Participant Resources

What is Research?

According to the Code of Federal Regulations, research is defined as “... a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

Research can be interventional (where investigators measure the outcome of a particular treatment or approach, often referred to as a “clinical trial”) or it can be non-interventional (where investigators collect data in the forms of surveys, medical chart information, and other methods, to learn more about certain phenomena via observation only). To learn more about the types of clinical trials, please visit the National Institutes of Health.

Why Participate in Research?

Research participants generally choose to participate in research because:

• They want to help advance the scientific understanding of medicine.
• They want access to clinical trials to potentially aid in their own care or the understanding of their disease or condition.

What Does Participation in Research Involve?

The nature of participation in research varies depending on the study. Each research study has a different goal and therefore different steps, or methods, to achieve that goal.

Before agreeing to participate in research, a member of the study team will explain everything involved and outline all of the risks and benefits of participating. Patients will generally be given ample time to ask questions and talk with others before consenting.

Even once patients have agreed to be a part of the research, they still can choose to stop participating at any point. Before stopping, it is important that the research coordinator and investigator be notified of this decision in case doing so has an impact on clinical care.

What Should be Considered Before Participating in Research?

It is important to consider:

1. What is involved in the study? Will it fit the patient’s lifestyle? For example, if the study involves coming to the hospital once a week, is that realistic for the patient?
2. Do the benefits of the study outweigh the risks? The benefits could be in the form of direct benefit to the patient, to the population of patients with a particular condition or disease, or to society at large. If there is any uncertainty about the risks and benefits, the patient should ask questions and consult others before agreeing to participate.
3. What is the difference between research and standard of care? The goals for research and standard of care differ. The goal of research is to contribute to generalizable knowledge; whereas standard of care practice is for the sole purpose of treating the patient.

To participate in research at Hackensack Meridian Health:

1. First consult with your own doctor. Discuss the best way for you to participate.
2. Go to https://clinicaltrials.gov/ and search for research studies at Hackensack Meridian Health. You will find all the active studies here, information on them, and how you can participate.

Participant Rights and Protection at Hackensack Meridian Health

Hackensack Meridian Health fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research. Before any research can be conducted, it must be approved by an ethics committee (referred to as the Institutional Review Board). The review and conduct of research at Hackensack Meridian Health conforms to all applicable federal, state, and local laws and regulations and is guided by the principles set forth in the Belmont Report.

The Human Research Protection Program (HRPP), in partnership with its research community, is responsible for ensuring the ethical and equitable treatment of all human participants in research conducted under its auspices. Its primary mission is to safeguard the health and welfare of human research participants by ensuring that their rights, safety and well-being are protected.

Our institution is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

For more information about our program, please contact ora@hmhn.org.