Hello, I’m Renee Levinson, Associate Director of Continuing Education and today I will be speaking about the ASHA Continuing Education Board’s transparency requirement. This presentation was developed by Ellen Fagan, Director of ASHA CE. As a leader in your state association, you need to know about this new CEB requirement related to transparency and openness in course planning, delivery and marketing so your association can adhere to it. Most state associations are ASHA Approved CE Providers and if not, your association may offer your convention or courses with one of our approved providers for ASHA CEUs. Either way, it’s important that you know about this new requirement so you can provide resources to help your ASHA CE Administrator and your association meet the requirement. If you are a planner or presenter for an ASHA Approved CE Provider, you need to know about this requirement as well.

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Even though this session is not offered for ASHA CEUs, I want to model

a correct disclosure for you. This is Ellen Fagan’s disclosure slide and

it’s a good idea to prepare a slide like this for attendees in the course to

read while you verbally explain your financial and nonfinancial

relationships related to the course content. Doing a disclosure at the

beginning of the course is part of this new transparency requirement.

As a presenter in a course, it is required that you give your disclosure.

It’s also a good idea to tell the audience a little about yourself and

your background.

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Another important element to include in all courses is a slide and a summary about

what you hope the attendees will walk away with as a result of attending your

session. You should frame those things with action verbs and describe what the

learners will be able to do as a result of your presentation. This is referred to as

learning outcomes. All presentations offered for ASHA CEUs are required to have

learning outcomes. Listed on the slide are the learning outcomes I hope you

achieve as a result of participating in this webinar.

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So let’s talk about the overall requirement itself. ASHA CE

Providers must comply with 4 components of the

transparency requirement. So you have a better

understanding of the overall requirement, let’s briefly look at

those 4 components. They are (1) management of course

content, (2) management of conflicts of interest, (3)

management of financial and in-kind support, and (4)

management of exhibits and advertisements.

Next we will go into more detail about these 4 components

and what you need to know as the state association president,

as the CE administrator for your state association, or as a

planner or presenter in a course offered for ASHA CEUs.

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The first requirement you need to be aware of has to do with what

should be included in a course, session or poster session offered for

ASHA CEUs and what you are prohibited from including.

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You and the ASHA CE Provider are responsible for ensuring that the

course, session or poster session content is focused on the science or

practice of speech-language pathology, audiology or speech-language-

hearing sciences. Courses, sessions, and poster sessions offered for

ASHA CEUs cannot include marketing or selling of products, services,

equipment or devices. In the course, the speaker can talk about

theoretical aspects or the details of operation of products, devices and

services; however, they cannot cross over into marketing those devices

or services.

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Everyone involved in course or session planning and delivery,

including organizations providing financial or in-kind support,

must be diligent about controlling course content so that

there is no attempt to persuade learners to favor, use,

promote, or purchase a particular product, device or service.

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If a speaker uses devices or equipment in the course or session for teaching purposes, they cannot engage in promoting or selling that equipment or device during the instructional portion of the course or in the same place or space where the course or session is taking place. Another component of managing course content relates to courses that focus on teaching the operation or theoretical aspects of only one device, only one product, or only one service. In the spirit of transparency, potential attendees need to know that the course or session will be limited to one product or service or that there will be limited or no information about similar products or services. Therefore the Provider and the speaker must disclose prior to the course starting that the course or session is focused on one product or one service; indicate what that product or service is; and indicate, if applicable, that there will be limited or no information about similar products or services.

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So to recap, the first requirement you need to remember has to do

with appropriate course/session content. We talked about what a

course should focus on and what is prohibited, specifically marketing.

Also, a session focused on a single product or service should be

disclosed to attendees at the beginning of the course.

The second important requirement for CE Providers and presenters in

their courses has to do with disclosing instructional personnel financial

and nonfinancial relationships that are relevant to the course content.

Let’s talk about what your CE Administrator is responsible for related to

speaker disclosure and what responsibilities the speaker has.

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All course planners and presenters must provide financial and nonfinancial relationship disclosure information usually by completing a disclosure form provided by the ASHA CE Provider.

State associations that are ASHA Approved CE Providers filed an application addendum with the CEB in 2012. In the application addendum, the Providers described the process they would use to get disclosures, what form they would use, how they would resolve any conflicts of interest, and how they would make disclosures available in promotional materials. For instructions and forms related to collecting and reviewing disclosure information, contact your organization's ASHA CE administrator.

Once the speaker disclosure forms are filled out by the potential speakers, the provider will review the forms and determine what needs to be disclosed in promotional materials at the presentation.

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The Provider will publish each speaker’s disclosure information so it is available to potential attendees as they are making decisions about attending the course or convention. The disclosures must be in promotional materials, such as brochures, your website, email blasts, etc. For large events with multiple speakers, where putting the disclosure information on a printed brochure is not feasible, consider creating a web page with the disclosure information and then including a link to the disclosure information on the brochure. The disclosure statement the provider publishes should be the same information that the speaker uses in their disclosure statement at the beginning of the course.

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To ensure that attendees in courses understand relationships that speakers have with the course content, all speakers must give both a verbal and a written disclosure at the beginning of their session. This disclosure statement identifies the financial and nonfinancial relationships they have that pertain to the content they are presenting. For most courses, a speaker can introduce themselves at the beginning of the course and include in their introduction the disclosure statement. Since most presenters have slides, they should include the disclosure statement on the slide so people can read it as they are speaking about it. Then they would move right into the course content preferably providing learning outcomes first. Poster session presenters should post their printed disclosure statements either on their poster boards or alongside the poster board so they are readily visible and legible to people reading their poster. Poster presenters should make a verbal disclosure if they start a presentation with a group of people in front of their poster.

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There must be a disclosure statement at the beginning of the course for each speaker even if they have no financial or no nonfinancial relationships to disclose. If there are several people on the paper or poster being presented, each person affiliated with the course must make a disclosure even if they are not present or are not speaking.

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Disclosures made at each course or session must include the speaker’s name, their relevant financial relationships or lack thereof, and their relevant nonfinancial relationships or lack thereof. Even if someone has no relevant financial relationships and no relevant nonfinancial relationships, they must make a disclosure statement to that effect. So an important element to this requirement is that a disclosure statement is expected for each speaker. A speaker cannot remain silent on this issue. Each speaker must make a disclosure statement. You must also provide disclosures for each author, including those who are not presenting in person.

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What are relevant financial relationships? Financial relationships are those relationships in which you benefit by receiving a salary, royalty, intellectual property rights, gift, speaking fee, consulting fee, honorarium, stipend, ownership interest (e.g., stocks, stock options, or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial relationships also include "contracted research" where the institution gets the grant and manages the funds and the individual is the principal or named investigator on the grant. Remember, relevant financial relationships are those relationships that are relevant to the course content that is being delivered.

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What are relevant nonfinancial relationships? Examples of relevant nonfinancial relationships are those relationships that might bias a speaker, including any personal, professional, political, institutional, religious or other relationship. Again, a nonfinancial relationship is relevant if it pertains to the course content being delivered. Everyone has biases and sometimes attendees come to a session because of a speaker’s particular nonfinancial relationships or professional biases. So don’t think of nonfinancial relationships or bias as something that is particularly negative in nature.

The next slides will provide you with more detailed examples of common nonfinancial relationships. Remember, these are only examples.

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Two common types of nonfinancial relationships are those that are personal and those that are professional. Examples of personal nonfinancial relationships include perhaps having a friend who works for a company and you are mentioning that company’s products or services in your presentation. Or you may have a friend or family member with a disorder that you are talking about in your presentation. Speakers should think about whether those relationships bias them in some way and if so, they would want to disclose that relationship. Also they should think about whether an attendee would perceive a personal or professional nonfinancial relationship as relevant and if so, the speaker should disclose that relationship.

It is common for many of us to have professional nonfinancial relationships. You might be a member of or leader in a professional organization and that relationship might impact what you present and how you present information. You might support a particular mission or initiative of a professional organization and that relationship might bias you toward that organization.

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Sometimes political bias might come into play in course content. For example, if you were talking about the Affordable Care Act and had a bias toward supporting one political party’s position on the issue, that would be a nonfinancial relationship you would want to share with the audience.

Institutional relationships could be similar in nature to professional relationships. You may be affiliated with a particular institution like a university or hospital, or sit on their board or volunteer for them. If that relationship impacts the course content, disclose it.

Religious bias may impact course content in various topic areas. For example if you are talking about end of life decisions and interventions and you have a bias based on religious tenets or a belief system, that would be something to disclose as well.

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Next let’s look at some examples of disclosure statements that a speaker might make at the beginning of a course or session. These sample disclosure slides can be shared with potential speakers for your association as examples of how to put together a disclosure statement.

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Here is an example of a presenter’s disclosure slide used at the beginning of a course. I’ll read it to you in a minute. This presenter is showing the slide to the audience and speaking about the information on the slide prior to beginning the course. This presenter has relevant financial relationships to disclose but he has no relevant nonfinancial relationships to disclose. Let me read it to you.

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Here is another example of a presenter’s disclosure slide used at the beginning of a course. I’ll read it to you in a minute. This presenter is showing the slide to the audience prior to beginning the course while speaking about the information on the slide. This presenter has no relevant financial relationships but she does have a relevant nonfinancial relationship to disclose. Listen to her disclosure statement as I read it.

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Here is another example of a slide that a presenter is projecting to the audience while reading it. This presenter has no relevant financial relationships and no relevant nonfinancial relationships. Let me read the slide to you. Remember, every presenter must speak to these two areas, financial and nonfinancial relationships, and must make a disclosure statement verbally and in print.

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You can lay out your slide in a narrative format like the previous ones

or in a bulleted type format like the slide shown here.

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To recap, we have talked about appropriate course content and that you can not allow marketing in courses offered for ASHA CEUs. Second, we talked about required elements of speaker disclosures and that every speaker must make a verbal and printed disclosure. Last, let’s talk about in-kind and financial support for the course.

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The Transparency Requirement stipulates that all ASHA CE

Providers must disclose any financial or in-kind support that is

given by another organization to support or pay for all or part

of the CE course. As the state association president, CE

administrator, or as a planner or instructional personnel in a

course, it is important that you know about this part of the

requirement. If you are the planner or presenter of a course,

you need to make the CE administrator of the state

association aware of financial or in-kind support that another

organization is providing to pay for all or part of the CE course.

Financial or in-kind support is not prohibited; it just has to be

disclosed to learners. The CE administrator is responsible for

making that disclosure available.

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To recap, we have talked about appropriate course content and that you can not market in courses offered for ASHA CEUs. Second, we talked about required elements of speaker disclosures and that every speaker must make a verbal and printed disclosure. And third we talked about disclosing financial and in-kind support. Last, let’s talk about ads and exhibits.

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Exhibits and advertisements are prohibited in the place where the course or session or poster session is being delivered. No advertising should appear in slides, handouts, on walls or lecterns, placed on chairs or other places in the space or room where the course is taking place. Our members are well aware that vendors have websites and catalogs and separate exhibits where members enjoy talking to vendors and viewing the latest products and devices and services.

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If devices or products are used as part of the instruction of the course or session, there can be no selling or marketing of the devices, products or services in the course or in the space where the course is being delivered.

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There are certainly a number of new elements to be aware of with this new requirement but the CE staff at ASHA is available to answer your questions that are unique to your situation. Each state association is assigned a CE Provider Manager in the ASHA CE team to help you with CEB requirements. Your CE Administrator should know who that person is. If you and your CE administrator want to ask questions about how to implement this requirement in your state association, schedule a conference call with the ASHA CE Provider Manager and they will be glad to talk to you about your questions. Another option is to email us at the address above and your email will be directed to your organization’s Provider Manager. Thanks for your interest in the new requirement! We look forward to working with you as you implement it.

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