Recruiting for Human Subjects Research

Purpose

To assist researchers in describing their plans for research recruitment in Cayuse Human Ethics. There are specific details that the Office of Research Compliance and the IRB are looking for to ensure ethical recruitment practices. Reviewing this guidance in advance of submitting your IRB protocol will improve the quality of your submission.

Scope

This guidance applies to all human subjects research studies conducted by OHIO researchers. This document contains general guidance and examples. We may ask for additional information on a study-by-study basis.

Minimum Information Required

Include the necessary information for potential subjects to determine their interest and eligibility. Ideally this will include researcher contact info, the purpose of the study, basic procedures that subjects would participate in (survey, interview, in-person assessment, blood draw, etc.), key eligibility criteria (gender, age range, specific medical condition, etc.), the subjects’ expected time commitment, and location of research. Include the IRB# on all recruitment communications and identify yourself as an OHIO researcher

Include the clean final draft of flyers, emails, verbal scripts, etc. as part of your submission. Only approved recruitment materials may be used.

Communication

  • Is the mode of communication clearly stated and explained in Cayuse submission?
  • Where will recruitment materials be disseminated?
  • Is prior permission needed?
  • How many times will potential subjects be contacted for recruitment?
  • How will you obtain the contact info?

Flyers

Include locations where flyers will be posted.

Emails/UCM

How many rounds of email reminders or follow-ups?

In general, the IRB will approve one follow-up for initial recruitment – additional follow-ups must be justified in the protocol.

How will you obtain the contact info?

  • Who will send the emails?
  • Are you using a listserv?
  • Using contact info for previous subjects who agreed to be contacted?
  • Will someone send on your behalf?

Online/Social Media
  • Where on social media?
  • Personal pages? Public or private groups? (Note: private groups are not considered “public” and require prior permission from group admins and considerations for confidentiality).
  • Any follow-up reminder posts?

Verbal (in-person)
  • Where will this occur? In non-public settings, prior permission may be required, and documentation may be needed

Telephone or Mail
  • Who is being targeted and how?
  • How many rounds of reminders or follow-ups?
  • In general, theORC/IRB will approve one follow-up for initial recruitment – additional follow-ups must be justified in the protocol

How will you obtain the contact info? 

  • Who will make the calls/send the mailings?
  • Are you obtaining a list or using a marketing service/survey center?
  • Using contact info for previous subjects who agreed to be contacted?

ResearchMatch Qualtrics Prolific, etc.

Ensure that your study design and research question is appropriate for and meets the requirements of the recruitment platform to be used.

Method of contact (how will interested parties learn more?)

Follow the guidance to the extent permissible by third party platforms – they may have limitations on what can be included in the recruitment message.

Method of Contact

For all recruitment methods: Include PI contact info. For non-exempt studies, indicate if PI is a student researcher and if so, include the advisor’s contact info as well.

For some research (such as online surveys), no direct contact may be required, but in addition to any survey links, appropriate contact info for PI and advisor (if applicable) must be included in the email or flyer.

For social media/online recruitment, to help ensure confidentiality of participation, discourage public communication - for example, if subjects have questions, they should contact you via your OHIO email, rather than ask in the comment section (use of OHIO email the preferred method of electronic communication, but alternative methods may be acceptable when intended to protect subject confidentiality). If someone who is not listed on the IRB protocol posts on your behalf (e.g., a group admin), they should not attempt to answer any questions about research participation. All questions must be directed to the study team.

Benefits and Compensation

Information in the recruitment material must be consistent with the Cayuse submission and Informed Consent Form (ICF); should not state “free” treatment or  benefit when it’s more accurate to say subjects will not be charged; compensation should not be overly emphasized (e.g., large print relative to other information).

FDA-Regulated Studies

Recruitment materials cannot make safety or efficacy claims; cannot draw comparisons to other drugs/devices; must state if test article is investigational.