TOP 10 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING HUMAN SUBJECTS RESEARCH

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1 Investigators Responsibility #1: Design and Implement Ethical Research Consistent with the Three Ethical Principles Delineated in The Belmont Report. The Belmont Report: Three Basic Ethical Principles: Respect for Persons Individual Autonomy Protection of Individuals with Reduced Autonomy Beneficence Maximize Benefits and Minimize Harms Justice Equitable Distribution of Research Costs and Benefits

2 Investigators Responsibility #2: Comply with all Applicable Federal Regulations Impacting the Protection of Human Subjects. Federal Regulations and Policy: 45 CFR 46-Basic DHHS Policy for Protection of Human Research Subjects; The Common Rule Additional Protections Included in 45 CFR 46: Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D: Additional Protections for Children Involved as Subjects in Research

3 Investigators Responsibility #2: Comply with all Applicable Federal Regulations Impacting the Protection of Human Subjects. Federal Regulations and Policy: FDA Regulations 21 CFR 50 Protection of Human Subjects (including Informed Consent) 21 CFR 56 Guidance for Institutional Review Boards

4 Investigators Responsibility #2: Comply with all Applicable Federal Regulations Impacting the Protection of Human Subjects. HHS vs. FDA Regulations: Basic Requirements for IRBs and for Informed Consent are congruent. Differences Center on Applicability: HHS Regulations apply to all Tulane University Human Subjects Research FDA Regulations based on use of FDA Regulated Products (Drugs, Devices, Biologics) and apply to all Biomedical Research involving FDA Regulated Products

5 Investigators Responsibility #3: Ensure that all Research Involving Human Subjects is Submitted to and Approved by the Appropriate Institutional Review Board. Definitions: Research-A Systematic Investigation Designed to Develop or Contribute to Generalizable Knowledge Human Subject-A Living Individual about whom an Investigator Conducting Research Obtains Data through Intervention or Interaction with the Individual, or Identifiable Private Information Institutional Review Board (IRB)-A committee charged with the review of human participants research to assure that the rights and welfare of human participants are adequately protected.

6 Investigators Responsibility #3: Ensure that all Research Involving Human Subjects is Submitted to and Approved by the Appropriate Institutional Review Board. Why do we need IRB review? No one can be objective about their own work People underestimate the risks involved in things they are very familiar with People overestimate the benefits of things that are important to them

7 Investigators Responsibility #4: Comply with all Applicable IRB Policies, Procedures, Decisions, Conditions, and Requirements. The IRB Approves Research based on the 7 Criteria for Approval: (45 CFR ) Risks to Subjects are Minimized Risk/Benefit Ratio is Reasonable Equitable Selection of Subjects Informed Consent is sought from each subject (45 CFR ) Informed Consent is appropriately documented (45 CFR ) Provisions for monitoring the data collected for safety Provisions for privacy and confidentiality Provisions for Vulnerable Populations

8 Investigators Responsibility #5: Implement Research as Approved and Obtain Prior IRB Approval For Changes. The Research Team is to follow the IRB Approved Protocol. The Research Team is to use the IRB Approved and Stamped Consent Form. Any Changes must be submitted and approved as an Amendment before put into practice.

9 Investigators Responsibility #6: Obtain Informed Consent and Assent in accord with Federal Regulations and as approved by the IRB. Informed Consent is not a single event or just a form to be signed rather, it is an educational process that takes place between the investigator and the prospective subject. The Basic Elements of the Consent Process include: Full disclosure of the nature of the research and the subject s full participation Adequate comprehension on the part of the potential subjects The subject s voluntary choice to participate

10 Investigators Responsibility #7: Document Informed Consent and Assent in accord with Federal Regulations and as Approved by the IRB. Consent Forms should be written in lay language and at an 8 th grade level for readability. Formatting of a Consent/Assent Form can help with comprehension including headings, indents, bolded type, charts, bulleted lists, etc. To assist with developing a cohesive Consent Form, the Tulane HRPO has developed Biomedical and Social/Behavioral Consent and Assent Templates including all required information. Also, a Glossary of Lay Terms for use in completing Consent Forms is available. These tools can be found on the HRPO website.

11 Investigators Responsibility #8: Report Progress of Approved Research to the IRB, as often and in the manner prescribed by the IRB. Continuing Reviews: An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year 45 CFR (e)/21 CFR (e) Continuing Review submissions should be submitted 60 to 30 days prior to expiration of research to avoid a lapse in IRB Approval, as NO RESEARCH ACTIVITY MAY BE CONDUCTED DURING A PERIOD OF LAPSE.

12 Investigators Responsibility #9: Report to the IRB any Injuries, Adverse Events, or other Unanticipated Problems Involving Risks to Subjects or Others, and Protocol Deviations. During the conduct of any Research Protocol, Unanticipated Problems and Protocol Deviations must be reported. Tulane HRPP SOPs Section 8 covers Unanticipated Problems Involving Risk to Subjects or Others and contains the Reporting Requirements. Tulane HRPP SOPs Section 9 covers Protocol Violations, Deviations, and Exceptions and contains the Reporting Requirements. The HRPP Policies can be found on the HRPO Website.

13 Investigators Responsibility #10: Retain Signed Consent Documents and IRB Research Records for at least 3 years past completion of the Research Activity. The Tulane University HRPO recommends that PIs and Research Teams keep a Regulatory Binder for each research study. In an effort to assist PIs and Research Teams with the organization of their Research Studies, a guidance document is available on the HRPO Website with instructions on Creating a Regulatory Binder.

14 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING CLINICAL RESEARCH Overview of Clinical Trials: Research studies involving patients or populations at risk for disease May be directed at questions of causation, prevention, early detection or treatment Designed in a scientific manner and conform to ethical standards To increase knowledge Importance of Clinical Trials: To provide evidence-based patient care or prevention of disease To improve the quality of care

15 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING CLINICAL RESEARCH All Clinical Trials at Tulane University must comply with ICH-GCP Guidelines Good Clinical Practice (GCP) is the international and scientific standard for designing, conducting, recording and reporting trial that involve the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety and well-being of study subjects are protected and consistent with the Declaration of Helsinki. Compliance also ensures that clinical trial data and reported results are accurate and credible.

16 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING CLINICAL RESEARCH Why do we need GCP? International concern for the protection of human subjects involved in research has increased Historical Influences (WWII, vulnerable populations) Need for research to advance medical knowledge Unified to facilitate mutual acceptance of clinical data by regulatory authorities

17 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING CLINICAL RESEARCH The Research Team: A group of people working together in a systematic and scientific manner to establish facts Consists of the PI, Co-Investigators, Clinical Coordinators, Data Managers, Research Pharmacist, Research Subjects, Institutional Review Board (IRB), and Regulatory Bodies Committed to applying the principles of GCP in the conduct of clinical research The Protocol Document: A detailed plan and instructions for the conduct of the clinical trial Guidebook for those involved in the day-to-day care of the patient enrolled on the trial The Research Team should all read and comprehend the Protocol Document. Many errors can be avoided if the entire Research Team shows understanding of the Protocol in its entirety.

18 INVESTIGATOR RESPONSIBILITIES WHEN CONDUCTING CLINICAL RESEARCH Conclusions: Clinical Trials imply a disciplined approach to the care of patients enrolled on the studies. A Research Team approach is ideal. The PI is ultimately accountable and responsible for the conduct of the clinical trial. The PI should strive to meet the high standards of GCP in order to provide public assurance that the rights, safety and well-being of subjects are protected, data is accurate, and reported results are credible.