Protecting Human Research Subject Doing - ….pptx

NIH Regional Seminar Research Involving Human SubjectsFreda E. YoderDivision of Education and DevelopmentOffice for Human Research Protections (OHRP)Department of Health and Human Services (HHS)Ann M Hardy, Dr.P.H.NIH Extramural Human Research Protection Officerand Certificates of Confidentiality CoordinatorMaria Stagnitto RN, MSNNIH Extramural Human Research Protection OfficerOffice of Extramural Research (OER)National Institutes of Health (NIH)Outline Part IWhat is OHRP?Ethical PrinciplesHHS Regulations ApplicabilityExempt ResearchNIH human subjects policies and procedures How to complete the Human Subjects Section of your NIH grant applicationPart IIProtections Afforded by the Regulations: Assurances, IRB Review, Informed ConsentReporting Requirements Compliance OversightNIH Inclusion PoliciesPost-award responsibilitiesCertificates of ConfidentialityCase studies and Q AOutline What is the Office for Human Research Protections (OHRP)?Provides leadership in protection of rights, welfare, and wellbeing of subjects involved in research conducted or supported by US Department of Health and Human ServicesProvides clarification and guidanceDevelops educational programs and materialsMaintains regulatory oversightProvides advice on ethical and regulatory issues pertaining to biomedical and behavioral researchCurrent Organizational StructureHHS Kathleen Sebelius, Secretary Assistant Secretary for Health Howard Koh, Assistant Secretary for HealthOther HHS Entities (FDA, NIH, CDC, etc)OHRP, Office of the DirectorJerry Menikoff, DirectorMelody Lin, Deputy DirectorInternational ActivitiesMelody Lin, Deputy DirectorSecretary’s Advisory Committee on Human Research Protections (SACHRP)Division of Education and DevelopmentElyse I. SummersDirectorDivision of ComplianceOversightKristina Borror DirectorDivision of Policy and AssurancesIrene Stith-ColemanDirectorProtecting Human Subjects is a Shared ResponsibilityInstitutionIRBInvestigatorSubjectsResearch TeamSponsorAdvocatesFam