help! i need a geek!
TRANSCRIPT
HELP!I Need a Geek!
Kathy Phipps, DrPHASTDD Data Coordinator
Finding a Geek Closer to HomeState Health Department
Epidemiology/Evaluation section
Local Health Department (in some cases)University
Biostatistics or epidemiology facultyGraduate student
ASTDD
ASTDD Geek SquadMike Manz
Kathy [email protected]
To request technical assistanceComplete request formEmail to Stuart Lockwood
www.astdd.org/docs/TARequestForm1-29-04.dot
TA Available Through ASTDDBasic Screening Survey
Assistance with planningSample selectionData entry programsData analysis
Oral Health Surveillance SystemsAssistance with development of a system
Resources Available from ASTDDEpi Info data entry & analysis filesBSS Planning GuideSample BSS Examiner TrainingBest practices
Engaging the Community
Engaging the CommunityImportant to engage the community prior to collecting dataWho is the “community”
PublicProvidersAgency staffResearch community
Engaging Your Agencyand Research Community
Why is this Important?Can assist with
Protocol developmentData collectionData analysisData interpretationReport preparation
Acronyms Research Community will want to Talk About
MCH
IRB & HIPAA
BSS
BMI
CSTE
ASTDD
CDC
Human Subjects & Privacy IssuesIRB reviewHIPAA compliance
Research & IRB ReviewInstitutional Review BoardLaws require IRB approval for research
Federal Policy for the Protection of Human Subjects (the “Common Rule”)IRB must review federally-funded researchMay apply to all research regardless of fundingSome state & local laws authorize IRB reviews
Research & IRB ReviewLegal requirements of IRB review do not address public health practiceIRB review not required for non-researchResponsibility to protect human participants in public health practice…
Federal, state, & local administrative oversight
What is Research?Common Rule & HIPAA definition
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizableknowledge
Characteristics of ResearchInvolves living individualsInvolves, in part, identifiable health infoInvolves research subjects who are selected and voluntarily participateSupported by principles of bioethics
Public Health Practice Does not require IRB reviewMaking the distinction between research and public health practice can be difficult
collection of identifiable health informationactual or potential risksfurther the public good
www.cste.org
What is Public Health Practice?Proven methods to monitor health statusInvestigate unusual occurrences of diseaseImplement preventive control measures
Characteristics of Public Health PracticeLegal authorizationGovernment duty to perform activityDirected by public health authorityMay involve persons who did not give informed consentSupported by public health ethics
CSTE DefinitionThe collection and analysis of identifiable health data by a public health authority for the purpose of protecting the health of a particular community, where the benefits and risks are primarily designed to accrue to the participating community.
Public Health PracticeIdentifiable health data may be collected without informed consent
acquisition of data is a function to achieve public health goalspublic has authorized the activity through lawsadministrative protections of individual interestspublic health officials are accountable to the public
OH Surveys - Research or PHP?Identifiable health data
No - Common Rule & HIPAA do not apply
General legal authorityacquire any health data needed to monitor health conditions in the population
Specific intenttest a hypothesis - research
OH Surveys - Research or PHP?Participant benefits
PHP should contribute to improving health
Subject selectioncontrol group - researchrandom selection of participants - research
Other State SurveysPRAMS
Not research - no need to receive IRB approval
YRBSNon-identifiable health dataNot researchNo informed consent necessary
Oral Health SurveysThree IRBs waived oral health surveys
One university IRBTwo health department IRBs
SummaryOH surveys are public health practiceWho decides?
health agency or IRB
My recommendationsubmit letter to IRBask for waiver
HIPAAHealth Insurance Portability and Accountability Act of 1996Protected health informationCovered entities
health planshealth-care clearinghouseshealth care providers
HIPAAPermits private health information to be shared for specified public health purposes such as surveillance.
HIPAA & Oral Health SurveysCollect non-identifiable data
do not collect namecollect date of birth only if you need it for BMI calculations
Protect confidentialityprivacy envelopes
For More Information on HIPAAHIPAA Privacy Rule and Public Health
Guidance from CDC and the U.S. Department of Health and Human Serviceswww.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm
Office for Civil Rights - HIPAAMedical Privacy - National Standards to Protect the Privacy of Personal Health Informationwww.hhs.gov/ocr/hipaa
Questions?