I Need To Change Something About My Study

Please see the CMH Institutional Review Board website on the intranet for information on how to modify your protocol. 

• 1. Modifications to a study may be classified as major (the risk/benefit assessment changes or the aims/design of the study change) or minor. A conversation with the GME Research Staff can guide you in the right direction as to whether or not your study must be amended and if so, which forms to use. 
  2. Generally, if your study was originally reviewed on an Expedited basis, the modification will be reviewed on an Expedited basis; the same logic stands for Full Board Review.  
  3. Some common reasons that an amendment is required (and their associated forms) include:
     • Change in PI, 
     • Change in research team, 
     • Change in protocol (including: title, sites, subjects, consent form, recruitment, enrolment, consenting, data collection methods/tools, changes in funding, changes in Conflicts of Interest among Research Study Team members)

Recruitment can be tricky – even for seasoned researchers. This might be an opportunity to take a hard look at your recruitment and consenting plan to review the specific barriers: why wouldn’t a participant say yes to your study?  A chat with your Research Study Team and GME Research Staff can help you troubleshoot and make any necessary IRB amendments. A few common considerations:

1. 1. Was the potential participant pool large enough?
      • Does CMH have the patient population you thought it did or might you need to broaden your eligibility criteria? You might chat with GME Research Staff who can connect you with CMH data on your study population to make more targeted projections on feasibility. 
      • If so, is there any criterion/comorbidity you could take off but analyze separately *while still* maintaining integrity of the research question + scope of the project + scientific value? 
   2. Are there logistical barriers?
      • Do you need to translate your consent form into additional languages?
        • If you need translation assistance, please discuss with GME Research Staff, who can connect you to resources. 
      • Are there additional/other recruitment sites that could help funnel patients your way? 
      • Does your Research Study Team have what it needs to screen, recruit and consent properly? Do you need more support from your Research Study Team or more Research Study Team members?
   3. Is it happening, just too slowly?
      • What can you do to adjust your projected time budgeted for enrollment and the subsequent study plan? 
   4. Are they just not saying yes?
      • Could it be the flyer/script recruiters are using? Is there something turning folks off that could be reframed? Do you need to add materials/ recruiters? (Reminder: IRB must approve all materials and methods, including flyers/emails/scripts/etc. If you are looking for inspo, check out the Informed Consent and HIPAA Authorization template on the CMH Institutional Review Board website on the intranet.)
      • Could it be the time burden? 
      • Is compensation offered and if so, is it appropriate to the commitment? Are there specific parts of your study that even you would have a hard time consenting to? 
      • Is the recruitment site appropriate? Do patients have the wherewithal to process the opportunity? Is there anything that could be done to improve the environment?

If you need to change something about your recruitment and/or consenting approach, be sure to submit a protocol amendment to the IRB.