To hear President Trump say, the COVID-19 vaccine will arrive soon.
“We think we will have a vaccine by the end of this year and we are trying very hard,” he said to Fox News last week.
While many health experts say that ambitious goals are unrealistic – most say vaccines for widespread use are unlikely until the earliest next year – Trump’s comments raise some interesting questions.
How will researchers recruit subjects for the COVID-19 vaccine or healing test? Will scientists wait for infected or interested people to contact them? Will they use other ways to find suitable research participants?
If the latter, it seems fair to wonder how confidential our medical records are. There is no faster way to recruit research subjects than by reading people’s health service files and seeing who qualifies.
Joel Engel, a resident of Westlake Village, suspected this happened to him a few days after he received two phone calls asking if he wanted to enroll in UCLA’s sleep study.
Engel, a writer, said he was treated at a UCLA facility about five years ago.
“Callers say they need people of a certain age in good health,” he told me. “I asked how they knew my age and condition. I can’t get a straight answer. “
Engel’s concern is that UCLA violates federal medical privacy law Health Insurance Portability and Accountability Act, which prohibits unauthorized access to people’s medical information.
“How else do they know to call me?” he wondered.
That’s a fair question.
And with the global pandemic raging, maybe all Americans should wonder if their medical records are as confidential as they thought.
Are we all a fair game for research given the extraordinary circumstances?
Short answer: No. And yes.
“You can’t just fish around people’s medical records,” said Arthur Caplan, a professor of bioethics at New York University. “HIPAA forbids it.”
In addition, there are no provisions in the law that say a pandemic or other public health emergency creates exceptions that allow researchers to protect privacy protection.
“The public health crisis should not affect recruitment for sleep studies,” said Mildred Cho, associate director of the Center for Biomedical Ethics at Stanford University.
However, he and other medical privacy experts note that legal loopholes do exist.
Perhaps the most important exception to HIPAA in the age of coronavirus is what is known as the “preparation for research” provision.
This allows researchers to examine people’s medical records to ascertain whether there are enough potential candidates for the study.
This provision does not give the researcher the right to contact possible study participants. That will require advance permission from the patient.
“Usually the only people who are allowed to make direct patient contact for research are patient health care providers,” Cho said, which means that only your doctor can reach out in this regard.
But, once again, there are exceptions.
Nancy M.P. King, co-director of the Center for Bioethics, Health and Society at Wake Forest University, said the hospital’s institutional review board, which oversees ethical issues, can independently limit patient privacy rights if at all possible.
Such councils “have a set of protocols that investigators must follow, which can produce summons like your readers mentioned,” he told me.
This clearly has implications for high-speed race and high stakes for the COVID-19 vaccine.
If researchers believe certain types of patients show the most promising promise for testing, such work can be greatly accelerated if scientists know who to contact.
Which brings us back to the question: How did they find you?
Engel said he was told about the sleep study he wanted being carried out by the Norman Cousins Center for Psychoneuroimmunology at UCLA, which he had never dealt with.
He asked the woman who called his house. He contacted the director of the Norman Cousins Center. No one can or will say how they got access to Engel’s information.
Phil Hampton, a UCLA Health spokesman, told me by email that the campus medical center conducted “clinical trials and other research involving patients.”
“Consistent with the laws governing patient privacy, when looking for patients to participate in research studies, our practice is to contact only patients from whom we have written consent,” he said.
I conveyed this to Engel, who replied that he “did not remember giving them written permission to use my medical records for anything other than medical care.”
Apparently there is a reason for that.
Acting on an allegation, I asked Hampton if there was a good print in the form of routine privacy that people signed when they were treated at a UCLA medical facility that allowed the use of their information for research purposes.
He replied: “I can confirm that the patient’s signature on the privacy practice form authorizes UCLA outreach for the purpose of asking about the patient’s interest in participating in an approved research study.”
Bingo.
The practice seems to be widespread. Spokesmen for the Cedars-Sinai Medical Center and USC told me that their patients agreed with the same language when they checked in. They say this is the “standard” in many hospitals.
If so, this is another reminder of the importance of reading printed documents. You never know what’s lurking there.
Although we would like to consider our medical records locked up, this is far from the case.
“Our records are not kept as secret as we thought,” said Matthew Weinberg, a professor of medical ethics at the Philadelphia College of Osteopathic Medicine. “Many individuals and organizations have official access to our personal medical information.”
If this makes you unable to sleep well at night, don’t worry. UCLA is researching that.
