Quicklinks to Resources
- Clinical Study Planning Checklist
- Business Objects
- Learning Management System (LMS)
- Maestro Care Clinical Research (DOCR Wiki)
- myRESEARCHhome (MRH) Portal
Obtaining Institutional Approval
Clinical research at Duke is a collaboration among study teams and various central offices. Steps in the institutional approval process are outlined below.
CRU/Oversight Organization Review
Once the study team enters the study information and documentation into the iRIS system, the Clinical Research Unit (CRU) or Oversight Organization (OO) reviews the study.
The CRU/OO review specifically looks at operational study feasibility. This review considers how the study will be funded (including the internal cost assessment), if the research is aligned with the mission and direction of the CRU, if there is a patient population to support the research, and if there are any elements of the study that will compete or conflict with ongoing research. The CRU/OO reviews the protocol for the amount of effort, clinical space, or equipment required.
For studies involving only retrospective data collection, RPMs have the option in iRIS to pass the study on to the IRB without assigning any CRU/OO reviewers and to issue final CRU/OO approval. This will be left up to the CRU/CROU Directors to decide whether or not to expedite the review process in this way for retrospective studies.
DUHS IRB Review
The IRB conducts an ethical review of clinical research. An ethical review is an examination of the ethical implications of the study design, including the appropriateness of the study activities, risks and benefits, costs to participants, compensation, and anticipated outcomes compared to currently available standard therapies. To perform the review, the IRB looks at the protocol, the consent documents, and the consent process.
Specialty Committee Review
Depending on the type of study, specialty committees may need to review the study in the iRIS system. Some committees must review before the IRB approval and some afterwards. Possible committees include:
- Cancer Protocol Committee (CPC) - Reviews all research protocols involving cancer patients before submission to the DUHS IRB
- Duke Center for Living - Reviews protocols that use the resources or patients at the Center for Living
- Davis Ambulatory Surgery Center - Reviews protocols that involve the patients or use of resources at the center
- Duke Early Phase Research Unit (DEPRU) - Reviews protocols that involve the patients or use of resources of the unit. Some studies performed at the unit will be reviewed by an independent review board, with the DUHS IRB performing an administrative review only.
- Duke Health Raleigh Hospital Committee - Reviews protocols that involve the patients or use the resources of the hospital require approval from the Clinical Trials Specialist and Chief Medical Officer.
- Hypobaric or Hyperbaric Unit Safety Committee - Reviews research projects that use the chamber.
- Duke Stem Cell Research Oversight Committee - Reviews all research with human embryonic stem cells or other human stem cells.
- Institutional Biosafety Committee - Reviews all research protocols involving select agents (defined by the Centers for Disease Control and Prevention), including but not limited to recombinant DNA, to ensure compliance with all national, state, and local requirements.
- Product and Resource Equipment Team (PERT) [LS1] Committee - Reviews research that requires the use of the operating room or surgical care beyond the standard of care.
- Pathology - The Department of Pathology reviews research involving human tissues (biopsies, resection, or excess/waste tissues) to ensure the proposed study will not interfere with pathologic evaluations of tissues needed for routine current or future clinical care.
- Radiation Safety Committee - Reviews protocols that employ ionizing radiation in any amount that is in addition to standard-of-care before IRB approval.
- Veterans Administration Hospital Institutional Review Board - Reviews protocols that use the resources of the Durham Veterans Administration.
Modifications and Office Reviews
After receiving IRB review, additional office reviews or updates may be required. The IRB will provide specific guidance about the changes that need to be made to the study or the study’s documentation, or any additional committee review.
DOCR will email the study coordinator, Principal Investigator, Research Practice Manager, and Financial Practice Manager to inform them of what is required for DOCR approval. If you are unsure of your study’s approval status with DOCR, send an e-mail to DOCR-Startup@dm.duke.edu. Receiving DOCR approval in the iRIS system is based on several items.
- Maestro Care or Beacon Build - DOCR performs an operational assessment, ensures that patient billing is set up correctly, and creates the Maestro Care build of study activities and procedures.
- ClincalTrials.gov Registration - Studies classified as "applicable clinical trials" or that are funded by NIH and meet their definition of a clinical trial must be registered in ClinicalTrials.gov.
The Office of Research Contracts (ORC) drafts, reviews, and negotiates agreements for research done in the School of Medicine and School of Nursing. They also draft and negotiate data use agreements and material transfer agreements. ORC reviews the study-related injury language in a consent form against the language in the legal contract to ensure consistency.
ORC approval is required for studies that are industry-funded and require execution of a contract. In order to obtain ORC approval, an electronic copy of the fully executed agreement must be sent to ORC_Industry_Contracts@duke.edu. In some cases, the requirement for ORC approval shows up even when there is no contract required or the study is not industry-funded. In these situations, please contact ORC_Industry_Contracts@duke.edu to request that they review the study and release ORC approval as necessary.
What to Do If My Study Is Held Up In the Approval Process?
Depending on the approval status, study team members may choose to contact the IRB, the DOCR Start-up Team, or ORC for additional information regarding any steps remaining for approval.
Need help navigating the approval process? Contact the DOCR Start-up Team by email at DOCRemail@example.com to increase efficiency of study approval, start-up, and implementation.
Permissible Research-Related Activities Prior to IRB and Institutional Approval
The Permissible Research-Related Activities Prior to IRB and Institutional Approvals policy defines the research-related activities allowed during the period between IRB approval and institutional approval.
Before IRB approval, study teams can perform reviews preparatory to research, site qualification visits, investigator meetings, and register the study in clinicaltrials.gov.
After IRB review (the date of the convened IRB meeting) and before IRB approval is issued, study teams can perform site initiation visits.
In the interim period between IRB approval and institutional approval, the study team can ascertain potential participants; perform a site initiation visit; complete participant-related training; set-up regulatory binders; set-up IDE billing framework; get a drug or device shipment; and set up Maestro Care, Willow, or Beacon order sets.
During the interim period, study teams cannot contact or communicate with potential participants, advertise or recruit participants, or conduct any part of the consent process.
Use of Standardized Measures or Validated Assessment Tools for Research Quality Improvement Studies
In response to the use of standardized measures or validated assessment tools in research quality improvement studies, the Office of Licensing and Ventures has identified two tools which are not suitable for use at Duke.
Duke Investigators who use standardized measures OR validated assessment tools for Research and Quality Improvement studies are advised NOT to use:
- Morisky Scale (medication non-adherence assessment tool). As an alternative to using the Morisky Scale, the Office of Licensing and Ventures recommends using the Self-Reported Medication Nonadherence Measurement. The Self-Reported Medication Nonadherence Measurement was developed by Dr. Corrine Voils. If your study is interested in using this tool, contact Kathy Emerson in the Office of Licensing and Ventures. The Self-Reported Medication Nonadherence Measurement is also available in Spanish, Malay, and Chinese translations. For more information and a link to publications: https://www.surgery.wisc.edu/research/researchers-labs/corrine-voils-phd/self-reported-medication-nonadherence-measurement/.
- CERAD modification of the Boston Naming test (neuropsychological assessment tool). Those interested in this measure must get permission from the copyright holders of the Boston Naming test.