In this time of constant data collection, the boundaries of a person’s right to control how their personal data is used have become uncertain and contentious. Take social media giant Facebook, which is currently facing blowback for sharing users’ data without, many feel, properly informing users of its actions or getting their consent.

Research institutions are grappling with similar questions about informed consent policies in medical research. The right of medical trial participants to receive all pertinent information about a trial before they decide whether to enroll is a crucial component of ethical medical research in human subjects. Researchers must inform potential participants about a trial’s purpose, benefits, risks and data collection policies. However, figuring out what information a potential participant needs, how to present it and whether participants have understood it is not always simple.

The U.S. Office for Human Research Protections (OHRP) regularly holds events to educate regulatory and institutional officials, such as institutional review board (IRB) members, who manage their institutions’ research ethics policies, about best practices.

Harvard Catalyst, the NIH-funded clinical and translational science center, co-hosted such a symposium at Harvard Medical School earlier this month to discuss the recently revised OHRP regulations and the challenges of achieving informed consent. The center’s Regulatory Foundations, Ethics, and Law Program, led by Barbara Bierer, HMS professor of medicine at Brigham and Women’s Hospital, offers guidance to investigators and promotes interinstitutional research, hosting several events each year.

“When we seek informed consent, we often have multiple goals in mind,” said keynote speaker Steven Joffe, professor of pediatrics and chief of the Division of Medical Ethics at the University of Pennsylvania Perelman School of Medicine.

“When we seek informed consent, we often have multiple goals in mind,” said keynote speaker Steven Joffe, professor of pediatrics and chief of the Division of Medical Ethics at the University of Pennsylvania Perelman School of Medicine. Joffe acknowledged that, while there are institutional benefits of informed consent, institutions should also focus on the participant-centered goals of informed consent, such as educating and giving participants accurate expectations for the trial and promoting their best interests.

Jerry Menikoff, director of the OHRP, spoke on both days of the Harvard symposium. Menikoff said that the priority for informed consent documents under the new rule is to make the consent form a helpful decision aid rather than a mere risk disclosure document. Researchers should emphasize that potential trial participants have a choice rather than pressing for enrollment.

“Ask yourself, how often do consent forms spell out the reasons why participating may not be the best choice for you?” Menikoff said.

In order for an informed consent document to be a good decision aid, it needs to be user-friendly, Menikoff said. Information should be concise, focused and written in plain language.

Other speakers also emphasized the importance of a patient-centered focus for informed consent. Sally Okun, vice president for policy and ethics of PatientsLikeMe, spoke about the flaws of using the “reasonable person standard” (RPS) for informed consent documents. The RPS establishes what information a researcher should disclose based on what an average person might want to know about enrolling in a trial. However, a generic standard is too rigid for medical trials because patients have individual needs, Okun said.

Depending on their disease and disease stage, patients will have different expectations and value different outcomes when deciding whether it is in their best interest to enroll in a trial. Patients for whom a trial is the best or only curative option may not care about side effects or risks. Patients prioritizing quality of life, however, may care deeply.

Okun recommended that IRBs invite people representative of a trial’s study population—separate from those invited to enroll—to participate in designing the trial, including the informed consent process. Giving patients a voice would not only improve the content of consent forms but also build trust between researchers and patient groups, she said.

During a Q&A, Joffe supported Okun’s idea, saying that in his experience on an IRB, the board could not help viewing consent protocols through a professional lens. They tried to make judgments about what would be important for patients and families to understand, but as outsiders they often missed their mark, he said.

That researchers and IRBs do a poor job of designing informed consent documents was confirmed in a study conducted by Laura Beskow, professor at the Vanderbilt University Center for Biomedical Ethics & Society. Beskow spoke about how she and her colleagues conducted a national survey in which people were given a sample informed consent document based on input from medical experts. When quizzed on the document’s content, 80 percent of people failed to reach the minimum comprehension score.

The medical experts were shocked and divided on how they would proceed with these results in a real trial, Beskow said. Some decided that if a person could not pass a comprehension test within a few tries, they were not qualified to enroll. Others argued that comprehension is less important than willingness to volunteer, and that if a patient wanted to enroll in a trial that could improve their care, they should be allowed to regardless of comprehension.

The study highlighted the ambiguity inherent in the informed consent process. The researchers interviewed all wanted to protect patients’ best interests, but they had opposing views on how to accomplish that goal.

Informed consent is complex, and only becoming more so as emerging technologies expand the boundaries of data collection and sharing in medical research. Patient tissue or data collected for one trial can now be preserved in perpetuity and used repeatedly, even after a patient’s death. How can researchers ensure that patients understand which protections for their medical information they are signing away? The best path forward, according to the symposium speakers, is to keep an open dialogue going and invite patient communities and advocates to join the discussion.