1

APPENDIX G

American Nurses Credentialing Center’s

Content Integrity Standards

For Industry Support in Continuing Nursing Educational Activities

(Effective date: 1/1/2013)

(Updated: 5/1/2013)

(Updated: 8/8/2014)

A.Introduction

B.Definition ofa CommercialInterestOrganization

C.RelatedOrganizations

1.Separatefederaltax IDnumber

2.Separatelegal entity

3.Operationalstructureseparation

a.Phone,faxline,email

b.Web sites/linksto websites;

c.Electronicdatabasesand hard copydocuments;

d.Writtenpoliciesand procedures

e.Governancestructureandpersonnel;

f.Independent decisionmaking

4.Controlofeducationalcontent

D.TypesofCommercialSupportforContinuing Nursing EducationalActivities

1.Financial Support

2.“In-Kind”Support

E.Ensuring ContentIntegrityof an EducationalActivity in thePresenceof Commercial Support

1.Writtenagreementbetween Commercial InterestandProvider

2.Payments

3.UnusedFunds

4.Accountingof Expenses

5.JointProvidership

F.Conflictof InterestEvaluation andResolution

G.AdditionalCriteriaforEnsuring ContentIntegrity

1.Promotion

2.Advertisements

3.Recruitment

4.Confidentiality

5.Advertising anEducationalActivity

6.AcknowledgementofCommercialSupport

7.Distribution oftheEducationalActivity

8.ContentoftheEducationalActivity

a.Slides,handoutsorothermaterials

b.Live(in-person)activities –Logos andtrademarks

c.Enduring materials- Logosand trademarks

d.Web-basedmaterials–Logos andtrademarks

e.Evaluations

f.Learnerrecruitment

H.Exhibits,Promotions andSales

I.Giveaways

J.Failure to Comply

K.Complaints

A.Introduction

The American NursesCredentialing Center’sContentIntegrityStandards forIndustrySupport inContinuing Nursing EducationalActivitiesserves as aresourceforProviders*toplan,implementand evaluatequality continuing nursing educationalactivitieswithintegrity,freefromthe undueinfluence ofcommercial interestorganizations.Federal law,corevaluesfortheAccreditationProgram (2009 and2013Application Manuals,AccreditationProgram)andtheCodeof EthicsforNurseswith InterpretiveStatements(ANA,2001)create thefoundation forthese standards,which aredesigned to helpProviderscomplywith Food andDrugAdministration Guidanceon Industry-Supported Scientific andEducationalActivities.

*”Provider”referstoan ANCCAccreditedProvideroran organization orindividual

approved byan ANCCAccreditedApprover(ApprovedProviderorIndividualActivityApplicant).

B.Definition of a CommercialInterestOrganization

TheAmericanNursesCredentialing Center(ANCC)defines an organization ashaving acommercialinterest(“CommercialInterestOrganization”)* if it:

  • Produces,markets,sellsordistributeshealth caregoods or servicesconsumedby orused on patients;
  • Is owned oroperated,in wholeor inpart,by an organization thatproduces,markets,sellsor distributeshealthcaregoodsor servicesconsumedbyorusedon patients; or
  • Advocatesforuse of theproductsor servicesofcommercial interestorganizations.

(*Reference: AccreditationCouncilforContinuing Medical Education(ACCME)Standards of CommercialSupport,August2007( -ANCC’sdefinition isintendedtoensurecompliancewithFood andDrug Administration GuidanceonIndustry-Supported Scientific andEducationalActivities andconsistencywith theACCMEdefinition)

Commercial InterestOrganizationsareineligibleforaccreditation.

Anorganization isNOTa Commercial InterestOrganization* ifit is:

  • A governmententity;
  • A non-profit(503(c))organization;
  • A providerof clinical servicesdirectly to patients,including but not limitedto hospitals,health careagencies andindependent healthcarepractitioners;
  • Anentity thesolepurposeof whichis toimproveorsupport thedeliveryof health caretopatients, including butnotlimitedtoprovidersordevelopersofelectronichealthinformationsystems,databasesystems,andqualityimprovement systems;
  • A non-healthcarerelatedentity whoseprimarymission is notproducing,marketing orselling or distributing health care goodsorservicesconsumed byorusedon patients.
  • Liabilityinsuranceproviders
  • Health insuranceproviders
  • Groupmedicalpractices
  • Acutecarehospitals(forprofit andnotforprofit)
  • Rehabilitation centers(forprofit andnotforprofit)
  • Nursing homes(forprofitand notforprofit)
  • Bloodbanks
  • Diagnosticlaboratories

(*Reference: AccreditationCouncilforContinuing Medical Education(ACCME)Standards of CommercialSupport,August2007( -ANCC’sdefinition isintendedtoensurecompliancewithFood andDrug Administration GuidanceonIndustry-Supported Scientific andEducationalActivities andconsistencywith theACCMEdefinition)

C.RelatedOrganizations

ParentOrganization–Anorganization thatowns oneormoresubsidiaryorganizations.A parentorganizationthatis a Commercial InterestOrganization isnoteligibleforaccreditation.

SubsidiaryOrganization–An organizationthat isowned bya parentcompany.Asubsidiary ofa CommercialInterestOrganization is noteligibleforaccreditation.

SisterOrganizations–Two organizationsthat share acommon parentownerare“sisterorganizations.” Anorganizationmaybe eligibleforaccreditationifitestablishes andmaintains anadequatecorporatefirewall toshield itfromtheinfluenceof asisterorganizationthat isa CommercialInterestOrganization.

Adequacyof acorporatefirewallwill beevaluated byexamining evidencedemonstratingindependence,based onthefollowingfactors:

1.Thecommercial interestorganization andits non-commercialinterestsisterorganization(the“educationalorganization”)haveseparatefederaltax IDnumbers;

2.Thecommercial interestorganization andtheeducationalorganization areseparate legalentities;

3.Theoperationalstructureofthecommercial interestorganization andtheeducationalorganization areseparateand distinct,including butnotlimitedto:

  • Phone,faxand email communication;
  • Web sites/linksto websites;
  • Electronic andhard copydocuments;
  • Writtenpoliciesand procedures thatmayimpactthedeliveryofcontinuing education;
  • Separategovernancestructures andpersonnel; and
  • Independence in decisionmaking;

4.Educationalcontentforactivitiesis planned, developed,implemented andcontrolledexclusivelybytheeducationalorganization.Thecommercialinterestorganization mayhavenoinfluenceovercontentof theeducationalactivity.

D.TypesofCommercialSupportforContinuingNursingEducationalActivities

Commercial InterestOrganizationsmayprovidemonetaryfunding orothersupport(“CommercialSupport”)forcontinuing nursing educationalactivitiesin accordancewith thefollowingfundamentalprinciples:

(1)Commercial Supportmustnotinfluencethe planning,development,content,implementationorevaluation ofan educationalactivity;AND

(2)Receipt ofCommercialSupportmustbedisclosedtolearners.

Commercial Supportmaybeusedtopayfor allor part of aneducationalactivityand forexpensesdirectlyrelatedtotheeducationalactivity,including but not limitedto:travel,honoraria,food,supportforlearnerattendanceand locationexpenses.Commercial Supportmaybeusedtosupportmorethanoneeducationalactivity atthesametimeormultipleactivitiesover aperiodoftime.

Commercial Support is:

1.Financial Support-money suppliedbya Commercial InterestOrganization tobeusedbya Providerforexpensesrelated totheeducationalactivity.Financialsupportmaybeprovidedas an unrestricted grant,educationalgrant,donationorscholarship.

2.“In-Kind”Support–materials,spaceorothernon-monetaryresourcesorservicesusedby aProviderto conductan educationalactivity;which mayincludeand is notlimitedtohuman resources,marketing services,physical space,equipmentsuch asaudio-visualmaterials andteaching tools(forexample,anatomicmodels).In-kind donationsmay not bearthetradenames,logosorotheridentifying insignia of theCommercial InterestOrganization.In-kind supportmaynotincludepromotionof goodsorservicesoftheCommercial InterestOrganization.In theeventthatthetradename,logo orotheridentifying insigniacannotberemoved(i.e.embedded in the pieceof equipment),theProvidermustensurethatlearnersareawareof similarproductsproducedby othercompanies. In addition,disclosureofthe in-kind donationmustbeprovidedtolearners.

E.EnsuringContentIntegrityofan EducationalActivityin the PresenceofCommercialSupport

Commercial InterestOrganizationsproviding Commercial Supportforcontinuingeducationalactivitiesmaynotinfluencetheplanning,implementation orevaluation ofan educationalactivity.Thefollowingrequirementsto ensurecontentintegritymustbesatisfied bytheProviderwhen CommercialSupport is accepted:

1.WrittenAgreement.There mustbe awritten agreement between a CommercialInterestOrganizationproviding Commercial Supportand theProviderutilizingCommercial Support. The writtenagreementmustinclude the following:

a.Nameofthe Commercial InterestOrganization;

b.NameoftheProvider;

c.Completedescriptionof allCommercialSupportprovided, including bothfinancial andin-kind support;

d.Statementthatthe Commercial InterestOrganizationwill notparticipate inplanning,developing,implementing or evaluating theeducationalactivity;

e.Statementthatthe Commercial InterestOrganizationwill notrecruitlearnersfromtheeducationalactivityfor anypurpose;

f.Descriptionof howCommercial SupportmustbeusedbytheProvider

i.UnrestrictedUse: Commercial Supportgivenfreelyand withoutconstraintby the Commercial InterestOrganization and theProvider has solediscretionto administerCommercial Supportas appropriateforplanning,developing,implementing orevaluating theeducationalactivity;

ii.Restricted Use: CommercialSupportgiventosupporta specificaspectof aneducationalactivitysuch as meals, breakoutsessionsor speakerhonoraria

g.Signature of adulyauthorizedrepresentativeoftheCommercial InterestOrganization withauthoritytoenterintobinding contractson behalfof theCommercial InterestOrganization;

h.Signature of adulyauthorizedrepresentativeof the Providerwithauthority toenter intobinding contracts on behalfoftheProvider;and

i.Dateonwhich thewrittenagreementwas signed.

2.Payments. AllpaymentsforexpensesrelatedtotheeducationalactivitymustbemadebytheProvider. TheProvidermustkeep a recordofall paymentsmadeusingCommercial Supportfunding.Commercial Supportfunds mayonlybeusedtosupportexpensesdirectlyrelatedtotheeducationalactivity.

3.UnusedFunds. TheCommercial InterestOrganizationmayrequestthereturnofunusedCommercial Supportfunds.

4.Accountingof Expenses.TheCommercialInterestOrganization mayrequestthat theProvidersubmita recordofhowCommercialSupportfundingwas spent.

5.JointProvidership. Intheeventthatmorethantwo organizationswillbeproviding aneducationalactivityreceiving Commercial Support(jointlyproviding),theorganizationidentified asthe“Provider” ofthe activity isresponsible formanaging CommercialSupportfunds in adherence withthe ANCCAccreditation criteria.A CommercialInterestOrganizationmaynotjointlyprovide educationalactivities.

F.ConflictsofInterestEvaluation and Resolution

Thepotentialforconflictsof interestexistswhenan individualhastheabilityto controlorinfluence thecontentof aneducationalactivityandhas a financial relationship withacommercialinterest,*theproductsor servicesofwhich arepertinent to the content oftheeducationalactivity.TheNursePlanneris responsibleforevaluating thepresenceor absenceofconflictsofinterestand resolvinganyidentifiedactualor potentialconflictsof interestduringthe planning andimplementation phasesof an educationalactivity. Ifthe NursePlannerhas anactualorpotentialconflictof interest,heor sheshouldrecuse himself orherselffromtheroleas NursePlannerfortheeducationalactivity.

*Commercialinterest, asdefinedbyANCC,is anyentityproducing,marketing,reselling, ordistributing healthcaregoods or servicesconsumedby or used on patients,oranentitythat isownedorcontrolledbyanentitythatproduces,markets,resells,ordistributeshealthcaregoodsor servicesconsumedbyorused onpatients.Nonprofit orgovernmentorganizations,non-healthcare-relatedcompanies, and healthcarefacilitiesare notconsideredcommercial interests.

Employees ofcommercial interestorganizationsarenotpermitted toserveas planners,speakers,presenters,authorsand/orcontent reviewers if thecontentoftheeducationalactivity is relatedto theproductsorservicesof thecommercial interestorganization.

Employees ofcommercial interestorganizations arepermittedtoserve as planners,speakers,presenters,authorsand/orcontent reviewers if thecontentoftheeducationalactivity is NOTrelatedtothe productsofthecommercial interestorganization.

Individuals who have non-employeerelationships withcommercial interestorganizations(seebullet2below)arepermitted toserveasplanners,speakers,presenters,authorsand/orcontent reviewersas longas theProviderhasimplementeda mechanismtoidentify,resolveand disclosetherelationship asoutlined in thesestandards.

TheNursePlanner isresponsible forensuring that allindividuals whohave theabilitytocontrolor influencethecontentofan educationalactivitydiscloseall relationshipswith anycommercialinterest,including but notlimitedto membersofthePlanning Committee,speakers,presenters,authors,and/orcontentreviewers.Relevantrelationships**mustbedisclosedtothelearnersduring thetimewhentherelationship isin effectandfor 12monthsafterward.All informationdisclosedmustbesharedwith theparticipants/learnerspriortothestart oftheeducationalactivity.

**Relevantrelationships,asdefinedbyANCC,arerelationshipswith a commercialinterest if theproductsor servicesofthecommercial interestarerelated tothecontentoftheeducationalactivity.

  • Relationships withanycommercialinterestofthe individual’sspouse/partnermayberelevantrelationships andmustbereported,evaluated, andresolved.
  • Evidenceofa relevantrelationship withacommercial interestmayincludebut isnotlimitedto receiving asalary,royalty,intellectualpropertyrights,consulting fee,honoraria,ownership interest(stockand stockoptions,excluding diversifiedmutualfunds),grants,contracts,orotherfinancial benefitdirectlyorindirectlyfromthecommercial interest.
  • Financial benefits maybeassociated withemployment,managementpositions,independent contractorrelationships,othercontractualrelationships,consulting,speaking,teaching,membership onan advisorycommitteeorreviewpanel,boardmembership, andotheractivitiesfrom whichremuneration isreceivedorexpected fromthe commercial interest.

Evaluation

TheNursePlanner isresponsible forevaluating whether any relationship witha commercialinterestis consideredrelevant to thecontentofthe educationalactivity.Disclosuresmaybecategorized in thefollowing ways:

  • Norelationship with a commercialinterestexists.Noresolution required.
  • Relationship withacommercial interestexists.Therelationship with thecommercialinterestis evaluatedbytheNursePlannerand determinednotto berelevanttothecontentoftheeducationalactivity.Noresolution required.
  • Relevantrelationshipwitha commercialinterestexists.Therelevantrelationshipisevaluatedbythe NursePlannerand determinedto bepertinentto thecontentoftheeducationalactivity.Resolution is required.

Resolution and ActivityAssessment

Actionstakentoresolveconflicts ofinterestmustdemonstrateresolution oftheidentifiedconflictsofinterestprior topresenting/providing the educationalactivitytolearners. Suchactionsmustbedocumented andthedocumentationmustdemonstrate(1)theidentifiedconflict,and(2)howtheconflictwasresolved. Actionsmayincludebutare notlimitedto thefollowing:

  • Removing theindividualwithconflictsof interestfromparticipating in allparts oftheeducationalactivity.
  • Revisingthe roleofthe individual withconflictsof interestso that therelationship is nolongerrelevanttotheeducationalactivity.
  • Not awarding continuing education contacthoursfora portionor allof theeducationalactivity.
  • Undertaking reviewof theeducationalactivitybyacontentreviewerto evaluateforpotentialbias,balancein presentation,evidence-based contentorother indicator ofintegrity,andabsenceofbias,AND monitoringtheeducationalactivity to evaluateforcommercial biasin thepresentation.
  • Undertaking reviewof theeducationalactivitybyacontentreviewerto evaluateforpotentialbias,balancein presentation,evidence-based contentorother indicator ofintegrity,andabsenceofbias,ANDreviewing participantfeedbacktoevaluateforcommercial biasin theactivity.

Disclosure

Individualsrefusingto discloserelationshipswith CommercialInterestOrganizationsmay notparticipate in anypartoftheeducationalactivity.

G.AdditionalCriteria forEnsuringContentIntegrity

1.Promotion. A CommercialInterestOrganizationmaynot promote itsgoodsor servicesinrelationtothecontentof an educationalactivityatanytimeduring which theeducationalactivitytakesplace including theintroduction andconclusionofthe activity,regardlessof theformatofthe educationalactivity.

2.Advertisements forthe Commercial InterestOrganization. Advertisementspromotingthe productsor servicesofa CommercialInterestOrganization in relationto thecontentof aneducationalactivitymustbephysicallyseparatedfrom the educationalactivity,regardlessof theformatofthe educationalactivity.

3.Recruitment.A CommercialInterestOrganization\maynotrecruitlearnersfromanaudiencefor anyreason.

4.Confidentiality.Providersmaynotsharecontactinformation related tolearnerswithoutwritten permissionfromthelearner.

5.Advertising anEducationalActivity. ACommercialInterestOrganizationmayadvertisean educationalactivityforwhichit hasgivenCommercial Support.Examplesofadvertisingmayincludebut are notlimitedto:SavetheDatecards,flyersandemails.

6.AcknowledgementofCommercialSupport. ProvidersmayacknowledgeCommercialSupportprovidedbya CommercialInterestOrganization onmarketingmaterialsfortheeducationalactivity.

7.Distribution oftheEducationalActivity. A CommercialInterestOrganizationmaynotdistributeeducationalactivitiesdirectlyto learners.

8.ContentoftheEducationalActivity. Content isthe responsibilityof the Providerof theeducationalactivity.Allmaterialsused fortheeducationalactivitymustbefreefromcommercialbias.Toguardagainstthe presenceofcommercial bias,theProviderisresponsibleforensuring thefollowing:

a.Slides,handoutsorothermaterialspresentedto thelearnerrelatedto theeducationalactivitydonotdisplayanylogosor othertrademarksof aCommercial InterestOrganization;

b.Live(in-person)educationalactivities are presentedwithoutreferencetoaCommercial InterestOrganization;acknowledgementof commercial support islimitedto thename oftheentityprovidingsupport

c.Enduring materialsdonotincludelogos,trademarksorotherinsigniaof, orreferencesto,a CommercialInterestOrganization;acknowledgementofcommercialsupport islimited to thenameof theentityprovidingsupport

d.Web-basedmaterialsdonotincludelogos,othertrademarksorother insigniaof,or referenceto, aCommercialInterestOrganization;acknowledgementofcommercialsupport islimited to thenameof theentityprovidingsupport

e.Evaluationsof theeducationalactivity makenoreferencetoa CommercialInterestOrganizationor itsproductsor services; and

f.Learnersarenotrecruitedfor anypurposeduring theactivityorevaluation.

H.Exhibits,Promotionsand Sales

Commercial InterestOrganizationsmaynotexhibit,promoteor sellproductsor servicesduringthe introductionofan educationalactivity,whiletheeducationalactivitytakesplace or attheconclusion ofan educationalactivity,regardless oftheformat oftheeducationalactivity. Exhibits, promotion andsalesmustbeseparatedfromthe educationalactivity.Thefollowingstandardsapplyto exhibiting,promoting andselling productsor services:

  • Exhibiting,promoting andselling productsmaynottakeplace during aneducationalactivity;
  • Marketing or advertising for exhibits, promotions or sales may not be included within educational activity content (e.g., slides, handouts, enduring materials).
  • Marketing or advertisement for exhibits, promotions or sales must take place in a location that is physically separated from the area where educational content is delivered.

I.Giveaways

Commercial Interest Organizations may provide giveaways for learners, as long as there is physical separation between accessing the giveaway and learner engagement in the educational activity. Educational materials for an activity may not be packaged in items bearing logos, trademarks of a Commercial Interest Organization.

J.Failure to Comply

Failure to comply with the American Nurses Credentialing Center’s Content Integrity Standards for Industry Support in Continuing Nursing Educational Activities may result in suspension or revocation of accreditation or approval.

K.Complaints

All complaints related to a Provider’s compliance with the American Nurses Credentialing Center’s Content Integrity Standards for Industry Support in Continuing Nursing Educational Activities will be investigated by the ANCC Accreditation Program Office.

Reprinted with permission from ANCC Accreditation Program.

American Nurses Credentialing Center, 8515 Georgia Ave., Suite 400, Silver Spring, MD 20910 / 1-800-284-2378 / nursecredentialing.org

OHIO NURSES ASSOCIATION

CONTINUING EDUCATION APPROVER COUNCIL

Commercial Support Decision Tree

YESNO

Sample commercial support agreement

Approved Provider

Commercial Support Agreement

A commercial interest, as defined by the American Nurse's Credentialing Center (ANCC), is any entity producing, marketing, reselling, or distributing healthcare goods or services consumed by or used on patients, or an entity that is owned or controlled by an entity that produces, markets, resells, or distributes healthcare goods or services consumed by or used on patients. Nonprofit or government organizations, non-healthcare-related companies, and healthcare facilities are not considered commercial interests.

Commercial support is financial or in-kind contributions given by a commercial interest that are used to pay for all or part of the costs of a CNE activity.

Note: Organizations providing commercial support may not provide or joint provide an educational activity.

Title of Educational Activity:
Activity Location (if live): / Activity Date (if live):
Name of Commercial Interest Organization:
Name of Approved Provider:
Total amount of Commercial Support:
Area(s) of activity Commercial Interest organization would like to support:
Unrestricted
Restricted*
  • Speaker honoraria
  • Speaker expenses
  • Meal
  • Other (please list):

* Commercial interest may request that funds be used to support a specific part of an educational activity. The Approved Provider may choose to accept the restriction or not accept the commercial support. The Approved Provider maintains responsibility for all decisions related to the activity as described below.

Terms and Conditions
1. / All organizations must comply with the ANCC Content Integrity Standards for Industry Support in Continuing Educational Activities which is available on the ANCC Accreditation web page.
2. / This activity is for educational purposes only and will not promote any proprietary interest of a Commercial Interest organization providing financial or in-kind support.
3. / The Approved Provider is responsible for all decisions related to the educational activity. The Commercial Interest organization providing financial or in-kind support may not participate in any component of the planning process of an educational activity, including:
  • Assessment of learning needs
  • Selection or development of content
  • Selection of planners, presenters, faculty, authors and/or content reviewers
  • Selection of teaching/learning strategies
  • Evaluation methods

4. / The Approved Provider will make all decisions regarding the disposition and disbursement of commercial support in accordance with ANCC criteria.
5. / All commercial support associated with this activity will be given with the full knowledge and consent of the Approved Provider. No other payments shall be given to any individuals involved with the supported educational activity.
6. / Commercial support will be disclosed to the participants of the educational activity.
7. / Commercial Interest Organizations may not exhibit, promote or sell products or services during the introduction of an educational activity, while the educational activity takes place or at the conclusion of an educational activity, regardless of the format of the educational activity.

Statement of Understanding

An “X” in the boxes below serves as the electronic signatures of the representatives duly authorized to enter into agreements on behalf of the organizations listed and indicates agreement of the terms and conditions listed in the Commercial Support Agreement above.

Approved Provider Name:
Address:
Name of Representative:
Email Address:
Phone Number:
Fax Number:
Electronic Signature (Required) Date:
Completed By:
(Name and Credentials)
Commercial Interest Name:
Address:
Name of Representative:
Email Address:
Phone Number:
Fax Number:
Electronic Signature (Required) Date:
Completed By:
(Name and Credentials)

Ohio Nurses Association, 4000 East Main Street, Columbus, Ohio 43213 / 614-448-1027 / (Revised 12/2015)