Issues in Genomic Medicine and Research

Whether the search is for a diagnosis or a possible treatment, the tools and methods of individualized, or personalized, medicine are relatively new — even to many health care providers.

Genomics is a field of medicine that is rapidly growing and developing. The details of a person's genome may provide clues or sometimes direct answers that lead to treatment and improved care.

At Mayo Clinic, we do not use genetic and genomic information in isolation. To yield the best decisions and diagnoses, we integrate genomic information with other available medical information, from interviews and physical exams to conventional laboratory data. Individualized medicine involves patients in the care process — perhaps more than ever before.

Patient privacy

We know that genomic information is very personal — as is any part of an individual's medical record. Mayo Clinic has a long history of protecting and managing what today is known as the individual medical record since Mayo's Dr. Henry Plummer invented it in the early part of the 20th century. This is evidenced by the trust expressed over the years by Mayo patients. And Mayo takes that trust very seriously.

In that same tradition of respect and trust, the Center for Individualized Medicine — through integrated teams of bioethicists, medical geneticists (physicians), genetic counselors and other specialists — diligently develops its procedures and rules so patient rights are ensured.

Each patient decides the level of privacy he or she needs. Patients determine what information they wish to know and what information to share, if any, with other family members. Each area of the Center for Individualized Medicine includes regulations and procedures for protecting information and patient privacy. Specific safeguards and informed consent may be customized to fit the processes of each area, but all encompass protection for the individual patient.

Insurance

Many patients are concerned that information from their genomic tests may find its way to insurance companies and affect their insurance rates or their ability to be insured. Neither Mayo Clinic nor the Center for Individualized Medicine releases any genomic information to patients' insurance providers without consent from the patient.

Information security

Every genome sequence produces vast amounts of data that must be stored electronically — far more information, in fact, than is contained in most medical records. In the same way Mayo Clinic protects patient information and every electronic medical record, we safeguard all genomic information with multiple levels of security.

Mayo Clinic and the Center for Individualized Medicine do not share any information without explicit and informed consent from the individual patient or study participant.

Genomics in research

Genomic research differs from genomic clinical care. With research, the goal is to gather scientific information that may not necessarily result in health benefits to participants. Separate consent processes are required and expectations of outcomes vary.

Sharing of genomic research information often involves collaborators at Mayo Clinic and other institutions, but only with appropriate permissions from the participant. Permissible and appropriate access by staff to medical records is clearly documented, with compliance auditing and reporting as required.

Bioethics and community involvement

The Center for Individualized Medicine develops its policies and procedures so patient rights are fully protected and ethical practices are followed. The center works with an independent community advisory board of informed and interested citizens, as well as with national groups of bioethical experts, to arrive at the best practices in approaching the complex questions presented by genomic medicine and research.

Patients, research participants or members of the public are welcome to ask questions about any aspect of this new approach to medicine.