The IRB model created to protect human research subjects more than a half-century ago is in danger of being outstripped by technology-driven research and other forces. It must be “reimagined” for the 21st century to provide safe and ethical oversight of rapidly expanding research agenda, the authors of a recently published report argue.1

IRBs are facing an evolution of research methods and practices made possible to some extent by rapidly emerging new technology. As this trend continues, the authors question whether the ethical principles outlined in the landmark Belmont Report2 are still being met.

“The ethical principles of the Belmont Report have stood the test of time, generally speaking,” says co-author Camille Nebeker, EdD, MS, a research ethicist and educator at the Center for Wireless and Population Health Systems at the Qualcomm Institute in San Diego. “Our paper prompts reflection on whether we need to reconsider our existing structures to be more responsive to how research is presenting in today’s world.”

For example, Nebeker cites a study she conducted with her colleagues of active and sedentary behavior. The research subjects were asked to wear an outward-facing camera to determine how often and under what circumstances they sit or stand.

“While people who are not research participants can use a GoPro or smartphone to record their physical surroundings, download a fitness tracking app, and trace their location, the IRB initially denied approval of the study, citing risks to privacy,” she says. “The use of a wearable camera was problematic [because] it would capture images of people who were not participants. The current federal regulations do not address the potential protections for people who, by virtue of their proximity to a research participant, become part of the research data set.”

In this case the question arises: Does the ethical principle of “respect for persons” transcend the needs of bystanders and communities involved in research?

There are some 6,000 IRBs nationally tasked with protecting human research subjects, but they are working within a system that is “deeply and inherently flawed,” Nebeker and colleagues note. Among the evidence cited for this claim is a 2013 study that examined 104 protocols of 20 IRBs at 10 large medical institutions.3 The authors found that data monitoring and protection of vulnerable populations were rarely discussed, and 50% of the reviews did not compare risks and benefits. We asked Nebeker whether such findings may reflect practices at IRBs in nationally.

“I would say that paper documents concerns that have been anecdotal — that is, within institutions and between investigators,” she says. “Researchers talk amongst each other about the inconsistent actions, unpredictability, and strategies used to ‘get through’ the IRB. I’ve also been in conversations with colleagues where they ask whether what appears to be administrative in nature and holds up the approval of their studies actually impacts human research protections.”

Other articles and books have raised similar concerns, she notes, citing Carl Schneider’s The Censor’s Hand and Robert Klitzman’s The Ethics Police?

“A paper4 we published in 2015 documented the inconsistencies with reviewing technology-support research within my own institution, which has five IRBs at present,” she says. “I don’t fault the IRB analysts, coordinators, members, or directors — they are trying to do a good job. I’ve served on an IRB as either a member or as an institutional ex-officio for over 20 years, so I empathize with both sides of the issues. The existing structures do not have the agility needed to be responsive or, perhaps, those operationalizing the regulations are more focused on protecting institutions and risk management?”

Nebeker and colleagues say that “the time has come to reimagine and, ultimately, work toward redesigning our human research protections system so that it is responsive to both the evolution of general research practices and new forms of research enabled by technological advances.”

To address such issues and reimagine the IRB for the 21st century, the authors participated in a 2015 workshop comprised of 11 researchers and IRB professionals drawn from academic and research institutions in San Diego. Using a “design thinking” brainstorming method to generate ideas and solutions, they proposed several avenues for exploration.

For example, they proposed creation of informed consent protocols that would allow real-time feedback from participants, an approach which suggests that consent should be more of an ongoing process than a single decision point in the research protocol.

“Yes, ideally the consent process is bidirectional, ongoing and participant-centered,” Nebeker says. “Most people who have little or no formal training in academic research are not familiar with the scientific method and, subsequently, may not understand many of the required elements of what is relayed via the consent document or conversations. As we move into electronic delivery of informed consent using tablets and smartphones with no face-to-face component, it will be important to offer avenues of communications to participants and utilize the consent process to assist in developing a relationship with the participant rather than documenting a legal transaction. Ideally, we will work toward the democratization of research where the participants are more involved at study onset and have a voice each step of the way.”

Another idea is to empower researchers to protect participants, scaling back the role of the IRB. Researchers would post study plans and risk assessments and get review and feedback from peers in the research community. “In this scenario, responsibility for ethical conduct during the study would be shared by both the researchers and the peers who agreed that the plan would adequately protect participants,” the authors wrote.

“A form of this idea is actually being pilot-tested in a project that we call the Connected and Open Research Ethics, or CORE initiative,” Nebeker says. “We have designed and deployed CORE using a participatory research methodology that involves IRBs and researchers in shaping a web-based research ethics community resource. The idea is to have stakeholders in the mHealth and digital medicine ecosystem convene in the CORE community to share ideas, questions, and resources.”


  1. Bloss C, Nebeker C, Bietz M, et al. Reimagining Human Research Protections for 21st Century Science. J Med Internet Res 2016;18(12):
  2. Zucker B. The Belmont Report. In: Wiley Encyclopedia of Clinical Trials. New York, NY: John Wiley & Sons; Dec 14, 2007.
  3. Nebeker C, Linares-Orozco R, Crist K. A Multi-Case Study of Research Using Mobile Imaging, Sensing and Tracking Technologies to Objectively Measure Behavior: Ethical Issues and Insights to Guide Responsible Research Practice. J Research Admin 2015;46:118-137.
  4. Lidz C, Garverich S. What the ANPRM missed: additional needs for IRB reform. J Law Med Ethics 2013;41(2):390-396.