Research Compliance and Integrity

Lisa Hancock RN, CHP, CHC, MHAFebruary 1, 2012

Research Compliance & Integrity

Clinical research must be conducted in compliance with applicable laws, rules and regulations and with the promotion of the highest scientific and ethical standards. Conduct of the studies must meet the laws, rules, and policies governing research in the most efficient and effective way.

Objectives:

• Recognize the laws, rules and regulations of clinical research.

• Understand how to proactively prevent problems before they happen without impairing the research.

• Indentify any actual or potential conflicts of interest in research.

Human Subjects Ethical Principles

Belmont Report• Prompted in part by problems arising from the Tuskegee Syphilis

Study (1932–1972) and based on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978), the Department of Health, Education and Welfare (HEW) revised and expanded its regulations for the protection of human subjects.

• In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.”

• Today the Belmont Report serves as a historical document and provides the moral framework for understanding regulations in the United States on the use of humans in experimental research.

Human Subjects Ethical Principles

• The Common Rule is a rule of ethics regarding biomedical and behavioral research involving human subjects in the United States. These regulations governing Institutional Review Boards for oversight of human research came into effect in 1981 following the 1975 revision of the Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D.

• Subpart A ("The Common Rule") is the baseline standard of ethics by which any government-funded research in the US is held, and nearly all academic institutions hold their researchers to these statements of rights regardless of funding.

Research Policy

The use or disclosure of protected health information for research must comply with HIPAA Privacy Policies and Procedures regarding Authorization for use or disclosure of protected health information and with requirements of the Institutional Review Board

• This Policy and Procedure applies to all research subjects and all human research not involving research subjects which:– Is conducted at our facility;– Is conducted by our Employees, faculty or staff, under

the IRB, regardless of location; – Uses patient information;– Is Sponsored by our facility.

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What is Deidentified?

• All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and [t]he initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.

• all elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;

• voice and fax telephone numbers; • electronic mail addresses; • medical record numbers, health plan beneficiary numbers, or other health plan account

numbers; • certificate/license numbers; • vehicle identifiers and serial numbers, including license plate numbers; • device identifiers and serial numbers; • Internet Protocol (IP) address numbers and Universal Resource Locators (URLs); • biometric identifiers, including finger and voice prints; • full face photographic images and any comparable images; and • any other unique identifying number, characteristic, or code.

Attendance at Industry-Sponsored Conferences

This is covered by our policy on Sponsorships of Conference or Educational Meetings.

• Healthcare Professionals may attend Industry-sponsored educational meetings, lectures and conferences containing objective scientific and educational information where industry support is prominently disclosed.

Healthcare Professionals: • May not accept any reimbursement from Industry for

registration fees, transportation, lodging, or incidentals to defray the costs of attendance for the Professional or his/her spouse.

• May attend modest receptions and meals provided in connection with the conference.

• May not accept food without actually participating in the educational conference.

Industry-Sponsored Research Projects

Covered by the Conflict of Interest in Research policy• All Industry-sponsored research projects must be reviewed

and approved by The Research Institute. • Institutional Review Board, The Research Institute, and/or

Conflicts of Interest in Research Committee.• The Research Institute, IRB, and COIRC will consult with the

Office of Compliance and Department Chair, as appropriate, where this policy and the conflict of interest policy both apply.

Institutional Conflict of Interest in Research: Policy and Procedure

• The objective of this policy is to promote the highest ethical standards in the conduct of research in situations where institutional conflicts of interest (“ICOI”) may occur, and to determine those instances when an ICOI is unacceptable. An ICOI may occur when a financial interest has the potential to bias research conducted by its employees or students, or creates an unacceptable risk to human subjects.

• This policy represents one aspect of our commitment to address and manage conflicts of interest. Other policies that address conflicts of interest include:

• The Conflict of Interest in Research policy addresses conflicts of interest that arise from individual financial interests related to research.

Institutional Conflict of Interest in Research: Policy and Procedure

Principles • We encourage our faculty, staff, and students to participate

in meaningful research and to benefit society through the transfer of knowledge to the public and private sector. Our research will be conducted with integrity and objectivity, and in a manner that protects the safety of human subjects. As set forth in this Policy, we are also committed to ensuring that its own financial interests do not create an ICOI that might bias research conducted by its faculty, students and staff.

New Rules and Regulations that will affect Research

Financial Conflict of Interest2011 Revised Regulations:

• The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).

The Sunshine Provision• The Section 6002 provision requires that beginning in 2013, all

manufacturers of a drug, device, biological or medical supplies must report any transfers of value or payments exceeding $10 (as indexed by Consumer Price Index) to physicians and/or teaching hospitals to the Secretary of Health and Human Services on an annual basis. This information will be available on a public, searchable website.

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FCOI Regulations - Final Rule• Revising the regulations on Responsibility of Applicants for

Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors

• Federal Register published August 25, 2011

– http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf (this link points to a non-HHS website which may not be accessible to all visitors)

• Implementation no later than 365 days after publication of the final rule in the Federal Register, i.e. August 24, 2012. In the interim:– Institutions comply with 1995 regulations– Institutions revise policies, establish procedures for compliance,

and train Investigators– NIH provides training materials for extramural community and

NIH staff, expands FCOI reports database

• Basic framework remains the same

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Major Areas Addressed in the Revised Regulations

• Definition of Significant Financial Interest (SFI)• Extent of Investigator Disclosure • Information Reported to PHS Awarding

Component (e.g. NIH)• Information made accessible to the public• Investigator Training

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Major Changes to the Regulations

Significant Financial Interest (SFI)– Minimum threshold of $5,000 generally applies to

payments and equity interests (was $10,000 or >5% ownership)

– Includes any equity interest in non-publicly traded entities– Exclusions include income from seminars, lectures, or

teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an Institution of higher education.

– Excludes income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

Investigator Disclosure– All SFIs related to Investigators’ institutional

responsibilities– Institutions responsible for determining whether SFIs

relate to PHS-funded research and are financial conflicts of interest (FCOI)

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Major Changes to the Regulations

Reporting to PHS Awarding Component (NIH)– Previous requirements, (grant/contract number, name of

PD/PI, name of Investigator with FCOI) plus:• Name of the entity with which the Investigator has a FCOI• Value of the financial interest• Nature of FCOI, e.g. equity, consulting fees, honoraria• A description of how the financial interest relates to PHS-

funded research and the basis for the Institution’s determination that the financial interest conflicts with such research

• Key elements of the Institution’s management plan

Public Notice– Before spending funds for PHS-supported research, an

Institution shall ensure public accessibility of information on certain SFIs that the Institution has determined are related to the PHS-funded research and are FCOI, via a publicly accessible Web site or by a written response to any requestor.

Investigator Training– FCOI training required for Investigators before

engaging in PHS-funded research, every four years thereafter, and immediately under designated circumstances.

Sunshine Provision

• The Physician Payment Sunshine Provision is found at Section 6002 of the Patient Protection and Affordable Care Act, which establishes a system for reporting payments and other transfers of value to physicians and teaching hospitals from manufacturers of drugs, devices, biological, or medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP), and to require reporting of physician ownership or investment interests in such manufacturers.

• The start date for RECORDING of the Sunshine Provision is January 1, 2012.

• In other words companies will begin to report what they have given to physicians and teaching hospitals (minus a few exceptions'.)

• The information will become public on March 31, 2013.

Sunshine Provision

Under the Sunshine Provision the following applies: • Covered Recipients are Physicians AND Teaching hospitals (in

other words does NOT just apply to physicians only) • Food is defined as a payment that will require the company to

disclose under the provision • Educational materials are excluded from reporting if the

amount does not exceed $100 in a calendar year.• So, if the pharma can supply educational materials that are

less than $100 in total without food it will not require reporting. It does not matter whether it is a non prescribing nurse or not as Sunshine covers CHLA as a teaching hospital.

• Many teaching hospitals banned "Lunch and Learn" conferences a long time ago because of the appearance of impropriety. Now with the Sunshine Provision, the information will become public.

Definition of Payment under the Sunshine Provision

• Gift;• Food; • Entertainment; • Travel or trip; • Honoraria; • Research funding or grant; • Education;• Research;• Charitable Contribution;• Direct Compensation for Serving as Faculty or Speaker for Medical Education Program; • Consulting fees; • Ownership or investment interest;• Royalties; • license fee; • speaking fees; • dividends;• profit distribution;• stock or stock option grant;• Any categories of information the secretary determines appropriate;

Compliance Hotline

• Toll Free

• Confidential

• Answered by independent contractor

To provide an avenue for any workforce member to raise ethical, moral, legal, compliance, privacy or financial concerns and reassurance that he/she will be protected from retaliation for reporting issues in good faith.

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Questions?

Lisa Hancock RN, MHAChief Compliance & Privacy Officer