Partners in Research:

Data Sharing, Privacy, and Consent -Changing the Conversation

by Joyce Graff based on the Minutes of the DCLG meeting

A group of sixteen patient advocates from around the country who form the NCI Director’s Consumer Liaison Group (DCLG) met in February 2011 to study the issues in making patient tissue and data more available for research toward a cure for cancer.

Currently, data is collected on a project-by-project basis. Patients are asked to provide information during the course of a project, including some medical history information. This information is often scant, based on patient memory and notes, not on the actual detailed medical records. One patient’s records may be scattered among many hospitals, in many states, mostly on paper, and mostly inaccessible.

Patients provide information to the project, which is then owned by the institution where the project is based. It is not “owned” by the researcher, and no longer “owned” by the patient. Under the law, it is “owned” by the institution. If another similar project is launched, even if the research team and institution are willing to share, the incompatibilities of their record-keeping systems often pose additional barriers to sharing. If the information is computerized, the technical difficulties could potentially be overcome with investment in bridging the two computer systems, or there may be additional technical or policy barriers. As a group, the DCLG believes that researchers, patients, and advocacy organizations must work together to find workable solutions to these challenges that meet the needs of all the people interested in moving the research forward.

Informed consent and privacy are complicated issues, and the many dissimilar efforts to solve these problems have complicated it further. The goal here is to protect the privacy of the individual while furthering research. We must all keep our eye on that goal. If we advance research while not protecting the patient from the misuse of his or her information, we have not done the right thing and have created mistrust among the patients. And similarly, if we protect the privacy of the patient by impeding research, then all of us lose. Patients and researchers should agree on this one common goal and work together in an atmosphere of mutual respect and partnership to achieve it. We cannot learn without data. We cannot achieve research goals without the active participation of the widest possible group of participating patients from all walks of life.

Most of the conversations currently under way are focused on small changes to the current way of doing things. This limits the conversation. We need to step back and take a broad “systems” view—not just how this screw fits into that bolt, but how the total engine works, or even: is there a better engine altogether? We don’t really care about any particular process, we care about how the job gets done. And the job is bigger than any one institution or any one patient.

If we simply focus on how a given institution can protect the patients, we are not getting to the bigger problem. If we simply focus on patients’ rights without worrying about the impact of such rules on the progress of research, we are not getting to the bigger problem. The bigger problem is: how to we cure cancer?

Here is one version of the vision. Let’s take any one question in cancer. We have a group of people who have that particular kind of cancer. We see them at or after they have been diagnosed with that cancer, and we try various kinds of treatment with them.

Would it not be useful if we could look back through their medical records and find the earliest time they reported symptoms that might have been foreshadowing that cancer? Perhaps we could see the details of their Complete Blood Counts (CBC’s) over the last 10 years, and see how that has evolved. Were there early signs that we didn’t know at the time might be telling us there was trouble brewing? Could we use that knowledge to identify people at earlier stages?

There are questions, for example, about the long-term effects of having a number of radiation-based diagnostic imaging tests and/or radiation treatments. Do those add up? We see long-term survivors of radiation treatment who now have leukemia or other secondary cancers. But can we look back and see the dates and details of the radiation doses they received so that we might be able to compare the total accumulated dosages of radiation over time. Currently that information is rarely recorded, and if it is, one institution keeps it in a different way than another. Most of the time, they simply say that the patient had a CT and here are the images, and of course the images are held by the institution where the scan was performed. The patient is expected to ask for them (if desired) and keep their own file of mammoth films and now CD’s and written reports, but rarely are the actual radiation dosages even recorded.

Electronic health records are one step. At least if information is captured in a computer, it is easier to search it. Nonetheless, computerization alone is not the end of the conversation. The systems used by the various institutions need to interoperate in order for one patient to be able to collect all of his or her records in one place. If you move from one city to another, can you take your records with you on a CD? Wouldn’t that be nice! Even within one city, one doctor may or may not be able to access the scan you had last week at the other hospital.

As patients and advocates, we have the opportunity to move the conversation out of the institution and into the advocacy community.

As patients and advocates, we have the oppor­tunity to move the conversation out of the institution and into the advocacy community. We don’t really care what system a given institution chooses. We care that each one of us can see and touch our own records—all of them—and can bring them together, make them available to the next doctor, or to the Emergency Room physician when we are on a trip. The technology is there to make that possible. We need to insist on it.

We also have the opportunity to take ownership of the collection of patient information needed to work on our disease of interest. Instead of asking patients to provide access to their data to a particular research team or institution, putting that data now under the “ownership” and policy constraints of that institution, perhaps we could ask the patients to provide access to their data to an advocacy group which then is authorized to provide access to a research team for a given purpose, without disclosing the identifying information for the parti­cipants, but with the ability for the advocacy group to go back to the participating patient and ask addi­tional questions or suggest a clinical trial that might be of interest. The advocacy community has the opportunity here to unlock patient data resources for research. This is one of the goals of having the VHL Research Database. Please participate in this effort. See http://www.vhl.org/research/resdb.php or request a paper copy of the questionnaire on page 15.

It is critically important to engage the patients themselves in research. Without the patients, their tissue and their information, there is nothing for the researchers to study, and no progress can be made on the diseases we so desperately want to cure. While there are still many problems in the way, the energy, intention, and creative thinking of the patient community can help to reach above the current mass of details—getting us out of the weeds and focused on the real problem of curing cancer and other diseases. Please help by contributing surgically removed tissue to our Tissue Bank. You can register now to get the paperwork accomplished. Then before any surgery, please contact the VHL Tissue Bank at NDRI and let them know the surgeon’s name and the date of the surgery. To good folks at the NDRI will take it from there, arranging for pickup of the tissue, preservation in the proper method, and conveyance of the tissue to the Bank and to the appropriate research team. Prior arrangement is critical, as samples need to be flash-frozen within minutes of removal from the body in order to be of good quality for modern research. Write to bank@vhl.org or phone 800-222-6374 to get the latest copies of the required forms.

The DCLG are your representatives to the National Cancer Institute and the National Institutes of Health, working to move from today’s fractionated environment to an environment where the lifelong medical records of a large number of people with VHL or other diseases—starting long before the first tumor emerges—will be available for study in a way that protects your personal privacy, but gives researchers the perspective needed to prevent, diagnose more promptly, and treat more effectively the tumors of tomorrow. Not only is this important to research, it will be of enormous benefit to each individual to understand the trends in their own medical data, and use that knowledge to optimize their own health.

As printed in the VHL Family Forum 19:2, April/May 2011. For permission to reprint, please contact VHL Family Alliance, editor@vhl.org. Further information is available from the VHL Family Alliance, info@vhl.org.