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Clinical Research

CLINICAL TRIAL AGREEMENTS 

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.

Federally-sponsored clinical trials

Submitting Proposals

All proposals for federally-sponsored clinical trials must be processed through OSR and require completing an InfoEd Proposal Development (PD) record and satisfying all other compliance requirements.  No study subject related activity can be initiated until appropriated IRB approval has been obtained and either a Notice of Grant Award is received or a subcontract agreement has been executed by OSR.

Budget Tips for Federally-sponsored Clinical Trials

  • F&A rate: The Federal sponsored research rate is applicable.  The on-campus or off-campus rate should be used as applies to the project.
  • IRB fees: IRB fees are not charged to Federally-sponsored projects.
  • Per patient rates: If a per patient rate is provided, F&A must be backed out of the per patient rate.
  • Multisite trials: If Northwestern University is the prime site for a proposed multisite trial, complete subcontractor information from all sub-sites must be submitted to NIH with the initial application.

NIH Clinical Trials

In October 2014, in order to more clearly distinguish between clinical trials and clinical research studies, the National Institutes of Health (NIH) revised its definition of a clinical trial as follows: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.  This revised definition applies to competing grant applications and contract proposals submitted to NIH on or after January 25, 2015. NIH implemented additional policy changes related to clinical trials in 2017-2018. For more information on these changes, visit our NIH Clinical Trials page.

For more information on clinical studies in general or to search for a clinical study, visit ClinicalTrials.gov.

Industry-sponsored clinical trials

Industry-initiated clinical trials and PI-initiated clinical trials are a subset of clinical research that must meet certain criteria in order to qualify for the clinical trial indirect cost rate. Regardless of any tentative understanding between the principal investigator (PI) and the sponsor, all industry-sponsored clinical trial agreements (CTA) must be processed by OSR on behalf of the University.  Visit our page on Clinical Trial Agreements for more information about executing a CTA.

Resources for Northwestern PIs and staff

Advisory Council for Clinical Research (ACCR)
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.

Northwestern University Clinical and Translational Science Institute (NUCATS)
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.

NUCATS – Center for Clinical Research (CCR)

CCR offers investigators a range of clinical research support services including budget preparation, regulatory and subject recruitment assistance, support for ClinicalTrials.gov, and general assistance with finding research resources.