What We Learned At PRIM&R This Year

Representatives from BRANY, CITI, Protocol Builder, and HPR Consulting are all still abuzz about the great conference hosted by PRIM&R this year. We have returned to our work newly energized and inspired and  have spent the past couple weeks back in our offices talking about what we learned and would like to share these reflections with you.

Confirmation that proposed changes to the effective date for the revised Common Rule continues to elude us.

When federal agencies released the revised Common Rule, research professionals were left with many questions. Not the least of these was, “when will we really have to implement this”?  The Department of Health and Human Services has been delayed in providing guidance to help the research community prepare for compliance.

Research professionals are still preparing to implement the new rules to the best of their understanding, even though there has been a request for a one-year delay on the effective date. Despite the request for delay, there are potentially three burden-reducing provisions that could be implemented during the delay period and it is still unclear which are included. Also, it’s important to note that the request for delay has not been granted, and is going through its process of review and consideration.

We will continue to monitor this situation closely.

Patients and their advocates are taking science and research into their own hands.

Patient advocacy is not a new phenomenon, but the use of social media has given patients and their advocates powerful new tools in nudging researchers to address their needs.

Using readily available technology, wearable devices, and social media, patients are crowdsourcing and collecting data about themselves and compelling researchers to take action to help them. Patients and their advocates are challenging traditional methods used to design research studies and recruit research subjects.

For many patients, this is literally a matter of life and death. Patients with debilitating and deadly diseases, such as ALS, have little patience for clinical trial start-up delays and bureaucracy. This so-called “democratization of research” will continue to have a significant impact on research, subjects, and human subject protection.

Ethics sometimes trump regulatory compliance.

Lifetime Achievement Award Recipient Ruth Macklin implored attendees to remember their humanity in implementing regulatory compliance measures. Regulations are critically important, of course, but the driving mandate is to protect human subjects in research. This should always be the priority over checking a proverbial box in a compliance checklist. Research professionals should understand ethics and context, and apply regulations accordingly.

Informed consent continues to be a challenge.

Developing useful consent forms has always been a challenge for research professionals tasked with human subject protection. Even with the implementation of new technologies, such as digital consents and the use of videos, it is still a challenge to ensure consumers understand the risks and benefits of participating in clinical research. Research professionals must still be sure to account for participants’ literacy, and consider using shorter, simpler words, and verbiage in their consent process.

Pervasive data may be more powerful than big data.

We have all heard plenty about the power of big data — the collection, processing, and analysis of massive volumes of data points. But data scientists alerted conference attendees to the importance and impact of pervasive data, which add context to big data. It is collected via many channels beyond the electronic medical record or genomic database. It can include personal, social, behavioral, economic, geographic, political or any other information and it’s disturbingly easy to access.

With social media, wearable and connected home devices, and data collected by giants such as Facebook, Google, and Amazon, the lines between medical and social data can easily blur.

The current ethics framework is ill-prepared to address the tsunami of pervasive data and how it can be used. Even the revised Common Rule struggles to address this type of data science in research. Yet, while consumers will freely reveal intimate details about themselves in social media and are willing to allow big online companies to amass this information about them, they are still generally protective when it comes to their personal medical information.

The conference opened significant and important dialogue about these critical issues that are facing us. While there are no easy answers, we welcomed the opportunity to interact with our colleagues around the country. We will continue to monitor and report our understanding of these issues, and we hope to see you at next year’s PRIM&R conference!