Once you’re ready, please download the PEER Simple IRB Template, and review the checklist and instructions. Although the template has specific instructions for what information should be included in each section, the information below provides additional information about each section. We recommend reading the information below first, while having the template open next to it. Keep an eye out for examples!

To obtain approval, you will need to submit both the IRB application and the required supplementary documents. This section focuses specifically on filling out the application itself. Please see the next section to learn more about the Supplementary Documents. If additional issues or questions also come up along the way, please refer to the IRB FAQs.

Section I: Cover Page & Personnel

On the first page of your application, you will:

  • Enter the name of your sponsoring organization and/or community.
  • Enter the title of your project.
  • Create and enter your protocol number.
  • Fill in Section I: Personnel.

Also, please do NOT fill in the gray box at the top right of the application, which indicates whether your application will receive Full Board Review or Expedited Review. This designation is made by the chair of the Genetic Alliance IRB. A description of the IRB designations are listed below:

Full Board Review: A study review process in which a quorum of members from an Insitutional 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.

When making a determination about a study’s review status, the IRB chair considers whether there is an appropriate minimization of risks; appropriate risk-benefit balance; equitable selection of subjects; documentation of consent (or a waiver of documentation); appropriate data monitoring; and appropriate measures for the protection of subject privacy.

Protocol Numbers

Your protocol number is a unique ID composed of two pieces: an abbreviation that’s associated with your sponsoring organization or community and is chosen by you, and a three digit number that catalogues your protocol chronologically. Setting a protocol number is helpful to you and the IRB in keeping track of your protocols, especially if you plan on having multiple in the future. An example, “AAAA001”, is provided in the template. Don’t forget to update this! Chances are you will only need to update the abbreviation, and can leave the “001” as is: for most communities establishing a PEER registry, submission of your application to establish and operate a PEER registry will be your first encounter with the Genetic Alliance IRB.

Example: PXE International is an advocacy organization serving individuals with pseudoxanthoma elasticum, commonly referred to as PXE. They numbered their application to establish and launch a PEER registry as “PXE001”.

Personnel

Section I of the template requires you to list the identities of your Principal Investigator (PI) and any co-investigators. We defined these individuals’ role in your study earlier, in the 'Understanding the IRB Process' section. You may review the descriptions again below:

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.

Organizations and communities sponsoring PEER registries frequently ask whether the PI of their registry should be an external partner who is a physician or researcher, versus someone who is an employee or volunteer of the sponsoring organization or community. While the PI can be an external partner this is certainly not a requirement. When choosing a PI you should be choosing the individual who has the clearest vision for your registry, and will be able to drive the project forward. For some organizations and communities this does turn out to be an external partner – for instance, a physician that has worked with your participant community for many years, and who is potentially on something like the sponsoring group’s medical advisory board. For others, this individual is a staff person or volunteer at the sponsoring organization or community. Either approach is fine!

Your choice of PI will inform whether or not you choose to list a correspondent in your application. If your PI is an external partner, you should be sure to list the individual at your sponsoring organization or community who is liaising with him or her throughout the project. If your PI is a staff person or volunteer at your sponsoring organization or community, but is working closely with another individual to implement your registry (such as a program manager or study coordinator), you may wish to list that second individual as the correspondent, as well.

If your PI or other key personnel also need to complete the human research participant protections training, they can obtain a free certificate online through the NIH or CITI.

Section II: Nature and Purpose of Proposed Study

In the research description section, you will:

  • Provide a technical (scientific) abstract.
  • Provide information on research design, methodology, and data analysis.
  • Provide a lay summary.

For an application to establish and operate a PEER registry, your technical abstract should function primarily as background, and answer: why are you doing this, how are you doing this, and what do you hope to accomplish? The information you provide on the research design and methodology section should focus on your methodology for collecting registry data; for instance, a high-level summary describing the content of the surveys you have developed, and how you plan to deliver them. (You’ll have space to specify the actual content of these surveys elsewhere.) Your lay summary should be developed with an eye towards “the public”, and should quickly and succinctly describe what you’re doing, and why. This material can also be very useful when developing outreach materials.

If you are also submitting an application to seek approval for data analysis, this section may look a little different. Your abstract should touch on the nature of the data analysis you are doing, and on your intent in doing so. Your research design, methodology, and data analysis section will also need to address this analysis, and provide some insight into your methodology for working with the data.

Not sure whether to include data analysis in your initial application to establish and operate a PEER registry? Revisit our section on defining key study components for your IRB application.

Section III: Human Participant Protection

The next section is about human participant protections. Here, you will answer a series of questions about what populations you’re working with, and what methods you’ll use to recruit them to your registry.

Research Population

This section of the application addresses the “who” of recruiting for your registry, with a specific focus on the inclusion of vulnerable populations. The Common Rule defines vulnerable populations as pregnant women, human fetuses, neonates, prisoners, decisionally impaired individuals, and children. If you are working with vulnerable populations (which many PEER registry sponsors are) you must demonstrate to the IRB how you will protect their rights and welfare.

To do this, you must first demonstrate justification for inclusion: in other words, why do you need to include vulnerable populations in your registry at all? (If you do not plan to include vulnerable populations you can skip ahead to the next section.) For most PEER registry sponsors, inclusion of vulnerable populations is justified by the fact that their condition or topic of interest impacts people across their life spans, and that exclusion of vulnerable populations runs the risk of providing an inaccurate picture of community.

Justifying Inclusion Of Vulnerable Populations

The Joubert Syndrome and Related Disorders Foundation serves individuals and families impacted by Joubert syndrome and related ciliopathies. In their application to establish and launch a PEER registry, they indicated that they would include pregnant women, human fetuses neonates, decisionally impaired individuals, and children as participants in their registry. Here’s why…

“As this registry will capture individuals’ data across the lifespan, pregnant women with JSRD cannot be excluded. It is also estimated that 90% of individuals with JSRD are 17 years of age or younger. As such, inclusion of fetuses, neonates, and children is also essential to understanding the manifestation and onset of JSRD. Finally, as persons with JSRD may have intellectual deficiencies and many are decisionally impaired, their inclusion is imperative to capturing a representative population of individuals with JSRD.”

Next, you’ll need to provide an explanation of how you’ll protect these populations’ rights and welfare. The set-up of PEER, which allows participants to make their own decisions about how and with whom their data is shared, provides a baseline for the inclusion of the vulnerable populations. If there is no additional risk for vulnerable populations in comparison to the risk experienced by a regular adult participant, then all you need to do is state that these populations experience no special risk.

Of course, things can be a little more complicated in cases where the participant cannot provide consent to participate in research in the traditional form. The usual legal age of consent to participate in research in the United States is 18, which means that children under the age of 18 (a category which necessarily includes human fetuses and neonates) typically represent a scenario different from a “regular adult participant”. When it comes to consenting children to participate in research, a parent or guardian must be present to assist the child in understanding the nature of the research. However, that parent or guardian cannot always simply consent on behalf of the child, either: in certain situations, assent must be obtained from children who are eight years of age or older. Assent means that the child has agreed to participate in the research, but is doing so with the assistance of the parent or guardian.

Things are slightly different for decisionally impaired individuals. Decisionally impaired individuals of any age do not have the capacity to provide consent or assent. In cases where a deciaionally impaired individual might be expected to provide consent or assent based on their age, a legally authorized representative (LAR) must instead act as their go-between. The LAR can be an adult parent or an adult non-parent. Regardless of the relationship, though, he or she must agree to have legally authorized status for the individual.

Protecting The Rights & Welfare Of Vulnerable Populations

When explaining how they would protect the rights and welfare of vulnerable populations, the Joubert Syndrome and Related Disorders Foundation said…

“There is no special risk associated for pregnant women. There is also no special risk for human fetuses, neonates, children under the age of 18 or decisionally impaired individuals whose parent or legal guardian act on their behalf.

With regard to the rights of the decisionally impaired individuals 18 years of age or older, additional safeguards will be considered, depending upon the complexity of the impairment due to JSRD. Whenever possible, the subject may give consent for him- or herself with the support of a family member. A family member designated as next of kin or the legally authorized representative may also give permission.//

Identifying Research Participants

The next section deals with identifying research participants. We ask that groups also submit a proposed outreach plan for recruiting participants to the registry. Your outreach plan does not need to be complicated. The IRB reviewer simply needs to know a bit about who you will be targeting your outreach to, and how you will be communicating with them.

Your outreach plan should provide a high-level overview of your goals for outreach and engagement along with your proposed strategy for attaining those goals. Your outreach plan should also:

  • Explain your experience with this population
  • Describe your relationship with your community and any past work
  • Include sample, draft outreach messages such as social media posts or recruitment emails

You do not need to submit literal outreach pieces but rather a “boiler plate” to give the IRB reviewer a sense of the language that you will use to recruit participants to your registry. This is to make sure you’re not overly solicitous or overly stating the benefits of the research and that the risk-benefit balance doesn’t change drastically. You are welcome to submit outreach messages in any form such as a Word document of sample social media posts. Some additional examples of good “levels of detail” are provided below.

  • DO provide an example Facebook message or two that you might use to promote the registry. One might utilize a personal story to promote the registry, while another might talk about the importance of research in general.
  • DO NOT write out every single Facebook message you plan to post over the next month.
  • DO include the text of your launch announcement – for instance, a press release, if you plan to put one together – along with information about how you will distribute it.
  • DO NOT include all material (online or in print) examples of all the different versions of this announcement that you’ll distribute – for instance, an email announcement about the registry, a letter to families, brochure, tweets and Facebook posts, a post on a community member’s blog, and so on. Simply noting the “how” of the distribution is sufficient.

Groups are also encouraged to use the Template Outreach Plan (which is about three pages in length). Please also feel free to look at our Sample Outreach Plans from organizations currently using PEER.

If there are any changes in your outreach you will need to submit an amendment. Please refer to the ‘Amendments and Renewals’ section for more information.

Section IV: Informed Consent Process

The last section of the application deals with the informed consent process. Because the informed consent process is already incorporated within PEER, groups do not have to submit their plan for obtaining informed consent as part of their application. Participants in PEER will be informed about the registry and their privacy rights and agreements when they sign up for the registry. A sample email which is generated by the PEER system (and can be edited by groups) to participants signing up for the registry is below:

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This ensures that participants are aware of what they signing up for. However, if you plan to conduct your own research, you will need to complete a separate IRB application and include the informed consent process to check to see if the principle of autonomy if followed.

Section D: Risk Mitigation Plan

The risk mitigation plan is designed to address any risk that is specific to your PEER project (versus to PEER as a whole). Unlike your survey and outreach plan, you do not need to attach anything to the template application for your risk mitigation plan. Instead, the plan will consist of your responses to the questions in Sections C and D of the application template.

If relevant, you may wish to include links to your organization’s own Terms of Service or Privacy Policy, which are distinct from PEER’s, in Section D-G (the portion on Risks and Inconveniences). Sample risk mitigation plans from organizations currently using PEER can be found in Sections C and D of the PXE International and Joubert Syndrome and Related Disorders Foundation applications. Their applications can be found in the ‘Do you have any examples of outreach plans from other organizations?’ section of the FAQ’s (which are listed under ‘Additional Resources’)

Data Confidentiality

Future Data Use

Please keep in mind that you are submitting an IRB application to establish and operate a PEER registry. You will need to submit other IRBs or amendments if you want to do data analysis, develop a research protocol, etc. Please see the Keeping Your Approval Up to Date: CRs and Amendments section for more information.


After filling out the IRB application, prepare the supplementary documents for your application:

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