Frequently Asked Questions
Why does the American College of Cardiology (ACC) use the term "relationship with industry" instead of "conflict of interest?"
Although the ACC recognizes the need to disclose relationships for the purpose of transparency, it does NOT believe that these "relationships" are necessarily conflicts. When all relationships are disclosed with the appropriate detail regarding category and amount, and managed appropriately, the ACC believes that potential bias (conflict) can be avoided and that the ACC program or activity is strengthened since the necessary expertise is accessible.
Why does ACC require that members disclose ALL health care relationships with industry and other entities (RWI) on a yearly basis, whether they are relevant to a specific activity or program or not?
Unfortunately, there are those who judge the value or trustworthiness of a program, a product, or a position based on a perception (real or imagined) that the developer has an inherent conflict of interest. The College's RWI Policy is an effort to mitigate these perceptions of bias by providing total transparency of member's relationships for all ACC activities.
- What do I do when a relationship ends or I initiate a new relationship at some point throughout the year?
ACC created the Disclosure Database to make it easier for members to catalog activities and relationships in one place at one time. Members may be asked throughout the year to participate in a variety of activities on behalf of the ACC (all of which require disclosure of RWI) and can easily access the database at any time to update information. The ACC Disclosure Database a "one-stop-shop" for members to record their RWI in one place at one time with easy access and full reporting to all staff for all programs. No need to fill out multiple forms, repeating much of the same information, for every ACC activity.
- How do I know when/if an RWI is considered a conflict of interest (relevant) for a specific activity and what should I do if it is?
Again, any RWI, even if it is deemed "relevant" for a specific program or activity, is not necessarily a conflict of interest. Each program or activity of the ACC will review all RWI and identify/notify each participant if/when an RWI is considered relevant for a given activity and how that relevancy impacts the program or activity.
REMEMBER that ACC's RWI Policy is 2-tiered process: Tier 1 is the process of disclosing ALL RWI into ACC's Disclosure Database. Tier 2 is the process of reviewing each relationship for the purpose of judging if it's relevant to a specific topic/activity. This is done by ACC staff and leadership and may vary for a given ACC activity (such as writing an article for CardioSource, speaking at an ACC educational program, or authoring a guideline).
- I still don't understand how my RWI impacts what I do for the College.
Your RWI impacts you differently depending on what ACC activity you are involved in. For examples, members of an ACC committee or task force are asked to voluntarily recuse themselves from participation in discussions if the committee takes under consideration an issue where a relationship could be perceived as relevant. In these cases, you are on the honor system and it is your responsibility to notify the Chair. If you are invited to speak at ACC CME educational program, you will be required to list all relevant RWI on a slide and disclose on all printed materials. If you are invited to participate on a guideline writing panel, you may not write or vote on any recommendations (or explanatory text) if you have an RWI that is deemed as relevant. In all of these examples, staff will inform you in advance and help facilitate adherence to the policy.
- Do I have to list relationships even though I never received any honoraria or travel expenses?
Yes. Although we are providing information on whether a member was paid or not, it is the "relationship" with a company/vendor/sponsor that could be perceived by others as a "conflict of interest." Again, just because an RWI exists (and must be disclosed) does not necessarily mean that it is relevant for a given ACC activity/situation.
- What if I was a speaker or consultant but received no honoraria or travel support, do I still have to include it in the database.
Unless the activity was provided by an accredited ACCME provider (such as ACC or AHA), if it was funded by industry, you still must disclose it. All accredited ACCME activities are excluded from disclosure since they are subject to separate and distinct policies and procedures.
- I thought that if a company/organization was a "not for profit" that "it didn't count." I am on a DSMB for clinical trial sponsored by NIH. Do I have to list it?
Yes, it must be disclosed. The ONLY exclusion for a "non-profit" company relates to ACCME accreditation (see FAQ #7). In the case of participation on an NIH DSMB, it must be disclosed although it likely will NOT be considered relevant depending on the activity/subject in which you participate. Staff will review any/all RWI and notify you if any are considered relevant.
- If I was a speaker or consultant but I requested that my honoraria be donated to a charity (and I did not self-designate the charity) do I still need to list it?
Yes, it must be disclosed.
- What if I participated in research that was funded by industry but I don't think it is relevant to the program/activity in which I am participating.
It still must be disclosed. ALL RWI must be disclosed. The staff and leadership for the specific activity/program will determine if/when the research is relevant or not relevant for the given ACC activity/program.
- Do I have to disclose travel reimbursement?
Yes, unless the program is ACCME-accredited…then you do not.
- If I was a speaker at a program that was sponsored by a non-profit company but funded by an educational grant from a drug company or other for-profit company, do I still need to disclose it?
Yes – UNLESS the sponsor of the program was an ACCME-accredited provider (such as ACC or AHA) in which case it is excluded from disclosure regardless of where the funding came from.
- My institution is participating in a cardiology-related clinical trial but I am not involved in any way in the trial. Do I need to disclose it as a relationship in the ACC database?
If any area for which you have direct decision-making responsibility receives any funding as a result of the trial, the relationship must be disclosed. It should be listed as an "institutional relationship" and may or may not be considered relevant depending on the ACC content/activity in which you are engaged.
- My institution is participating in a clinical trial and I am designated as a PI on the trial. Do I need to disclose it as an institutional relationship or a personal relationship?
YES, whether uou are PI, a co-PI, an investigator, a steering committee member, a collaborator or a consultant you must disclose the relationship as a "personal (research) relationship." Another way of thinking about it is: 1) if you are/will be co-author of data analyses including abstracts and manuscripts related to the trial, or; 2) if you have oversight of the research, report data, or receive money from the trial sponsor (including direct salary support and/or staff salary support [including staff that you share], overhead charges), or; 3) receive travel funds to attend investigator meetings hosted by the sponsor. In each of these examples, the relationship should be disclosed as a "personal relationship" and not an "institutional relationship" in ACC's Disclosure Database.
- What if my institution is recruiting patients and I am not involved in the trial in any way but I had to sign a Form 1572 because some of patients are being recruited, do I need to list in the ACC database?
No. If your institution is recruiting patients only and your participation does NOT include any of the scenarios listed in FAQ #14, you do not have to list it as an institutional or personal RWI.
- What if the clinical trial is funded by NIH? Do I still need to disclose it?
If you answered YES to any of the examples in FAQ #14, then the answer is YES, it still must be included in the ACC database. If you answered YES to FAQ #15, however, then the answer is NO, you do NOT have to include in the ACC database.
- What if my institution receives industry funding for cardiology fellowships or other cardiology programs and products?
If the industry dollars support any program or product for which you have direct decision-making responsibility, then YES, it should be disclosed as an "institutional relationship."
- Should members declare if they are "PI mentors?"
If the PI mentorship is sponsored by a non-profit company/organization, it does NOT have to be listed as an RWI. However, if the PI mentorship is for an industry-funded effort, it should only be declared if the mentor receives formal funding through the award, financial compensation for consulting, or is in a position of authority to direct the spending of the funds.
- What if I am a consultant for a drug company?
The disclosure database requires that you provide the name of your employer. If you are a consultant, for a drug company for which you receive a 1099, that relationship must be disclosed. If you are actually employed by a drug company, you may be precluded from participating in certain ACC activities, such as participating on a guideline writing panel, by virtue of your employment.