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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.

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Compliance Issues

What Department Administrators

Need to Know

1


Agenda
Agenda

  • Overview of Compliance Issues

  • Central Office Perspective

  • Departmental Perspective

2


Broad overview
Broad Overview

  • Review for some

  • Update for others

  • Introduction for many

3


Essential questions
Essential Questions

  • Who “invented” compliance?

  • Why is it important?

  • When should we worry?

4


More questions
More Questions

  • What is covered?

  • Where will it hurt?

5


Central office perspective
Central Office Perspective

  • Role of Central Offices

  • Analysis of the Impact

  • Devising or Revising Policy

6


Additional concerns
Additional Concerns

  • Implementation Strategies

  • Monitoring for Compliance

  • Consistency Issues

7


Departmental perspective
Departmental Perspective

  • Role of Department Administrators

  • Participation in the Process

  • Translating Policy

8


Departmental worries
Departmental Worries

  • Imposing Requirements on Faculty

  • Monitoring for Compliance

  • Consistency Issues

9


Essential questions1

Who ?

What ?

When ?

Where ?

Why ?

Essential Questions

10


Compliance issues for research administration
Compliance Issues For Research Administration

  • Definition

  • Risk Assessment

  • Financial & Management Issues

  • Institutional and Individual

11


Definition
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
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
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
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
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
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
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
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
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
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
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
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
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
Institutional and Individual Issues

  • Misconduct in Science

  • Conflict of Interest

  • Responsible Conduct of Research (Pending)

25


Institutional and individual issues1
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
Institutional and Individual Issues, cont’d

  • Data Access and Retention

  • Confidentiality of Patient Records

  • Privacy Act of 1974

  • Other

27


Misconduct in science
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
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 d1
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 d2
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
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
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 d1
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
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 policy1
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
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
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
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 regulations cont d
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
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
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 d1
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 d2
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 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 regulations1
Animal Care Regulations

  • Requirements:

    • IACUC appointed by President/CEO

      • Committee composition

    • Training mandatory

    • Two facilities inspections and program review per year

46


Animal care regulations2
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
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
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
Elements of Instruction in RCR

  • Data acquisition, management, sharing, and ownership

  • Mentor/trainee responsibilities

  • Publication practices and responsible authorship

  • Peer review

50


Elements of instruction in rcr cont d
Elements of Instruction in RCR, cont’d

  • Collaborative science

  • Human Subjects

  • Research involving animals

  • Research misconduct

51


Elements of instruction in rcr cont d1
Elements of Instruction in RCR,cont’d

  • Conflict of interest and commitment

  • Institution determines content, length, format, and whom to include as “research staff”

52


Research involving recombinant dna molecules
Research Involving Recombinant DNA Molecules

  • Revised guidelines issued by NIH in October 2000

  • Applies to research funded by public or private agencies external to the NIH if the Institution receives NIH funds for related research

53


Research involving recombinant dna molecules cont d
Research Involving Recombinant DNA Molecules, cont’d

  • Institutions required to establish and implement policies that comply with NIH guidelines

  • Biosafety Committee must be established in accordance with NIH requirements

54


Research involving recombinant dna molecules cont d1
Research Involving Recombinant DNA Molecules, cont’d

  • Committee reviews and approves all non-exempt rDNA research and keeps minutes and makes them available to the public on request

  • Reports must be filed as required by NIH

55


Research involving human gene transfer
Research Involving Human Gene Transfer

  • Investigators must:

    • Obtain prior RAC review, IRB approval and all applicable regulatory authorizations for experiments involving deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research participants

56


Research involving human gene transfer cont d
Research Involving Human Gene Transfer, cont’d

  • IND from the Food and Drug Administration is required

  • Annual Data Report Forms to NIH Office of Biotechnology Activities

57


Research involving human gene transfer cont d1
Research Involving Human Gene Transfer, cont’d

  • Submit serious adverse events immediately to the IRB, IBC, Office of Human Research Protections (if applicable) and NIH OBA, followed by full written report to each

58


Hazardous materials
Hazardous Materials

Applicable to:

  • All awards over $2000 for construction

  • All awards over $2,500 for other activities

59


Hazardous materials cont d
Hazardous Materials,cont’d

Requires:

  • Notification to employees

  • Preparation and submission of a material safety data sheet

60


Data access and retention
Data Access and Retention

  • OMB Circular A-110 Section.53(b)

    • “Financial records, supporting documents, statistical records and all other records pertinent to an award shall be retained for a period of three years from the date of the submission of the final expenditure report”

61


Data access and retention cont d
Data Access and Retention, cont’d

  • OMB April 11, 1994 Letter to NSF General Counsel

    • “The term ‘all other records pertinent to an award’ was meant to encompass all records that were produced in connection with a grant. Therefore, laboratory records and primary data should be retained for three years and the recipient should provide access to the records.”

62


Confidentiality of patient records
Confidentiality of Patient Records

  • Meant to protect patients seeking drug and alcohol treatment

  • Applicable to programs funded in whole or in part by federal funds

63


Confidentiality of patient records cont d
Confidentiality of Patient Records, cont’d

  • Flow-down requirements to subrecipients

  • Records can only be released with consent of patient except:

    • When identity withheld

    • When authorized by court

64


Confidentiality of patient records hipaa
Confidentiality of Patient Records: HIPAA

  • Health Insurance Portability and Accountability Act of 1996 (HIPAA)

  • Provisions:

    • Patient education on privacy

    • Patient guaranteed access to medical records

    • Patient must give prior approval before release of records

65


Confidentiality of patient records hipaa cont d
Confidentiality of Patient Records: HIPAA, cont’d

  • Health Insurance Portability and Accountability Act of 1996 (HIPAA)

  • Provisions: cont’d

    • Release of minimum necessary for health care purposes only

    • Provide recourse if violated – Civil and criminal penalties through the DHHA Office for Civil Rights

66


Privacy act of 1974
Privacy Act of 1974

  • Protects the rights of individuals

  • Generally not applicable to colleges and universities except when maintaining a system of records for the government

  • If clause is included in contract, make sure that it is appropriate; if appropriate, coordinate with federal agency

67


Additional critical areas
Additional Critical Areas

  • Civil Rights, Non-discrimination

  • Delinquent Federal Debt

  • Debarment and Suspension

  • Procurement Integrity

68


Additional critical areas cont d
Additional Critical Areas,cont’d

  • Drug-free Workplace

  • Drug-free Workforce

  • Drug- and Alcohol-free Schools

  • Small Business Utilization and Subcontracting

  • Lobbying

69


Perspectives
Perspectives

  • Central Offices

  • Departmental Administrators

70


The compliance process

The Compliance Process

The University’s Role

What, Why & How

71


Central administration

Central Administration

Our Role in the Compliance Process

72


Central s role an overview
Central’s Role An Overview

  • Be alert to forthcoming regulations

  • Read & interpret the regulations

  • Determine the impact of the regulations for and on your campus

73


Central s role cont d
Central’s Role cont’d

  • Inform those on campus who need to know & get their attention

  • Help formulate campus policies

  • Help develop new procedures

74


Central s role cont d1
Central’s Role cont'd

  • Assist in the implementation of the new procedures

  • Assure that the procedures are implemented according to the policy

  • Monitor that procedures are being followed

75


Central s role cont d2
Central’s Role cont'd

  • Certify to agencies that policies and procedures are in place (in proposals, MOA, etc)

  • Report back to agencies

  • Be able to withstand an audit from an agency

76


The Business Officer’s Role

Our Role in the Compliance Process


The business officer s role an overview
The Business Officer’s RoleAn Overview

Our job begins when Central’s ends

78


Compliance is an expanding universe
Compliance Is an Expanding Universe

  • Many agencies

  • Many issues

  • Many regulators

79


The business officer s role
The Business Officer’s Role

  • Participate in the development of campus compliance programs

  • Central will not be aware of all the issues you need to consider

  • Where should the expertise reside?

80


The business officer cont d
The Business Officer cont'd

  • Make sure that the programs are as flexible as possible

  • Bring up unusual or exceptional cases

81


The business officer cont d1
The Business Officer cont'd

  • Make sure that the implementation is feasible at the department level

  • Conflicting requirements

  • Business process – can campus systems do some of the work?

82


The business officer cont d2
The Business Officer cont'd

  • Implement the regulations to work effectively in departments

  • Who will do what?

  • What do you have to change?

83


The business officer cont d3
The Business Officer cont'd

  • Minimize interference with and disruption of academic programs

84


The business officer cont d4
The Business Officer cont'd

  • Ensure that department staff are trained and kept informed

85


The business officer cont d5
The Business Officer cont'd

  • Monitor business and research activities to ensure compliance

  • Be prepared for an audit

86


WHY BOTHER?

Does complying with external regulations matter?


Why do we bother
Why Do We Bother?

  • Increased federal concerns about how public monies are spent & administered

  • Increase exposure to public scrutiny for research institutions

  • Potential liability to the campus if regulations are ignored

88


Why do we bother cont d
Why Do We Bother? cont'd

  • Risk of loosing federal (and state) funding

  • Exposure to external (and internal) audits -- site visits

  • Putting the campus and the faculty at jeopardy

89


WHY BOTHER?

Loss of public trust

increasing federal concerns

potential legal liability


The newspaper rule

“The Newspaper Rule”

Thou shalt be proud to read about thine own campus in the newspaper

91


How to accomplish the university s role

How to Accomplish the University’s Role

The Steps to Success (or Failure)

92


How to proceed succeed

How to Proceed & Succeed

understand your campus

&

your faculty

93


Success for central administration

Success for Central Administration

Communicate, Educate & Train

94


How to succeed
How to Succeed

  • Get a copy of the regulations and read them yourself (every one)

  • Review the literature for comments (NCURA Newsletter, Federal Grants News, COGR Minutes)

  • Talk to colleagues at other institutions - get their opinions

95


How to succeed cont d
How to Succeed cont'd

  • Determine who is impacted by the regulations (the entire campus, a subset, an individual investigator?)

  • Analyze and summarize the regulation for senior administration

96


How to succeed cont d1
How to Succeed cont'd

  • Get information out EARLY and OFTEN (newsletters, web, emails)

  • Involve all appropriate members of your campus in formulating policies and procedures (buy-in and tie-in)

  • Form committees, ask for feedback, hold discussion sessions

97


Please see supplemental handout 1 2
Please See Supplemental Handout #1 & #2

  • A sample of the SPO newsletter Research Advocate

  • Compliance Quick Guide

98


How to succeed cont d2
How to Succeed cont'd

  • COMMUNICATE --COMMUNICATE --COMMUNICATE --

  • EDUCATE -- EDUCATE -- EDUCATE

  • TRAIN -- TRAIN -- TRAIN

99


The formula for success

The Formula for Success

Show that you have thought through the path that the institution has taken

100


Success at the departmental level

Success at the Departmental Level

The regulations are coming...

have a plan for implementation

101


Implementation
Implementation

  • Determine the effect of the regulation on your researchers

  • Determine the effect on your staff

  • Determine the effect on the department’s business processes

102


Understand the research environment
Understand the Research Environment

  • What are the politics in your department?

  • What are the current issues and concerns for your department?

  • Constituencies

103


The environment cont d
The Environment, cont'd

  • Missions – research, teaching, service?

  • Infrastructure at the departmental level to handle all the demands

104


The business officer
The Business Officer

  • Determine the effect on other areas of the department’s operation

  • What does payroll need to know?

  • What does purchasing need to look for?

105


Success communication
Success - Communication

  • Understand the requirements, articulate them to others, anticipate questions

  • What do people need to know, need to do?

106


Communication cont d
Communication, cont'd

  • Written materials - keep them short and visually clear (e.g.)

  • Use a standard format – familiarity breeds comprehension

107


Success anticipate questions
Success - Anticipate Questions

  • What are the changes?

  • Why do I have to do this?

  • How do I do this?

108


Anticipate questions cont d
Anticipate Questions, cont'd

  • How much will this cost? (me)

  • Who pays?

  • Why doesn’t overhead cover this?

109



Recent regulations

Recent Regulations

How we dealt with them at the Berkeley campus

111


Recent regulations1
Recent Regulations

  • PHS/NSF Conflict of Interest guidelines -- the worrisome

  • OMB Circular A-21 changes in F.6.b (charging administrative costs) -- the painful

  • Cost Accounting Standards (CAS) -- the torturous

112


Please see supplemental handout 3
Please See Supplemental Handout #3

  • Quick Guide for CAS

113


The worrisome

The Worrisome

PHS/NSF Guidelines for Financial Conflict-of-Interest

114


Financial conflict of interest
Financial Conflict-of-Interest

  • 1995 PHS/NSF issue new guidelines on disclosing financial conflict-of-interest

    • investigators receiving support for projects must disclosure “significant” personal financial interest “related” to the project

115


Central s participation

Central’s Participation

The Worrisome

116


Conflict of interest central s part
Conflict-of-Interest Central’s Part

  • Put out loads of information via newsletter, articles, web site, emails -- communicated that regulations were forthcoming long in advance

  • Worked with Office of the President to determine impact on the entire UC system

117


Please see supplemental handout 4
Please See Supplemental Handout #4

  • Articles in the Research Advocate Announcing the Regulations

118


Conflict of interest cont d2
Conflict-of-Interest, cont'd

  • Created new internal procedures to incorporate regulations in the proposal process

  • Created new forms for investigators to certify that there are no financial conflicts

  • Created new forms for investigators to disclose positive interests

119


Please see supplemental handout 41
Please See Supplemental Handout #4

  • Research Advocate Issue with Special Addition on Regulations

120


Conflict of interest cont d3
Conflict-of-interest, cont'd

  • Created new data base to record positive financial conflicts

  • Incorporated the review of positive financial disclosures in an already existing faculty committee structure

121


What happened in the departments

What Happened in the Departments?

Not too much impact

122


Conflict of interest department s part
Conflict-of-Interest Department’s Part

  • Read and followed the new guidelines

  • Instructed faculty to complete new forms

  • Assured that forms were incorporated into proposal process

123



Changes in a 21 f 6 b
Changes in A-21 F.6.b

  • July 1993 OMB issued A-21 revisions clarifying direct vs indirect charges to federal funding

    • Administrative costs should be indirect & the university should pay for them

125


Changes in f 6 b cont d
Changes in F.6.b., cont'd

  • What costs?

    • Administrative salaries, clerical salaries, telephones, memberships, postage, etc.

126


Central s participation1

Central’s Participation

Painful but not too difficult

127


What did central do cont d
What did Central do?, cont'd

  • Interpreted the guidelines

  • Wrote articles in newsletters to explain changes and their impact

  • Allowed re-budgeting of awards when appropriate and when it met the OMB guidelines

128


Please see supplemental handout 42
Please See Supplemental Handout #4

  • Articles in Research Advocate and University Guidelines on Allowability of Rebugeting Awards

129


What did central do cont d1
What did Central do?, cont'd

  • Issued guidance --

    • The decision to charge clerical & administrative salaries rests with the departments. Departmental files must be documented.

130


What happened in the departments1

What Happened in the Departments?

The very painful part

131


Administrative costs cont d
Administrative Costs, cont'd

  • Understanding what is an allowable charge to a project

  • Identifying alternate fund sources

  • Labor relations issues - layoff and seniority; cascading compliance issues

132


Administrative costs cont d1
Administrative Costs, cont'd

  • Secretary switches to other PI’s

  • Business process issues

  • Who will do the work? Who will pay?

133


Administrative costs cont d2
Administrative Costs, cont'd

  • Pressure on other funds sources

  • Recruitment/retention

  • Overhead return (not any)

134


F 6 b positive outcomes
F.6.b - Positive Outcomes

  • Labor-saving strategies at department expense (purchasing)

  • Redesigning process to be more user-friendly

135


The ultimate keys to success
The Ultimate Keys to Success

  • Foster relationships and develop trust

  • Work together in a climate of appreciation and understanding

  • Get it done so it works!

136


Summary strategies for success
Summary Strategies for Success

  • What we tried that worked!

  • What we tried that didn’t!

137


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