SRC II Attachment 7.pdf

Policy on Disclosure of Financial, Business, and Professional Interests Related to EPC Evidence Reports and Other Products

Purpose of Policy To maintain public confidence in the scientific integrity and credibility of work produced by the Evidence-based Practice Centers (EPC), it is essentialthat all aspects of the process and methodological approach on which the EPC evidence reports rests, are clear and respected. The need for maintaining the scientific integrity of EPC products extends to and includes disclosure of participants' financial, business, and professional interests which are related to the subject matter of an EPC evidence report or other product or which could be affected by the findings of the EPC work. Disclosure of financial, business and professional interests assists AHRQ in carrying out its stewardship responsibilities in use of public resources to obtain evidence-based products in which the health care community, providers, purchasers, payers, and consumers will have confidence.

Disclosure is required of EPC staff, consultants, subcontractors (see Definition in Appendix), and members of the Technical Expert Panels (see Definition in Appendix). 45 CFR Part 94, a copy of which has been provided to all of the EPCs and is available upon request, establishes a system whereby contractor institutions maintain required financial disclosure statements. The PI or a designated senior staff member will discuss the statements of all parties related to each project with the an AHRQ official involved with the EPC program such as the task order officer and/or the program director before each individualis formally assigned or asked to work on each project.

Related financial, business and professional interests of EPC staff, consultants, and subcontractors do not, of themselves, disqualify one from substantive participation in development of an EPC evidence report or other product. AHRQ will consider such interests along with other technical strengths and weaknesses of an EPC's overall proposal and the comparative scientific strength of other available experts and options, as part of the agency's decision-making process prior to award of contract, task order, or work assignment.

The disclosure requirements are limited - in all cases:

(a) directed to those EPC staff, consultants, and subcontractors, who will play a substantive role in development of a particular evidence report or other product;

(b) related to the subject matter of the EPC evidence report or other anticipated product; and

(c) requesting information regarding interests that might be effected by the findings of a particular Report or other product; acquired or held during any part of the 12 months prior to date of submission of a proposal in response to a Request for Task Order (RFTO) or Work Assignment, and continuing until AHRQ has approved publication of the evidence report or other product.

Any change to financial, business, or professional interests from completion of an updated disclosure form to AHRQ acceptance of the final evidence report or other product must result in a disclosure covering the interim period to the responsible contract official that is immediately discussed with and submitted to the responsible AHRQ official. Individuals are reminded that changes to financial, business or professional interests the course of a project should not create a conflict of interest.

AHRQ/EPC Disclosure Form Version. 01.01.08

Financial Interests With respect to the types of financial interests to be disclosed, AHRQ is guided by the Department of Health and Human Services Regulations 45 CFR Part 94. While guided by these Regulations, AHRQ's policy requires disclosure of financial interests involving $1,000 or more for EPC staff, consultants, and subcontractors (as defined), and involving $10,000 or more for members of the Technical Expert Group. For both, the amounts include such interests held by the discloser's spouse and dependent children.

Business and Professional Interests Business and professional interests include leadership and official roles in business, professional and trade associations, advocacy groups, and as principal investigator (see Definitions in Appendix) of research funded by the private sector, related to the subject matter of the EPC report or other product. In addition, to these categories of financial interests set forth in the Regulations, any consulting and research funded by private entities that have a financial interest in the subject matter of a particular EPC report or other product, are also to be disclosed.

Implementation of AHRQ's Disclosure Policy AHRQ will review the substance of issues presented on the disclosure forms of the EPC Staff, Consultants, and Subcontractors that include disclosure of financial, business and professional interests included in the proposal submission. Any concerns about potentialconflicts by AHRQ will be discussed with the Director of the EPC that submitted the proposal. To ensure the transparency and credibility of the EPC program, AHRQ reserves the right to require that an individual with a potential conflict not participate in the collection or analysis of data, or in the writing or review of report findings. The affected EPC will be given an opportunity to substitute someone in a revised proposal.

Prior to the approval of TEP members, the EPC, will obtain a completed disclosure form from each potential member, and will discuss issues presented therein and upon request submit pertinent portions of those completed forms to the AHRQ reviewing official. AHRQ will review the information for potential conflicts that would unduly and unnecessarily bias the technical contributions of the TEP member. If such potential conflicts are found and can be avoided without a damaging loss of expert review, then the proposed TEP member will not be approved to participate. Note that TEP members must be approved by AHRQ before an individual can participate on a TEP.

Although AHRQ will make every effort not to release personal information, documents and related communications may be able to be obtained under the Freedom of Information Act. Evidence reports or other products should include a disclosure of interests for contributors. Thus, with respect to participants in the development of every EPC report or product, there will be transparency and openness of any conflicts so that readers and users may evaluate the reliability of the document. We anticipate that the lack of conflicts for the majority of participants will more than balance any conflicts indicated for a small minority of individuals who participated with potential conflicts of interest.

Definitions For purposes of the AHRQ Policy on Financialand Professional Interests Related to EPC Evidence Reports and Other Products, the following definitions apply. Most definitions are those in 45 CFR 94. Definitions that are marked with asterisk are established by AHRQ.

Contractor: An entity that provides property or services for the direct benefit or use of the Federal Government.

** EPC Staff, Consultant, and Subcontractor:

An individual who substantively contributes to the

(a) design of the literature search strategy;

(b) establishment of inclusion and exclusion criteria;

(c) review of abstracts and full text studies;

(d) decisions on which studies shall be included or excluded from the evidence report or other product;

(e) grading or rating the quality of studies and body of evidence;

(f) analyses of the evidence; or

(g) writing or editing any portion of the evidence report or other product.

Institution: Any public or private entity or organization (excluding a Federalagency) that

(a) submits a proposalfor a research contract whether in response to a solicitation from the Public Health Service (PHS) or otherwise; or

(b) assumes the legal obligation to carry out the research required under the contract.

Principal Investigator: The principal investigator and any other person who is responsible for the design, conduct, or reporting of a research project funded by PHS. For purposes of the requirements related to financial interests, pertinent financial interests of spouse and dependent children are to be included.

Significant Financial Interests Anything of monetary value that when aggregated for the (a) individual, (b) individual's spouse, and (c) individual's dependent children, exceeds $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, or represents more than a five percent (5%) ownership interest in any single entity. Such interests include but are not limited to:

· Salary or other payments for services (e.g., consulting fees or honoraria)

· Equity interests (e.g., stocks, stock options or other ownership interests)

· Intellectual property rights (e.g., patents, copyrights and royalties from such rights)

The term `significant' financial interests does not include:

· Salary, royalties, or other remuneration from the applicant institution;

· Ownership interests in the institution if the institution is an applicant under the Small Business

Appendix

Innovation

· Research (SBIR) program;

· Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

· Income from service on advisory committees or review panels for public or nonprofit entities;

· Equity interest that when aggregated does not exceed $10,000 in value and does not represent more than a five percent ownership interest in any single entity;

· Salary, royalties or other payments that when aggregated for the individualand individual's spouse and dependent children over the next 12 months; are not reasonably expected to exceed $10,000.

** Technical Expert Panel:

A Technical Expert Panel (TEP) is a multi-disciplinary group which serves as a resource for the EPC. For certain evidence reports or other products, AHRQ requires theEPCsto establish a TEP for each task order and work assignment. As a rule, a TEP is comprised of 6-12 members. Depending on the subject matter of a task order or work assignment, members of the TEP may include, for example, the designated representative of the public or private entity that nominated the topic that is the focus of the EPC's task order or work assignment, a representative of relevant professionalsocieties, third party payers, consumers, clinicians, methodologists, and industry. In recognition of their stature as uniquely qualified and respected authorities, individuals may be invited to serve on TEPs irrespective of their financial, business, or professionalinterests, related to the subject matter of the evidence report or other product.

Such interests must be disclosed to the EPC and AHRQ. AHRQ willacknowledge the TEP member's interest in a nonspecific way in the published report or other product to anticipate and diminish challenges.

TEP members may or may not receive a modest honorarium (e.g., $500) from the EPC, for their service.

Unlike EPC staff, consultants, and subcontractors, TEP members may not participate directly in writing or editing any portion of the draft or finalevidence report or other product. TEP members include representatives of the Partner who participate in TEP calls and therefore, should expect to complete a disclosure.

**Peer Reviewers The peer reviewer role provides written input after the draft report is produced and a variety of perspectives are sought. Although the potential impact of bias from an individual is minimal compared to other roles on EPC projects, disclosure of conflicts will be requested in the interest of transparency and to help create balance on the review panel.

EPC Disclosure Form - EPC Staff, Consultants, and Subcontractors

Project

EPC

Statement of Financial Interests Please list below each corporation, company, firm, research organization, education institution or other organization (proprietary and non-for-profit, domestic and foreign) in which (a) you, (b) your spouse, and/or (c) your dependent children, have financialinterests of $1,000 or more (including research funded by private entities on which you are principalinvestigator), in the manufacture and distribution of a device, pharmaceutical, dietary supplement or other over-the-counter product, screening/assessment tool, or procedure, or their competitors, which are related to the subject matter of the EPC report or other product that willbe developed with your participation. Required disclosure includes interests held during the 12 months prior to date of receipt of the EPC proposalresponding to the Request for Task Order or Work Assignment and continues until AHRQ has approved publication of the evidence report or other product. Dollar amounts of such interests are not required to be disclosed.

*NOTE: Please write “None” if you have no interests to disclose.

Statement of Business and Professional Interests Please list below the name of any professional society or association, company, firm, research organization, educational institution, or other organization or institution (proprietary and not-for-profit, domestic and foreign) in which your (or your spouse's and/or dependent child's) services will be provided, with or without compensation, including on a part-time or seasonal basis, as an (a) officer; (b) medical staff; (c) board member; (d) trustee; (e) director;

(f) expert advisor; or (g) consultant, that is related to or has interest in the subject matter of the EPC report or other product that will be developed with your participation. Required disclosure includes interests or positions held during the 12 months prior to date of receipt of the EPC proposal and continues until AHRQ has approved publication of the EPC evidence report or other product.

*NOTE: Please write “None” if you have no interests to disclose.

Print Name

I certify that the information provided on my and my family's financial interests, and my business and professional interests, is true and complete.

Date

Signature

Statement of Business and Professional Interests Please list below your business and professional affiliations with entities that are related to or have interest in the subject matter of the EPC evidence report for which your input on the Technical Expert Panel is requested. List the name of any corporation, professionalsociety or association, company, firm, government agency (federal, state and local), research organization, educational institution, or other organization or institution (proprietary and not-for-profit, domestic and foreign) in which your services have been, or will be or is expected to be provided, with or without compensation, including on a part-time or seasonal basis, as an (a) officer; (b) medicalstaff; (c) board member; (d) owner; (e) trustee; (f) director; (g) expert advisor; or (h) consultant. Required disclosure includes interests held during the 12 months prior to award of contract and continues until AHRQ has approved publication of the evidence report or other product. If you have no such business or professional affiliations, please write “none”.

*NOTE: Please write “None” if you have no interests to disclose.

Statement of Significant Financial Interests Please list each corporation, company, firm, research organization, educationalinstitution, or other organization or institution (proprietary and not-for-profit, domestic and foreign) in which (a) you; (b) your spouse, (c) your dependent children, have significant financial interest (as defined in attached DHHS Regulations 45 CFR 94) that are related to the subject matter of the EPC report or other anticipated product. Please also disclose research support, if any, from private commercialentities that have a financialinterest in the subject matter of the EPC report or other product.

Required disclosure includes interests held during the 12 months prior to award of contract and continues untilAHRQ has approved publication of the evidence report or other product. It is not necessary to disclose dollar amounts of such interests. Use additionalsheets, if needed.

*NOTE: Please write “None” if you have no interests to disclose.

EPC

Project

EPC Disclosure Form - TEP Members

I certify that the information provided on my and my family's significant financialinterests, and my business and professionalinterests, is true and complete.

Print Name

Date

Signature

Policy on Disclosure of Financial, Business, and Professional Interests Related to EPC Evidence Reports and Other Products Purpose of Policy To maintain public confidence in the scientific integrity and credibility of work produced by the Evidence-based Practice Centers (EPC), it is essentialthat all aspects of the process and methodological approach on which the EPC evidence reports rests, are clear and respected. The need for maintaining the scientific integrity of EPC products extends to and includes disclosure of participants' financial, business, and professional interests which are related to the subject matter of an EPC evidence report or other product or which could be affected by the findings of the EPC work. Disclosure of financial, business and professional interests assists AHRQ in carrying out its stewardship responsibilities in use of public resources to obtain evidence-based products in which the health care community, providers, purchasers, payers, and consumers will have confidence.

Disclosure is required of EPC staff, consultants, subcontractors (see Definition in Appendix), and members of the Technical Expert Panels (see Definition in Appendix). 45 CFR Part 94, a copy of which has been provided to all of the EPCs and is available upon request, establishes a system whereby contractor institutions maintain required financial disclosure statements. The PI or a designated senior staff member will discuss the statements of all parties related to each project with the an AHRQ official involved with the EPC program such as the task order officer and/or the program director before each individualis formally assigned or asked to work on each project.

Related financial, business and professional interests of EPC staff, consultants, and subcontractors do not, of themselves, disqualify one from substantive participation in development of an EPC evidence report or other product. AHRQ will consider such interests along with other technical strengths and weaknesses of an EPC's overall proposal and the comparative scientific strength of other available experts and options, as part of the agency's decision-making process prior to award of contract, task order, or work assignment.

The disclosure requirements are limited - in all cases:

(a) directed to those EPC staff, consultants, and subcontractors, who will play a substantive role in development of a particular evidence report or other product;

(b) related to the subject matter of the EPC evidence report or other anticipated product; and

(c) requesting information regarding interests that might be effected by the findings of a particular Report or other product; acquired or held during any part of the 12 months prior to date of submission of a proposal in response to a Request for Task Order (RFTO) or Work Assignment, and continuing until AHRQ has approved publication of the evidence report or other product.

Any change to financial, business, or professional interests from completion of an updated disclosure form to AHRQ acceptance of the final evidence report or other product must result in a disclosure covering the interim period to the responsible contract official that is immediately discussed with and submitted to the responsible AHRQ official. Individuals are reminded that changes to financial, business or professional interests the course of a project should not create a conflict of interest.

Financial Interests With respect to the types of financial interests to be disclosed, AHRQ is guided by the Department of Health and Human Services Regulations 45 CFR Part 94. While guided by these Regulations, AHRQ's policy requires disclosure of financial interests involving $1,000 or more for EPC staff, consultants, and subcontractors (as defined), and involving $10,000 or more for members of the Technical Expert Group. For both, the amounts include such interests held by the discloser's spouse and dependent children.

Business and Professional Interests Business and professional interests include leadership and official roles in business, professional and trade associations, advocacy groups, and as principal investigator (see Definitions in Appendix) of research funded by the private sector, related to the subject matter of the EPC report or other product. In addition, to these categories of financial interests set forth in the Regulations, any consulting and research funded by private entities that have a financial interest in the subject matter of a particular EPC report or other product, are also to be disclosed.

Implementation of AHRQ's Disclosure Policy AHRQ will review the substance of issues presented on the disclosure forms of the EPC Staff, Consultants, and Subcontractors that include disclosure of financial, business and professional interests included in the proposal submission. Any concerns about potentialconflicts by AHRQ will be discussed with the Director of the EPC that submitted the proposal. To ensure the transparency and credibility of the EPC program, AHRQ reserves the right to require that an individual with a potential conflict not participate in the collection or analysis of data, or in the writing or review of report findings. The affected EPC will be given an opportunity to substitute someone in a revised proposal.

Prior to the approval of TEP members, the EPC, will obtain a completed disclosure form from each potential member, and will discuss issues presented therein and upon request submit pertinent portions of those completed forms to the AHRQ reviewing official. AHRQ will review the information for potential conflicts that would unduly and unnecessarily bias the technical contributions of the TEP member. If such potential conflicts are found and can be avoided without a damaging loss of expert review, then the proposed TEP member will not be approved to participate. Note that TEP members must be approved by AHRQ before an individual can participate on a TEP.

Although AHRQ will make every effort not to release personal information, documents and related communications may be able to be obtained under the Freedom of Information Act. Evidence reports or other products should include a disclosure of interests for contributors. Thus, with respect to participants in the development of every EPC report or product, there will be transparency and openness of any conflicts so that readers and users may evaluate the reliability of the document. We anticipate that the lack of conflicts for the majority of participants will more than balance any conflicts indicated for a small minority of individuals who participated with potential conflicts of interest.

AHRQ/EPC Disclosure Form Version. 01.01.08 Definitions For purposes of the AHRQ Policy on Financialand Professional Interests Related to EPC Evidence Reports and Other Products, the following definitions apply. Most definitions are those in 45 CFR 94. Definitions that are marked with asterisk are established by AHRQ.

Contractor: An entity that provides property or services for the direct benefit or use of the Federal Government.

** EPC Staff, Consultant, and Subcontractor:

An individual who substantively contributes to the

(a) design of the literature search strategy;

(b) establishment of inclusion and exclusion criteria;

(c) review of abstracts and full text studies;

(d) decisions on which studies shall be included or excluded from the evidence report or other product;

(e) grading or rating the quality of studies and body of evidence;

(f) analyses of the evidence; or

(g) writing or editing any portion of the evidence report or other product.

Institution: Any public or private entity or organization (excluding a Federalagency) that

(a) submits a proposalfor a research contract whether in response to a solicitation from the Public Health Service (PHS) or otherwise; or

(b) assumes the legal obligation to carry out the research required under the contract.

Principal Investigator: The principal investigator and any other person who is responsible for the design, conduct, or reporting of a research project funded by PHS. For purposes of the requirements related to financial interests, pertinent financial interests of spouse and dependent children are to be included.

Significant Financial Interests Anything of monetary value that when aggregated for the (a) individual, (b) individual's spouse, and (c) individual's dependent children, exceeds $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, or represents more than a five percent (5%) ownership interest in any single entity. Such interests include but are not limited to:

· Salary or other payments for services (e.g., consulting fees or honoraria)

· Equity interests (e.g., stocks, stock options or other ownership interests)

· Intellectual property rights (e.g., patents, copyrights and royalties from such rights)

The term `significant' financial interests does not include:

· Salary, royalties, or other remuneration from the applicant institution;

· Ownership interests in the institution if the institution is an applicant under the Small Business

Appendix

Innovation

· Research (SBIR) program;

· Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

· Income from service on advisory committees or review panels for public or nonprofit entities;

· Equity interest that when aggregated does not exceed $10,000 in value and does not represent more than a five percent ownership interest in any single entity;

· Salary, royalties or other payments that when aggregated for the individualand individual's spouse and dependent children over the next 12 months; are not reasonably expected to exceed $10,000.

** Technical Expert Panel:

A Technical Expert Panel (TEP) is a multi-disciplinary group which serves as a resource for the EPC. For certain evidence reports or other products, AHRQ requires theEPCsto establish a TEP for each task order and work assignment. As a rule, a TEP is comprised of 6-12 members. Depending on the subject matter of a task order or work assignment, members of the TEP may include, for example, the designated representative of the public or private entity that nominated the topic that is the focus of the EPC's task order or work assignment, a representative of relevant professionalsocieties, third party payers, consumers, clinicians, methodologists, and industry. In recognition of their stature as uniquely qualified and respected authorities, individuals may be invited to serve on TEPs irrespective of their financial, business, or professionalinterests, related to the subject matter of the evidence report or other product. Such interests must be disclosed to the EPC and AHRQ. AHRQ willacknowledge the TEP member's interest in a nonspecific way in the published report or other product to anticipate and diminish challenges.

TEP members may or may not receive a modest honorarium (e.g., $500) from the EPC, for their service. Unlike EPC staff, consultants, and subcontractors, TEP members may not participate directly in writing or editing any portion of the draft or finalevidence report or other product. TEP members include representatives of the Partner who participate in TEP calls and therefore, should expect to complete a disclosure.

**Peer Reviewers The peer reviewer role provides written input after the draft report is produced and a variety of perspectives are sought. Although the potential impact of bias from an individual is minimal compared to other roles on EPC projects, disclosure of conflicts will be requested in the interest of transparency and to help create balance on the review panel.

AHRQ/EPC Disclosure Form Version. 01.01.08 EPC Disclosure Form - EPC Staff, Consultants, and Subcontractors

Statement of Financial Interests Please list below each corporation, company, firm, research organization, education institution or other organization (proprietary and non-for-profit, domestic and foreign) in which (a) you, (b) your spouse, and/or (c) your dependent children, have financialinterests of $1,000 or more (including research funded by private entities on which you are principalinvestigator), in the manufacture and distribution of a device, pharmaceutical, dietary supplement or other over-the-counter product, screening/assessment tool, or procedure, or their competitors, which are related to the subject matter of the EPC report or other product that willbe developed with your participation. Required disclosure includes interests held during the 12 months prior to date of receipt of the EPC proposalresponding to the Request for Task Order or Work Assignment and continues until AHRQ has approved publication of the evidence report or other product. Dollar amounts of such interests are not required to be disclosed.

*NOTE: Please write “None” if you have no interests to disclose.

Statement of Business and Professional Interests Please list below the name of any professional society or association, company, firm, research organization, educational institution, or other organization or institution (proprietary and not-for-profit, domestic and foreign) in which your (or your spouse's and/or dependent child's) services will be provided, with or without compensation, including on a part-time or seasonal basis, as an (a) officer; (b) medical staff; (c) board member; (d) trustee; (e) director; (f) expert advisor; or (g) consultant, that is related to or has interest in the subject matter of the EPC report or other product that will be developed with your participation. Required disclosure includes interests or positions held during the 12 months prior to date of receipt of the EPC proposal and continues until AHRQ has approved publication of the EPC evidence report or other product.

*NOTE: Please write “None” if you have no interests to disclose.

I certify that the information provided on my and my family's financial interests, and my business and professional interests, is true and complete.

Statement of Business and Professional Interests Please list below your business and professional affiliations with entities that are related to or have interest in the subject matter of the EPC evidence report for which your input on the Technical Expert Panel is requested. List the name of any corporation, professionalsociety or association, company, firm, government agency (federal, state and local), research organization, educational institution, or other organization or institution (proprietary and not-for-profit, domestic and foreign) in which your services have been, or will be or is expected to be provided, with or without compensation, including on a part-time or seasonal basis, as an (a) officer; (b) medicalstaff; (c) board member; (d) owner; (e) trustee; (f) director; (g) expert advisor; or (h) consultant. Required disclosure includes interests held during the 12 months prior to award of contract and continues until AHRQ has approved publication of the evidence report or other product. If you have no such business or professional affiliations, please write “none”.

Statement of Significant Financial Interests Please list each corporation, company, firm, research organization, educationalinstitution, or other organization or institution (proprietary and not-for-profit, domestic and foreign) in which (a) you; (b) your spouse, (c) your dependent children, have significant financial interest (as defined in attached DHHS Regulations 45 CFR 94) that are related to the subject matter of the EPC report or other anticipated product. Please also disclose research support, if any, from private commercialentities that have a financialinterest in the subject matter of the EPC report or other product. Required disclosure includes interests held during the 12 months prior to award of contract and continues untilAHRQ has approved publication of the evidence report or other product. It is not necessary to disclose dollar amounts of such interests. Use additionalsheets, if needed.

EPC Disclosure Form - TEP Members

I certify that the information provided on my and my family's significant financialinterests, and my business and professionalinterests, is true and complete.

AHRQ/EPC Disclosure Form Version. 01.01.08