Compliance Issues

Compliance Issues What Department Administrators Need to Know 1

Agenda • Overview of Compliance Issues • Central Office Perspective • Departmental Perspective 2

Broad Overview • Review for some • Update for others • Introduction for many 3

Essential Questions • Who “invented” compliance? • Why is it important? • When should we worry? 4

More Questions • What is covered? • Where will it hurt? 5

Central Office Perspective • Role of Central Offices • Analysis of the Impact • Devising or Revising Policy 6

Additional Concerns • Implementation Strategies • Monitoring for Compliance • Consistency Issues 7

Departmental Perspective • Role of Department Administrators • Participation in the Process • Translating Policy 8

Departmental Worries • Imposing Requirements on Faculty • Monitoring for Compliance • Consistency Issues 9

Who ? What ? When ? Where ? Why ? Essential Questions 10

Compliance Issues For Research Administration • Definition • Risk Assessment • Financial & Management Issues • Institutional and Individual 11

Definition • Compliance: An act of complying, obeying, or submitting to someone or something else, as in “compliance with the law.” - Gilbert Law Dictionary 12

A Question of Risk What is the likelihood that an employee, such as faculty member, an administrator, a staff member, or research assistant, will fail to follow an external or internal policy, procedure, law, rule or regulation that applies to the activity in which they are engaged and will result in monetary losses or negative publicity to the institution? 13

Risk Assessment • A process to evaluate the likelihood of risk and ensure that policies, procedures, laws, rules or regulations are know and followed by all employees. 14

Risk Assessment Process • Identify and develop risk inventories • Rank risks identified • High to Low • Develop and implement programs and materials to educate employees about the risks • Keep up with the changing risk environment 15

Financial and Management • Office of Management and Budget (OMB CIRCULARS) • Applicable to all awards: grants, contracts, cooperative agreements • Federal Acquisition Regulations (FAR) (first published, Federal Register, (9/19/83; on-going revisions) : Applicable to Procurement Actions 16

OMB Circulars • A-21 Cost Principles for Educational Institutions (Revised October 27, 1998) • A-133 Audits of States, Local Governments and Non-Profit Organizations (Revised June 24, 1997) 17

OMB Circulars Applicable to Financial Assistance Awards • A-110 Grants and other Agreements with Institutions of Higher Education, Hospitals, and other Non-Profit Organizations: Uniform Administrative Requirements (Revised November 1993, Amended September 30, 1999)(grants and cooperative agreements) 18

Additional OMB Circulars Which May Impact Awards to Educational Institutions • A-87 Cost Principles for State, Local and Indian Tribal Governments • A-122 Cost Principles for Non-Profit Organizations 19

Additional OMB Circulars Which May Impact Awards to Educational Institutions, cont’d • A-102 Uniform Administrative Requirements for Grants an Cooperative Agreements With State and Local Governments 20

OMB Circular A-21 • Direct Costs and Facilities versus Administrative (F&A) Costs (i.e. Indirect) • Factors Affecting Allowability of Costs • Factors Affecting Allocability of Costs 21

OMB Circular A-21, cont’d • Allowable and Unallowable Costs: A-21, J. section • Cost Accounting Standards • A-21, section F.6.b: “normally indirect” costs 22

OMB Circular A-133: Audits of States, Local Governments and Non-Profit Organizations • Establishes audit requirements for state and local governments and other non-profit organizations receiving federal funds 23

OMB Circular A-133: Audits of States, Local Governments and Non-Profit Organizations, cont’d • Defines federal responsibilities for implementing and monitoring those requirements 24

Institutional and Individual Issues • Misconduct in Science • Conflict of Interest • Responsible Conduct of Research (Pending) 25

Institutional and Individual Issues • Use of Human Subjects in Research • Use of Animals in Research • Recombinant DNA Molecules • Hazardous Materials 26

Institutional and Individual Issues, cont’d • Data Access and Retention • Confidentiality of Patient Records • Privacy Act of 1974 • Other 27

Misconduct in Science • Government-wide policy issued December 2000 • Replaces PHS (1989) and NSF (1991) policies • Federal agencies have until December 2001 to implement the policy (i.e., to accept and issue or codify the policy) 28

Misconduct in Science, cont’d • Research misconduct is defined: “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results” 29

Misconduct in Science, cont’d • Institutions must develop policies and procedures to deal with allegations of misconduct to include: • Definitions • Written policy • Inquiry and investigational phases 30

Misconduct in Science,cont’d • Institutions must develop policies and procedures to deal with allegations of misconduct to include: Cont’d • Protection of whistleblowers • Reporting to agency • Retention of records • Certification requirements 31

Conflict of Interest • PHS Regulation and final NSF policy effective on October 1, 1995 • Regulation/policy similar in content • Contractors/grantees must have adequate policies 32

Conflict of Interest, cont’d • Disclosure of financial interests of faculty and family must be made by PIs and others having decision-making authority over conduct of work 33

Conflict of Interest, cont’d • Specific criteria for review will be at institution’s discretion • Management of conflicting financial interest must be undertaken • Institutional records must be kept are subject to federal review 34

Conflict of Interest Institutional Policy • Considerations for policy development • Who will be covered? All faculty, all PI’s, only those PIs on certain projects? • Frequency of disclosures • To whom will the disclosures be made? • Review and Appeal Process 35

Conflict of Interest Institutional Policy • Considerations for policy development • Definition of Conflict of Interest • Creation of a disclosure form • Identification of “office of record” • Sanctions for violation of policy • Coordinating with Human Subjects Board 36

Use of Human Subjects in Research • 45 CFR 46, as amended by 56 FR 28003 • 21 CFR 50 and 50 – FDA 37

Use of Human Subjects in Research, cont’d • Under the Federal Policy (Common Rule) awardees and their collaborating institutions become "engaged" in human subject research whenever their employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain, release, or access individually identifiable private information for research purposes. 38

Elements of Compliance with Human Subjects Regulations An Assurance for the Protection of Human Subjects must be filed with the federal government if the institution is "engaged" in Federally-supported human subject research. • The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions. 39

Elements of Compliance with Human Subjects Regulationscont’d • All projects whether externally funded or not are subject to these regulations • Annual report is required • Training is mandatory 40

Human Subjects Regulations, cont’d • Establishes committee requirements and requires that a committee be appointed by the President of the University • Requires that institutions establish written procedures for: (a) conducting IRB initial and continuing review, approving research, and reporting IRB findings to investigator & institution; 41

Human Subjects Written Procedures, cont’d (b) determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred; 42

Human Subjects Written Procedures, cont’d (c) ensuring that changes in approved research are reported promptly to the IRB and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and 43

Human Subjects Written Procedures, cont’d (d) ensuring prompt reporting to the IRB, institutional officials, and the FDA, of any (i) unanticipated problems involving risks to subjects or others in any covered research; (ii) serious or continuing noncompliance with Federal, institutional, or IRB requirements; and (iii) suspension or termination of IRB approval for FDA-regulated research. 44

Animal Care Regulations • Animal Welfare Act (P.L. 89-544, as amended by P.L. 91-579, 94-279, 99-198, and Department of Agriculture regulations (CFR Title 9, Subchapter A, Parts 1-4) • PHS Policy on Humane Care and Use of Laboratory Animals (Revised September 1986, reprinted October 2000) 45

Animal Care Regulations • Requirements: • IACUC appointed by President/CEO • Committee composition • Training mandatory • Two facilities inspections and program review per year 46

Animal Care Regulations • Requirements: cont’d • Minority reports included • Filing of Assurance and annual report • IACUC reviews all funded and non funded animal research 47

Instruction in Responsible Conduct of Research • Final Policy issues by HHS December 1, 2000 • Policy Suspended February 21, 2001 • May return! 48

Instruction in Responsible Conduct of Research, cont’d • Builds upon existing PHS requirement for trainees to have instruction in responsible conduct • Extends training requirement to all research staff 49

Elements of Instruction in RCR • Data acquisition, management, sharing, and ownership • Mentor/trainee responsibilities • Publication practices and responsible authorship • Peer review 50

Compliance Issues