Clinical Research Primer for Nurses

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  • Worked in clinical research in radiation oncology for 9 years in varying capacitiesCurrently completing JD, MA
  • Research:~ databases used for QA are not to be used for research~ just gathering stuff in a excel sheet is the systematic collectionHuman subject~ the vast majority of dataset you engage with here are going to have a mix of living and deceased subjects. Therefore they require IRB approval. Even if they are all deceased, you need to submit to the IRB for an exemption ~ biospecimens when linked with ANY clinical data are definitely human subjects research
  • Clinical research is incredibly regulatedBefore a protocol even open in radonc, it has to go through the review above
  • Compliance within clinical research is taken very seriouslyIt is subject to all of the regulations around medicine PLUS those specific to research
  • Subjects on trials receive a mix of standard of care assessments and assessments that are specific only to the protocol A person can provide regular treatment procedures to a patient on a clinical trial, without being engaged in research 1 of 3 pages of assessments required by the studyThese assessments were then reviewed by Dr. Chmura to determine what items the patient would receive even if they werent participating in the protocol, and what assessments were specific to the protocol. That is, what is standard of care vs researchThis particular document is used for billing but also helps illustrate The blending of the two into the course of the patients treatmentProvide examples of research assesments
  • Definition of Key Research Personnel:~ someone who consents subjects~ named on a grant~ lab people using the specimens~ statisticans~ medical students~ those named on the abstract/paper
  • This is submitted by Amber to the CCTO and then reviewed by the IRBCompleting CITI Research Training refresher training required if done more than 3 years agoFeel free to come to our weekly RadOnc Clinical Research Meeting and DSMB on Fridays at 1130am in the conference room learn about our active projects, common issues in clinical research administration, ask questions! there is often food


  • 1. CLINICAL RESEARCH PRIMER FOR NURSES Amber Meriwether, Research Professional Department of Radiation Oncology, The University of Chicago
  • 2. What is Human Subjects Research? • Research • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102(d) • Human Subject • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information [about]. 45 CFR. 46.102(f)
  • 3. Examples of human subjects research • Collecting samples of body fluid or tissue • Implanting or using a device • Recording information that is not routinely collected in the course of • • • • • • treatment Administering a drug or new combinations of therapy Administering RT at non-standard doses or in non-standard ways Evaluating a diagnostic technique Interviewing, surveying or observing human subjects Reviewing medical records Reviewing already collected specimens
  • 4. Radiation Oncology Clinical Research Regulatory Process New Research Protocol Involving human subjects: Send to Amber Meriwether • • • • to start administrative process Biospecimens tied to outcome data Research databases Clinical Trials Collaborations with other departments or institutions Radiation Oncology Internal Review • • • Amendments to Existing Protocol Most listed administrative review points not required Quarterly Safety Review for High Risk Continuing Renewal by the Institutional Review Board Audits by Study Sponsor and University Agents Annual Review by the Scientific and Accrual Monitoring Committee Feasibility (time commitments, cost, data collection) Physics assessment and credentialing Interdepartmental Agreements Contracts and budget determinations Grants & Contract Manager CCTO Regulatory Manager Clinical Trials Review Committee University Research Administration (URA) or OCR review Institutional Review Board Weekly Review by RadOnc Data and Safety Monitoring Board Enroll Patients and Collect Data
  • 5. Why is research compliance such a big deal? • NCI • Suspension of medical practice • Medical Board • Issue sanctions, including loss of license • FDA • will not accept data from subjects or sites with significant deviations • publishes their findings of noncompliance • Can ban investigators from engaging in further research • maintains a publically accessible list on their website of “Disqualified/Totally Restricted List for Clinical Investigators” • Can shut down entire research institutions • Academic Centers • Sanctions against investigators • Can shut down studies or entire research programs • Academic Journals • Will not publish research without valid IRB approval
  • 6. What role do clinic nurses play in research?
  • 8. Radiation Oncology Clinical Research Subject Enrollment Process Treatment Team Pitches Protocol Treatment Team notified Screening Performed Research Nurse/Coordinator via email Patient interested Research Nurse/Coordinator paged for consent of patient Patient declines Research Nurse/Coordinator notified and documents decision Research Protocol Carried Out Data Manager submits information to sponsor Nurse/Coordinator: verifies eligibility, enrolls subject, coordinates care within protocol specifications, carries out research procedures with Investigators, reports Adverse Events, and documents per protocol - - - Ensure assessments carried out per protocol specifications - Provide subject with research documents at standard of care visits (questionnaires) Notify research nurse/coordinator of Serious Adverse Events Treatment Team provides standard of care within protocol specifications
  • 9. When is someone engaging in human subjects research? • Key Research Personnel • Persons who have direct contact with subjects, contribute to the research in a substantive way, have contact with subjects’ identifiable data or biological samples, or use subjects’ personal information
  • 10. What are the requirements for engaging in human subjects research? Clinical research education • study specific training documented it in the study file • Completing CITI Research Training and Conflict of Interest Statement (COI) • • Documentation of credentials • Signed copies of CV and license on file with the CCTO • Approval of status as member of the protocol specific research team • Amending the IRB protocol • Depending on the sponsor, modifying the site roster
  • 11. Who can consent a patient to a research study? What is required of the consent process? • Only a person named as a consenter on the research protocol with the IRB and Sponsor • For trials in our department, only faculty and research staff • For databases, only faculty, residents and research staff • Consent process must be documented • All the holes on the consent form must be completed • Only the patient can sign and date the form for themselves • If the patient is unable to sign themselves, contact a research staff member for proper documentation for alternative procedures
  • 12. What is an adverse event? • An adverse event is any undesirable experience associated with the use of a medical product in a patient. • A serious adverse event is any adverse event that results in: • Death • Life-threatening • Hospitalization (initial or prolonged) • Disability or Permanent Damage • Congenital Anomaly/Birth Defect • Required Intervention to Prevent Permanent Impairment or Damage • Other Serious (Important Medical Events) • Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events.
  • 13. A patient on a clinical trial had an adverse event, what should I do? • Immediately contact the research nurse or research coordinator for the study • Research staff will report the AE per sponsor and institutional requirements • Must be reported within 10 days if three elements are met: • unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol, investigator’s brochure, drug or device product information, informed consent document, or other research materials; and (b) the characteristics of the subject population being studied, including underlying diseases, behaviors, or traits; • related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and • suggests that the research places subjects or others at a risk of unknown harm or addition/increased frequency of harms(including physical, psychological, economic, legal, or social harm) than was previously known or recognized.
  • 14. What role do clinic nurses play in research? • • • • Provides standard of care within protocol specifications Help ensure assessments carried out per protocol specifications Provide subject with research documents at standard of care visits (questionnaires) Notify research nurse/coordinator of serious adverse events (SAEs)
  • 15. What can I do to help with clinical research? • Document! • Required study evaluations (e.g. performance status) • Documentation of review of medications • Deviations from protocol specifications • Evaluation performed outside of study window • Deviating from the scope of protocol
  • 16. I want to learn more about clinical research, where can I find information? • Contact department research staff • Visit the Comprehensive Cancer Center’s website of currently approved protocols and documents • Participate in addition research training