Getting Through The Approval Process
Objectives Discuss why it is necessary to get informal and formal approvals Describe the documents that DUHS IRB requires for approval Describe definitions of IRB and IRB approval Discuss what HSP is Describe DUHS IRB reviewing process Duke Translational Nursing Institute 2
Approval Informal approval, or buy in Support and participation of peers and unit leadership Formal approval Institutional Review Board (IRB) Site-Based Research Units (SBR) Review Duke Translational Nursing Institute 3
+ Informal Approval Process Identify key stakeholders An individual or a group who will be affected by the study but possibly not directly involved in the development or data collection for the study Share a patient population Staffing pool that will be involved in data collection Interest in the outcome of the patients being studied Vested interest in the question Duke Translational Nursing Institute 4
Informal Approval (continued) Get feedback from stakeholders early in the proposal process Leadership buy-in Physician participation - particularly regarding access to patients Staff participation Clarify the commitment of stakeholder Level of commitment will vary among the stakeholders Level of commitment should be clarified from the start Duke Translational Nursing Institute 5
Informal Approval (continued) Contracts and agreement External contracts and grants: Send to Office of Research Affairs (ORA) to obtain an institutional approval before the IRB submission Internal agreement Verbal agreement Limited number of stakeholders Good relationship with stakeholders Written agreement Stakeholders are likely to forget about a verbal agreement For documentation of administrative approval Required by IRB if funding is provided Duke Translational Nursing Institute 6
Formal Approval Process IRB: an Institutional Review Board established in accord with and for the purposes expressed in Code of Federal Regulations (CFR) TITLE 45 PUBLIC WELFARE, Department of Health and Human Services, PART 46, PROTECTION OF HUMAN SUBJECTS IRB approval: the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. Duke Translational Nursing Institute 7
Formal Approval Process Institutional Review Board (IRB) To protect the rights of human subjects who will be enrolled in the study To evaluate and resolve any ethical issues which may arise in the course of the study Must review and approve all research on human subjects, both patient and staff research, conducted in the institution prior to beginning data collection Duke Translational Nursing Institute 8
What Needs Approval? The IRB must review and approve all research on human subjects, both patient and staff research, conducted in the institution prior to beginning data collection Duke Translational Nursing Institute 9
Formal Approval (continued) Site Based Research Units (SBR) review A review of your proposal by other experts within your institution The purpose of this review is to ensure content validity as well as legal, ethical, and scientific standards. After the protocol is submitted to the DUHS IRB, SBR reviewer is assigned by the director of the specified SBR When the SBR review is complete the study automatically progresses to the next step, IRB review Learn about SBR: http://crso.som.duke.edu/modules/crso_sbrg/index.php?id= 62 Duke Translational Nursing Institute 10
IRB Process Expedited vs. Exempt? Human Subject Regulations Decision Charts a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations in CFR 45 part 46. http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm Also see the lecture given by the DUHS IRB Senior Chair, Dr. Falletta on January 2010: Find the ppt presentation in Past Things You Need To Know at CRSO website - http://crso.som.duke.edu/modules/crso_resrch/index.php?id=2 Duke Translational Nursing Institute 11
IRB Process Expedited vs. Exempt If a protocol is not exempt and does require review, it may still be able to qualify for expedited review To undergo expedited review the protocol must involve no more than minimal risk Please see additional pdf files on this subject in this website DecisionCharts.pdf ExemptVsExpedited.ppt Duke Translational Nursing Institute 12
Must have: IRB Requirements Protocol Consent form and HIPAA waiver if applicable Study summary Others may be required and the information can be found at DUHS eirb website: https://eirb.mc.duke.edu/ Duke Translational Nursing Institute 13
IRB Requirements Resource Duke Translational Nursing Institute 14
IRB Requirements Resource Duke Translational Nursing Institute 15
Required Components of a Consent Form Research purpose and rationale of study Study procedure or methodology Benefits of participating Risks or possible discomfort incurred due to participation Alternative treatments, therapies or options if one does not participate Procedures to ensure confidentiality/hipaa language Research related injury clause (i.e. responsibility for, and coarse of action in the event of) Statement guaranteeing voluntary participation Consent for participation Duke Translational Nursing Institute 16
Strategies To Speed The Approval Process Follow the guidelines as exactly as possible. Include all appendices Tools Surveys/questionnaires Consent Enlist the help of expert Duke Translational Nursing Institute 17
Enlist the Help of Expert Contact DTNI: email dtni@mc.duke.edu call 919-668-2344 Associate Director: Bradi Granger, PhD, RN Clinical Research Manager: Yong Choi, MSN, RN Statistician: Yanfang Zhao, MS Administrative Assistant: Tina Johnson Duke Translational Nursing Institute 18