IMPAACT Financial Conflict of Interest and Disclosure Policy
The IMPAACT Network seeks to maintain objectivity in all of its research by ensuring that the selection of
products for testing, as well as the design, conduct and reporting of research is not biased by conflicting
financial interests of IMPAACT leaders and/or investigators who are responsible for the research.
In accordance with the provisions of the US Code of Federal Regulations (CFR) 42 CFR 50/F and 45 CFR 94
and with 21 CFR Part 54, IMPAACT is required to ensure that:
 Investigators have disclosed any significant financial interests.

Records of financial disclosure are maintained according to the sponsor’s requirements.

Conflicting interests of investigators are managed, reduced or eliminated.
Specifically, all individuals who meet the definition of “key personnel” as defined in the NIH HIV/AIDS Clinical
Trials Networks Financial Disclosure Policy and Procedure described below must provide the required financial
disclosure information annually.
As a study-specific requirement, all site personnel listed on a FDA Form 1572 for a study inducted under an
Investigational New Drug (IND) application with the US Food and Drug Administration must have on file at the
site a completed financial disclosure form prior to enrollment of any participants in that study; likewise, any new
personnel added to the FDA Form 1572 must complete a disclosure form within the specified timeframe.
Compliance with 42 CFR 50/F and 45 CFR 94 – NIH Financial Conflict of Interest Policy
The IMPAACT Network is a party to the NIH HIV/AIDS Clinical Trials Networks Financial Disclosure Policy and
Procedure: https://www.hanc.info/smctl/Documents/Cross-network%20FDCOI_SOP.pdf which describes the
requirements and procedures for financial disclosure for all named networks. These policies and procedures
were developed to identify significant financial interests of researchers in the NIH HIV/AIDS Clinical Trials
Networks and avoid conflicts of interest, or the appearance of such conflicts, in the networks’ activities.
IMPAACT Network members required to disclose under this policy include:
 All members of the Scientific Leadership Group.

All members of a Study Monitoring Committee, Endpoint Review Committee, and the Multidisciplinary
Protocol Review Committee.

Protocol Chairs, Co-Chairs, Vice-Chairs, and other protocol team members who make direct and
significant contributions to the study and/or the study data, as determined by network leadership (e.g.,
protocol virologist, immunologist, pharmacologist and SDMC personnel).
Members of a protocol team who do not have key decision-making roles, including industry representatives
and federal government employees (who are required to report under other federal guidelines) are not required
to disclose under this policy.
Annually, the Office of HIV AIDS Network Coordination (HANC) distributes the “Statement of Financial, Equity,
and Intellectual Property Interests” (Appendix A of the cross-network SOP) to Network members who are
required to disclose financial information. A Review Committee including the Network Chair, Vice Chair,
Operations Center Director or designee, and the DAIDS Program Officer is responsible for review and
mitigation of potential conflicts. This process and the responsibilities of the Operations Center are detailed in
the cross-network SOP.
Compliance with 21 CFR 54 – FDA Financial Disclosure by Clinical Investigators
As part of marketing applications for new human drugs and biological products, and marketing applications and
reclassification petitions for medical devices, sponsors of clinical research studies are required to disclose to
the US Food and Drug Administration (FDA) certain financial arrangements between sponsors and clinical
investigators and certain interests of clinical investigators in the product under study or in the sponsor of the
study. To fulfill this requirement, Clinical Research Sites (CRSs) involved in the conduct of IMPAACT studies
conducted under an Investigational New Drug (IND) application with the FDA are required to maintain
documentation of certain financial arrangements and interests.
This is not a new requirement; however, DAIDS issued guidance on the process for collection and monitoring
of Financial Disclosure Forms for all site investigators and sub-investigators listed on the Form FDA 1572,
effective 1 July 2014. This guidance is available on the DAIDS Regulatory Support Center website:
http://rsc.tech-res.com/protocolregistration/.
IMPAACT has developed a Financial Disclosure Form, available on the IMPAACT website or through the
Operations Center, to be used to record the required information at each site. Alternatively, an equivalent form
provided by a pharmaceutical company co-sponsoring an IMPAACT study may be used.
Requirements and Procedures

For each study being conducted under an IND, the designated financial disclosure form must be
completed by all site investigators and study staff listed on the FDA Form 1572 to disclose their own
financial interests as well as those of their spouses and dependent children, prior to enrolling any study
participants.

As a condition for site-specific activation of an applicable IMPAACT study, the Investigator of Record
will be required to confirm that disclosure forms have been completed by all site investigators/staff
listed on the FDA Form 1572 and that these forms are on file.

As new CRS personnel are added to the FDA Form 1572, these personnel must also complete the
designated disclosure form.

If there is a change in an individual’s financial interests during the course of the trial, an updated
disclosure form must be completed.

Upon completion of the study, as part of study close-out procedures, all forms will be reviewed and
updated as needed.

All original and updated disclosure forms must be filed and retained in the site’s regulatory binder along
with the original and updated FDA Form 1572. The completed financial disclosure forms need not be
submitted to DAIDS or the IMPAACT Operations Center unless requested.

NIAIDS/DAIDS and NICHD clinical site monitors will review the FDA Form 1572 and completed
disclosure forms on file to verify site compliance.

If an applicant of a marketing application requests the completed disclosure forms, the Operations
Center will provide instructions and coordinate collection of the necessary documents.

Addition details are included in the DAIDS guidance document available on Regulatory Support Center
website: http://rsc.tech-res.com/protocolregistration/.
IMPAACT Clinical Investigators
Disclosure of Financial Interests and Arrangements for US FDA
Please complete all of the information below, including providing your signature where indicated.
1. Protocol Number: IMPAACT P1070
2. Protocol Title: Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and
Children ≥3 Months to <36 Months of Age
3. Site Name/Number: <INSERT SITE NAME/NUMBER>
4. Participating Pharmaceutical/Biotechnology Company(s): National Institutes of Health (Laboratory of Infectious Diseases)
5. Principal Investigator/Subinvestigator name as listed on 1572 : <INSERT INVESTIGATOR NAME>
Principal Investigator
Subinvestigator
6. Investigator Contact Information:
<INSERT INSTITUTION NAME, TELEPHONE NUMBER, FAX NUMBER, E-MAIL ADDRESS>
7. Indicate by marking YES or NO if any of the financial interests or arrangements of concern to FDA (as described below)
apply to you, your spouse, or dependent children.
Any financial arrangement entered into between you and any participating pharmaceutical/ biotechnology
company whereby the value of the compensation to you for conducting the study could be influenced by the
outcome of the study? This includes compensation that could be greater for a favorable clinical result,
compensation in the form of an equity interest in any participating pharmaceutical/biotechnology company or
compensation tied to sales of the product tested in the above study such as a royalty interest.
YES
NO
If yes, please describe:
Any significant payments of other sorts from any participating pharmaceutical/biotechnology company? This
could include, for example, payments made to the investigator or the institution to support activities that have a
monetary value greater than $25,000 (i.e. a grant to fund ongoing research compensation in the form of
equipment, or retainers for ongoing consultation of honoraria).
YES NO
If yes, please describe:
Any proprietary interest in the product tested in the study such as a patent, trademark, copyright, or licensing
agreement. ?
YES NO
If yes, please describe:
Any significant equity interest in any participating pharmaceutical/biotechnology company? This would include,
for example, any ownership interest, stock options, or other financial interest whose value cannot be easily
determined through reference to public prices, or an equity interest in a publicly traded company exceeding
$50,000.
YES NO
If yes, please describe:
In accordance with 21 CFR § 54.1 to 54.6, I declare that the information provided on this form is, to the best of my
knowledge and belief, true, correct, and complete. Furthermore, if my financial interests and arrangements, or those of my
spouse and dependent children, change from the information provided above during the course of the study or within one
year after the last patient has completed the study as specified in the protocol, I will notify DAIDS promptly.
8. Signature
IMPAACT Disclosure of Financial Interests and Arrangements
FINAL: 30 July 2014
9. Date:
Page 1 of 1