission is received. Satisfactory approval from the appropriate ancillary review group must be obtained prior to the IRB issuing their final study approval.
• Avoid modifications during the IRB review process — Unless requested by the IRB or ancillary reviewers, the IRB submission and review process is most efficient when no further changes are made to the protocol until after initial IRB approval. If you identify a modification you’d like to make, we advise you to hold off and submit a protocol modification once the study is IRB-approved.
• Consistent document versioning — Your protocol should be version 1 until you submit to the IRB. Subsequent modifications are a new version number (V2, V3, etc.).
• Submit your protocol as a Microsoft Word document — Do not submit as a PDF.
• Use track changes — Once you submit the protocol to the IRB, make any requested changes using track changes so the IRB can easily ascertain what has been revised.
• Don’t get started until you receive approval — Make sure no work is completed on study procedures until the project is approved by the UMN IRB.
• Closely monitor progress in ETHOS — Be sure to respond to any questions or pre-review clarifications in ETHOS to avoid delays in receiving approval.
• Complete training requirements — Make sure all study team members have completed UMN and other required training, including CITI and HIPAA training.
• Plan ahead — IRB review times can vary, so it’s best to plan ahead and submit as early as possible to satisfy deadlines.

Conduct your study

Once you’ve received IRB approval, you can begin conducting your study procedures as outlined in your study protocol.

• Closely read the IRB approval letter — Keep a close eye out for information about matters such as expiration dates and waivers of consent.
• Follow the protocol — It sounds simple, but make sure you follow the protocol exactly as written.
• Submit any protocol modifications and personnel changes to the IRB — If you need to revise and make changes to the protocol or add or remove study staff, submit a protocol modification to the UMN IRB. The Clinical Research Support Center can help review revisions to the protocol and submit it to the IRB.
• Understand when modifications require new submissions — When thinking about whether a modification to a project will instead require a new submission to the IRB, consider the 3 P’s: Purpose, population, and procedures. If at least two of the three change as a result of the modification, a new protocol and IRB application may be required.