Getting Through The Approval Process

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1 Getting Through The Approval Process

2 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 Human Subject Protection (HSP) Describe DUHS IRB reviewing process Duke Translational Nursing Institute 2

3 What Are Types Of Approval? Informal approval, or buy in Support and participation of peers and unit leadership Formal approval Institutional Review Board (IRB) Site-Based Research (SBR) Units Review Duke Translational Nursing Institute 3

4 + Why Is It Important To Obtain Informal Approval? The support and participation of peers and unit leadership will be invaluable to the success of your study. Peer support serves to speed the project s completion and also contributes to enthusiasm and general buy-in for the study. Administrative support is equally valuable and may impact the degree to which the study ultimately influences practice in your institution. Duke Translational Nursing Institute 4

5 + How To Obtain Informal Approval 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 5

6 How To Obtain Informal Approval 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 6

7 What Is DUHS Process for Nursing Research/Projects Approval? Fill out a Nursing Research/Project Organizational Feasibility Form Obtain these signatures in the following order: 1. The PI 2. Nurse manager 3. Clinical Operations Director 4. Associate Chief Nursing Officer 5. Nursing Research Scientist 6. DUHS Chief Nursing Officer Keep the completed Feasibility Form in the study regulatory binder Duke Translational Nursing Institute 7

8 What Is Nursing Research/Project Organizational Feasibility Form? A form required to obtain DUHS administrative approval for staff research/projects Duke Translational Nursing Institute 8

9 DUHS Training Requirements Training to be completed prior to eirb submission IRB Human Subjects Protection (HSP) Certification via CITI modules which are self paced online modules. General information is available: Clinical Research Support Office (CRSO) New Investigator workshop. When you register for the class, you will be required to complete on on-line pre-assessment. This course is offered only once a month. Duke Translational Nursing Institute 9

10 What Is 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 10

11 What Does IRB Do? 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 Duke Translational Nursing Institute 11

12 What Needs IRB 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 12

13 Site Based Research Review A component of the IRB process is review by a specified Site Based Research (SBR) Unit. The SBR serves as the operating business unit and is responsible for the integrity, financial accountability, regulatory compliance, quality and academic productivity of clinical research studies You will need to specify an SBR as part of the eirb submission process Learn about SBR at Duke: Duke Translational Nursing Institute 13

14 What Does a SBR Review? 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 Duke Translational Nursing Institute 14

15 IRB Process Types of Submissions Regular Study Application Most common IRB will determine is study is eligible for expedited review or requires full board review Expedited Application for Exemption from IRB review Only IRB can make a declaration of exemption from RIB review (includes Exempt (45 CFR (b)), Not Human Subject Research (45 CFR (f)), & Not Research (45 CFR (d)). Duke Translational Nursing Institute 15

16 QI as Research DUHS IRB has set an expectation that Quality Improvement projects which are externally disseminated are to be submitted for an IRB determination vities_vs_research_ pdf Duke Translational Nursing Institute 16

17 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 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 - Duke Translational Nursing Institute 17

18 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 Additional information on this subject is available Duke Translational Nursing Institute 18

19 Must have: Protocol IRB Requirements Consent form and HIPAA waiver if applicable Study summary Research Data Security Plan Others may be required and the information can be found at DUHS eirb website: Duke Translational Nursing Institute 19

20 IRB Requirements Resource Duke Translational Nursing Institute 20

21 IRB Requirements Resource Duke Translational Nursing Institute 21

22 Most Common eirb Submission Errors Same information in multiples places does not match (e.g. accrual number on application vs. in informed consent and summary) Not referring to updated summary instructions Use of obscure acronyms on summary What a waiver of Consent/HIPAA is and when it is required (85-90% of the time) Lack of required signoffs on Sub-committee page Standard language needs to be updated (e.g. HIPAA, contraception, injury statement) Accrual: IRB approves # of consented subjects, not number enrolled. Expected screen failures should be included in accrual numbers Forgetting to mark exclusion of pregnant woman Errors in Conflict of Interest (COI) section Duke Translational Nursing Institute 22

23 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 23

24 Enlist the Help of Expert DTNI: DUSON ORA: DUHS Research Nurse Scientist: Duke Translational Nursing Institute 24 24

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