In this section, we go over the Institutional Review Board (IRB) process and how it relates to PEER and your registry. We'll help you understand what an IRB is, what is covered under PEER's IRB, and what pre-work needs to be done in preparation for your IRB application.

IRB Overview

An IRB approval is essentially a 'seal of approval' to ensure that overall, your research or project benefits the participants, and does not harm the participants involved. The Federal Drug Administration officially defines an IRB as:

…an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.1

There are three primary types of IRBs. If using our Genetic Alliance IRB, the IRB conducts an expedited review of PEER because it is a minimally invasive and extensive project for participants.

Full Board Review: A study review process in which a quorum of members from an Institutional Review Board (IRB) reviews the study, as opposed to studies which receive expedited review or are exempt from review.

Expedited Review: A study review process in which the Institutional Review Board (IRB) chair or chair designee reviews the study without the full membership of the IRB. Applies to studies that are lower risk than studies requiring Full Board Review, but still involve sufficient risk that they are not exempt from review.

Exempt From Review: A study review process whereby the study is exempt from any form of review by an Institutional Review Board (IRB). Typically applies to studies conducted using data which is publicly available, and from which subjects cannot be identified directly or through linked identifiers.

Familiarize Yourself With PEER From A Regulatory Point Of View

In the introductory section of the wiki you learned that Genetic Alliance has already obtained IRB approval for PEER as a platform. The original approval was granted by Western IRB in 2014, with continuing review following in 2015 and 2016, before the IRB of record was transferred to the Genetic Alliance IRB in 2017. Before going too much further with your registry’s specific IRB application you should familiarize yourself with the original terms of this approval.

To start, please review the complete PEER protocol submitted to Western IRB, attached, together with relevant appendices.

Following review of PEER and its privacy settings, Western IRB granted PEER something that’s known as a “waiver of documentation of consent” for use of the platform, under 45 CRF 46.117. The waiver means that organizations creating PEER registries are not typically required to obtain written informed consent from the participants they enroll (though of course there are some exceptions – please see our section on Conducting Research With PEER Data to learn more). This is possible because use of the platform qualifies as “minimal risk research” – one of the possible reasons laid out for a waiver of documentation of consent under 45 CRF 46.117. Use of PEER is minimal risk partly because of the nature of participants’ interactions with the platform (they typically just answer survey questions, and are not directed to any medical interventions), but also because of the granular and dynamic nature of PEER’s privacy settings.

45 CRF 46.117 refers to Title 45 (Public Welfare) of the Code of Federal Regulations, Part 46 (Protection of Human Subjects). Title 45 is the principle set of rules and regulations issued by federal agencies of the United States as regards public welfare. Part 46 falls under Subtitle A -Department of Health and Human Services, and as indicated by its name, focuses specifically on protection of human subjects. Section 117 is contained under Subpart A: Basic HHS Policy for Protection of Human Research Subjects, and refers specifically to documentation of informed consent.

45 CRF 46:117 is part of the “Common Rule”, a set of federal regulations that outlines basic provisions for IRBs, informed consent, and Assurances of Compliance (a type of written agreement in which organizations conducting certain types of research with human participants state that they will comply with federal regulations). The same regulations are used across fifteen different federal agencies (which is where the name “Common Rule” comes from), and have been heavily influenced by the Belmont Report.

Those interested can read the Common Rule in full here. (Subpart A of 45 CFR 46 constitutes the entirety of the text.)

If you actually go into the Code of Federal Regulations, you’ll also see that Section 117 states the following:

“In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.”

The Western IRB has indeed required that PEER include such a statement. When participants register with PEER their registration email includes a link to a written statement from Sharon Terry, the PI for PEER. Below you’ll see the text included in that registration email:

IMPORTANT NOTICE: You are considering the possibility of enrolling in a system that is designed to enable you to decide with whom you wish to share certain information concerning yourself (or about someone for whom you provide care). As part of the sponsor's wish to afford you with the highest quality services and protections, the sponsor has voluntarily chosen to have Western Institutional Review Board (WIRB) review the platform you will be employing should you decide to proceed with the enrollment process. WIRB is an independent organization established in 1968 specifically to certify human subject protection for health-related research programs. Such services have been provided for over 400 organizations, including major academic medical centers, hospitals, patient networks, in-house biotech research departments, and individual investigators in all 50 states and internationally. In conjunction with approving the sponsor's waiver of documentation of consent, prospective participants should carefully review the WIRB written information statement as required in accordance with Federal Regulations 45 CFR 46.117 and 21 CFR 56.109(d).

Many organizations wish to make the registration email more specific to their own project, and for this reason we’ve also given you the ability to provide participants with a second written information statement of your own. If you would like to write your own statement, please submit this as part of your IRB application. Find out more about this feature here.

If you’d like, you can also review other documents associated with PEER’s IRB approval from Western. The original certificate of approval is available for review here. Continuing reviews for 2015 and 2016 are available to review here and here.

Preparing Your Application

Checkpoint: Have you defined the elements of your survey? It’s a good idea to finalize these before submitting your research protocol.

Define Key Study Components and Draft Your Survey

When filling out your application for IRB approval, you will be asked to write a research plan and outreach plan. Before beginning to work on these, you should make sure your research team can agree on answers to the following overarching questions including:

  • What is your objective in starting this registry?
  • What need does this registry fulfill?
  • What impact will this registry have on your participant community? On the public?
  • What are the short-term and long-term goals you hope to accomplish with the registry?
  • Who is invited to participate in the registry? How will you reach them?
  • What data will you collect from these participants (patient-reported data, medical records, etc.), at what time points (one-time or longitudinal)?
  • Who will be entering in the data (participants themselves, parents on behalf of their children, etc.)?

If you haven’t done so already, we encourage you to download our Study Design Worksheet to aid you in answering these questions. Fill it in and circulate it to your registry team, or hold a meeting of the team and work on filling it in together. We also suggest that you seek feedback from additional stakeholders. These stakeholders might include…

  • Other staff members within your organization (engagement experts, community organizers, etc)
  • Medical experts
  • Members of your participant community, including affected individuals, families, and caregivers

Depending on the focus of your registry you may also wish to solicit feedback from other stakeholder groups, including individuals with regulatory experience or experience with clinical trial design around a relevant condition. Some PEER communities choose to collect data that can be used in patient-focused drug development, or in the development of assessment tools for clinical trials (for instance, they collect data that could be used to design measures for assessing quality of life, assessing gain of function in degenerative conditions, and so on).

After completing the Study Design Worksheet, review our section on Survey Development to get a deeper dive in developing your actual survey, which is required as part of your IRB application.

If you already have a survey developed, then please feel free to continue within this section.

Get Certified In Human Research Participant Protections

As part of the IRB, the Genetic Alliance IRB requires that all key personnel for a study submit documentation confirming that they have completed human research participant protections training. Key personnel include your principal investigator (PI), any co-investigators or co-PIs, and the study project manager(s) and/or coordinator(s) that work on your registry.

Principal Investigator (PI): The person in charge of the design, implementation and overall conduct of a research study and study personnel. Delegates responsibilities for certain study procedures (e.g. consent, analyses, manuscript prep) to study team members. Must be named on informed consent documents and screens (if relevant). If there are any complaints or adverse events this individual is responsible for informing the study sponsor (if different from the organization to which the PI belongs). In the case of an audit regarding complaints or adverse events the IRB will hold this person accountable.

Co-Investigators/Co-Principal Investigators (Co-PIs): Assist the PI of a research study with the design, implementation and overall conduct of the study, and can represent the study when the PI is unavailable.

Study Project Manager/Coordinator: Works hand in hand with the Principal Investigator of a research study to implement all study procedures. Usually handles all the day-to-day study requirements, including preparation of all study documents and databases, and communication with participants.

Not sure who’s who for your registry? Take a look at our FAQ!

There are multiple acceptable forms of human research participant protections training. The two most common tend to be the National Institutes of Health (NIH) Office of Extramural Research Protecting Human Research Participants (PHRP) training or the Collaborative Institutional Training Initiative (CITI) Human Research Subjects (HSR) training, though some academic institutions provide their own. If you or one of your key personnel has already taken a course like this, all that is needed when applying for IRB approval is to submit the relevant certificate of completion. If you or one of your key personnel has not completed a course in human research participants protections, however, you will need to do this.

We recommend the NIH Protecting Human Research Participants (PHRP) training: it is free, and will take 3-4 hours to complete. Sign up for the NIH Protecting Human Research Participants (PHRP) training today at, and ask other members of your team to do the same.

Define Plans to Analyze Data

While most communities who are at the point of establishing a registry do not have a plan to conduct specific analyses of registry data at the point of launch, it’s possible that you may already know of analyses you wish to conduct after a certain period of data collection. If this is the case, you should not just treat your application as an application to establish and operate a PEER registry. You should also describe the data analysis you intend to conduct. Questions to consider include…

  • What is the objective and/or hypothesis associated with your analysis?
  • What evidence do you have to support this objective or hypothesis?
  • How will you conduct your data analysis?


Data Analysis: Inclusion In Initial Vs. Subsequent IRB Applications

As mentioned above, it’s unlikely that you’ll include a plan for analysis in this initial application. That’s okay: it’s typical for PEER registry sponsors to wait and submit an IRB amendment, or in some cases a separate application, once they’ve had a chance to observe trends in their data and are ready to start conducting analysis.

Sometimes, however, an organization launches with a plan for conducting data analysis already in hand. For instance, one of the communities using PEER recently used the data they were collecting to try to replicate a study by the team behind the T1D Exchange Clinic Registry. The original paper assessed the prevalence and associated predictive factors of autoimmune conditions that are co-morbid with Type 1 Diabetes. The PEER community decided to conduct the same type of analysis, but looked at autoimmune diseases that are co-morbid with Celiac disease. They easily identified which variables they would be assessing, and how.

If you know in advance that you would like to do something similar and conduct a focused analysis of a few variables within your registry, this data analysis plan can be included in your IRB application to establish and operate a PEER registry. At that level of specificity, it is not necessary to wait to flesh out your project and submit an amendment later.

For more information about the regulatory requirements that come into play when conducting analyses of data collected using PEER, please consult our page on Conducting Research With PEER Data.

When you are ready to begin filling out the IRB application, please download the template in the next section: