HIPAA can be a barrier to research participation

Effect most prevalent among African Americans

The implementation of the Health Insurance Portability and Accountability Act (HIPAA) has added length and complexity to the process of getting research approved.

Now there is some evidence that it may actually affect recruitment of subjects, who are turned off by the legalistic language and whose suspicion is aroused when asked to sign an authorization form.

A study conducted at Emory University in Atlanta looked at African-American patients, finding decreased willingness to participate in a hypothetical study after reviewing both informed consent and HIPAA forms, compared with patients confronted only with an informed consent document.

Anne Lang Dunlop, MD, MPH, an assistant professor of family and preventive medicine at Emory, says she believes the impact of HIPAA isn't limited to African-American subjects.

"I think the concerns about HIPAA may be more prevalent among African Americans," Dunlop says. "But this is probably an issue that affects other racial and ethnic groups as well."

She says the results point to the need for further study of the potential impact of HIPAA on the willingness of African-American individuals—as well as individuals of other racial and ethnic groups—to enroll in clinical research studies. The study also suggests a need to develop strategies that protect patient privacy that don't overwhelm participants with difficult forms.

"We need to make sure that we're looking at our informed consent and HIPAA authorization forms through the patient's lens," Dunlop says. "I think sometimes we take what we know as researchers for granted. But we don't consider that a lot of people, even those with a college education who might not have a science background, aren't necessarily understanding it."

Suspicious of forms

Dunlop says she began to focus on HIPAA after an experience she had recruiting subjects for a study. Her team was trying to sign up mothers of very low-birthweight babies for specialized medical care at no cost to them, and initially, found the women to be excited about enrolling.

"Then I would haul out that informed consent and [separate] HIPAA form," she says. "And many of the women who were initially quite interested said, 'Wait a minute—what are you asking me to sign?' It raised a lot of suspicion and concern about what we were really doing. What were we tracking? Why were we asking them to sign off on these forms?"

Dunlop says her perception was that it was the HIPAA form that was causing the most concern, and attributes part of the problem to the fact that some mothers she was recruiting may have had drug problems or other issues that caused them to worry about keeping custody of their children.

"In going through the HIPAA form, they would see that we were sharing information with public health authorities—the government, basically," she says. "They couldn't understand why the information was being shared. And I don't think the form necessarily laid that out in a way that was easy to digest."

Dunlop began to wonder whether concerns about HIPAA forms were dissuading other potential subjects from participating in research.

It's a difficult question to study, because obtaining HIPAA authorization is mandated by federal law. So Dunlop created a hypothetical study, asking patients at Grady Memorial Hospital, Atlanta's large public hospital, and at Emory's own outpatient clinics to review the forms and give their impressions. What did specific sections of the informed consent and HIPAA forms mean to patients? Did any of the sections raise specific thoughts or concerns? Did they affect patients' willingness to participate in this hypothetical study?

Dunlop says her study focused on African-American patients because of the well-documented mistrust that population has had about medical research in the wake of the infamous Tuskegee Syphilis Study. She says it also is clearly demonstrated that African Americans are underrepresented in clinical research studies.

"Among people of all races and ethnicities, you will have people who have mistrust of research, medicine, and physicians," Dunlop says. "But I think because of historical wrong-doings, this is just more prevalent among African Americans.

"I wanted to hear from African-American patients in the South, close to Tuskegee, about why they would or would not participate in a research study and look at what kinds of concerns are potentially raised by the informed consent and HIPAA processes."

Study tests separate form

The hypothetical Phase 3 study compared an experimental antihypertensive drug with an established medication. The consent form and HIPAA documents were prepared according to the Emory IRB's existing guidelines. Dunlop says she used a separate form for HIPAA because Emory, and many other institutions, require or suggest this approach, particularly with low-literacy populations.

Potential subjects were asked by Dunlop's research team to participate in a study of why people do or do not take part in medical research. Those who agreed were asked for demographic information, but did not have to reveal identifying information.

One group reviewed only the informed consent document for the Phase 3 study with the study team. They then were asked whether they would be willing to participate in the study, and to give a reason for their decision.

A second group reviewed both the informed consent form and the HIPAA form. Those participants were asked not only whether they would enroll in the study, but also whether they would release their information for participation in the study.

Responses were audio-recorded and analyzed. Overall, those who received both the HIPAA form and the informed consent document were less willing to participate in the Phase 3 study—only 31% would agree, compared to 42% of those receiving only the informed consent form. Inter-group differences were particularly marked for males, those age 40 or older, and those with high school or less education.

Those receiving the HIPAA form who did not want to participate in the Phase 3 study most often cited some form of mistrust of research, researchers, or research institutions as their reason (about 53%, compared to 40% of those seeing only the informed consent document).

Additionally, nearly 40% of the HIPAA group cited privacy concerns, compared to less than 3% of the non-HIPAA group.

"When we compared the people who were shown HIPAA to those who just got the informed consent, privacy concerns were higher in every group that saw the HIPAA form," Dunlop says. "That was a result I didn't expect going into this."

Also surprising to Dunlop was the number of people in the HIPAA group who expressed concerns about how participating in the study would affect their health insurance eligibility or coverage. It was a response that she and her research assistants hadn't anticipated at all.

But in retrospect, it made sense. After all, Dunlop notes, the proper name of HIPAA is the "Health Insurance Portability and Accountability Act," which is clearly spelled out in the form.

"I think many of us—doctors and researchers—we might just read right over that because it doesn't mean anything to us. It's just HIPAA," she says. "But people who are not so overly exposed to this acronym saw that and said, 'Health insurance? What does this have to do with my health insurance?' And it really raised concerns."

She says the health insurance concerns were raised by younger and older participants. Those who had a high school education or more were more concerned than less educated participants.

"The people who were more carefully reading it were the ones who seemed to have the most concerns about it," Dunlop says.

Easing mistrust

Dunlop is quick to point out that concerns over the HIPAA form were not the principal reason that participants gave for declining to be in the study. Overall, fear of side effects was the most common reason cited; structural barriers and lack of perceived benefit were also common reasons.

Building on her current work, Dunlop's team is in the process of testing whether showing participants an educational video that explains how subjects are protected in research can help combat mistrust as a reason for non-participation.

"I think that sort of education of patients, potential participants, or even just laypeople, to help them realize what research is and that there are protections in place, would probably do more to foster trust in research, research physicians, and research institutions than anything else," Dunlop says.

She says that she does not believe IRBs are at fault for making the HIPAA requirements too daunting, since it is a federal mandate that institutions are concerned about fulfilling.

"I think for a lot of these institutions, their livelihood really depends on the blessing of the federal government—knowing they're doing everything according to the standards," Dunlop says. "They tend to take a very conservative approach."

But she thinks that institutions should consider showing more flexibility with HIPAA, taking care that their approaches pass muster with the U.S. Department of Health and Human Services.

"We really need to be doing more research to find an alternative means of [carrying out] informed consent and HIPAA that's simpler and still satisfies the law," Dunlop says.

Dunlop adds that a recent comparative analysis of the HIPAA Privacy Rule and the Common Rule revealed that requirements for individual authorization overlap substantially, suggesting that a minimal addition of text to the informed consent form might satisfy authorization requirements under the HIPAA Privacy Rule.

If the federal government agreed with that assessment, this could ease the potential negative impact of HIPAA on research enrollment, as well as its potential for raising concerns about privacy and health insurance eligibility and coverage, Dunlop says.


Dunlop AL, Graham T, Leroy Z, et al. The impact of HIPAA authorization on willingness to participate in clinical research. Ann Epidemiol 2007 Aug 4; Epub ahead of print.