Non Find 1: Financial Interest Disclosure for Non-PHS Funded BU Research (externally funded and/or human subject research at Boston University (BU) only)
This information is being requested in accordance with BU policy and must be filled out if you will be responsible for the design, conduct, or reporting of human subject research at BU, and/or, any research activity that is externally funded by an entity other than (a) an agency under the Public Health Service[1], (b) the American Heart Association, (c) the American Cancer Society, (d) the Arthritis Foundation, (e) the Susan G. Komen Foundation or (f) the Alliance for Lupus Research at BU.
This disclosure form is due no later than the time of application. Send all forms to or via fax at 617-414-4738.
Home Institution: / School/
Department:
Full Project Title:
Principal Investigator: / Project Period: / to
Prime Sponsor: / Coulter Translational Research Partnerships / Sub-Sponsor (if any):
Award number:
'
BU/BMC Grant Admin Office: BU-CRC BU-MED Other: BU-Biomedical Engineering Proposal ID#:
1. Do you, your spouse, or dependent children have any significant financial interests that would reasonably appear to be affected by your above-described research? Yes No
2. Do you, your spouse or dependent children have any significant financial interests in an entity whose financial interests would reasonably appear to be affected by this research”? Yes No
“reasonably appear to be affected” may refer any of the following:
1. anything of monetary value, including a salary, consulting fee, honorarium or other payment for service;
2. equity interests, including stocks, stock options or other ownership interests; and
3. intellectual property (IP) rights, including copyrights, royalties, and patent rights, or, where a clinical “investigator” (i.e., someone responsible for the design, conduct or reporting of the research) is inventor (whether IP is licensed or not).
Exceptions:
a. salary, or other remuneration (not including royalties) from Boston University or Boston Medical Center;
b. income from public or non-profit entities for seminars, lectures, teaching engagements, service on advisory committees, or review panels; or
c. salary, royalties or other payments from a single entity (or group of affiliated entities) that, when aggregated over the next twelve months, are not expected to exceed $10,000. /
(a) Research uses or involves intellectual property (“IP”) (i.e., technology, drugs, products or services) owned by or licensed to the investigator (e.g., via patent or copyright); or
Research uses or involves IP for which the investigator receives royalties, or has the right to receive royalties.
(b)
(i) The investigator (or spouse or dependent child) -
receives compensation from, or, has equity in - an entity
(ii) AND –
The research is receiving any kind of support (“in kind” or monetary) from that entity;
Proprietary access to data or rights to IP coming out of the research is/are owned by that entity (e.g., pre-publication access to results of the research);
Research aim(s) overlap with aims of that entity;
Research uses or involves IP owned by or licensed to that entity;
Research results could enhance the value of, or further validate, or increase the interest in IP owned, made or provided by that entity; and/or
New IP could result from research under this grant and potentially be of interest to that entity.
I certify that the above information is complete and true to the best of my knowledge and that I have read the Boston University conflict of interest policy.
Signature:______Date: ______
Principal investigators must complete the next page à
1. What is the actual/proposed award amount for the project? Proposed Year : $ Entire Project: $
2. Human Subjects? No Yes - IRB #
3. Special Designations:
SBIR (Small Business Innovation Research) grant
STTR (Small Business Technology Transfer) grant
Pre-clinical study
Applied / applying for an IND or IDE
(Investigational New Drug or Investigational Device Exemption through the FDA)
4. Please summarize the specific aims of the research. You may attach a project summary or abstract.
5. Please list all those responsible for the conduct, design or reporting of the research, even if they are from an institution other than BU or BMC (unless they are working under a subaward, and the subaward agreement states they will follow the subaward institution’s COI policy). At minimum, you must include all those designated as “Senior/key personnel” in the grant application, if that list exists. Please ensure that all of these people fill out and submit these financial interest disclosure forms. Failure to do so may delay funding.
Name / Role in Research / Email address / Home Institution
(if not BU or BMC)
Questions? Email
When to submit this form
NEW or RENEWAL SPONSORED PROJECTS: A Financial Interest Disclosure form must be submitted as part of the application package by all those responsible for the design, conduct, reporting human subject research or research activities externally funded by an entity other than an agency under the Public Health Service, the American Heart Association, the American Cancer Society, the Arthritis Foundation, the Susan G. Komen Foundation or the Alliance for Lupus Research, as identified by the BU Principal Investigator.
HUMAN SUBJECTS PROJECTS: A Financial Interest Disclosure Form must be submitted by all those responsible for the design, conduct, reporting human subject research at BU. (However, if this form has already been filed with a NEW or RENEWAL project application, an additional one is not required.)
MATERIAL CHANGE IN PROJECT: At any time during the life of project, this form must be submitted by the Investigator in the event of any MATERIAL CHANGE, such as
· the Investigator is newly added to the project
· there is a material change in the information previously disclosed.
Where to submit this form
Boston University Office of Research Compliance
85 East Newton Street, M-810F
Boston, MA 02118
Fax: (617) 414-4738 Email:
*Agencies within the Public Health Service and Other Organizations Adopting PHS standards
• Administration for Children and Families (ACF)
• Administration on Aging (AoA)
• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances and Disease Registry (ATSDR)
• Alliance for Lupus Research
• American Cancer Society
• American Heart Association
• American Lung Association
• Arthritis Foundation
• California Breast Cancer Research Program (CBCRP)
• California HIV/AIDS Research Program (CHRP)
· Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• Juvenile Diabetes Research Foundation (JDRF)
• Lupus Foundation of America
• National Institutes of Health (NIH)
• Substance Abuse and Mental Health Services Administration (SAMHSA)
• Susan G. Komen Foundation
NIH Institutes and Centers
• National Cancer Institute (NCI)
• National Eye Institute (NEI)
• National Heart, Lung, and Blood Institute (NHLBI)
• National Human Genome Research Institute (NHGRI)
• National Institute on Aging (NIA)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• National Institute of Allergy and Infectious Diseases (NIAID)
• National Inst. of Arthritis & Musculoskeletal & Skin Diseases (NIAMS)
• National Institute of Biomedical Imaging and Bioengineering (NIBIB)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• National Institute on Deafness & Other Communication Disorders (NIDCD)
• National Institute of Dental and Craniofacial Research (NIDCR)
• National Institute of Diabetes and Digestive& Kidney Diseases (NIDDK)
• National Institute on Drug Abuse (NIDA)
• National Institute of Environmental Health Sciences (NIEHS)
• National Institute of General Medical Sciences (NIGMS)
• National Institute of Mental Health (NIMH)
• National Institute on Minority Health and Health Disparities (NIMHD)
• National Institute of Neurological Disorders and Stroke (NINDS)
• National Institute of Nursing Research (NINR)
• National Library of Medicine (NLM)
[1] Public Health Service (PHS) agencies are AHRQ, ATSDR, CDC, FDA, HRSA, HIS, NIH, SAMHSA (a detailed list is on the last page), and are covered by a separate form – Financial Interest Disclosure – which can be found at bu.edu/orc/coi/forms/).