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
Center for Childhood Deafness
Youth From 36 States and 5 Countries
Have Been Admitted to the Boys Town Behavioral Health Services
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 pre-
grant 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
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.
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.
Stage 2 - Electronic Review
of Grant Application
• Reviewers are notified by email (10 working days prior to grant due date).
– Link provided to share directory of research grant (PDF)– Reviewer reviews file (average response – 6 days)
– Email 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
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/5R01DC006648-05
DUE DATE: 03/05/2009
TITLE/NAME ELECTRONICALLY REVIEWED DATE OF EMAIL APPROVAL
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.
Original Signature Required for PD/PI
Approved 2/19/09, 10:36am
Co-Investigator Donna Neff
Approved 2/19/09, 2:58pm
Director of Research
Walt Jesteadt same as above
Division Director
Walt Jesteadt same as above
Grants Accountant
Theresa Langer Approved 2/20/09, 11:48am
Director of Finance or Associate Administrator of Finance
Leigh Jean Koinzan or Mary Brown-Zoucha Approved 2/20/09, 8:18am
VP & Director of Health Care, FFBH, and Director of BTNRH
Patrick Brookhouser Approved 2/20/09, 3:34pm
Chairperson,BTNRH Institutional Review Board (IRB)
Patrick Connell Approved 2/19/09, 5:39pm
Are Human Subjects Involved: YES NO
If YES to Human Subjects, is the IRB Review Pending: YES NO
Human Subject Assurance Number: FWA00004176
IRB Approval Date: 04/11/08
Protocol #: 04-11-XP Exemption #: (if applicable)
Chairperson, Institutional Animal Care & Use Committee (IACUC)
JoAnn McGee N/A
Are Vertebrate Animals Used: YES NO
If YES to Vertebrate Animals, is the IACUC Review Pending: YES NO
Animal Welfare Assurance Number: A3349-01
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.
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
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.
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”.