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NSF, NASA, EPA, AID, CIA, and the Consumer Product Safety Commission. ZCZWZZZGPC3$ Federal Regulations and PolicyAdditional Protections included in 45 CFR 46: Subpart B - Additional DHHS Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (revised November 13, 2001) Subpart C - Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research b.X7c p N  Food and Drug Administration> Regulations: IRB - 21 CFR 56 Informed Consent - 21 CFR 50 2/:$  %Differences in HHS & FDA RegulationsBasic requirements for IRBs and for Informed Consent are congruent Differences center on differences in applicability HHS regulations based on HHS support of the research FDA regulations based on use of FDA regulated product: drugs, devices, or biologics&ww  -Determining Applicability of HHS Regulations!Research - a systematic investigation designed to develop or contribute to generalizable knowledge Human Subject - a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information ^b [ Nb Identifiable Private Information Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects. [45 CFR 46.102(f)] DZZ$$n$Individually Identifiable The identity of the subject is or may readily be ascertained by the investigator or associated with the information. 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'{Iy___PPT10Y+D='  = @B +  0  x(  x x 6\  ` (Education Activities x 0^  0 vPresentations and Training Programs Workshops and Research Forums Respond to Constituent Inquiries: Email ohrp@ososphs.dhhs.gov Telephone 301-496-7005 or 866-447-4777 e b$$     $k)H x 0޽h ? 3fffff3̙3f̙y___PPT10Y+D='  = @B +  0 ta(  t t 6m   'Education Resources t 0u   PH@___PPT9" |Educational Materials --PRIM&R  Investigator 101 CD -- IRB Guidebook (1993) http://www.hhs.gov/ohrp/irb/irb_guidebook.htm --Videotape Series: "Protecting Human Subjects (1986) http://www.hhs.gov/ohrp/references/resource.htm --Human Subject Assurance Training http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp d $: - 7 0# 3:Q-8/3& 0Q~ 0H t 0޽h ? 3f3fff̙3ff̙y___PPT10Y+D='  = @B +  0 (    68z  P0 'Quality Improvement  0 |  P@ WConsultation to improve institutional programs of human subjects protection --Voluntary --Separate from Compliance Oversight Multiple methodologies --Self-evaluation tool --Teleconference/Videoconferences --Site visits\LZ3ZZJZL$3$JH  0޽h ? 3fffff3̙3f̙y___PPT10Y+D='  = @B +  0 (    6 p@ 5!Compliance Oversight Jurisdiction  0| P  T@ 45 CFR 46 (see, e.g., 45 CFR 46.103(e)) OHRP Approved AssuranceH  0޽h ? 3fffff3̙3f̙y___PPT10Y+D='  = @B +  0  (     (xaxa1 ?%     Z xaxa1 ?pP For-Cause Compliance visit Not-For-Cause Compliance visit Common Findings Outcomes of compliance visit http://www.hhs.gov/ohrp/compliance/,i$i$p H  0޽h ? ?^^___PPT10e.+D='  = @B +  0  p(    6<  P SACHRP  04   ` \Secretary s Advisory Committee on Human Research Protections (SACHRP) first meeting held in July 2003 Chair, Dr. Ernest Prentice, University of Nebraska OHRP provides supportZ$H  0޽h ? 3fffff3̙3f̙y___PPT10Y+D='  = @B +3  0 ZR(    6(  0 .Inter-Agency Participation  0 0  FDA and OHRP- Regular Coordination Meetings -- Unanticipated and Serious Events -- 407 Issues Human Subjects Research Subcommittee (HSRS) - Dr. Bern Schwetz, Chair-OHRP -- Common Rule Agencies and Departments -- Standardize the interpretation of the 45 CFR 46, Subpart A ,4Kh,4KhH  0޽h ? 3fffff3̙3f̙y___PPT10Y+D='  = @B +  0 +#(    6h  C"?@ 'Lyndi Lahl, R.N., M.S. 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