Emily Brown

by Emily Brown

IRBs Face Important Questions in the Digital Age

Guest blogger Sarah Nelson recently shared the lessons she took from July’s Ethics and Regulation in the Digital Age Conference, including the importance of relying on our pre-digital era expertise to guide us forward. But researchers aren’t the only ones who need to prepare for digital.

Sarah closed her blog by saying she doesn’t envy the IRB’s responsibility to fit new protocols into an old framework. This touches on the question that NWABR Board of Directors President Cami Gearhart posed in the conference’s opening session: How do IRBs resolve issues about ethics and technology that society itself has not resolved?

The speakers at the conference took on those issues and left us with new ideas to consider.

 

Should we return clinical trial results to participants?

The European Union recently published new regulations that require a summary of aggregate study results, in lay terms, for participants. This regulation could prove a precedent for other countries to follow.

Aggregate data, when returned to participants, has the power to validate a participant’s experience and provide important closure to being part of a study. At the same time, such results could cause distress. Given its generalized nature and an inability to interpret aggregated results for a specific individual, participants might draw their own conclusions, accurately or not.

Barbara Bierer believes the research industry is “losing the goodwill of the people” by appearing to obfuscate clinical trial findings. Barbara and her colleagues have found that participants generally want to know trial results, even if they’re only provided in aggregate. Since the industry depends on participants and their altruism, it cannot afford to violate that relationship.

 

How Much Information Does an Informed Consent Need?

The informed consent of participants has always been a difficult issue: how much information is too much? What is too little? How can we ensure participants are truly informed when they agree to participate in research? Jeremy Block suggested that the introduction of technology brings new dimension to these questions.

In his presentation, Jeremy argued that new consenting methods are ripe for wide adoption and success, but also for faults.

When he gave a paper-based consent a ResearchKit makeover using icons, layered information, and video, Jeremy created a simple overview of research to those who wanted just that. But he also had the potential to provide more detail for anyone who wanted it.

Jeremy said it’s important not to get caught in the digital weeds of eConsent review. To illustrate his point, he asserted that there shouldn’t be a high level of concern around verifying identities beyond the thresholds we use today.

Jeremy also urged IRBs to pay close attention to compliance when using digital technology. Increased efficiencies through technology can allow for, as he put it, “really efficient non-compliance.”

 

How Do We Fit the Digital Era into a Legacy Framework?

Cheryl Grandinetti dedicated her presentation to discussing FDA policies that apply to technology in research, some of which are new and others of which have been around for some time.

At the newer end of policies are recent FDA guidance documents about eConsent in trials and applying medical device requirements to mobile health apps. At the other end, however, are the FDA’s Part 11 requirements which date to 1997—a time before Google, Facebook, Twitter, and the iPhone. Cheryl acknowledged that this and similar regulations need updating.

What remains unclear are questions of security and logistics. How should new policies be audited? How are new technologies and resources validated? When is it important to seek validation? How much continuous data does a PI or the FDA need to see?

Eric Mah asked all of the IRB members in the audience to raise their hands. He then asked how many had “confidence they were doing [mHealth reviews] right.” They all lowered their hands.

The FDA is working with the Clinical Trials Transformation Initiative (CTTI) and multiple stakeholders to align documentation with the modern research setting, of which the industry is deeply in need.

 

Where Do We Go from Here?

These questions do not have clear or easy answers, but the conference speakers delved into them. They provided the kind of insights and guidance that IRBs—and society—need to consider in this digital age of research.

 

Miss the 2016 conference?

Be sure to look for more information about next year’s conference! It will be held in Summer 2017.

 

Tags: , ,