My Study Got Approved

Step one: share the good news! It is the PI’s responsibility to share any IRB-related updates with your Research Study Team. But your responsibilities don’t stop there:

1. 1. Once the IRB has approved your consent form for CMH patients, do not distribute consent forms to patients until you have received the PDF version of the consent form from the IRB with barcodes.
      • Pro Tip: print the form instead of copying it multiple times, which reduces the barcode quality. Ensure that the IRB study number/consent form version date is formatted onto each page of the consent form submitted to the IRB.
   2. According to this policy, if your study requires funding from GME, you need to submit your budget for approval to the ADGME. Please see “What if my study needs funding” for more information.
   3. PI responsibilities after IRB approval:
      • Liaise between Research Study Team and IRB;
      • Oversee enrollment (making sure that only those with IRB approval are enrolling subjects), data protections, and  HIPAA protections;
      • Order any necessary labs/tests beyond standard of care ONLY IF cost is covered for the patient
      • Immediately report to the IRB any:
        • Conflicts of Interest
        • Protocol deviations resulting in an Adverse Event / Serious Adverse Event (as well as a statement on the corrective action plan taken for the incident)
        • Adverse Events/Serious Adverse Events (regardless of cause)
        • Significant findings that occur during the study that might affect subjects’ decisions to participate or continue participating
        • Death of a subject (regardless of cause); 
      • Discuss with the GME Research team any changes in study protocol AND submit any amendments to IRB *prior to* implementing any changes, including modifications in PI, research team, and 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). 
      • Respond to any IRB inquiries. Based on your study type, you may expect to be contacted by the IRB for a Continuing Review – a general check in on how your study is going and if any changes need to be made to your protocol. 
      • Close or hand off the study once it is appropriate. If you are closing the study, notify the IRB and submit a final report (see sections “My study has been completed” and “I’m graduating”).  If you are graduating and will not have a chance to complete the project, identify who will take over the study.

Even after you receive IRB approval, there are a couple of reasons you may need to contact the IRB: you may need to make an amendment (see the “I need to change something about my study” section), report an adverse event or serious adverse event occurs, or notify the IRB of significant new findings.

• • An Adverse Event (AE) is any untoward medical occurrence in a research participant receiving an investigational pharmaceutical product or device-regardless of causal relationship. Examples include any abnormal lab finding, symptom, or disease associated with the intervention. If in doubt about whether or not something is an AE, call the IRB to discuss your situation. AEs must be reported in writing to the IRB for Full Board review to determine next steps.  If a deviation from the IRB-approved protocol results in a reportable AE, you must report the AE,  the mechanism, and a Plan of Correction. It is worth noting that the IRB has the authority to suspend or terminate a study that is not being conducted according to the approved protocol or established policies.

You are expected to complete the Continuing Review Annually  – a general check in on how your study is going and if any changes need to be made to your protocol. The IRB will send you a notification when the updates are due.

If, in the course of your study, significant new findings arise (either within your study or the published literature) that may make the study more risky for participants or affect their willingness to participate, you will need to notify participants and contact the IRB with a proposal for how you would inform participants plus any new consent forms and/or contact letters for participants.