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Institutional Review Board (IRB) Policies

IRB Investigator and Key Study Personnel Conflicts of Interest

EFFECTIVE DATE: 10/30/2013

POLICY:

I. It is the policy of the Saint Joseph Regional Medical Center (SJRMC) Institutional Review Board (IRB) that all conflicts, potential conflicts or perceived conflicts of interest be reported to the IRB for review to assure protection of the rights and welfare of participants in human subjects research. Conflicts of interest will be eliminated when possible and effectively managed and disclosed when they cannot be eliminated.

II. The purpose of this policy is to promote objectivity in programs and funding that support the research, scholarship and service mission of the Institution. It will do so by establishing standards to ensure there is no reasonable expectation that the design, conduct or reporting of funded research or cooperative agreements with companies or groups will be biased by any conflicting financial interest of research investigators, study staff, students or immediate family members. Complete disclosure and expeditious review of such conflicts or potential conflicts is in the best interest of all of those involved in the research and the administration. As such, the IRB has established the Research Conflict of Interest Committee (RCOIC). The members of the RCOIC will be appointed by the Chairperson of the IRB. The IRB Chairperson will delegate the RCOIC as the group responsible for evaluation of all potential significant conflicts of interest. All completed Research Conflict of Interest Disclosure forms with a box checked “yes”, will be provided to the RCOIC for review. The RCOIC will determine if a potential or significant conflict of interest exists. The RCOIC will provide the Office of the IRB with their findings in writing and shall advise the IRB of the steps to be taken to disclose the conflict of interest as necessary. The IRB will review the RCOIC determination and will include in their approval determination letter what action shall be taken to resolve or disclose the conflict.

III. Required Training

A. In order to ensure research investigators and their research staff are aware of the required disclosure of potential financial conflicts of interest, the NIH Office of Extramural Research Financial conflict of interest online tutorial or an additional module in the CITI program must be completed every three years or in the event the federal requirements are updated. This certificate must be turned into the Office of the SJRMC IRB and will be kept on file in the Office of the IRB. If the investigator receives funding through an NIH grant or award, the investigator and all key research personnel will be required to complete the NIH Office of Extramural Research Financial conflict of interest online tutorial. The NIH Financial Conflict of Interest Training certificate of completion must be submitted to the Office of the IRB upon completion of training. It must also be submitted with the initial application and continuing renewal documents for IRB review and records for any study that is NIH funded.

B. The IRB requires each investigator and their research staff update the disclosure form at least annually during the period covered by the grants, research study or project or within 30 days of identifying or acquiring a new significant financial interest and at one year after the study is completed.

C. Training will be documented by one or more of the following: 

1. Submission of the CITI training module completion training certificate being printed and provided to the Office of the IRB.

2. Submission of the NIH Financial Conflict of Interest completion training certificate being printed and provided to the Office of the IRB.

3. The printed name, signature and date of an investigator and key research personnel on an Office of the IRB training session attendance record.

IV. Required Actions

A. As grantees, investigators are responsible to ensure they are compliant with the requirements set forth by any public health service for entering FCOI information into the PHS system provided. Investigators must report and disclose appropriately within the timelines required for each grant project in which they are involved.

B. Investigators must ensure that they and all key research personnel comply with all required procedures set forth by this policy.

V. Failure to Comply

A. The IRB Chairperson will review any instances of non-compliance with this policy and will send those to the VP of Finance for futher review and action. Non-compliance with this policy may result in sanctions or disciplinary action, including but not limited to one of more of the following:

1. Written reprimand;

2. Suspension of project funding;

3. Suspension of research study(s)

4. Restriction of privileges;

5. Suspension without pay

6. Dismissal; and/or

7. Other appropriate sanctions or discipline, depending on the severity and nature of the non-compliance.

8. Potential notification of non-compliance to the research sponsor.

B. Existing Saint Joseph Regional Medical Center policies and procedures, and/or applicable and federal laws shall govern the procedures for imposing sanctions or discipline, and the nature of the sanctions.

PROCEDURE:

A. This procedure outlines the process for reporting and disclosing any conflicts of interest in human subjects research. 

I. Investigator Responsibilities. 

a. Investigators, including their immediate family, must disclose to the Saint Joseph Regional Medical Center IRB (IRB) who has delegated authority to members who will serve as the Research Conflict of Interest Committee (RCOIC) for all conflicts/ potential conflicts of interest in association with the human subjects research project under review. This includes assuring that all Key Study Personnel conflicts are disclosed and reported as well.  

b. Written disclosures must be performed and submitted: 

1. With the initial IRB application using the IRB application form;

2. At each continuing review of the project using the continuing review form; and

3. Within 10 days of becoming aware of any change and/or previously undisclosed significant financial interest using the “Request for Modification Form” (IRB Form).

c. The Investigator must comply with all recommendations of the RCOIC to minimize the conflict.

d. Investigators are to complete the NIH Office of Extramural Research Financial conflict of interest online tutorial or the online CITI tutorial module for financial conflict of interest. Once completed the investigators must submit the completion certificate to the Office of the IRB.

e. Investigators are to complete the NIH Financial conflict of Interest training modules if their study is funded by the NIH. Once completed the investigators must submit the completion certificate to the Office of the IRB.

f. As grantees, investigators are responsible to ensure they are compliant with the requirements set forth by any public health service for entering FCOI information into the PHS system provided. Investigators must report and disclose appropriately within the timelines required for each grant project in which they are involved. 

B. IRB Committee Responsibilities. 

I. The IRB forwards disclosures of significant financial interest to the designated members of the RCOIC as appropriate.

II. The IRB may approve the research pending review and approval by the RCOIC.

III. The final recommendations of the RCOIC are sent to the IRB Committee Chair for review. If the RCOIC has not imposed any additional criteria that would impact the previously determined risk-potential benefit profile of the study, the Chair or a designated Committee Member may conduct an expedited review of the RCOIC final recommendation. Otherwise the research and the recommendations of the RCOIC are reviewed by the convened IRB. 

IV. The IRB may choose to accept or not accept the recommendations of the RCOIC. If the IRB does not accept the recommendations of the RCOIC, it will include in its decision and IRB minutes the reasons for non-acceptance in a letter to the RCOIC members and the Investigator.

V. If the IRB determines there is a conflict of interest, when the Investigator is so notified, the following options may exist:

a. Investigator may submit an action plan of proposed handling of disclosure

b. Investigator may choose to not do the study

c. The study informed consent may be revised to include said disclosure

VI. The Office of the IRB will provide investigators and key study personnel with the NIH Office of Extramural Research Financial conflict of interest online tutorial website to access for completion of required research conflict of interest training.

VII. The Office of the IRB will maintain an education record for the NIH Financial conflict of interest training completion. 

VIII. The Office of the IRB will maintain an education record for any type of research Conflict of Interest training by creating an attendance record and including documentation of the training as was presented.

C. IRB Coordinator  Responsibilities. 

I. The IRB Coordinator forwards any disclosures of significant financial interests to the RCOIC as applicable for review with a completed “Conflict of Interest Annual Financial Disclosure Form”.  In the event more information is needed to complete this form or there are additional questions, the IRB Coordinator contacts the Investigator for more information or clarification prior to forwarding.

II. The IRB Coordinator makes appropriate database entries assuring documentation of the conflicts of interest and the nature of the conflict in the notes section of the database.

III. The IRB Coordinator assures that final recommendations from the RCOIC are reviewed by the IRB Chairperson and accepted by the IRB prior to releasing a signed approval letter.

IV. The 2012 Financial Conflict of Interest Regulation requires that conflicts of interest policies, as well as any Significant Financial Interest (SFI) determined to be a “financial conflict of interest” or “FCOI”, (defined as an SFI that could directly and significantly affect the design, conduct or reporting of PHS-funded research) must be made available on a publicly accessible website maintained by the grantee organization..

V. The IRB Coordinator will assist with the maintenance of training records for research conflict of interest.

D. Institutional Responsibilities.  

I. The RCOIC reviews all conflicts of interest deemed significant in accordance with Institutional policies and Federal regulations.  

II. The RCOIC makes recommendations to the IRB according to IRB policies, as applicable.  

III. The IRB is informed in writing of the outcome of the review from the RCOIC.  

IV. If the Institution’s policy on Financial Conflicts of Interest (COI) includes standards that are more stringent than the 2012 FCOI Regulation, the Institution, Investigator and IRB must adhere to its internal policy and provide reports regarding identified interests in accordance with its own standards.

V. Provide educational opportunities for training and information on research financial conflicts of interest and disclosure.  

RELATED DOCUMENTS:

• Saint Joseph Regional Medical Center Research Conflict of Interest Disclosure Form

• Research Conflict of Interest Annual Financial Disclosure Form

• Promoting Objectivity in Research Significant Financial Interest Disclosure Form  

DEFINITIONS: 

Research/Conducting Research: “Research” shall mean any organized program of scientific inquiry. “Conducting Research” includes designing research, directing or serving as an investigator, performing laboratory experiments, having a role in soliciting informed consent from research subject or making decisions related to the eligibility of patients to participant in research, analyzing or reporting research data, or submitting manuscripts or abstracts concerning the research for publication.    

Individual Conflict of Interest: A circumstance such that any action or decision in which an individual is substantially involved with the research may have direct or predictable effect on a financial interest of the individual, spouse, domestic partner, minor child, or organization in which the individual serves as an officer, trustee, partner or employee.

Research Personnel: The term investigator means the project director or principal investigator or any other person regardless of title or position, who is responsible for the design, conduct or reporting of research to be done at Saint Joseph Regional Medical Center (SJRMC).

• Immediate Family Member: Spouse, domestic partner, or minor child.

• Significant Financial Interest: Any of the following financial interests of any key research personnel, or his or her immediate family, in aggregate. (The thresholds described below apply to the aggregate ownership of a key research personnel and his / her immediate family. For example, if an Investigator, his/her spouse, domestic partner and dependent children own together $5,000 worth of equities in the sponsor and/or its affiliated companies). The thresholds do not apply to the combined ownership of all Investigators or Key Research Personnel.

o Income in excess of $5,000 from a publicly-traded entity (a company whose stock is available for purchase by general public) during past 12 months.

o Stock values in excess of $5,000 at the time of disclosure in a publicly traded entity.

o A combination of the above two items (stock and income) that exceeds $5,000.

o Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity (such as a start-up company).

o Compensation that exceeds $5,000 from a non-publicly traded entity in the past 12 months.

o Income related to intellectual property rights paid by any source other than the investigators or Key Research Personnel’s current institution. 

o Any reimbursed or sponsored travel paid by an entity, including non-profit organizations, but excluding travel sponsored by or reimbursed by a government agency, a U.S. institution or higher education or a research institute affiliated with such, a medical center or an academic teaching hospital. The specific details that must be disclosed are: the name of the entity sponsoring the travel and purpose, destination, and duration of the travel.

o Any other interests required under the Institutional policy.   

REFERENCES/STANDARDS:

• 21 CFR 46.103, 107
• 21 CFR 56.107
• 21 CFR 54
• 45 CFR Part 50 subpart F
• 45 CFR Part 94
• 45 CFR 74.14, 74.62 and 92.43
• FDA Information Sheets, FAQ’s, Section II, question 12
• OHRP Guidance on Financial Relationships
• IRB Procedure VI.C.1, “Procedure for Disclosing Investigator and Key Study Personnel Conflict of Interest”
• CITI Financial Conflict of Interest: Overview of Investigator Responsibilities and COI Rules
• NIH Financial Conflict of Interest  http://grants.nih.gov/grants/policy/coi/ 
• FDA Financial Disclosure by Clinical Investigators Guidance for Industry  http://www.fda.gov/RegulatoryInformation/Guidances/ucm126832.htm
• Saint Joseph Regional Medical Center, “Conflicts of Interest Policy” 
• Trinity Health Conflict of Interest Policy 8-20
• Trinity Health Annual Conflict of Interest Disclosure Form
• Saint Joseph Regional Medical Center Annual Financial Disclosure Form
• HHS Final Rule August 25, 2011
• 42 CFR pts 50 & 94
• National Institute of Health Financial Conflict of Interest Online Research Tutorial http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm
• Transparency Reports and Reporting of Physician Ownership or Investment Interests, 76 Fed Reg. 78742 (December 19, 2011) proposed rule. Section 6002 (Sunshine Law) 
• Patient Protection and Affordable Care Act, Pub. L No 111-148, 124 Stat. 119 amended by Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152, 124 Stat. 1029 (herein after cited as PPACA) § 6402

 

IRB Committee Member, IRB Consultant, and IRB Staff Member Conflicting Interest

EFFECTIVE DATE: 10/30/2013

POLICY:

I. It is the policy of the Saint Joseph Regional Medical Center (SJRMC) Institutional Review Board (IRB) that all conflicting interest’s of an IRB Committee Member, IRB Staff Members or IRB Consultant be reported to the Office of the IRB for review to assure protection of the right and welfare of participant in human subjects research. The reporting should be completed before review of any research under IRB jurisdiction. Conflicts of interest will be eliminated when possible and effectively managed and disclosed when they cannot be eliminated.

II. IRB Committee Members, IRB Staff Members and IRB Consultants with a conflicting interest may not participate in any portion of the review of research activities, including voting, except to provide information requested by the IRB and must absent themselves from the meeting during the IRB’s deliberation, discussion and vote on the affected research. This also pertains to IRB Committee Members, IRB Staff Members and IRB consultants whose immediate family member has any conflicting interest.

III. The purpose of this policy is to promote objectivity in programs and funding that support the research, scholarship and service mission of the institution. It will do so by establishing standards to ensure there is no reasonable expectation that the design, conduct or reporting of funded research or cooperative agreements with companies or groups will be biased by any conflicting financial interest of the Institutional Review Board members, consultants or staff. Complete disclosure and expeditious review of such conflicts or potential conflicts is in the best interest of all of those involved in the review of the research, conduct of the research and in the administration and oversight of the research.

IV. Conflicts of interest must not compromise the rights and welfare of research participants or the integrity of the research review process. The regulations do not provide flexibility in the management of an IRB member, IRB Staff member, or IRB consultants conflicting interest. Specifically the regulations require that IRB members must not participate in the review of research in which they have a conflicting interest, except to provide information requested by the IRB.

V. Conflicts of interest may also be non-financial, such as when an IRB member, IRB Staff Member or IRB consultant is asked to review research in which he/she is also a member of the research team. Other “personal or professional” conflicting interests are described below. An individual may opt out of a review for any reason, including a conflicting interest not specifically described by this policy.

VI. When a conflicting interest is identified, an IRB member, IRB staff member or IRB consultant may not participant in any type of review of the research conducted by the IRB, including initial or continuing reviews, review of modifications or other reviews (i.e. event reports, unanticipated problems, and potential non-compliance). This requirement applies to reviews conducted by convened IRB and those performed by expedited procedures.

VII. Financial Conflicts of Interest:

A. An IRB member, IRB Consultant or IRB Staff member is considered to have a conflicting financial interest when he/she (or a member of his/her immediate family) is receiving compensation for services or has financial interests or intellectual property rights that would reasonably appear to be affected by the research as outlined by the significant financial interest definition found at the beginning of this policy.

B. The Office of the IRB requires each IRB member and Office of the IRB research staff update the disclosure form at least or within 30 days of identifying or acquiring a new significant financial interest. 

VIII. Training:

A. In order to ensure IRB Members and Office of the IRB staff are aware of the required disclosure of potential financial conflicts of interest,  the NIH Office of Extramural Research Financial conflict of interest online tutorial or an additional module in the CITI program must be completed every three years or in the event the federal requirements are updated. This certificate must be turned into the Office of the SJRMC IRB and will be kept on file in the Office of the IRB. 

B. Training will be documented by one or more of the following: 

1. Submission of the CITI training module completion training certificate being printed and provided to the Office of the IRB.

2. Submission of the NIH Financial Conflict of Interest completion training certificate being printed and provided to the Office of the IRB.

PROCEDURE: 

A. This procedure outlines the process for reporting, reviewing and disclosing of any conflicts of interest by IRB members, IRB staff and IRB Consultants who are involved in the review of research to be conducted and being conducted at Saint Joseph Regional Medical Center.

B. IRB Members, IRB Staff and IRB Consultants Process for Disclosure 

I. IRB Members, IRB Staff and IRB Consultants are asked to complete the IRB Member, IRB Staff, and IRB Consultant Annual Conflict of Interest Disclosure Form when they are appointed to the Board if a current disclosure form is not already on file. All are required to update the disclosure form annually and whenever there are changes in their (or their immediate family members) financial interests. IRB members, IRB staff and IRB Consultants will refer to the Saint Joseph Regional Medical Center IRB Standard Operating Procedure and the Saint Joseph Regional Medical Center Institutional Policy for information about financial and non-financial conflicts of interest.

C. IRB Committee Members, IRB Staff and IRB Consultants Responsibilities

I. All will examine materials assigned to them upon receipt and identify any financial and/or non-financial conflicts of interest. If a conflict of interest exists, the committee member, IRB Staff member or IRB Consultant should immediately contact the appropriate Office of the IRB Staff member or management so that the review can be reassigned to another IRB member, IRB Consultant or IRB Staff member. IRB staff will document in writing a conflict of interest as the reason for reassignment. 

II. All may contact the Conflict of Interest Administrator or IRB Chairperson for information or assistance with conflict of interest questions. The IRB Chairperson will make a final determination about whether a conflict of interest as defined by the Saint Joseph Regional Medical Center Institutional Review Board Conflict of Interest Policy and Saint Joseph Regional Medical Center Institution Policy exists. In the case that the IRB Chairperson has a potential or perceived conflict of interest, the institutional official will make a final determination whether a conflict of interest as defined by the Saint Joseph Regional Medical Center Institutional Review Board and Saint Joseph Regional Medical Center Institution Policy exists in which case a Vice Chair or Co-Chair may be assigned to review.

III. IRB Member must recuse from any vote which directly involves a study in which they have disclosed a conflict of interest. The IRB member is responsible for noting to the meeting minute taker during the vote that they are recusing from voting. The IRB member will be asked to leave the room during the vote.

D. Documentation of Conflicts of Interest 

I. The Office of the IRB Clinical Research Associate assigned to record IRB meeting minutes is responsible for documenting that an IRB member did not participate in the convened review of research in which a member has a conflicting interest. IRB minutes will record when the member left the room, with the reason being noted as because of a conflict of interest. IRB members out of the room due to a conflict of interest are not counted toward the meeting quorum. Office of the IRB staff assigned to the meeting are responsible for monitoring IRB meeting attendance to ensure a quorum is maintained. 

II. IRB Member disclosed conflicts of interest will be kept on file in the Office of the IRB and made only accessible to Office of the IRB staff who are responsible for assigning reviewers.

E. Training

I. Training for IRB members, IRB Staff, IRB consultants will be documented by review of policy and completion of the Financial Conflict of Interest Disclosure Form. Training may also be documented by the completion of the CITI module for Financial Conflict of Interest, completion of the NIH FCOI online tutorial or at an IRB meeting or educational offering where research FCOI is presented and discussed. Attendance in a group setting will be documented by a sign in sheet.

RELATED DOCUMENTS:  

• IRB Member, IRB Staff Member and IRB Consultant Financial Disclosure Form (attached)
• IRB Member Recusal Agreement (attached)

DEFINITIONS: 

• Individual Conflict of Interest: A circumstance such that any action or decision in which an individual is substantially involved may have a direct or predictable effect on a financial interest of the individual, spouse, minor child, or organization in which the individual serves as an officer, trustee, Board or executive member, partner or employee.
• IRB Committee Member: An individual serving as an IRB Committee Member including Chairs, the IRB members, IRB reviewers, alternates or expert consultants regardless of voting privileges.
• IRB Staff: An individual who is assigned to specific work by the Office of the IRB. They may be, but not limited to, a, clinical research associate/assistant, or IRB Coordinator
• Immediate Family Member: An IRB Chairperson, IRB committee member, IRB consultant or IRB Staff Members spouse, domestic partner, or minor child
• Non Financial Conflicts of Interest: An interest other than monetary of an individual (or his/her immediate family) in the design, conduct, or reporting of the research or other interest that competes with an IRB member’s (or consultants) obligation to protect research participants and potentially compromises the objectivity and the credibility of the research review process. 
• Significant Financial Interest: : Any of the following financial interests of any IRB Member, IRB Staff Member or IRB Consultant, or his or her immediate family, in aggregate. (The thresholds described below apply to the aggregate ownership of a key research personnel and his / her immediate family. For example, if an Investigator, his/her spouse, domestic partner and dependent children own together $5,000 worth of equities in the sponsor). The thresholds do not apply to the combined ownership of all Investigators.

o Income in excess of $5,000 from a publicly-traded entity (a company whose stock is available for purchase by general public) during past 12 months.
o Stock values in excess of $5,000 at the time of disclosure in a publicly traded entity.
o A combination of the above two items (stock and income) that exceeds $5,000.
o Any amount of equity (stock, stock options, or other ownership interest) in a non-publicly traded entity (such as a start-up company).
o Compensation that exceeds $5,000 from a non-publicly traded entity in the past 12 months.
o Income related to intellectual property rights paid by any source other that the investigators current institution. 
o Any reimbursed or sponsored travel paid by an entity, including non-profit organizations, but excluding travel sponsored by or reimbursed by a government agency, a U.S. institution or higher education or a research institute affiliated with such, a medical center or an academic teaching hospital. The specific details that must be disclosed are: the name of the entity sponsoring the travel and purpose, destination, and duration of the travel.
o Any other interests required under the institutional policy.    

REFERENCES/STANDARDS:

• 21 CFR 46.103, 107
• 21 CFR 56.107
• 21 CFR 54
• 45 CFR Part 50 subpart F
• 45 CFR Part 94
• FDA Information Sheets, FAQ’s, Section II, question 12
• OHRP Guidance on Financial Relationships
• IRB Procedure VI.C.1, “Procedure for Disclosing Investigator and Key Study Personnel Conflict of Interest”
• CITI Financial Conflict of Interest: Overview of Investigator Responsibilities and COI Rules
• NIH Financial Conflict of Interest  http://grants.nih.gov/grants/policy/coi/ 
• FDA Financial Disclosure by Clinical Investigators Guidance for Industry http://www.fda.gov/RegulatoryInformation/Guidances/ucm126832.htm
• Saint Joseph Regional Medical Center Policy, “Conflicts of Interest Policy” 
• Trinity Health Conflict of Interest Policy
• HHS Final Rule August 25, 2011
• 42 CFR pts 50 & 94
• Trinity Health Annual Conflict of Interest Disclosure Form INST. 02/104
• Transparency Reports and Reporting of Physician Ownership or Investment Interests, 76 Fed Reg. 78742 (December 19, 2011) proposed rule. Section 6002 (Sunshine Law) 
• Patient Protection and Affordable Care Act, Pub. L No 111-148, 124 Stat. 119 amended by Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152, 124 Stat. 1029 (herein after cited as PPACA) § 6402.
• Applicable Regulations
• 21 CFR 56.107
• 45 CFR 46.107
• DHHS Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection”

Research Conflict of Interest Committee

EFFECTIVE DATE: 10/30/2013

POLICY:

I. The Research Conflict of Interest Committee (RCOIC) is established to review all potential significant conflicts of interest in research activity at Saint Joseph Regional Medical Center. 

II. Composition: The committee shall have 3 members at a minimum. The members shall be trained and familiar with the application of the federal and institutional regulations, guidances and policies for research conflict of interest.

III. Meetings: The RCOIC must meet monthly at such time and place as shall be selected, consistent with guidelines approved by the Institutional Review Board (IRB). Special meetings may be called by the Institutional Review Board Chairperson as emergent issues arise.

IV. Appointment of Members: Members shall serve a 1 year renewable term. Members may resign from the committee with 60 days’ notice. Members may be removed by the committee chair if they are unable to fulfill their role. 

V. Powers: The Committee is authorized to review completed Research financial conflict of interest forms and advise the Institutional Review Board of the application of the federal regulations, institutional policies and Institutional Review Board Policies regarding potential and significant financial conflicts of interest.

VI. Documentation: All RCOIC members shall sign and abide by the research conflict of interest policies that require disclosure of any potential conflict that a member’s private financial interests may have with the individuals whose research conflict of interest is being reviewed. The RCOIC member must disclose and excuse themselves from reviewing any persons research conflict of interest disclosure that they may have a conflict with.

VII. Meeting minutes shall be created for each RCOIC meeting documenting discussion that takes place surrounding the review of specific disclosures of conflict of interest. The minutes shall be provided to the Office of the IRB within 1 week of the RCOIC meeting by the RCOIC chair.

RePromoting Objectivity in Research -Financial Interest Disclosure search Conflict of Interest Committee

EFFECTIVE DATE: 10/30/2013

POLICY:

I. All investigators, as defined in this policy, which engage in clinical research will disclose all significant financial and fiduciary interests to Saint Joseph Regional Medical Center (SJRMC) on an ongoing basis. 

II. Purpose:  SJRMC, its physicians and associates are committed to conducting their institutional activities in accordance with the highest standards of integrity and ethics and in compliance with all applicable laws and regulations related to conflicts of interest and objectivity in research.  To promote the ethical conduct of research SJRMC has established this policy and related forms and procedures to identify and address conflicts of interest in the context of human subject research.

III. Financial interests in human subjects research are distinct because financial interests are discretionary, and because the perception is widespread that they may entail special risks.  Specifically, opportunities to profit from research may affect – or appear to affect – a researcher’s judgments about which subjects to enroll, the clinical care provided to the subjects, and even the proper use of subjects’ protected health information. Financial interests also threaten scientific integrity when they foster real or apparent biases in study design, review, data collection and analysis, adverse event reporting, or the presentation and publication of research findings.  The purpose of this policy is to set forth information about and procedures to identify and address conflicts of interest in the context of human subjects research.  

PROCEDURE

A. Successful implementation of this policy assumes a shared responsibility by the Investigator and SJRMC.

I. Investigator Responsibilities 

a. All Principal investigators, co-investigators, and research coordinators who consent research participants must completely and accurately disclose all SFIs on an annual basis or as changes occur. Examples include SFIs in any External Entity that: 

1.  Sponsors the Investigator’s research; 

2. Has made or pledged a gift to SJRMC that benefits the Investigator’s research; 

3. Has products, services or research interests that could reasonably appear to be affected by Investigator’s research; or

4. Sells goods or services to SJRMC that will be used in Investigator’s research.

b. The Investigator is required to submit an updated disclosure within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.

c. All Investigators must complete training on FCOI prior to engaging in research.  Re- training must be completed at least every four years and immediately when any of the following circumstances apply:

1. An Investigator is new to SJRMC; 

2. SJRMC revises its conflict of interest policies or procedures in any manner that affects the requirements of Investigators; or 

3. SJRMC finds that the Investigator is not in compliance with this policy or Management plan.

B. SJRMC Responsibilities

I. Maintain a written policy on FCOI that complies with applicable laws and regulations.

II. Maintain the Institution’s FCOI policy publicly. 

III. Develop, provide and monitor FCOI training.

IV. Review each submitted “Promoting Research Objectivity-Significant Financial Interest Disclosure Form” to identify any potential FCOI in accordance with applicable laws and regulations. At SJRMC the Institutional Official and/or designee will carry out this function.

V. Any identified potential FCOI will be reviewed by the Conflict Interest Committee, which will then determine and document mitigation actions to manage the FCOI.  

VI. Establish adequate enforcement mechanisms and provide for sanctions or other administrative actions to ensure researchers are in compliance with the management plan.

VII. If SJRMC carries out research through a sub-recipient (e.g., subcontractors or consortium members), SJRMC must take reasonable steps to ensure that the sub-recipient’s FCOI policy is in compliance with requirements for disclosure.  

VIII. If the sub-recipient cannot provide such certification, a written agreement between SJRMC and the sub-recipients shall state that sub-recipient investigators are subject to SJRMC FCOI policy and specify time period(s) for the sub-recipient to report all identified FCOI to SJRMC.

C. Management of FCOI 

I. To the extent possible and reasonable under the circumstances, the Conflict of Interest committee will work with the researcher to develop the means for the research to take place while protecting the objectivity of the research, its participants and uphold/maintain scientific integrity.  Listed below are several possible resolutions for Management of the FCOI that may be recommended:

a. Public disclosure of FCOI (e.g., when presenting or publishing the research, to staff members working on the project or to the IRB);

b. For research projects involving human subjects research, disclosure of FCOI directly to participants;

c. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;

d. Modification of the research plan;

e. Change of personnel or personnel responsibilities or disqualification of personnel from participation in all or a portion of the research;

f. Reduction or elimination of the SFI (e.g., sale of an equity interest); or 

g. Severance of relationships that create FCOI.

II. Notify the IRB of the FCOI and the related Management plan.

III.Determine the appropriate strategies to properly oversee and manage potential conflict(s), taking into consideration the possible remedies as outlined below.

IV. Inform the researcher of the actions taken and decisions made by the Conflict of Interest Committee.

D. Reporting of FCOI

I. If PHS is a funding source to any research activity, SJRMC will provide to PHS all FCOI information prior to the expenditure of funds and within 60 days of any subsequently identified FCOI. 

II. SJRMC shall provide a written response to any requestors (within five business days of the request) information concerning a SFI that meets the following three criteria: a) The SFI was disclosed and is still held by the Investigator; b) Institution determines that the SFI is related to the PHS-funded research; and  c) Institution determines that the SFI is a FCOI.

III. Such written response shall include the following information: 

a. Investigator’s name; 

b. Investigator’s title and role with respect to the research project;  

c. Name of the External Entity in which the SFI is held;   

d. Nature of the SFI; and    

e. Approximate dollar value of the SFI (dollar ranges are permissible: 

1. $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000  by increments of $50,000) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.  

E. Sanctions

I. Sanctions and penalties for non-compliance with this policy or Management plans arising from this policy will be determined by the Institutional Official with advice from the Conflict of Interest Committee.  Sanctions may include, but are not restricted to:

a. Removal of Investigator from participation in research;

b. Letter of reprimand;

c. Termination of grant support;

d. Notification to funding agencies and/or professional journals and societies;

e. Suspension; or

f. Dismissal.

F. Maintenance of records

1) All records related to the implementation of this policy (e.g., disclosure forms, minutes of meetings called to manage conflicts, minutes of the Conflict of Interest Committee and notifications to funding agencies) shall be maintained by the Institutional Official and designee.  These records will be kept in a secured fashion for a period of at least three years following the termination or completion of the research activities.  

DEFINITIONS: 

• Conflict of Interest means a situation in which a Significant Financial Interest may compromise, or have the appearance of compromising, an Investigator’s judgment in conducting, reviewing or reporting research.

• External Entity means any natural person, corporation, partnership, sole proprietorship, association, organization, holding company, joint stock company, receivership, trust, governmental agency or subdivision regardless of whether organized for profit, nonprofit or charitable purposes.

• Equity Interest means any stock, option or other ownership interest in an External Entity.

 • Family Member means the Investigator’s spouse and dependent children. 

• Financial Conflict of Interest (FCOI) means that SJRMC has determined the conflict could directly and significantly affect the design, conduct or reporting of research

• Institutional Responsibilities means an investigator’s professional responsibilities on behalf of the institution including research, research consultation, teaching, clinical practice, institutional committee memberships, and services on panels such as Institutional Review Boards (IRB) or Data Safety Monitoring Boards. 

• Investigator means the Principal Investigator (PI) and any other personnel, regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposed for such funding, which includes, co-investigators and research coordinators

• Manage or Management means to take action to address a financial conflict of interest which includes reducing or eliminating the financial conflict of interest to ensure that the design, conduct and reporting of research is free from bias or the appearance of bias.

• PHS means the Public Health Service of the U.S. Department of Health and Human Services (DHHS), and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).   Examples of PHS funding mechanisms include:

o Grants
o Cooperative agreements
o Career Development Awards
o Center Grant of Individual Fellowship Awards
o Any activity where funding is provided by PHS

• Research means a systematic investigation, study or experiment designed to develop or contribute to general knowledge relating broadly to public health, including behavioral and social-sciences research.  

• Significant Financial Interest (SFI) means an Investigator’s (and/or his/her Family Members’):  

o Remuneration (any monetary or other financial benefit such as salary, consulting fees, honoraria or paid authorship) from any External Entity (not those paid by SJRMC  that is related to the Investigator’s research activities and exceeds $5,000 during the 12-months prior to the disclosure when aggregated for the Investigator and their Family Members;
o Equity Interest in any External Entity that is related to the Investigator’s research activities (for publicly- traded External Entities an SFI exists only if the Equity Interest exceeds $5,000 in value when aggregated for the Investigator and their Family Members);
o Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
o Reimbursed or sponsored travel that is not related to the Investigator’s Institutional Responsibilities, such as travel required for awarded Grant activity. Note: travel may be paid on behalf of the Investigator and not directly reimbursed to the Investigator so that the exact monetary value may not be readily available but still must be estimated.
o An SFI does not include the following:

Salary, royalties or other remuneration paid by SJRMC to the Investigator and intellectual property rights assigned to SJRMC; 

Income from seminars, lectures or teaching engagements sponsored by a federal, state or local government agency, or an institution of higher education as defined at 20 U.S.C. 1001(a);

Income from service on advisory committees or review panels for a federal, state, or local government agency, or an institution of higher education as defined at 20 U.S.C. 1001 (a).

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. 

REFERENCES/STANDARDS:

• FDA regulations 21 CFR part 54
• Federal Public Health Service regulations 42 CFR part 50, subpart F; and 45 CFR part 94 
• National Science Foundation Grant Policy Manual 510, as amended by 60 FR 35820 (1995).
• *State of Michigan follows federal regulations in this area and does not maintain state rules or regulations governing financial conflicts of interest in clinical research.

Saint Joseph Regional Medical Center  |  5215 Holy Cross Parkway, Mishawaka, IN 46545  |  574-335-5000

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