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Frequently Asked Questions

FAQs for Patients

What is research?

Research is an effort to answer a question. Physicians do research because they want to learn what works best to help patients with a specific disease or condition. Some other words that describe medical research are: protocol, study or trial; or experiment, registry or survey. Research is not the same as treatment, but it can include treatment.

Why is research important?

Research discoveries can improve people's health. A research study may or may not help you personally. In the future, the results could help others who have a similar health problem.

Who oversees research at Spectrum Health?

All research involving patients at Spectrum Health Hospitals and/or clinics is overseen by the Spectrum Health Research and Human Rights Committee, also known as the Institutional Review Board (IRB). Research must be performed in compliance with regulations and guidelines established by the United States Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), the International Conference on Harmonization (ICH), and the National Institutes of Health (NIH).

What is an IRB?

IRB stands for Institutional Review Board. An IRB is a specially constituted committee established to protect the welfare of human subjects enrolled in biomedical or behavioral research. Spectrum Health has its own IRB, and it is known as the Spectrum Health Research and Human Rights Committee.

Who does research at Spectrum Health?

Faculty physicians, residents, attending physicians, nurses and other health care providers perform research at Spectrum Health. Medical residents and students who are rotating through Spectrum Health as part of their coursework may also be involved in research.

What types of research are conducted at Spectrum Health?

A variety of research is done at Spectrum Health. It includes chart reviews, questionnaires and surveys, patient interviews, treatments and interventions, or use of an experimental drug or device in the treatment of a patient.

How much research takes place at Spectrum Health?

There are approximately 800 open and approved studies at Spectrum Health. Nearly 10 percent of these studies are being conducted in collaboration with other health care institutions (hospitals and universities throughout the United States).

What does the Spectrum Health research department do?

The Spectrum Health research department provides administrative and clinical research support to faculty physicians, residents, attending physicians and other health care providers in a variety of local, national and international clinical trials. The clinical research staff provides accountability 24 hours a day, seven days a week for study trials that occur in both inpatient and outpatient settings.

What is HIPAA?

HIPAA refers to the Health Insurance Portability and Accountability Act, which went into effect in April 2003. Its purpose is to protect patient health information from being misused. It is often referred to as the Privacy Rule and serves to control access to and disclosure of a patient's health information. The Spectrum Health Research and Human Rights Committee (IRB) also serves as the Privacy Board for Spectrum Health.

How does HIPAA apply to research?

HIPAA applies to all research where a subject’s protected health information is collected and subject to disclosure (release) to investigators outside the Spectrum Health system. If a patient does not authorize the release of their protected health information to the institutions and persons related to the research study, he/she cannot participate in that research study.

Does a patient have to pay to participate in research?

A patient does not have to pay to participate in a research study. Study-related medical charges are not the patient’s responsibility and will not be billed to their insurance company. These charges typically are covered by a research grant or the sponsor of the research study. Depending on the study, a patient may receive a small payment for participation.

Do I have to participate in research?

No. Research participation is strictly voluntary. Your decision to participate, or not, will not affect your health care.