IRB Form 6 – Conflict of Interest Questionnaire

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IRB Form 6

FARMINGDALE STATE COLLEGE

Institutional Review Board

Conflict of Interest Questionnaire for Research

(Form Approved: February 2007)

Date:

All Farmingdale State College investigators seeking internal or external funding to conduct research, training, or evaluated testing are required to complete and file a signed Conflict of Interest Questionnaire for Research (CIQR) with the submission of every proposal. If any of the answers to the questions on the CIQR are affirmative, the investigator is required to file an Investigator Disclosure Form (IDF) within seven business days from the day the CIQR is received. If a new reportable significant conflict of interest arises at any time during the period after submission of the proposal through the period of the award, the filing of a new or updated IDF is required.

Conflicts of interest arise with increasing frequency from the diversity of roles research college faculty are expected to play. Rather than ignoring or seeking to prohibit them, Farmingdale State College will endeavor to develop and implement conflict management strategies in order to facilitate the fulfillment of these diverse faculty roles in support of the College’s multiple missions. An affirmative answer to a question on the CIQR will initiate the process of developing a management strategy; there may be rare cases where no strategy can be developed that will satisfy all relevant constraints.

The Institutional Review Board Policy and Procedures Manual, Policy #15 – Conflict of Interest/Financial Disclosure Policy contains a thorough explanation and description of this topic. The following definitions will assist you in filling out this COI questionnaire.

Investigator: The Principal Investigator, Co-Investigators and all other persons who are responsible for the design, conduct, or reporting of research as described in an application or prospective application made through Farmingdale

State College for support of research.

Significant Financial Interest: Anything of monetary value to the Investigator that would reasonably appear to be directly and significantly affected by work externally funded, including but not limited to: salary or other payments or services (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options, warrants or other ownership interests); and intellectual property rights (e.g. patents, copyrights and royalties from such rights). Examples include ownership of stock, stock options, or any equity, debt, security, capital holding, salary or other remuneration, or financial consideration, or thing of value for services as an employee, consultant, officer, or board member in:

1. the entity to which the application will be submitted;

2.

3. any entity that owns or has applied for the patent manufacturing of marketing rights to product or procedure involved in, or will predictably result from, the work described in the application. any entity that is known by the Investigator to own or have applied for such rights in any product or procedure that will predictably result from the work described in the application; or

4.

5.

6. any entity that will be a sub-recipient from the University of funding resulting from the application; any entity where the value of financial interests exceeds $10,000 or represents more than a 5% ownership interest for any one enterprise or entity when aggregated for the Investigator and all related parties; any entity from which the Investigator consults or receives other remuneration where the value is greater than

$10,000 annually.

Excluded are:

1. salary, royalties or other remuneration paid to an Investigator by Farmingdale State College

2. income from seminars, lectures or teaching engagements sponsored by public or nonprofit entities;

3. income from service on advisory committees or review panels for public or nonprofit entities;

4. financial interests in business enterprises or entities if the value of such interests do not exceed $10,000 and do not represent more than a 5% ownership interest for any one enterprise or entity when aggregated for the

Investigator and related parties.

5. consulting or other remuneration from business enterprises or entities if the value does not exceed $10,000 annually.

IRB Form 6

Related Party: Spouse, domestic partner, & dependent children, siblings, parents, or equivalents by marriage, or other individuals residing in the household.

IRB Form 6

Farmingdale State College Conflict of Interest Questionnaire for Research

Procedure: Each investigator must attach a signed CIQR to the IRB application. The form must be signed by the appropriate Department Chair and Dean. If any investigators identify an actual, potential, or apparent conflict of interest on this form (i.e., if they checked “yes” to any of the questions below), that individual must also complete an Investigator Disclosure Form (IRB Form 6a).

Specific instructions: Answer all questions below. Once every question is answered, certify and sign the form.

Use a separate form for each investigator. Append the completed and signed forms for all investigators to the

IRB application packet.

Name of Investigator: Department:

College/Division:

Proposal Title:

Sponsor(s) of proposed activity:

For profit (sub)contractor(s):

Vendors of services, supplies, or equipment with an aggregate value in excess of $10,000:

Questions Yes

1. Do you or any related party hold a position of management, such as board member, director, officer, partner trustee, employee or consultant with a sponsor, a vendor or

(sub)contractor related to the proposed activity?

2. Do you or any related party have a Significant Financial Interest in a Sponsor, vendor, or

(sub)contractor related to the proposed activity?

3. Have you or any related party assigned to a Sponsor, a vendor, or (sub)contractor related to the proposed activity rights to a disclosed intellectual property, pending patent application or an issued patent to an invention(s), or copyright for software?

4. Do you or any related party gave a Significant Financial Interest in a for-profit Entity that will manufacture or commercialize any drug, vaccine, device, product, procedure, or process that is associated with or that will predictably result from the proposed activity?

5. Do you or any related party have a Significant Financial Interest in a for-profit Entity that can reasonably be expected to benefit directly and significantly from the design, conduct, or reporting of the proposed activity?

6. If you answered yes to any of questions 1-5, is it reasonable to anticipate that your financial interest could be directly and significantly affected by the design, conduct, or reporting of the proposed activity?

7. Is there anything else you would like to disclose?

If yes, explain:

Investigator Certification:

● I have read and understood Farmingdale State College’s Conflict of Interest Policy for Research

● I agree to file a new or updated Investigator Disclosure Form as required

● I certify that all the answers in this questionnaire are accurate and truthful to the best of my knowledge

____________________________________________________

Investigator Signature

______________________

Date

No

IRB Form 6

Institutional Review of COI Questionnaire

IRB Form 6

Chair

Name:

Department:

I have read this Conflict of Interest Questionnaire ad

Concur with the assessment provided in this questionnaire

Seek clarification regarding one or more of the answers given in this CIQR for the following reasons:

________________________________________

Chair Signature

__________________

Date

Dean

Name:

Department:

I have read this Conflict of Interest Questionnaire ad

Concur with the assessment provided in this questionnaire

Seek clarification regarding one or more of the answers given in this CIQR for the following reasons:

________________________________________ __________________

Dean Signature Date

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