A Seamless Research Compliance Program for Small Health Care Institutions

Transcription

1 A Seamless Research Compliance Program for Small Health Care Institutions Pat Connell RN, MBA, CHE, CBHE, CIP, CHC, Vice President of Behavioral Health, Research & Health Care Compliance, and Government Relations for Boys Town National Research Hospital and Boys Town Boys Town National Research Hospital Downtown Medical Campus Pacific Street Medical Campus

2 Center for Childhood Deafness

3 Youth From 36 States and 5 Countries Have Been Admitted to the Boys Town Behavioral Health Services

4 Program Objectives Learn how to start compliance activities before grant submission, including techniques for using existing office software to track and document research compliance activities. Explore various strategies for incorporating multiple departments into research compliance programs. Learn how a seamless system approach from pregrant submission to post-grant review can improve the effectiveness of your research compliance program. Why did we go down this pathway? To reduce potential compliance problems To protect our reputation To increase organizational competence To reduce the temptation to operate outside of the box To increase researchers success and satisfaction

5 Why use a systematic approach? Because research compliance is a system, whose various pieces have to interact effectively to be successful and meet compliance standards. To demonstrate commitment at every level of the organization. To reflect a team or family approach for working together.

6 Seven Stages for Success Stage 1 Initial New Hire Orientation Stage 2 Review of Grant Application Stage 3 IRB review Stage 4 Progress Reports Stage 5 Not-For-Cause Audits Stage 6 IRB Continuing Review Stage 7 Grant Closing Stage I Initial New Hire Orientation Orientation (on-line) CITI (every 2 years) Healthcare Compliance Research Compliance Special Topics (on-line) such as: HIPPA for researchers Informed assent or consent Preparing grants Audit ready record management Consultation and Technical Assistance Grant Preparation, technical assistance, and transfer of grants in and out of organizations * Every on-line course requires a post-test with a minimum pass score. Test results are forwarded to their supervisor and their electronic HR record.

7 Stage 2 -Electronic Review of Grant Application Reviewers are notified by (10 working days prior to grant due date). Link provided to share directory of research grant (PDF) Reviewer reviews file (average response 6 days) feedback provided to Research Coordinator who notify PI of changes needed or approval (same day) PI revises application (ranges from 1-4 day) Reviewers Principal Investigator and/or Co-Investigator Grants Accountant Director of Research Associate Administrator of Finance Chairperson, BTNRH IRB (if human subjects are involved) Chairperson, BTNRH IACUC (if animals are involved) Director of BTNRH

8 Boys Town National Research Hospital Patrick E. Brookhouser, M.D. Vice President & Director of Health Care, Father Flanagan s Boys Home (FFBH), and Director of Boys Town National Research Hospital (BTNRH) GRANT PROPOSAL SIGN-OFF SHEET TYPE OF GRANT APPLICATION: New Competing Continuation (Renewal) Revised or Amended (Resubmission) Competing Supplement (Revision) Annual Grant Progress Report Grant Subcontract Final Grant Report Other PROJECT TITLE: DECISION PROCESSES IN DETECTION AND DISCRIMINATION AGENCY: NIH-NIDCD/5R01DC /05/2009 DUE DATE: TITLE/NAME Program Director/ Principal Investigator (PD/PI) Walt Jesteadt ASSURANCE: (1) that the information submitted within the application is true, complete and accurate to the best of the PI s knowledge; (2) that any false, fictitious, or fraudulent statements or claims may subject the PI to criminal, civil, or administrative penalities; and (3) that the PI agrees to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application. Co-Investigator Donna Neff Director of Research Walt Jesteadt Division Director Walt Jesteadt Grants Accountant Theresa Langer Director of Finance or Associate Administrator of Finance Leigh Jean Koinzan or Mary Brown-Zoucha VP & Director of Health Care, FFBH, and Director of BTNRH Patrick Brookhouser Chairperson,BTNRH Institutional Review Board (IRB) Patrick Connell Are Human Subjects Involved: YES NO If YES to Human Subjects, is the IRB Review Pending: YES NO Human Subject Assurance Number: FWA Chairperson, Institutional Animal Care & Use Committee (IACUC) JoAnn McGee Are Vertebrate Animals Used: YES NO If YES to Vertebrate Animals, is the IACUC Review Pending: YES NO Animal Welfare Assurance Number: A ELECTRONICALLY REVIEWED DATE OF APPROVAL Original Signature Required for PD/PI Approved 2/19/09, 10:36am Approved 2/19/09, 2:58pm same as above same as above Approved 2/20/09, 11:48am Approved 2/20/09, 8:18am Approved 2/20/09, 3:34pm Approved 2/19/09, 5:39pm IRB Approval Date: 04/11/08 Protocol #: XP Exemption #: (if applicable) N/A IACUC Approval Date: Protocol #: Please return this form to Barb Olmedo, BTNRH Coordinator of Research Administration Stage 3 IRB Review In addition to the normal human subject protection functions, the IRB reviews: How the IRB protocol matches the funding grant application and any amendments. How and the frequency of protocol monitoring by the research compliance auditor. Any special consideration for protocol auditing.

9 Stage 4 Progress Report Reviews Principal Investigator Director of Research Division Director Grants Accountant Associate Administrator of Finance Chairperson, BTNRH IRB (if human subjects are involved) Chairperson, BTNRH IACUC (if animals are involved) Director of BTNRH Stage 5 Not-For-Cause Audits Two individuals trained (they have fulltime jobs in non-research areas) 48 hours notice Minimum sample size (30 records or 10% of subjects) Non-voluntary 3-6 hours per audit including report preparation Audit utilizes consistent methodology and components PI required to prepare action plan Random re-audits Seen by researchers as a learning and continuous improvement process

10 Stage 6 IRB Continuing Review Grant Progress Reports Continuing Review Application Summary of: Progress to date, adverse events, progress in meeting recruitment and enrollment goals, early findings, etc. Update consent or assent forms Not-for-cause audits & action plan progress For-cause audits & action plan progress Stage 7 Grant Closing PI request permission for IRB to close protocol PI prepares closing report which includes a summary of activities IRB support staff provide direction on how to organize storage to include: subject logs, consent and assent forms, and other related research related materials. Protocol documentations is boxed and sealed for a minimum of three years in a central locked storage area. Three years later tickler file raises how many additional years before files can be shredded. This decision is made jointly by IRB and Research Compliance Officer.

11 Changing the Organization Culture Commitment to compliance that is driven from top down No exceptions in following the process. Customer service mentality with all reviewers resulting in timely feedback to PIs. Developing process Champions amongst senior researchers and division directors. Provide ongoing feedback to all PIs so everybody learns from each others experiences. Our simple goal is that we are here to help each other.