Template Language for the Institutional Review Board (IRB)

For investigators wishing to add ResearchMatch as a recruitment method to an existing or future IRB protocol, template protocol and email language is provided below:

Institutional Review Board (IRB) documents

The following template language has been created by ResearchMatch. Researchers may include it within their amendments when adding ResearchMatch to an existing IRB protocol or specifying ResearchMatch as an anticipated recruitment tool for a future protocol.

Summary

I am requesting the use of ResearchMatch.org as one of the recruitment tools for this protocol.

Basic information regarding this tool

ResearchMatch.org is a national electronic, Web-based recruitment tool that was created through the Clinical & Translational Science Awards Consortium in 2009 and is maintained at Vanderbilt University. There is no cost for researchers at participating institutions in the ResearchMatch network to use ResearchMatch for the purposes of feasibility analysis or recruitment. The Vanderbilt IRB provides oversight for ResearchMatch as a recruitment tool and this has been documented within the ResearchMatch IRB Letter of Understanding (available upon request). However, individual requests to use ResearchMatch as a recruitment tool should be submitted to the participating institution's IRB. For more general information regarding ResearchMatch, please visit www.researchmatch.org.

Registration

Term definition: ResearchMatch researcher — A researcher according to ResearchMatch may be a protocol's principal investigator (PI) and/or the PI's recruitment proxy (e.g., key study personnel or another appropriate individual authorized to recruit for studies in accordance to IRB of Record policy). Proxy researchers undergo PI approval prior to being routed to Institutional Liaison approval.

This recruitment tool may be utilized once the researcher registers for recruitment access through ResearchMatch.org. After registration of basic contact information and details regarding this study, the request will be forwarded to this institution's ResearchMatch Institutional Liaison for approval. In the process of registering this study in ResearchMatch, the researcher will upload the most current IRB approval letter or documentation of other IRB determinations (e.g., exempt from IRB review) for this protocol.

The ResearchMatch Institutional Liaison will review study information and evidence of IRB approval and will set the ResearchMatch expiration date to mirror that of the IRB approval — as is stated on the IRB approval letter specific to this study.

Search capability

After being granted recruitment access, researchers will be able to search for appropriate matches amongst the non-identifiable ResearchMatch volunteer profiles in the system. Researchers may enter study inclusion/exclusion criteria in the ResearchMatch Search Builder, which will yield a list of potential matches to such criteria.

Contacting ResearchMatch volunteers

Researchers will send out IRB-approved content in the initial recruitment message to these potential matches (ResearchMatch volunteers) through ResearchMatch. This study's recruitment content will be inserted into the standard ResearchMatch electronic notification that informs possible matched volunteers that a researcher has identified them as a potential match for their study. The secure ResearchMatch clearinghouse will route this standard notification that includes this specific study content (i.e., similar to the content available on a flyer or poster) to each of these potential ResearchMatch volunteer matches and they will have the option of replying yes, no, or not respond through a set of quick links available in this notification. THIS MESSAGE WILL NOT INCLUDE THE STUDY'S DIRECT CONTACT INFORMATION (e.g., EMAIL, PHONE) AS RESEARCHMATCH WILL MEASURE THE RESPONSE RATE THROUGH THE CLEARINGHOUSE'S QUICK LINKS MADE AVAILABLE IN THIS ELECTRONIC MESSAGE. These response rate metrics will be made available to researchers through their ResearchMatch dashboard as well as the Institutional Liaison dashboards. By responding yes, the volunteer has authorized ResearchMatch to release their contact information to the researcher(s) responsible for that study. This information will be made available on the researcher's ResearchMatch study dashboard. The researcher will be responsible for managing this contact information as called for by their IRB-approved study protocol.

Managing my study

ResearchMatch will also be collecting aggregate data regarding the status of ResearchMatch volunteers within the study. ResearchMatch volunteers consent to this within the ResearchMatch volunteer agreement. The ResearchMatch enrollment continuum will allow researchers to indicate where the volunteer currently stands within the recruitment process and thus helps researchers monitor the utility and effectiveness of using this resource.

Access expiration

A researcher's access to recruit via ResearchMatch will last only as long as their IRB study approval or determination. The expiration date of ResearchMatch access will mirror the expiration date of the IRB-approved study. Researchers will be able to submit current IRB approval letters for the lifetime of my study and thus provide evidence of successful continuing review applications. If an unintentional lapse in time occurs and the researcher is not able to submit this continuing review evidence via ResearchMatch, their ResearchMatch data will not be deleted by they will not have access to searching the registry for recruitment purposes or contacting new volunteers until they have uploaded a current IRB approval letter which is once again routed for Institutional Liaison review.

Recruitment emails

Recruitment emails distributed through ResearchMatch cannot exceed 2,000 characters including spaces.

The sample message below should be customized as indicated by bracketed text:

Mayo Clinic is seeking [healthy volunteers] to participate in a research study. The purpose of this study is to [learn more about sleep habits].

You may be eligible to participate if:

• [You are over 18 years old]
• [You are a non-smoker]

Your participation will last for [one month] and includes [two] study visits. We will ask you to [complete a diary of your sleep habits]. You will be compensated for your time.

NOTE: Message must not contain any personal contact information — Contact through ResearchMatch is essential to ensure correct tracking.

Investigators contact potential volunteers through a secure mail system that collects 'yes,' 'no,' and no response information for each study and aggregate for Mayo Clinic. Volunteers responding 'yes' will authorize release of contact information to researchers, at which time they become responsible for managing the contact.