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”.