Institute for Health Freedom

Poll Shows Americans Endorse “Consent of the Studied"

Only 1 Percent Would Give Researchers Free Use of Medical Records without Patient Consent

A national survey conducted by Harris Interactive found that many Americans believe their personal health information is not adequately protected by the federal privacy rule, state laws, and health-care organizations.

When asked if they agree that “The privacy of personal medical records and health information is not protected well enough today by federal and state laws and organizational practices,” 58 percent said yes (17 percent strongly, 41 percent somewhat). [Emphasis added.] Dr. Alan F. Westin, professor of public law and government emeritus at Columbia University, concluded that “the HIPAA [Health Insurance Portability and Accountability Act] privacy rule and its enforcement does not seem to have given a national majority much confidence in national health privacy protection,” according to Modern Healthcare.

The poll also found that although most people generally trust health researchers to protect the privacy of their medical records, only 1 percent of respondents would give researchers free use of that information without specific consent. Following are questions and responses regarding trust and patient consent:

Yet, Americans feel strongly that researchers should first obtain patients’ consent before using their data*:

What’s more, some groups were more likely (than the 38 percent above) to say they would want researchers to describe the study to them and get their consent for each use. For example, some of the groups that were more likely to demand an explanation and consent included:

Top Concern with Non-Consensual Data Disclosure: Patients Would Feel Violated and Lose Trust in Researchers

Regarding what harm could be done if personal health information was disclosed without patients’ consent, 77 percent responded, “I would feel violated and my trust in the researchers betrayed.” Other commonly cited concerns included being:

Finally, when asked if they agreed that “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”—50 percent said yes (12 strongly; 38 somewhat).

Overall, the survey findings show that most Americans generally trust medical researchers “somewhat” to keep their health information private, but they first want researchers to explain studies to them and get their consent for each study.

Our nation’s longstanding ethic of “consent of the governed” applies to today’s medical researchers. Americans clearly are demanding “consent of the studied.” Researchers can prevent Americans from feeling violated and betrayed by upholding the precious ethic of informed consent.

* The pollsters presented the following detailed setup question, followed by five (randomized) alternatives:

“When conducting health studies, researchers often want to select patients whose personally-identified medical or health information is contained in patient records. Sometimes, the patients will be invited to give general approval to have their records used in future health research. Or, the researchers may seek patient consent to join a specific study. For some studies, researchers seek to include the patient information automatically in the research, without seeking any consent.

“The researchers promise, as required by federal and/or state health privacy laws, that no personally-identified health information of research subjects will be disclosed outside the research group and that security measures will be applied to protect the data.

“Researchers must also have the project approved by a Human Subject Protection or Privacy Board. These groups decide whether the importance of the research and the safeguards promised outweigh potential risks to privacy or data security, or other risks to research participants.

“Some say that patient interests in privacy and data security are not protected well by such procedures, and there is little policing of researcher practices. It is argued that patients must be asked for consents—either specific or general—for all health research.

“Health researchers say many patients would not respond or agree to requests for permission, creating a sample that would not accurately reflect the group whose health condition or status are being studied. They also say obtaining permission for each health study would be very costly and time-consuming, and there is no pattern of health researchers disclosing the personal medical information of research subjects.

“In these situations [which of the following answers] is closer to your opinion?”

“Researchers would be free to use my personal medical and health information without my consent at all.”
“I would be willing to give a general consent in advance to have my personally-identified medical or health information used in future research projects without the researchers having to contact me.”
“My consent to use my personal medical and health information would not be needed as long as the study never revealed my personal identity and it was supervised by an institutional review board.”
“I would want each research study seeking to use my personally-identified medical or health information to first describe the study to me and get my specific consent for such use.”
“I would not want the researchers to contact me or to use my personal or health information under any circumstances."

Self-Governing People Shouldn’t Have to Await Tribunal Approval before Making Private Health-Care Decisions

The move by the U.S. government to restrict the ability of Medicare patients to spend their own money on medical care is denying these patients an elemental right: the right to save their own lives. That is the conclusion of Kent Masterson Brown in the Cato Institute policy analysis “The Freedom to Spend Your Own Money on Medical Care: A Common Casualty of Universal Coverage.”

“Over the last 20 years, the Medicare bureaucracy—and to a lesser extent, Congress itself—has limited the freedom of Medicare beneficiaries to purchase medical services with their own money,” writes Brown. “Those limitations violate beneficiaries’ right to privacy, undermine a tool that could reduce the burden Medicare imposes on taxpayers, and may deny care to Medicare beneficiaries outright, or deny them access to the highest quality care available.”

As the Canadian health system—vaunted by proponents of socialized medicine as a smashing success—moves away from self-pay restrictions for medical care, the United States, in its effort to provide universal coverage, is moving in the opposite direction, toward a system of treatment by tribunal.

The danger of universal coverage, Brown argues, is when the government fails to meet the needs of patients, then prohibits them from purchasing medical care on their own, locking patients in a situation much like the cell of little ease, a torture device in which the prisoner can neither stand, nor sit, nor lie down. This is not merely something that is occurring under foreign systems of socialized medicine. Instead, it exists today, in the United States, under the federal Medicare system.

Critics of self-pay argue that allowing patients to opt out of Medicare on a service-by-service basis would create a two-tiered health care system in which only the wealthiest seniors would have access to free choice. But stripped of soundbites and reduced to its essence, the main argument against denying the practice of private payment is this: a self-governing people should not have to await the approval of a tribunal before making private decisions about their own health care. Says Brown: “No issue more clearly illustrates the threat that national health insurance schemes pose to individual rights than the federal government’s attempts to prohibit Americans in the federal Medicare program from spending their own money on medical care.”

Brown concludes by offering suggested remedies for reform. “Congress should restore the freedom of Medicare beneficiaries to spend their own money on medical care as they see fit and prevent the federal bureaucracy from interfering in purely private and voluntary transactions between patients and their doctors. Congress should do so immediately, before Medicare’s looming financial troubles combine with this unwise policy and begin denying care to large numbers of seniors.”

The following news summary was distributed by the National Center for Policy Analysis:

In the ongoing debate over U.S. health care reform, the universal coverage mantra has collided, inevitably, with the cost issue: How would a substantial expansion of health care coverage be financed?

Some proponents of a single-payer (government) system of health insurance have responded: Not to worry. "Administrative costs" are so much higher for private insurance than for such systems as Medicare that a shift to a single-payer system would yield savings sufficient to provide coverage for all of the uninsured.

This estimate is likely to be too optimistic because not all of the current health care consumption by the uninsured is funded by the public sector, and because these estimates assume away increases in the prices of medical goods and services attendant upon a doubling of the population eligible for a Medicare-type program.