1. I Am Trying to Download an Attachment to the Disclosure and It Does Not Appear to Be

1. I am trying to download an attachment to the disclosure and it does not appear to be working – what is wrong?

Documents (especially larger files) can take several seconds to download. Please allow time for the download to complete before moving on to the next question. If you continue to experience a problem, please contact the IS HelpLine (ext. 9-3456 or through the Self-Service Helpdesk -

2. What types of interests am I required to disclose? For example, do I need to disclose any ownership of stock or income from my spouse’s employment?

All disclosure questions are based on an investigator’s institutional responsibilities. If you, your spouse, or dependents hold interests that are not related to your institutional responsibilities, such interests do not require disclosure. If your or your family’s income or investments do not relate to your work at Marshfield Clinic, there is no need to disclose this income/remuneration.

3. Who is considered senior/key personnel?

As referenced in the 2011 revised regulation, “senior/key personnel” in NIH-funded research are defined as: “The Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by the Institution under the regulation.”

Typically, Research Coordinators are not listed as key personnel, but if you question your role, please check any grant you are working on to be certain you are not required to make a disclosure.

4. What defines an “investigator”? I participate in research, but I am not sure if I need to make a disclosure.

This is a great question, and important to understand. While it is essential for “investigators” to disclose, individuals who do not meet the definition should not complete the form, as it creates undue processing burdens. Read on for more info:

As defined by Marshfield Clinic’s Investigator Conflicts of Interest in Research policy, an Investigator is defined as: “the project director or principal investigator and any other person, regardless of title or position, who is responsible for (has an obligation to answer for) the design, conduct, or reporting of research. At a minimum, this includes anyone identified as senior or key personnel by Marshfield Clinic in a grant application, contract proposal, progress report, or any other reports submitted to a funding agency by Marshfield Clinic or anyone named as principal or co-investigator in an IRB application.“
Other individuals, who do not meet the definition of Investigator above, may question whether the activities they are involved in would categorize them as an Investigator. The following examples would not meet the definition of an Investigator:

• An individual who provides medical services that would normally be performed as part of routine clinical care. The clinician does not administer an investigational agent or use a research protocol to dictate the patient’s care. Data regarding adverse events that occur during that care may be collected by another investigator or research staff but not by the clinician providing the medical service.
• An individual informs prospective subjects about the availability of research, or provides them with information about the research but does not seek or obtain informed consent or act as an investigator’s representative.
• Research support staff who collect, analyze or summarize data under the direction of an Investigator. The Investigator has delegated the task to research support staff but not responsibility for the task.

NOTE: Please do not enter the disclosure form until you are certain of the need to complete it. Please contact Kathy Leick (ext. 1-8840) or Amanda Musson (ext. 9-3578) if you have questions. Emails may be sent to

5. I do not have any interests to disclose. Do I still need to fill out and submit the disclosure form?

Yes. Marshfield Clinic’s policy, and the regulation, states that investigators who "participated in Research over the previous 12 months" are required to complete the training (every 4 years) and the disclosure form (at least annually). If you have received a request to make a disclosure, our records show you were active on a research project(s) as an investigator in the past 12 months. Proper completion, along with your electronic signature confirming completion, is therefore needed.

6. I have not participated in research recently (within 1-12 months ago). Do I still need to fill out and submit the disclosure form?

Yes. Marshfield Clinic’s policy states that persons who "participated in Research over the previous 12 months" are required to complete the annual disclosure.

If you received a request to make a disclosure, our records show you were active on a research project(s) as an investigator in the past 12 months. If you are no longer involved in any research projects, please note that IRB policy requires that PI’s and Co-I’s be formally removed from IRB approved studies via an IRB amendment. Please ask the PI of each study to submit an IRB amendment to formally remove you from the study. Until your research involvement ends, you are required to provide "transactional" disclosures on newly required interests - an on-going obligation of investigators.

Once you reach 12 months without being listed as a PI, Co-I, or key personnel on a project, you will no longer receive the annual request to complete the disclosure.

7. Where can I find more information on the regulations and Marshfield Clinic’s Conflict of Interest policy?

The Investigator Conflicts of Interest in Research policy is based on regulatory requirements and can be found on the intranet in the Policy & Handbook Library:

• Marshfield Clinic Intranet home page  Reference tab  Policies, Handbooks, & Forms  Policies, Protocols, Procedures, & Guidelines  Search by Policy Number (2346.6) or Title
• Link to policy:

8. I thought I completed my annual disclosure form, but I’ve received notice that I’m not finished. What might be going on?

You may not have realized it, but all questions in each of the 7 disclosure categories (marked by tabs horizontally across the top of the form) must be answered. Completion of the Training module is required every 4 years; “new” investigators must complete it prior to proceeding to the disclosure form. Investigators’ electronic signatures are also required as a final step. Please re-enter your disclosure through the following link:

Once you are on the Home screen of the disclosure application, click on the “In Progress Disclosure” icon. This should bring you to the disclosure you started earlier. A bolded message at the bottom of the screen indicates which categories (Tabs) of questions are unfinished and need completion. Proceed through the unfinished categories, view your disclosure summary, click “Submit” and provide your electronic signature. Once you’ve completed the disclosure form, you will receive a confirmatory notice and link to your completed submission.

9. The requirement for disclosing reimbursed or sponsored travel is confusing.

• What does this entail?

• Reimbursed Travel involves travel expenses that are incurred and reimbursed directly to an investigator
• Sponsored Travel is travel paid on the behalf of the investigator, but not reimbursed directly to the investigator so that the exact monetary value is not readily available (and thus should be estimated).
• Note that the disclosure de minimis for Reimbursed or Sponsored Travel was recently increased from $0 to $5000 (aggregated over 12 months) from one entity. A recent policy change accommodating this was prompted by a suggestion from NIH, since some other categories use a $5000 de minimis.
• While the new de minimis reduces investigator burden of disclosing every occurrence of travel, a word of caution is advised: Investigators will benefit from tracking sponsored or reimbursed travel throughout the year, so that if it ever reaches $5000 from one entity, the required disclosure can be made.

• What types of travel are exempt from disclosure?

• Travel reimbursed directly from Marshfield Clinic or the investigator’s employer if not MC
• Travel that is reimbursed or sponsored by a Federal, state or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institution of higher education (does not need to be a legal affiliation.)
• Travel that has been delineated in grants, contracts, or clinical trial agreements with MCRF are required to be disclosed, but if it can be confirmed that the travel is a planned part of the study, and the sponsor gives a check to Marshfield Clinic to cover all costs, it will be deemed as an appropriate travel expense.

10. What qualifies as an “Institution of higher education?” (This is an exclusion noted in most categories within the disclosure form)

As defined in 20 USC 1001(a), an Educational Institution meets all of the following:

1. Admit only students that have graduated from a secondary education school, or recognized equivalent of such a certificate;
2. Legally authorized within a state to provide that education beyond secondary education;
3. Awards bachelor’s degrees and no less than a 2 year program that is acceptable toward such a degree, or awards a degree acceptable for admission into a professional degree program;
4. Is a public or non-profit institution; and
5. Is accredited, or granted pre-accreditation status, and the Secretary of Education has assurance that institution will meet accreditation within a reasonable time. Accreditation search:

11. If I need help, who can I contact for assistance?

• Please contact the Information System’s Helpline at extension 9-3456 if you experience technical issues with the Conflict of Interest Disclosure application.
• Please contact Kathleen Leick at ext. #1-8840 or Amanda Musson at ext. #9-3578 if you have questions about how to use the application or have questions about the disclosure form.
• Or, you may direct questions to .

12. How can I tell if I completed the training last year?

• If you completed an electronic disclosure form in the past 12 months, the training was also completed. The software provides a notation for the date completed. It is required every 4 years.
• The training module can always be re-reviewed without problem. It is brief, but a great refresher.

• You may contact Kathleen Leick at ext #1-8840 or Amanda Musson at ext #9-3578 with questions. Or – you may pose the question to:

13. I completed this 11 months ago. I don’t have to fill it out again until my completion anniversary – right?

• Unfortunately, we do need you to complete it on this year’s timeline. – Our software is not sophisticated enough to track each person’s annual entry and “individual” due dates. The regulation requires disclosure “at least every 12 months” and on-going disclosures within 30 days of acquiring a new interest, so it is an ongoing obligation for investigators. Other institutions also schedule an “annual launch” with completion requirement deadlines.

• Could you please complete the form at your earliest convenience? The form design is improved from last year, so you’ll find it much easier to use. You may contact Kathleen Leick at ext #1-8840 or Amanda Musson at ext #9-3578 for help. Or - you may pose the question to:

• If you have any questions or concerns – please don’t hesitate to contact me.