Ask and ye shall receive: study

Part one of a two-part series

Many Americans will do their part when asked to allow their heath records to be used for medical research, but the operative phrase is "when asked."

And, for a plurality of those who do volunteer, that means being asked each and ever time their records are to be used, according to a recent study whose author said that it may be the first of its kind, specifically focusing on patient attitudes about healthcare privacy in the area of clinical research.

A pair of preliminary reports and two PowerPoint presentations about the study conducted by veteran privacy researcher Alan Westin, emeritus professor of public law and government with the Department of Political Science at Columbia University, were presented during two days of meetings earlier this month in Washington before the Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule. The committee operates under the Board on Health Sciences Policy of the Institute of Medicine at the National Academies of Science.

Among its goals, the committee is to "consider the needs for privacy of identifiable personal health information and the value of such privacy to patients and the public," according to explanatory material about it on the IOM Web site. The committee is to make recommendations about retaining or changing the status quo and seeking to balance "the needs and benefits of patient privacy ... against the needs, risks and benefits of identifiable health information for various kinds of health research."

Westin said in a telephone interview that he reviewed 43 national surveys taken since 1993 that at least touch on healthcare privacy issues. From them he pulled nine surveys with questions specifically related to health research and privacy. In those nine, majorities of respondents were "positive about health research and, if asked in general terms, support(ed) their medical information being made available."

But, according to Westin, his most recent work for the IOM, done in conjunction with Harris Interactive and involving 2,392 adult respondents surveyed online last month, is unique because it focuses on privacy issues involving the medical research community.

The study sought to find answers to research-specific questions such as:

How interested is the public in health research? How many persons have participated in a health research study? What were their experiences? How many people who were invited to participate in a health research study agreed and how many declined and why? What kind of notice does the public want about how their information will be used and how often do they want it? What are the privacy concerns of those who want notice and consent before they would be willing to participate in a research project?

At deadline, copies of Westin's presentations Oct. 1 and 2 were not yet available on the IOM committee's Web pages, but the researcher shared the PowerPoint presentation with Modern Healthcare and agreed to be interviewed. A final report of his work should be completed in a few weeks, Westin said.

"What was brand new was to go into detail into the health-research function," Westin said. "Something that was never done (before) was to collect a sample of people who have participated in health research" and measure their attitudes about the experience and compare it with the contemporary opinions of adults who have not been research subjects.

The good news for the research community is, despite a plethora of media reports on privacy and security breaches in the healthcare industry, most people still respect the aims of researchers and are willing to support their work.

The bad news is, perhaps because of these highly publicized privacy failures, people need more assurance than in the past that their healthcare information will be protected and, particularly, not end up being misused in ways that could hurt them. This new reality will necessitate some consciousness-raising on the part of researchers, who historically have seen themselves as the guys in white hats who should be above suspicion, according to Westin.

"Ever since I did a project for the National Academy of Sciences in 1979 and 1980, inside every organization, the one group that was avid to get the data was the researchers," Westin said. "This was the love of their life, and they knew they weren't going to be hurting anybody. They saw themselves as completely without blame. That situation is not true anymore. Fear of medical identity theft is the new fear in (the) closet these days."

In that vein, 17% of Westin's subjects agreed strongly and 41% agreed somewhat with the statement: Personal health information "is not protected well enough today by federal and state laws and organizational practices." That brought Westin to the conclusion that "the HIPAA privacy rule and its enforcement does not seem to have given a national majority much confidence in national health privacy protection."

As in previous studies, healthcare providers fare well in terms of patient confidence in their willingness and ability to protect the patient privacy. In response to the statement: "I generally trust my healthcare providersódoctors and hospitalsóto protect the privacy and confidentiality of my personal medical records and health information," 30% of respondents agreed "strongly" while 54% agreed "somewhat." Westin said he interprets the combined response rate of 83% (with rounding) as reflective of a very high level of patient trust.

Researchers didn't receive quite as strong an endorsement.

In response to the statement: "Health researchers can generally be trusted to protect the privacy and confidentiality of the medical records and health information they get about research subjects," 11% of respondents agreed strongly, while 58% agreed somewhat or 69% combined.

In addition, the survey data provides evidence of a nagging anxiety about healthcare research.

Westin's presentation reported that respondents "divided right down the middle" reacting to the statement, "Even if nothing that identifies me were ever published or given to an organization making consumer or employee decisions about me, I still worry about a professional health researcher seeing my medical records." Strongly agreeing were 12% of respondents, and agreeing somewhat were 38%. At the same time, strongly disagreeing were 15% and disagreeing somewhat, 35%.

Respondents' anxieties rest on a feeling that their sensitive information could be disclosed to an "unknown third party," even if no actual harm occurred or even was likely. Their fears prove to be not entirely groundless.

A combined 12% of respondents indicated either a doctor, hospital, clinic, health or life insurance company, pharmacy, employer or government program had "disclosed (their) personally identified medical or health information in a way (they) felt was improper." Projecting that percentage on the entire U.S. population produces an estimated 27 million adults with some claim to having experienced a health-related privacy violation by one of the above organizations.

Regarding research, 78% of respondents indicated that they were interested in reading or hearing about new health research studies, and 13% indicated that they had participated in a research study that used their personally identified medical or health information. Again, when projected against the entire U.S. population, Westin estimates that represents 29 million adults who have participated in some sort of research project.

Of those, 50% indicated they felt very informed about the purposes and procedures of the research study, and another 35% felt somewhat informed. A substantial majority (69%) of the participants indicated they had provided some of their information on a questionnaire or through an interview, 38% through a blood or tissue or other test result, 25% from a medical record from a doctor and 4% from a hospital.

About three-fourths (76%) of research-project participants indicated they'd been promised "that no personally identified medical or health information of (theirs) used in the study would ever be given to anyone outside the research staff," while another 21% were unsure and 3% responded they'd not been given such a promise. And overall, 58% of study participants responded that the experience was "very comfortable" while another 28% indicated it was somewhat comfortable.

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