On April 13, 2016, PRIM&R hosted a webinar titled Familiar Faces: Addressing the Challenge of Simultaneous and Sequential Study Enrollment, presented by Stephanie Collins Reed, PhD, CIP and Ilene Wilets, PhD, CIP.
This webinar defined and estimated the prevalence of simultaneous and sequential study enrollment across the research enterprise, discussed best practices for IRBs and investigators, and provided considerations for policy development. By the end of this webinar, attendees were able to navigate the tension between subject autonomy, risk, confidentiality, and data integrity when it comes to simultaneous and sequential study enrollment; provide informed support to their local research community for how to effectively manage this scenario; and draft a standard operating procedure (SOP) related to policy on co-enrollment.
After the webinar, the speakers answered some of the questions from webinar attendees that time didn’t allow for us to answer live. We’re pleased to share those answers with the readers of Ampersand. The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you’re interested in purchasing a recording for a group, please email firstname.lastname@example.org.
1. Can you speak to implications for participant confidentiality for databases aimed at checking participants’ enrollment status? Does the use of a database create HIPAA issues?
Stephanie Collins Reed (SCR): I think an important piece is the consent process. It should be made clear in the confidentiality section of the consent form and in the consent discussion what information, in general, will be shared with whom, and whether the information contains identifiers or is de-identified. Then it is up to the individual to decide whether they feel comfortable with those terms and will participate in the study.
Ilene Wilets (IW): In terms of HIPAA issues, in part, it may depend on whether you mean an internal/institutional database or an external/regional or national database. We are a HIPAA-covered entity so our Authorization to Use or Disclose Health Information during a Research Study (and our consent form) clearly specifies what identifying information, if any, will be shared with whom. This is particularly important if information will be shared with anyone outside of our covered entity. We also clearly explain if any information will be stored in an internal or external database. Study participants sign the HIPAA form for research indicating their understanding and agreement to the terms indicated in the form.
2. In your standard operating procedure, you suggested that should an investigator learn that a subject in his/her clinical study is also enrolled in another clinical study, the investigator should speak to that individual about co-enrollment. Can you tell us how that conversation should go? What are best practices if the subject is frustrated or angered by the conversation that has occurred?
IW: You should ask the subject to join you in a private space and approach the issue in a neutral, non-antagonistic fashion, since it is possible that the subject doesn’t realize that they may be “breaking the rules” so-to-speak. Honesty is the best policy at this point and you can just ask them why they are there. You can then explain that participation in two studies at the same time may jeopardize their safety and that it is not likely to be in their best interest.
SCR: If you handle it in a neutral manner and are transparent about the importance of the conversation (i.e., their own personal safety), in my experience, there will be little anger. If someone does become angered, it may be best to table further conversation at that time and revisit it later, with the knowledge that a decision would still need to be made whether to continue the participant in the study or not.
3. If you become aware that one of your participants is involved in another study, can you approach the other investigator? Doesn’t that compromise the study participant’s confidentiality?
IW: First and foremost, if co-enrollment is a criterion for discontinuation in your study, then you need to abide by that and discontinue the subject. Even if you do not have such a discontinuation criterion, should you suspect that your study and the “other” study are at cross-purposes and enrollment in both studies is contraindicated, it is advisable to engage the other investigator to discuss the situation. The intent of this dialogue is not to breach subject confidentiality, but rather, to safeguard subject well-being and maintain the integrity of collected data. Should you go this route, you should inform the study subject about your actions and provide reasonable justification.
4. Would it be ethical for somebody to dual enroll to beat placebo if they were in desperate need of treatment for a condition for which there is no known treatment?
IW: It would be considered unethical for an individual to dual enroll in a randomized placebo-controlled clinical trial for the purpose of increasing the odds of their assignment to an experimental treatment arm. If an individual falls under the radar and actually enrolls in the same therapeutic study at two different sites, he/she is likely to compromise the integrity of the data—regardless of which study arm they wind up in at each site. More importantly, dual enrollment in the same study could conceivably increase risk of harm to the study subject.
SCR: My first thought is that dual enrollment in the same trial would be hard to accomplish undetected. Usually a multi-site study has built-in checks for duplicate enrollment; for example, patient-participant databases and rigorous screening procedures. These mechanisms greatly reduce the likelihood of the same person enrolling in the same trial at two different locations.
5. It seems that, to an extent, the frequency and context of simultaneous and sequential study enrollment is not conclusive. Beyond the institution-specific level, what can professionals in the field (e.g., researchers, IRB professionals, study investigators) do to decrease this knowledge gap?
SCR: Again, there are commercial registries available that may monitor study participation and dual enrollment, but internal ones are just as important or useful in tracking and collecting such occurrences, particularly if you are a part of a large research facility or consortium.
IW: And with respect to the knowledge gap that exists due to the paucity of published research addressing this issue, we think this situation will soon change given the advent of tracking tools with global reach. Given the sophistication and utility of some of the newly developed tracking databases, we expect to see more published studies, more presentations and dialogue regarding the challenges of simultaneous and sequential study enrollment.
PRIM&R would like to thank Dr. Collins Reed and Dr. Wilets for sharing their expertise.
PRIM&R would also like to thank DupCheck for supporting this webinar. DupCheck is a web-based tool used globally to screen for duplicate patients and volunteers in clinical trials across studies, sponsors and therapeutic areas. Duplicate enrollment harms both study participants and studies.
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