Federal Regulations and UNM Faculty Handbook E110 state that all principle investigators, co investigators, and anyone who can affect the "design, conduct, or reporting" of research, must file a disclosure. 

For the purposes of these regulations and policy, the following definitions are used: 
•Design of Research means the planning of the strategy to conduct the research/project.

•Conduct of Research means the supervision or management of a study’s execution. This can include the principleinvestigator or co-investigator, but may also be performed by postdoctoral fellows and graduate students who have significant supervisory roles over junior researchers or technicians who are part of the project.

1. Sponsored UNM research.

2. Nonsponsored UNM research that is:

a) Human subject research;
b) Animal subject research; or
c) Research funded by a formal award from internal UNM sources based on submission of a proposal.

Futhermore, Faculty Handbook E60: Sponsored Research states "Sponsored research shall be construed to include sponsored research, service, training projects, and other categories of awards for all except basic capital construction and maintenance projects."

Effectively, this means that all projects going through OSP, whether funded or unfunded, need a disclosure associated with them. 

a. Non-UNM investigators named as Key Personnel or identified by the PI as being able to affect the design, conduct, or reporting of research.  They must complete both project disclosures and annual disclosures.  This includes consultants named as Key Personnel on disclosures. 

b. Disclosures are required for HSC Personnel who are named as Key Personnel on a UNM project that is submitted through Main/ Branch Campus Office of Sponsored Projects.  Subawards to HSC are handled as any other Subaward. 

c. Subawardees do not require a disclosure until time the subaward is processed.  If the subawardee has completed the required COI disclosure at their home institution and their home has a COI disclosure process that comports with Federal regulations, they need not complete one at UNM. 

You will be required to submit a project disclosure for each proposal/award, IRB protocol, internally funded project or IACUC protocol. 

In theory, once you have completed a proposal disclosure, you should not have to complete any further disclosures (IP or award).  OSP has procedures in place that will allow them, and us, to track these disclosures.  Turning a disclosure in at the time of proposal will give us enough time to complete your review by the time of the award. 

These disclosures, along with their dispositions (whether they have been reviewed and the outcome of that review) will be included in their annual disclosure.  An annual disclosure will be required once per year. 

There are several reasons for the requirement for project disclosures. 

1. Federal funders, such as PHS/NIH and Department of Energy (including the National Labs) require a project disclosure to be submitted at the time of the proposal.  We expect that other agencies are going to similarly require project disclosures within the next several years. NASA has recently completed the comment period for new regulations regarding COI (and Conflict of Commitment) by funding recipients, and we expect their guidelines to be similar to those imposed by PHS/NIH and DOE. 
2. Streamline has changed the way we do disclosures. The COI module is largely project based and we cannot turn off this functionality for some projects and not others.  We have designed the project questionnaire, however, so that they are short, especially if you don't have funding from PHS/NIH or DOE. 
3. Collecting all disclosures from all projects gives us a more holistic view of your research in your annual disclosure because Streamline automatically imports your project disclosures into your annual, along with their dispositions (whether they have been reviewed and the outcome of that review). 

COI disclosures are considered current for the academic year unless there are changes to your disclosure that would require re-submission, such as a change in significant financial interests or a change in outside interests or activities.

You should.  Certifying a disclosure will automatically result in a notification from Streamlyne.  A certified disclosure is a submitted disclosure. Note this email will come from Streamline and not our office.  It will not appear if you have turned off certain email options in Streamline. 

The COI disclosure is reviewed by COI Staff and the COI Committee may have access to your information. 

 All disclosures are submitted through UNM's Electronic Research Administration, system, Streamline.  We recommend you access Streamline on our submittal page, to take advantage of resources there. 

Each disclosure will receive an initial review  COI Staff. If there are disclosable interests related to institutional responsibilities in a disclosure, it will be sent to the COI Committee for a limited review or full committee review. The committee will determine if measures are necessary to manage, reduce, or eliminate any potential or actual conflict of interest found in the disclosure and what form that will take. Notification of decisions are sent to investigators via e-mail/Streamline notifications. 

The COI Committee is a peer-review committee consisting of ten voting members, including a Chair. Members are senior faculty representing the diverse disciplines and colleges on campus, senior administration staff with responsibility for contracts from Main Campus, and two outside community members.

Notifications regarding decisions on disclosure content are sent by e-mail to the investigator. The names of investigators having disclosures that DO NOT have disclosable interests related to institutional responsibilities are included on the list of compliant investigators and require no further action unless the investigator has a change in their disclosable interests which require the submission or editing  a an Outside Interest/Family Collaboration form.  The Committee will decide if further action is needed in the form of a decision memo with stipulation or a management plan. Notification of committee decisions are sent to investigator via e-mail/Streamline notifications. 

A management plan is a formal document that lays out a plan to manage, reduce, and/or eliminate any potential or actual conflict of interest based on the details included in the disclosure. The plan will be issued by the COI Committee and must be signed by both the investigator and the assigned monitor.

An investigator may appeal a COI Committee decision to the Provost or their designee. No research expenditures will be made while the appeal is pending.

The committee can implement any of the following:

• Modification of the research protocol to mitigate or eliminate the conflict
• Involve an independent investigator to collect, analyze, and interpret the data
• Appoint a monitor to oversee the research
• Disclosure of the financial interest in publications and presentations
• Severance of the investigator's relationships that create the conflict
• Exclusion of the investigator from participation in some part of the research
• Blind trust escrow account

Any changes in disclosable interests must be submitted within 30 days of the change. You can report these changes by adding or updating an Outside Entity or Family Collaboration within Streamline..

Examples:

• An acquisition of a company or position within a company that has subject matter overlap with the investigator's research on behalf of the institution.
• Appointment on a board that has subject matter overlap with the investigator's research on behalf of the institution.
• Change in a funding agency that would make the investigator subject to the 2011 Public Health Services (PHS) regulations: 1. Promoting Objectivity in Research (42.C.F.R. Part 50 [go to Subpart F]) or 2. Responsible Prospective Contractors (45 CFR Part 94) or 3. DOE's Interim Conflict of Interest Policy Requirements for Financial Assistance. 

Streamline functionality will allow OSP staff to see the status of your disclosure in real time. 

Streamline functionality will allow IRB staff to see the status of your disclosure in real time.