FAQ About the COIIR Questionnaire and Policy

Q. Where can I find the Policy?
A. It is located on this web site. Please use the "COI Policy" link on the right or you can call the Conflicts Officer at 3-2780 and he will send hard copy to whatever location you desire. PHS policy (42CFR§§50.603 and 50.604) is searchable at http://www.gpoaccess.gov/cfr/index.html.

Q. Why is it your business to know how much I receive from advising, consulting, licensing or any other activity outside of my normal Rush duties?
A. The Federal Government mandates an annual survey of this information in order to verify that its contractors are complying with guidelines for the avoidance of conflicts. Any conflict that exists and is not understood or properly managed by Rush can jeopardize the ability of Rush to do PHS-research and/or human subjects research. The COIIR Policy fulfills this requirement.

Q. Why do I need to fill this out?
A. The US government obligates all institutions and companies that receive federal funding to maintain policies related to conflicts of interest (42CFR§50.604). This includes an annual reporting obligation and proper management of conflicts that may exist. Rush maintains such a policy which further obligates its employees to make annual reports.

Q. I filled it out last year, why do I need to fill it out again?
A. The federal obligation renews each year thus each researcher at Rush is required to fill out the form every year. You are also responsible for updating this information every time you apply for a new PHS research award.

Q. Who should fill the form out?
A. According to PHS policy, any principal investigator and any other person who is responsible for the design, conduct or reporting of research funded by the PHS. This will include anyone with a Rush faculty appointment or persons who use Rush facilities to support their research or clinical activities. It may include post-doctoral fellows, technicians and/or students in your lab if they have independent responsibility for the design, conduct or reporting of funded research or if they are the awardee. If the post-doctoral fellow, technician and/or student is conducting PHS research under the supervision of a Rush faculty member and is not independent, they do not have to fill out this form.

According to Rush’s policy, for human subjects research any person involved in a human subjects research protocol that serves as a principal investigator or who is responsible for designing research, directing research, enrolling research subjects, obtaining subjects’ informed consent or making decisions related to eligibility to participate in research, analyzing or reporting research data, or submitting manuscripts concerning the research for publication. This will primarily be Rush faculty at all levels and includes adjunct faculty and affiliated physicians. It may include nurses, study coordinators and study directors to the extent that they have direct responsibility for the various phases of the human subjects protocol. This change from 2003 was made to further comply with Rush’s policy.

Q. My technician/study director/post-doc/etc. did not receive the form; does he/she need to fill it out?
A. The COIIR Committee cannot always determine if a staff member falls within the policy. As the PI, faculty member or physician responsible for the research, you should make the decision as to whether the person in question must fill out the form. The form is available on line; please direct your staff member to submit the questionnaire and we will add him/her to the list of recipients for future surveys.

Q. I filled some of this out when applying for my PHS- grant; why do I need to do so again?
A. The Conflicts Officer checks your responses against grant records to make sure that we are fulfilling our reporting obligations in advance of receiving federal funds for research. If there is gap in the reporting, the COIIR Committee will take steps to correct those errors and assure Rush’s compliance with federal guidelines.

Q. What is considered PHS-Research?
A. Federally funded research from any source (NIH, NSF, Defense, Energy, Education etc.). This includes direct awards and subcontracts from other institutions.

Q. I did not “Conduct Research” on human subjects or I did not have PHS-funded research last year, why do I need to fill this out again?
A. Circumstances may change from year to year; the lack of a conflict in one year does not automatically extend to subsequent years. Please note you are under additional obligations to notify the Committee if your situation changes during any year.

Q. I consider this confidential information; who has access to it?
A. Initially only the Conflicts Officer and the Administrative Assistant for the Associate VP for Research will see the full details of this survey. Procedures are in place to maintain your confidentiality and to limit access to the responses. If a conflict is determined to exist, the entire Committee must know of the conflict and such pertinent information as is needed to make a judgment. Steps for managing an identified conflict may include notifying the individual’s Department Chair or Section Director of the conflict. Other individuals with rights of access to certain information when a conflict exists include the Director of Sponsored Research Projects Office, IRB members and institutional officials.

Q. What if I do not wish to provide you with exact amounts that I have received from consulting, advising, etc.?
A. The policy limits your disclosure to amounts greater than $10,000 for salary, honoraria or consulting fees. Equity holdings that can be publicly valued have lower limits of $10,000 or 5%. There is no lower limit for licensing revenue. If you simply state that the amounts are “>$10,000” for any company, the COIIR Committee will not have sufficient information to make a decision other than that a conflict exists. By providing accurate information, the Committee has some flexibility in determining if a conflict exists. If you wish to avoid providing exact amounts, use the following ranges as a guide:

LEVEL	RANGE
A	>$10,000 but = $25,000
B	>$25,000 but = $50,000
C	>$50,000 but =$100,000
D	>$100,000 but =$250,000
E	>$250,000

Q. Are the values aggregate for all my interests? A. No, they are aggregate for each single firm or corporation based on the limits. For example, you and your family received more than $10,000 from Pfizer in salary, honoraria, etc. therefore it must be reported for Pfizer. However, you and your family received only $8,000 in salary, honoraria etc. from Merck, then you do not have to report for Merck.

Q. Do I need to report stock options? A. Yes, particularly when a value cannot be placed on the options. If the options were valued by a certified financial authority, then they will need to be reported only if they exceed the defined limits.

Q. I cannot accurately value my equity holdings in a start-up company; how shall I report these? A. You must report all of your, your spouses’ or your dependent children’s equity holdings in start-up companies that cannot be publicly valued. Report them as the number of shares and/or percentage ownership in the company.

Q. What about my equity holdings in 401(k), 403(b), IRA or other retirement accounts? A. Typically these will not count towards your total if they are not under your direct control but managed by fund managers. Only report those holdings that you, your spouse or your dependent children have a direct trading influence upon, such as those held in personal investment accounts or owner managed IRA’s and where they exceed the limits stated in the questionnaire.

Q. My remunerations from patents etc. are from licenses executed by my previous employer; do I still need to report these? A. Yes, but state that they are coming from patents etc, owned by your prior employer. You should always notify the IP Office at Rush of these relationships as soon as possible in case a question arises during your tenure at Rush. When you do so, the Director of the IP Office will be able to quickly determine whether a concern about this remuneration exists.

Q. What is a “rebuttable presumption”? A. The COIIR Committee will determine if a conflict exists based on your response to the form. If information is limited or not forthcoming, the decision will automatically apply that you are in conflict and that Rush must manage that conflict, possibly by removing your ability to Conduct Research on that subject, research program or competitor’s research. It may also impact your ability to apply for federal funding. You will have the opportunity to argue (rebut) the presumed conflict by demonstrating facts that will allow you to continue your research under conditions specified by the COIIR Committee.

Q. Why is this form so complex? A. Unfortunately, issues related to public law are almost always complicated. We do our best to obtain accurate information within the intent of the Policy and the law. After reviewing the forms and policies of other institutions, the COIIR Committee feels that this form is less complicated than those of our peers. However, we will always listen to your suggestions on how to make the form easier to use.

Q. How do I ask questions or make a suggestion about the COIIR Policy? A. The Committee is interested in hearing from you in order to make this process easier for all Rush employees. Send your comments to the Conflicts Officer, Matt Raymond, TOB Suite 456 either by e-mail, interoffice mail or by hand delivery. For questions, feel free to call Matt at 3-2780.