Clinical Research

What is Clinical Research?

Clinical Research is research that either directly involves a particular person or group of people or uses materials from humans, such as their behavior or samples of their tissue. Participants in clinical research are protected by guidelines and regulations such as FDA regulations, the World Medical Association's Declaration of Helsinki ethical policy, and NIH Clinical Research Policy. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is an independent nonprofit accrediting body, which promotes high quality clinical research. There are two types of clinical research: clinical research studies and (the more heavily regulated of the two) clinical trials.

What is a Clinical Trial?

Clinical trials are prospective biomedical or behavioral research studies on human research participants that are designed to answer specific questions about novel health-related therapies, drugs, devices, vaccines, or ways of using known interventions.  The goal of these studies is to determine if a new approach is safe and effective.  Clinical trials conducted in the United States must comply with the regulations set forth by the U.S. Department of Health and Human Services (HHS) at 45 CFR 46 and the Food and Drug Administration at 21 CFR 50 and 56.  Research at Northwestern University that involves human research participants must also be reviewed and approved by the university's Institutional Review Board. Proposals for NIH Clinical Trials must also comply with a number of policy changes that went into effect in 2017-18.

Clinical Trials at Northwestern

All proposed industry-sponsored clinical trial agreements as well as federally-funded clinical trial proposals must be processed by the Office of Sponsored Research. A number of clinical research resources and services are available to all investigators, trainees, and staff at Northwestern University, the Feinberg School of Medicine, and affiliate institutions, including:
The ACCR is dedicated to promoting compliant and responsible clinical research conduct through facilitating new ideas, promoting changes in organizational policies, and creating educational programming and relevant activities for the Northwestern Medicine clinical research community. ACCR serves the entire Northwestern Medicine clinical research community on the Chicago campus.
NUCATS functions as an integrated hub supporting and accelerating clinical and translational science across Northwestern University (including six schools), three nationally-renowned clinical partners, Chicago community and stakeholders, and the broad consortium of CTSA-funded institutions.
The CCR offers investigators research services including budget preparation, regulatory and subject recruitment assistance, research coordinators, support for, and general assistance with finding research resources.
The CRUs offer investigators physical facilities including inpatient and outpatient space, a core laboratory, as well as research nursing in which to conduct patient-oriented research. Facilities are located in Northwestern Memorial Hospital and Ann and Robert Lurie Children's Hospital.
Resources for Research Volunteers
If you are interested in volunteering to be a participant in a clinical trial, you can join one or more of the research registries at Northwestern University.  By answering a few survey questions, you may become eligible to be contacted for future research opportunities.  Interested volunteers may also call 1-855-NU-STUDY to speak with someone about their interests and available opportunities.