ACCREDITATION CRITERIA CONFLICT OF INTEREST CONTENT INTEGRITY Part I Conflict of Interest (COI) COI (Cont.) ANCC defines COI as existing when: An individual who has the ability to control content of an education activity has a relationship with a commercial interest organization, the products, and services of which are related to the content of the educational activity COI (Cont.) ANCC defines COI as existing when: ANCC considers relationships to be relevant if they existed within the past 12 months. Relationships of an individual’s spouse or significant other are also considered relevant. In other words, COI exists ONLY if there is a real or potential financial gain A Commercial Interest Organization (CIO) is NOT eligible for accreditation ANCC definition of a Commercial Interest Organization(CIO) AN ORGANIZATION THAT: ◦ Produces markets, sells or distributes health care goods or services consumed by or used on patients. ◦ Is owned or operated, in whole or in part, by an organization that produces, markets, sells or distributes health care goods or services consumed by or used on patients. ◦ Advocates for use of the products or services of a commercial interest organization. Exempt Organizations that do not have COI ◦ Government entity ◦ Non-profit 501c organizations ◦ Providers of clinical services directly to patients; including but not limited to, hospitals, health care agencies, and independent health care practitioners. Exempt Organizations that do not have COI ◦ Entity who the sole purpose is to improve or support the delivery of health care to patients; including but not limited to, providers or developers of electronic health information systems, database systems, and quality improvement systems. Exempt Organization that do not have COI (Cont.) ◦ Non-health care related entity whose primary mission is not producing, marketing, selling, or distributing health care goods or services consumed by or used on patients. ◦ Liability insurance providers ◦ Health insurance providers ◦ Group medical practices (2014 ANCC Content Integrity Standards) Exempt Organization that do not have COI (Cont.) ◦ Acute care hospitals (for profit and non-for-profit) ◦ Nursing homes (for profit and not-for-profit) ◦ Blood banks ◦ Diagnostic laboratories ◦ Employment with a college (2014 ANCC Content Integrity Standards) Related Organizations Which Have a COI ◦ Parent organization – organization that owns one or more subsidiary organizations. ◦ Parent organization that is a commercial interest organization. ◦ Subsidiary organization – organization owned by parent company which is a commercial organization. Related Organizations Which Have a COI (Cont) ◦ Sister organization – two organizations sharing a common parent organization (an organization may be eligible if it establishes and maintains adequate firewalls to shield said from sister organization that is a commercial interest organization). (2014 ANCC Content Integrity Standards) DISCLOSURE OF CONFLICT OF INTEREST (COI) It is critical that providers implement the following steps when planning educational activities: •Identify all individuals in a position to control content of the educational activity. •Collect and document any relationships that individuals in a position to control content have with any COI. •For individuals who have relationships with COI, evaluate whether the products and/or services of the COI are relevant to the content of the educational activity. •If relevant, the relationship must be resolved and disclosed to learners. DISCLOSURE OF CONFLICT OF INTEREST (COI) (Cont.) It is the responsibility of ALL involved with an educational activity to disclose if he/she is in a position to control or influence content of the educational activity. Any relationship declared with commercial interest organizations must be identified and evaluated for conflict of interest. If a potential or actual conflict is identified, they mus.t have a documented resolution mechanism. Disclosure must be placed on the Biographical/Conflict of Interest form. DISCLOSURE OF CONFLICT OF INTEREST (COI) (Cont.) It is the responsibility of the Nurse Planner to identify the presence or absence of actual or potential conflicts of interest and to resolve this issue during the planning and implementation phases of an educational activity. If the nurse has an actual or potential conflict of interest he or she must recuse self from the role as nurse planner for the educational activity. DISCLOSURES All Relevant Relationships Must be Disclosed to Learners: ◦ During the time the relationship is in effect. ◦ For 12 months after the relationship ends. ◦ Prior to the start of the educational activity. COI EXAMPLES Salary Royalties Intellectual property rights Consulting fees Ownership interest Grants Contracts Any other financial benefit received directly/indirectly from commercial interest organization STEPS TO RESOLVING COI Identify – individual with relationship with commercial organization (Includes spouse/significant other). It is the responsibility of the Nurse Planner to identify the presence or absence of actual or potential conflicts of interest and to resolve this issue during the planning and implementation phases of an educational activity. STEPS TO RESOLVING COI (Cont) Determine if there is a commercial interest relationship with planners, speakers, authors, content reviewers, and/or the spouse/partner. COI may include salary, royalties, intellectual property rights, consulting fees, ownership interest, grants, contracts or any other financial benefit directly or indirectly from a commercial interest. STEPS TO RESOLVING COI (Cont) Evaluate •No relationship •Relationship not relevant •Relevant relationship with resolution - Any individual who is in a position to control or influence the educational activity content must be evaluated from any association with commercial interest organization to determine if they may participate in the activity. STEPS TO RESOLVING COI (Cont) •Revising role of individual with COI so that the relationship is no longer relevant to activity •Not awarding continuing education contact hours for a portion or all of educational activity STEPS TO RESOLVING COI (Cont) •Undertake a review of activity by content reviewer to evaluate for potential bias, balance in presentation, evidence-based content or other indicator of integrity, and absence of bias, AND monitoring activity to evaluate for commercial bias. •Remove individual with COI from participating in all parts of the educational activity. Part II Content Integrity Content Integrity The content of a continuing nursing education activity or its related materials must promote improvements or quality in health care by giving a balanced view of therapeutic options. Activity Content Content must be planned to prevent bias by: ◦ Providing evidence of COI being identified, resolved and disclosed for all individuals in position on control content. ◦ Being evidence-based or chosen on best-available evidence ◦ Being planned independently from influence of commercial interest organizations. ◦ Being free from promotion or bias. Activity Content (Cont.) ◦ Should be congruent with purpose and objectives. ◦ Based on needs assessment and gap analysis. ◦ Provide information beyond restating objectives. ◦ Evidence-based or based on best-available sources (usually within last 6 years). For Additional Clarification Refer to ASNA’s Continuing Education Page (“resources”) http://alabamanurses.org/?page_id=12334 Or Contact: Ginger Collum, Nurse Peer Review Leader, ASNA collumva@gmail.com Charlene Roberson, Director of Leadership Services, ASNA charlenerasna@alabamanurses.org