Applying for IRB approval to use ResearchMatch

SUBMITTING A NEW IRB APPLICATION THAT WILL USE  RESEARCH MATCH

1. Describe the intended use of ResearchMatch in the Research Plan

Include a statement of  intent to use ResearchMatch in Item 11 Recruitment of the Research Plan.

  • ResearchMatch sends a recruitment message to potential participants who meet the criteria specified. This text must be reviewed and approved by the IRB. If the recruitment message is being submitted with the application (recommended), include a statement indicating that the proposed recruitment message is on a separate page labeled “ResearchMatch Message to Potential Participants.”
  • If the recruitment message is not being submitted as part of a new application, include a statement indicating that a recruitment message is not included and acknowledge that the content of the research message must be approved by the IRB prior to use.
2. Develop the Recruitment Message

Insert proposed text on the form entitled “ResearchMatch Message to Potential Participants” available here.

Suggested Recruitment Message Content:

  • A brief description of the study in lay terms
  • A brief summary of study procedures
  • In summary form, the eligibility criteria that will be used to admit the subjects into the study
  • A description of the incentives to the subject for participation in the study (e.g., payment or free treatment)
  • Studies involving experimental drugs or devices must clearly state that they are experimental or investigational. Do not use terms such as a “new” drug or device since the word new can imply "approved" or “even better” versus investigational, and would be considered coercive. In medical studies, no claims should be made, either explicitly or implicitly, that any experimental drug or device is safe or effective, or equivalent or superior to any other drug or device. Such representation would not only be misleading to subjects, but would violate FDA regulations concerning promotion of investigational drugs [21 CFR 312.7(a)] and investigational devices.

ResearchMatch text must not include any direct contact information (e.g. PI name, phone number, email, or website). Interested volunteers will respond via the web interface.

 
3. Indicate the intent to use ResearchMatch on the Face sheet

Check yes for  "Will recruit using ResearchMatch".

(Note: Social and Behavioral Science applications can include the use of ResearchMatch but will skip step #3 as the face sheet does not include this checkbox.)

AMENDING AN EXISTING IRB APPROVED PROTOCOL (EXPEDITED REVIEW)

1. Describe the intended use of ResearchMatch in the Research Plan

Modify Item 11, Recruitment of the Research Plan, to include a statement of  intent to use ResearchMatch to contact prospective participants. State that the text of the proposed recruitment message is on a separate page labeled “ResearchMatch Message to Potential Participants.”

Submit one version of the Research Plan with changes tracked and one clean version.

2. Develop the Recruitment Message

Insert proposed text on the form entitled “ResearchMatch Message to Potential Participants” available here.

Suggested Recruitment Material Content

  • A brief description of the study in lay terms
  • A brief summary of study procedures
  • In summary form, the eligibility criteria that will be used to admit the subjects into the study
  • A straightforward and truthful description of the incentives to the subject for participation in the study (e.g., payment or free treatment)
  • Studies involving experimental drugs or devices must clearly state that they are experimental or investigational. Do not use terms such as a “new” drug or device since the word new can imply "approved" or “even better” versus investigational, and would be considered coercive. In medical studies, no claims should be made, either explicitly or implicitly, that any experimental drug or device is safe or effective, or equivalent or superior to any other drug or device. Such representation would not only be misleading to subjects, but would violate FDA regulations concerning promotion of investigational drugs [21 CFR 312.7(a)] and investigational devices.

ResearchMatch text must not include any direct contact information (e.g. PI name, phone number, email, or website). Interested volunteers will respond via the web interface.

3. Cover Letter
  • Include a subject line stating “Request for Review of an Amendment” and include the IRB project number, study title, and the name of principal investigator at the top of the letter
  • Clearly state an intention to use ResearchMatch to contact prospective participants in the body of the letter
  • As with any amendments, the PI is expected to evaluate the affect of the proposed changes on risks to subjects, risk/benefit ratio, risk management procedures, etc. Use of ResearchMatch is not generally expected to affect risk. If this is true for the study, include a statement to this effect in a cover letter
  • Include a description of any changes to Research Plan made in step 1 above. This description should include specific item and pages where changes occur.
4. Indicate intent to use ResearchMatch on the Face sheet

Check yes for “Will recruit using ResearchMatch.”

(Note: Social and Behavioral Science applications can include the use of ResearchMatch but will skip step #3 as the face sheet does not include this checkbox.)

For more information contact CTRI Community Engagement office

858-657-5139 or contact by email ctri-community@ucsd.edu

This information is provided without the endorsement of the UCSD IRBs or HRPP. It should be noted that each project and amendment to an approved project is reviewed by the IRB/HRPP on an individual basis.