Article from the Boston Globe’s On Call Magazine, August 2000

By Helen Osborne, M.Ed., OTR/LA
President of Health Literacy Consulting

Clinicians routinely collaborate with researchers on projects designed to improve healthcare and healthcare options for their patients. Their roles range from recruiting patients to doing experimental studies to analyzing data. But while some research may involve familiar clinical routines, the context for those routines can differ greatly from that of your daily practice. Before you say yes to research, you should familiarize yourself with what the differences are.

Patients aren’t the only people who can discover themselves drifting in a sea of information they find hard to understand. Any time you move from one type of professional activity to another, such as moving from clinical practice to research, you’ll be faced with terminology and ways of thinking that may seem strange and difficult, even overwhelming. Sometimes, even concepts that you feel should be familiar, such as the concept of informed consent, require you to take a different approach than the one you are used to taking.

Moving into research can be an exciting enhancement to your career. But if you are not familiar with what’s involved, it can be an overwhelming experience. Just as you would encourage and expect a patient to ask questions and explore new ideas when confronting some new practice, you should do the same. The more you know about research before you start, the better able you are to decide when it might be the right move to make. Some of your best resources are people already doing research.

Diane Mahoney, RN, PhD, is a senior researcher at the Hebrew Rehabilitation Center for Aged (HRCA) Research and Training Institute in Boston. She leads a team of researchers and clinicians in studies of healthcare interventions with older adults. To recruit human subjects for that research, Mahoney works with Roberta Rosenberg, MEd. Rosenberg is the director of Outreach and Recruitment at the HRCA Research and Training Institute.

Clinicians can get a better sense of the research process, Mahoney and Rosenberg say, if they take the time to explore and understand some basic terms and concepts:

What is Research and Are There Different Types?

Research studies involving clinicians usually test the statistical significance of a hypothesis. They measure whether an intervention, such as a new treatment protocol, can improve patient care.

There are two types of research studies – basic and applied. Basic research, sometimes referred to as “bench science,” involves experimentation in the laboratory. Applied research takes place “in the field,” and uses human subjects. Applied research includes observational studies, such as record reviews, and intervention studies, such as drug testing and clinical trials.

How Is Research Regulated?

In order to protect people who participate as subjects, all applied research studies must meet research requirements established by the Federal government. These requirements mandate that benefits of the study must outweigh the risks to the subjects, that all subjects voluntarily consent to participate, and that subjects can stop participating in the study at any time without consequence.

Before an organization agrees to participate in human research studies, that organization’s institutional review board (IRB) must first approve. The National Research Act requires that an IRB review every active human research study that receives federal funding at least once a year.

What Sort of Things Should I Consider Before I Say Yes to Research?

Mahoney and Rosenberg both point out that there are a number of things you should consider. Here are three:

Think about what you and your patients have to gain if you get involved.

Here are some potential benefits to consider:

• You can meet and work with experts in your field.
• You have an incentive and a way to stay up-to-date with the latest developments.
• You can be trained on new equipment you might not otherwise have access to.
• Your patients may have access to state-of-the-art tests and treatments that might not be covered by their health insurance.
• Both you and your patients can have the satisfaction of knowing you are contributing to a collective body of knowledge that will help others in the future.

Think about the burdens of getting involved.

In order to collect the needed data, you almost certainly will be asked to complete forms and participate in interviews and training sessions. Your patients will be asked to make an investment of time and run the risk of disappointment if they are assigned to a control group or for some other reason do not receive the potential benefit of an intervention. Another burden to consider is the level of intrusiveness of the research study. That level is determined by how time consuming, psychologically stressful, and physically risky the study is.

Learn how concepts may differ from how you are used to thinking of them.

What may seem routine in your daily practice can take on added significance in research. It’s possible even that the concept may actually change. For instance, Rosenberg says, “Informed consent is a process, not a form.” To truly give informed consent, she explains, a subject must fully understand the goals, risks, and benefits of the study and voluntarily agree to participate. She adds that the informed consent process begins when a researcher first contacts potential participants and continues until the subjects either complete or leave the study. Whether clinicians merely refer patients to the study or get more involved in the actual research, Rosenberg says, they need to understand and make clear their role in the informed consent process.

The more you know about how research requires you to alter your routine your thinking about your clinical practice, the better able you will be to decide about getting involved and to help your patients make the same decisions.

Ways to Improve the Informed Consent Process

• Make sure the consent form is as simple and as clear as possible.
• Be sure the consent form fully explains the study.
• When creating consent forms or when explaining them, use everyday words whenever possible. For instance, say “heart attack” rather than “myocardial infarction.”
• Explain unfamiliar concepts by giving an example, such as equating randomization to flipping a coin.
• Make sure that consent forms are translated into participants’ primary language, and use alternative ways to describe concepts, such as disease names and treatment procedures, that have no literal translation.
• Regardless of the language it is written in, pre-test the consent form to make sure it is understandable by the intended audience.

Where to Find Out More

Printed Sources

• Rosenberg, R., M. Gagnon, P. Murphy-Gismondi, W. Lock Ooi, D. P. Kiel, L. A. Lipsitz (1996). Factors influencing subject willingness to participate in clinical gerontologic research. Aging Clinical and Experimental Research. Vol. 8, No. 6., 400-408.
• Tarlow, B.A., D. F. Mahoney (to be published, November 2000). The cost of recruiting Alzheimer’s disease caregivers for research. Journal of Aging and Health.
• The Harvard Cooperative Program on Aging Newsletter. This newsletter, published by the Harvard Cooperative Program on Aging, provides summaries and contact information for local research studies that are recruiting subjects. For more information, contact Marcie Freeman at HRCA, (617) 363-8654.

Web Resources

• National Institute of Health Bioethics Web site. This site is a resource for those with an interest in bioethics, including education, research involving human participants and animals, medical and healthcare ethics, and the implications of applied genetics and biotechnology. www.nih.gov/sigs/bioethics
• Office for Protection from Research Risks (OPRR); Human subject protection. grants.nih.gov/grants/oprr/oprr.htm

Other Resources

Diane Mahoney, PhD, and Roberta Rosenberg, MEd, both work at the Research and Training Institute at the Hebrew Rehabilitation Center for Aged in Boston, 1200 Centre Street, Boston, MA. Mahoney is the Director of the Enhancing Family Caregiving Program through Technology Research and Development, and Rosenberg is Director of Outreach and Recruitment.