For any other questions that are not listed, please submit them to gro.ecnaillaciteneg|snoissimbusbri#gro.ecnaillaciteneg|snoissimbusbri.

Table of Contents

Application-specific questions

Who should fill out the application?

Someone familiar with the details of your registry. It does not have to be the principal investigator, but the principal investigator should still have final review of the application, as he or she is responsible for the content within and must sign the application prior to submission.

Who should take the human research participant protections training?

Preferably anyone in your organization who is working on the registry, either before or after launch. However, at a minimum, the training must be taken by the key personnel for your registry, defined as the principal investigator (PI), any co-investigators or co-PIs, and the project manager(s) and/or coordinator(s) that work on your registry.

Who should I choose as my principal investigator?

Your principal investigator (PI) could be a member of your medical advisory board, but it could also be the leader of your organization. Ultimately, you should choose someone who has the time and dedication to make your project a success. This person need not have substantial research experience: you can and should consult with expert researchers throughout the process of designing your registry content, both before and after launch, but that does not necessarily mean that one of these individuals needs to be named as PI.

As a reminder, the PI is responsible for the design, implementation and overall conduct of a research study and study personnel — but he or she is not necessarily the person who carries these activities out. The PI should delegate responsibilities for various study procedures (e.g. content creation, data analyses, manuscript preparation) to study team members. If there are any complaints or adverse events during the study, the PI is responsible for informing the study sponsor (if different from the organization to which the PI belongs). Finally, in the case of an audit regarding complaints or adverse events, the IRB will hold the PI accountable.

What do I need to say in my IRB application if I plan to enroll children in the registry?

PEER currently requires all users to be 18 or older. For this reason, the system allows parents to enter information on behalf of their children. If you are enrolling children in your registry you should indicate that due to the age of this population you do expect parents to fill out information on their children’s behalf.

Below, you will find an excerpt from the Joubert Syndrome and Related Disorders Foundation on this topic (they have a population that is primarily caregivers, answering on behalf of a child or relative with Joubert syndrome).

From the JSRD001 Protocol submitted by the Joubert Syndrome and Related Disorders Foundation:

Parent/Guardian Permission and Assent

Parents/guardians will provide permission within the PrivacyLayer of PEER based upon participant-chosen privacy preferences. When possible, children’s assent will be obtained in oral or visual form. Some children with JSRD have global developmental delays or the condition may severely interfere with vision or hearing and render them incapable of providing assent due to lack of communication. Other children with JSRD that are able to communicate may also possess the ability to assent to or dissent from participation. Out of respect for children with JSRD as developing persons, all children will be asked whether or not they wish to participate in the research by the parent/guardian. Those with JSRDF that are able to provide assent will do so in written, oral, or other communication (such as sign language or iPad communication device) form. Assent or dissent will be asked in the form of a question with a yes/no answer, such as “Would you like to take part in the JS-LIFE Registry to better understand JSRD?”

Is there a way for parents to pass their children’s accounts to them once they turn 18?

Yes. This is currently handled via individual request (children turning 18 who would like to take control of their accounts should reach out at gro.mroftalpreep|sutcatnoc#gro.mroftalpreep|sutcatnoc), but in the future the process will be automated.

Do any other PEER users have more than one language option? What should I say about enrolling individuals who speak a language other than English?

No, not yet. We are currently seeking funding to make this possible (while we have the infrastructure for translating surveys in place, we would need to fund the translation of the system’s registration and navigation). If you are interested in learning more please contact Katherine Lambertson (gro.ecnaillaciteneg|nostrebmalk#gro.ecnaillaciteneg|nostrebmalk).

In the meantime, you have a few options for what to say in your IRB application if you wish to enroll non-English speakers. You can…

  • Write in your eventual intention of offering the survey in other languages. (An example of this from PXE International is provided below.)
  • Leave this out for now – if needed, you can make an update to this part of the application when you apply for renewal.
  • Develop and describe other methods for enrolling non-English speakers (for instance, phone navigators, in-person navigators at conferences, and so on).

From the PXE001 Protocol submitted by PXE International:

If English is not the subjects’ native language, will the consent process (information sheet and privacy settings process) be translated into their native language?

No. Individuals who speak other languages will be given the written information statement and survey in their language, but not until Phase II of this study. Meanwhile, for people who wish to access the survey, but speak a language other than English, we will use interpreters that we have relied on in the past: family members of individuals who do speak English, clinicians for the individuals and occasionally professionals who have volunteered for us.

Why would I want to add my own written information statement to my registry?

A general written information statement is provided to all participants during registration, in place of a traditional informed consent process (most registries are sufficiently low risk that a formal informed consent process is not required, though this may change for sponsors who choose to conduct a clinical trial or comparative study through PEER). The content of the general written information statement was approved by Western IRB as part of the original approval for PEER as a platform (which should be familiar to you from Part 1 of this wiki, "Getting Started With PEER"). You may review the content of this written information statement here.

Because the general written information statement does not contain content specific to your registry, you may wish to add your own written information statement to appear alongside it. This may be particularly relevant if there are risks to participating in your registry that, while sufficiently low-risk enough to not merit an informed consent form, may still not be represented in the current written information statement. For instance, if you ask questions that may cause some distress to participants (for instance, asking questions about depression, or about a deceased child), this may be something you wish to note. Alternatively, if there are additional benefits to participating in the registry other than those noted in the general written information statement (for instance, opportunity to enter to win a prize once enrolled) you may wish to note these.

Supplementary Document specific questions

Do I need to do anything special if I am planning to have multiple surveys?

When submitting multiple surveys, please be sure to attach all survey files. In the “Research Design and Methods” section of your application, where you are asked to describe your methodology for collecting data, you should also add a sentence or two explaining the flow of your surveys.

For instance:

“All participants will be asked to complete the General Information and Diagnosis surveys. Participants who indicate that they have received surgery or alternative treatments will be asked to complete the Surgery and Alternative Therapies surveys.”

What should I do if I already know that I will ask additional survey questions in the future?

If you already know that you will be asking additional questions of your participants, and you know what these questions are, please include them in your application. You may do so even if they have not been entered into the PEER Survey Toolkit – simply send them with your application in a separate document (Microsoft Word, Excel, etc). You should be sure to format your questions so that the IRB reviewer can easily understand the branching logic and question order/flow.

If you will be asking additional questions of your participants but you do not yet know what these questions will be, you may submit an amendment to your IRB application at a later date. (NOTE: There will be an additional fee for amendment review.)

What should I include in my outreach plan?

Your outreach plan should be a high-level overview of your goals for outreach and engagement, together with your proposed strategy for attaining those goals. Any format is fine, but if you like you can fill out this template outreach plan (which is about three pages in length).

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.

Do you have any examples of outreach plans from other organizations?

You are welcome to review the following example applications and plans from other organizations using PEER.

PXE International*

Joubert Syndrome and Related Disorders Foundation*

*Member of the Community Enagaged Network for All (CENA).

NOTE: Both examples go more in-depth in their outreach plans than is strictly necessary. The very specific contact lists in the JS-LIFE application from the Joubert Syndrome & Related Disorders Foundation (JSRDF), and the very detailed communications plans in the PXE HELP application from PXE International, are not fully necessary. They're simply examples of how those organizations used the outreach plan requirement for their various needs. JSRDF has a small medical community, and for them, the plan also served to expand their reach. Many individuals with PXE also have low vision, and so PXE International put together a very detailed for volunteer “Survey Navigators”, who had agreed to help participants with low vision take the survey.
‪In short, cater the plan to your needs, and don’t go over the top! Simpler is better. You want to show that you’re ready to do outreach and provide some example materials and communications, but also want to keep things fairly straightforward. 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 three months.

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 actual 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, tweets and Facebook posts, a post on a community member’s blog, and so on. Simply noting the “how” of the distribution is sufficient.

Submission specific questions

How much does the IRB cost?

Cost information can be found at:

Where do we submit our IRB?

When you are ready to submit your application, please submit your application and supplementary documents to gro.ecnaillaciteneg|snoissimbusbri#gro.ecnaillaciteneg|snoissimbusbri. We will send you both an invoice and your notice of approval over email. For IRB cost information, please click here.

How do I provide my survey in human-readable form?

The simplest way to provide your survey in human-readable form (which simply means that someone can read all of the questions in your survey, together with branching logic, without having to take it online) is to provide the list of survey questions from which you will build your PEER questionnaire. You do not need to include the list of elements that are captured during account registration and profile creation, shown below, as these are collected in all PEER portals and their collection has already been reviewed (by Western and the Genetic Alliance IRB).

  • Account Holder Email (accessible only if individual chooses to share contact information)
  • Account Holder First Name (accessible only if individual chooses to share contact information)
  • Account Holder Last Name (accessible only if individual chooses to share contact information)
  • Optional: Account Holder Mailing Address (street address accessible only if individual chooses to share contact information; information about state or province, country, and zip code available as part of survey data)
  • Optional: Account Holder Phone Number (accessible only if individual chooses to share contact information)
  • Profile First Name (accessible only if individual chooses to share contact information)
  • Profile Last Name (accessible only if individual chooses to share contact information)
  • Profile Date of Birth
  • Profile Living/Deceased Status
  • Profile Location (Country, State or Province, Zip Code)

Please do include any common data instruments which you are using in this list. Human-readable versions of these instruments are available upon request - please contact KyungSun Lee (gro.ecnaillaciteneg|eelk#gro.ecnaillaciteneg|eelk) for assistance.

COMMON DATA INSTRUMENTS (CDIs): In surveys, instruments are sets of questions made to gather data on a specific topic or area of interest. For instance, if you were developing a survey to assess patients’ perspectives on new cancer treatments, you might ask participants to fill out an instrument measuring quality of life. In PEER, common data instruments are instruments used across the platform, or “in common”. They capture information on a variety of general topics, from demographic information to interest in participating in research.

Using CDIs saves registry sponsors time and effort, and ensures consistent data collection and analysis across the platform. If you are using the Genetic Alliance IRB to approve your project it also makes review easier, as the Genetic Alliance IRB is already familiar with CDI questions.

CRs and Amendments specific questions

How frequently will I need to renew my IRB approval?

You will need to renew your approval every year the registry is still running. The renewal date is the one-year anniversary of your approval date. You will receive a reminder to submit your continuing review form (CR) from our IRB chair one month in advance of the due date, along with instructions on how to fill out the form.

We would like to analyze our registry data and possibly publish information based on the data. How would this change be classified in our continuing review?

Both analyzing registry data and/or publishing the data would be classified as minor amendments. You can fill out an amendment request, and attach it to your continuing review. Please be sure to reference in the CR that the proposed amendment is attached.

How do I find the number of subjects who refused to give their consent to participate in this study?

This number is zero for organizations using PEER. This measure is not applicable because of the way enrollment takes place in PEER: the platform does not have a traditional informed consent process because Genetic Alliance has been granted a waiver of documentation of consent, and enrollment is initiated by the participant.

How do I find the number of subjects who have withdrawn from the study since the last approval?

Participants can withdraw themselves from PEER by deleting their accounts, as outlined in the written information notice. However, sponsors currently cannot see accounts which accounts have been deleted. Therefore, this number will be zero for PEER groups, unless participants have contacted you specifically indicating a desire to withdraw.

Is the "latest version of the Protocol for this study" the IRB approval we submitted the previous year?

Yes, you can submit the IRB from last year if you do not have any changes. If you do have changes, please write it in the study protocol, and submit the updated version.

For the informed consent piece, can I just extract Section D on the Informed Consent Process from last year's IRB approval?

You may check the box indicating that you've attached the informed consent form, and then just write "The [registry name] uses PEER's standard consent process (participants are presented with the IRB-approved written information notice, and then choose their own privacy settings). Please see our study protocol, attached, for more detail if desired.

What would we include if we had a research partnership for the "Include a copy of any notice of grant award of sponsored research contract associated with the Protocol that currently supports this study" section?

You should only include this information if the researchers or other partnerships are financially supporting the registry.