IRB Submissions and Human Subjects Research Compliance. Georgia Health Sciences University

Transcription

1 IRB Submissions and Human Subjects Research Compliance Offi f H R hp t ti Office of Human Research Protection Georgia Health Sciences University

2 Objectives Identify the steps required to submit a protocol to the Human Assurance Committee (IRB) Di h l f li li Discuss the elements of a quality compliance system to ensure research compliance

3 Submitting to the IRB STUDY DESIGN eirb Sound Scientifically Study Team Compliance Human Subjects Protections Collaborations Health System ITSS Radiation Safety Biological Safety Chemical Safety Access Submitting Stipulations CITI HIPAA eirb PowerChart IRB Approval Graphic Standards Ancillary Approvals Required Training

4 Study Design Submitting to the IRB Sound Scientific Design Includes statistical analysis plan and justification for sample size Study Team Must be trained on the protocol and informed of changes Collaborations Within GHSU Outside of GHSU Requires approvals from the non affiliated entities IRB

5 Submitting to the IRB Study Design Human Subjects Protections The investigator must ensure risks to subjects are minimized i i by: Using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk Using procedures already being performed on the participants for diagnostic or treatment purposes Ensuring risks are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.

6 Submitting to the IRB Study Design Human Subjects Protections The investigator must ensure risks to subjects are minimized by: Ensuring there are adequate provision for monitoring the data collected to ensure the safety of participants Ensuring selection of subjects is equitable taking to account the purposes of the research, the setting in which the research will be conducted, the special problems of research involving vulnerable populations, the selection criteria, and the recruitment procedures Ensuring risks are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.

7 Submitting to the IRB Study Design Human Subjects Protections The investigator must ensure risks to subjects are minimized i i by: Ensuring the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants Ensuring there are adequate provisions to protect the privacy of subjects Ensuring there are adequate provisions to maintain the confidentiality of the data Ensuring there are adequate resources to protect participants

8 Submitting to the IRB Study Design Human Subjects Protections The investigator must ensure risks to subjects are minimized i i by: Ensuring informed consent is properly obtained or There is approval to waive: The consent process Documentation of consent HIPAA Authorization

9 Submitting to the IRB Levels of Review Non Human Subjects Research Determination Request Exempt Expedited Full Emergency

10 Training Submitting to the IRB All research team members must complete the following training i before they are added d to a protocol: CITI HIPAA eirb if they will require access to the electronic IRB submission system Additional training requirements, per the study

11 Submitting to the IRB eirb new electronic IRB submission, tracking, and compliance system Accessing eirb First Step must complete CITI Second Step complete the online eirb training module Third Step request access via the OHRP website Submit copy of CV Submit copy of CITI completion lti report

12 Submitting to the IRB Tips for Navigating eirb Use the Quick Facts Sheets Know your plan before you enter the system Call for assistance,

13 Submitting to the IRB IRB acts as the Gatekeeper for many ancillary approvals: ITSS Required for every study Health System Required if Health System resources will be used Facilitated through the OCIS Review Office Radiation Safety Biological Safety

14 Submitting to the IRB IRB acts as the Gatekeeper for many ancillary approvals: Chemical Safety Graphic Standards Required if advertisements or web postings will be used

15 Study Approval Approval notification via eirb Compliance and Submissions to the IRB don t end Protocol Revisions Personnel Changes Continuing i Review Reportable Events Study Closure

16 Ongoing Study Submissions Protocol Revisions Required for any changes to the protocol. Must be approved before the change may be implemented unless there is an over riding subject safety concern Changes to the PI Changes to locations Protocol changes Consent document changes

17 Ongoing Study Submissions Personnel Changes Required for any changes to personnel, must be approved before the personnel may begin work on the study Sub Investigators Study Coordinators Other Study Personnel Administrative Contact

18 Ongoing Study Submissions Continuing Review Required by federal law IRB must review the study at least annually Continuing review requests are due no later than 30 days before the study expires. If the study expires all study activities must cease Unless there is an over riding subject safety issue which must be communicated to and approved by the IRB Chair

19 Ongoing Study Submissions Reportable Events Required to be reported to the IRB as outlined in the policy (specific reporting time lines) Unexpected and Related Adverse Events Serious Adverse Events Unanticipated Problems Protocol Deviations Protocol Violations Safety Reports DSMB/DSMC Reports Reports of study suspension, enrollment closures, etc..

20 Ongoing Study Submissions Study Closure The IRB must be notified once your study is completed Submitted via the Continuing Review form in eirb

21 RESEARCH COMPLIANCE Education, training and expertise of research team Training when errors are identified Personnel Controls Ongoing Training of Research Team Agent accountability Access to the agent Delegation of Duties Safety Event Reporting Safety Controls Protocol Deviation and Management Assuring there are adequate facilities to conduct the research Source Documents Essential Regulatory Documents Data Collection Methods Records, Documents, and Revisions Controls Security and Confidentiality of documents PI Oversight Adherence to all regulations and policies Study Compliance SOPs Investigational Agent Controls Facility Controls Management Controls

22 Research Compliance Quality Systems approach to ensuring all aspects of research conduct and compliance are addressed d

23 Research Compliance Management Controls The PI is ultimately responsible for the conduct of the study and must take an active role in ensuring the study is conducted in compliance with all applicable regulations, policies, and laws

24 Research Compliance Management Controls The PI should ensure there are standard operating procedures for all aspects of the study The PI should oversee and supervise the conduct of the study

25 Research Compliance Personnel Controls The PI must ensure: All research team members are trained and educated don the study and have the expertise to perform their delegated tasks Ongoing training occurs throughout the lifetime of the study Training and corrective actions are in place when an error in study conduct is identified

26 Safety Controls Research Compliance The PI must ensure Duties are dl delegated dto other research team members and the delegation is documented appropriately Safety Events are reported per IRB and sponsor/sponsoring agency requirements Protocol deviations are managed appropriately and revisions to the protocol are implemented, if needed

27 Research Compliance Investigational Agent Controls The PI must ensure: There are controls documented dand executed to ensure Agent accountability Security regarding gaccess to the agent

28 Research Compliance Facility Controls The PI must ensure: There are adequate facilities to conduct the research The privacy of research subjects is maintained

29 Research Compliance Records, Documents, and Revisions Controls: The PI must ensure: Source documentation is present for all data collected All required regulatory document is present and organized There are controls to ensure the security and confidentiality of the records

30 Questions