RECOGNIZING AND KEEPING THE BOUNDARIES BETWEEN CLINICAL GENETICS AND

GENETIC RESEARCH:

 

HELPFUL HINTS FOR PATIENTS

 

Patients seeking genetic testing and counseling often find they are also eligible to participate in research.

For example, if you visit a genetic testing clinic because of a strong family history of colon cancer, you may

also learn that you are eligible to participate in a colon cancer research study. If you decide to participate in

both clinical testing and the research study, it is important to know that there is the potential for a blurring of

responsibilities between the clinic and the research project, particularly if this relationship continues for a

long time. Since this can be confusing, knowing the differences between the goals and functions of genetic

research and clinical practice can maximize your control and involvement in each.

 

Purpose/Commitment  The purpose of a research study is to test a hypothesis (a question) through structured

protocols and procedures. The design of a research study is set and can-not be altered for individual patients.

The purpose of a clinic visit is to enhance well-being. The focus is on the patient, and health care providers have

the flexibility to make recommendations based on what is best for the patient.

 

    Cost  The cost of medical tests often vary whether they are part of a clinic visit or part of a research study.

              For example, genetic testing costs which vary from hundreds to thousands of dollars may be no cost

              or reduced cost in a research study but fully charged to the patient or their insurance in a clinic visit.

 

    Confidentiality  Confidentiality is critically important to both clinics and research. The availability of genetic

              test results can vary. In a research study, test results are kept in separate research files and are not

              considered part of the patient’s medical records. This makes test results less likely to be accessed by

              insurance companies. Also, when re-search studies obtain Certificates of Confidentiality re-search data

              cannot be subpoenaed by a court of law. In contrast, clinics generally keep test results in the patient’s

              medical record. They do not obtain Certificates of Confidentiality.

 

Consent  Patients are always required to sign a consent form to participate in genetic testing. However, in the

clinical set-ting, the patient consents only for testing. In the research environment, a patient may consent to

complete surveys, participate in a study that may or may not include genetic testing, or to share personal

health information with other re-search groups. Thoroughly reading a consent form and keeping a copy for

yourself is very important.

Disclosure (reporting) of Test Results-When genetic testing is ordered in clinical practice, patients can

     always expect to learn about the results. However, in some re-search studies, test results may not be

     disclosed—often this is because researchers do not yet know what the test actually means—that’s why

     the study is being done.

Time Constraints-It generally takes less time to get genetic testing reports back when they are done in the

     clinical set-ting because you or your insurance company pays for this. In a research study, results are

     processed on a research study timeline, which can take years in some instances.

          Social Contribution- In some research studies, it is hard to immediately see any personal benefits however,

               you may be contributing to the future health care of cancer patients or high risk family members by

               providing small biologic samples (like blood) or information. Throughout the history of medicine, health

               care has frequently been improved by what we learned in research. The support of the public is critical

               to improving health care.