Conflicts of Interest – Institutional Review Boards ... - Dignity Health

Conflicts of Interest ? Institutional Review Boards, Facilities, and Investigators 70.7.001

DIGNITY HEALTH ADMINISTRATIVE POLICY AND PROCEDURE

FROM: SUBJECT:

Compliance Oversight Committee

Conflicts of Interest ? Institutional Review Boards, Facilities, and Investigators

EFFECTIVE DATE: February 22, 2013

REVISED:

January 17, 2012, September 1, 2010; February 27, 2009; (100.1.001) March 14, 2006

ORIGINAL EFFECTIVE DATE: (100.1.001) March 14, 2006

REPLACES: (100.1.001) Conflicts of Interest ? Institutional Review Boards, Hospitals, and Investigators, March 14, 2006

APPLIES TO: System Offices:

X

Acute Care Entities:

X

Non-acute Care Entities:

X

I. POLICY

It is the position of Dignity Health that participants in the review and conduct of research in Dignity Health facilities must disclose actual and potential conflicts of interest in order to assure the integrity and quality of both the review process and the conduct of the research, to protect human research subjects and to comply with law.

II. PURPOSE

The purposes of this Policy are: (1) to identify and manage potential or actual conflicts of interest in order to assure objectivity in the review, conduct, design, and reporting of research in Dignity Health facilities; (2) to assure that financial interests do not compromise the protection of research subjects; and (3) to prevent intentional or inadvertent participation in the decision-making process by persons having an actual or apparent conflict of interest.

This Policy applies to: (a) members of Dignity Health's Institutional Review Boards; (b) Dignity Health facilities as institutions in which sponsored research is conducted; and (c) Investigators and staff who conduct research in Dignity Health facilities. (d) Research funded under Public Health Service (PHS) grants, contracts or cooperative agreements (see Appendix 5, Section II). It does not apply to research that is not subject to review by an institutional review board under law.

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Conflicts of Interest ? Institutional Review Boards, Facilities, and Investigators 70.7.001

Dignity Health facilities may establish, in coordination with their Institutional Review Boards, facility-specific policies and procedures consistent with this Policy, to the extent necessary to carry out their responsibilities under this Policy.

For the purposes of 42 CFR Part 50--(Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought) this policy must be posted on a publicly accessible Dignity Health website (See Appendix 5, Section V).

III. DEFINITIONS

A. For purposes of this Policy, the following definitions apply, provided, however, that the definitions are intended to be consistent with the definitions contained in the Dignity Health Human Research Protection Manual (the "HPRO Manual"), published by the Dignity Health Human Research Protections Office ("HRPO"):

1. "Accountable Executive" means that person, designated in accordance with the HRPO Manual, who is responsible for administrative oversight of research activities conducted within a Dignity Health Facility.

2. "Business Position" means a position (such as an officer, director, employee, advisor, or consultant), whether paid or unpaid, held in the past 3 years by a Covered Individual or Family Member in or with a Research Business Entity.

3. "Conflict of Interest" shall have the meaning set forth in Section B below.

4. "Covered Entity" means Dignity Health and all Dignity Health Facilities.

5.

"Covered Individual" means the member(s) and alternate member(s) of

the IRB, Investigator(s), Study Coordinators and any other members of a

research team, at the discretion of the Accountable Executive.

6. "Dignity Health Facilities" means all Dignity Health hospitals and patient care locations that are owned by Dignity Health or by subsidiaries of Dignity Health that participate in Dignity Health's self-insurance program.

7. "Family Members" mean a Covered Individual's spouse; parents

(including stepparents); children and their spouses; siblings (including

stepbrothers and stepsisters); in-laws (father-, mother-, son-, daughter-,

brother-, or sister-in-law); grandparents and their spouses; and grandchildren and their spouses.1

8. "Federal Wide Assurance" means the assurance executed by Dignity Health and filed with the U.S. Department of Health and Human Services that certifies the compliance of Dignity Health and each of its registered IRBs with the laws governing IRBs and human subjects in research.

1 42 CFR 411.351. This definition is consistent with the federal Stark Law.

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Conflicts of Interest ? Institutional Review Boards, Facilities, and Investigators 70.7.001

9. "Human Subject" means (a) a living individual about whom an Investigator obtains data through interactions with the individual, or (b) a human being, living or dead, whose protected health information ("PHI"), as defined by Dignity Health policies and applicable laws, is obtained or used by an Investigator in the course of conducting a study.

10. "Institutional Review Board" or "IRB" means a board, committee or other grouping that: (a) is formally organized and designated by Dignity Health or a Dignity Health Facility to assure the rights and protect the welfare of human individuals participating in research, and (b) is identified and registered under Dignity Health's Federal Wide Assurance ("FWA")[, but excludes any entity that performs the functions of an IRB on behalf of a Dignity Health Facility pursuant to a written contract with Dignity Health or the Dignity Health Facility, such as Western IRB].

11. "Investigator" means an individual responsible for the design, conduct, or reporting of the results of work performed or to be performed under the research project, and includes Principal Investigators, Co-Investigators, SubInvestigators and any other individual who has independent responsibility for designing, conducting, or reporting the results of the research study.

12. "IRB Members" mean members and alternate members of an IRB as defined above.

13. "Material" or "material", as it applies to Financial Interests and Institutional Financial Interests (as defined in Section B below), means interests of a value of ten thousand dollars ($10,000) or more in the aggregate, regardless of when it is earned or expected to be earned.2 For research funded under Public Health Service (PHS) grants, contracts or cooperative agreements this threshold is Five Thousand Dollars ($5,000). (See Appendix 5 of this Policy).

14. "Research" or "research" means the systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, as more specifically defined in the HRPO Manual. The terms "clinical research," "clinical study," "study," "clinical investigation," "experiment," "clinical trial" are deemed to be synonymous with research. For purposes of this policy, research includes "Non-Dignity Health Research" as that is reviewed by an IRB in accordance with the Standards for Review of Research by a Dignity Health IRB as established by HRPO.

2 Cal. Health and Safety Code ? 24173 (c)(11).

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Conflicts of Interest ? Institutional Review Boards, Facilities, and Investigators 70.7.001

15. "Research Business Entity" means a company that is a Sponsor, an Investigator, contract research organization ("CRO"), clinical site management organization ("SMO"), an employer of an Investigator (other than a Dignity Health entity), or a company that provides goods and services to a Covered Entity in connection with the conduct of research.

16. "Sponsor" means either an individual or organization that takes responsibility for and initiates a clinical investigation. The Sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The Sponsor generally does not actually conduct the investigation unless the Sponsor is a Sponsor-investigator.3

17. "Study Coordinator" means the person who manages the daily activities of the study, including coordinating the recruitment, enrollment, treatment or testing of Human Subjects.

B. Conflict of Interest Defined. (Please reference Appendix 5, Section III of this Policy for specific definitions that apply to research projects funded under Public Health Service (PHS) grants, contracts or cooperative agreements).

1. "Conflict of Interest" as used in this Policy means a direct or indirect Financial Interest or a Business Position held by a Covered Individual, a Family Member or a Covered Entity in a Research Business Entity, and any Other Personal Interest that has the potential to influence or creates the appearance of influencing: (a) the design, conduct, or reporting of research; (b) the rights and welfare of Human Subjects; or (c) the ability of the IRB to make independent decisions in carrying out its responsibilities for the review and oversight of research. The existence of a Conflict of Interest does not reflect on the character of an individual.

2. "Financial Interest" means, subject to the exclusions listed in subsection c. below:

a) A direct or indirect ownership of stock or proprietary interests in a Research Business Entity (including stock warrants or stock options), or the holding of any debt interests in, any Research Business Entity;

3 21 CFR. Part 312.3 (b).

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Conflicts of Interest ? Institutional Review Boards, Facilities, and Investigators 70.7.001

b) Any compensation arrangement between a Covered Individual or Covered Entity and a Research Business Entity, which includes any arrangement involving the exchange of remuneration of any sort, including, without limitation:

(1) Salaries; (2) Consulting fees; (3) Stipends; (4) Unsecured or below market loans; (5) Honoraria in excess of $1000 (on an annual

aggregate basis); (6) Gifts or entertainment with a value in excess of

$300 (on an annual aggregate basis); (7) Grants, bequests and donations; (8) Payment for the reasonable costs of conducting

research; (9) Payment for the conduct of research in excess of

reasonable costs incurred, including, without limitation, excessive payments for enrollment of study subjects, milestone achievements or bonuses; (10) Any payments made to a Covered Individual or Covered Entity by a Research Business Entity to support activities of an Investigator, over and above compensation to conduct a particular study, such as a grant to fund ongoing research or to purchase equipment;4 (11) Any intellectual property rights granted to the Covered Individual or Covered Entity by the Research Business Entity in connection with the research.

4 21 CFR 54.2(f).

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