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Although federal regulations and guidance is cited herein, the presentation does not represent official policy guidance from the Department of Health and Human Services or the National Institutes of Health. !   33___PPT10i.~@ֲ +D=' = @B +"N @(    f^ѿ?6Slide Number Placeholder 5^ `  r*(   &   r`с0e0eRectangle 2 `}   `Overview of Presentation      rkс0e0eRectangle 3 `  9General banking issues/types of banks Applicable regulations Risks and risk assessment Methods for protecting subjects Consent Issues Access, dissemination, and other issues Protocol content Challenging/unresolved issues Tools to help  Z   33___PPT10i.f)+D=' = @B +"N  P  (     fPvѿ?6Slide Number Placeholder 6^ `  r*(   #   rsс0e0eRectangle 2P`   ]Jobs Are the New Assets Recycling the Suburbs The New Calvinism Reinstating The Interstate Amortality Africa: Open for Business The Rent-a-Country Biobanks Survival Stores Ecological Intelligence March 16, 2009 Issue P Z Z Z  3?  s    r0lс,e,eRectangle 3"ÿPK![Content_Types].xmlJ0*miG]`Hm6 Xwt?. g#Wi3E).+7 >ON ޑ1ˋz "+R RhB.} /<^ITխ%rHK4uK~I0xM e`|X}đ I`߽N4aG2$RKIZ)4(M9`ctB{m:f@`3n|O,ܗr޾jxR0T ,0@}WBLǬ5vPK!jUedrs/shapexml.xmlTmk8~pAKӗ:-t P"r,$9MI] 3E!M֔; }jQay1W+\5s|8L.F(;{ɏ5k )/,<iZ:k 2hZa[F"vL b3w|lzD9*񓤄{跩 a!C6 (.xAj.\zy/ s}kׁh.QпWijѢDN\[, 62CEf-nevoڛ®ݝO@leoadċ?!vPK!Ŗdrs/downrev.xmlDMK@Eax;;1"BTtQ[?k% 34.tys9d{1R; kZoE"2:wHVӓ܆-"A\,QAThe  Simplest Repository Model  $    (  rpwс0e0eRectangle 3  U Human Subjects? 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"&dgRp+i:M8V4TR֐8q}p:(C9@kCaSݤrzo_nsMyTf2>>H4Vg(n2\PK-![Content_Types].xmlPK-!Z,[ _rels/.relsPK-!\drs/downrev.xmlPK : `: 8B 8 c $1#"@PK![Content_Types].xml|N0 HC+jS8 @:Q۸ ??\o<7p]V޷O(I'6E=, ){Ō4>I)q7UuDހǏ)}nL"Mᴸ&g0eSA)΄2';2 WYu7{ɯΒzŘqFrj9K*(]mOlPK!Z,[ _rels/.relslj0 ``t_Pƈ[>,dgzjǎ?I'f#®Pb-\/Ƿ0Z]nLnp__3.iJV KQBiDžrL,Vʌ/7р4`ANar+m;E/'3U Aںv83/PK!\drs/downrev.xmlDAO0 Hȓt;@UMhh* .ݐkK{"{[F׋h=+M ĭז;m "&dgRp+i:M8V4TR֐8q}p:(C9@kCaSݤrzo_nsMyTf2>>H4Vg(n2\PK-![Content_Types].xmlPK-!Z,[ _rels/.relsPK-!\drs/downrev.xmlPK  ` 8B 8 c $1#"@PK![Content_Types].xml|N0 HC+jS8 @:Q۸ ??\o<7p]V޷O(I'6E=, ){Ō4>I)q7UuDހǏ)}nL"Mᴸ&g0eSA)΄2';2 WYu7{ɯΒzŘqFrj9K*(]mOlPK!Z,[ _rels/.relslj0 ``t_Pƈ[>,dgzjǎ?I'f#®Pb-\/Ƿ0Z]nLnp__3.iJV KQBiDžrL,Vʌ/7р4`ANar+m;E/'3U Aںv83/PK!\drs/downrev.xmlDAO0 Hȓt;@UMhh* .ݐkK{"{[F׋h=+M ĭז;m "&dgRp+i:M8V4TR֐8q}p:(C9@kCaSݤrzo_nsMyTf2>>H4Vg(n2\PK-![Content_Types].xmlPK-!Z,[ _rels/.relsPK-!\drs/downrev.xmlPK  8B 8 c $1#"@PK![Content_Types].xml|N0 HC+jS8 @:Q۸ ??\o<7p]V޷O(I'6E=, ){Ō4>I)q7UuDހǏ)}nL"Mᴸ&g0eSA)΄2';2 WYu7{ɯΒzŘqFrj9K*(]mOlPK!Z,[ _rels/.relslj0 ``t_Pƈ[>,dgzjǎ?I'f#®Pb-\/Ƿ0Z]nLnp__3.iJV KQBiDžrL,Vʌ/7р4`ANar+m;E/'3U Aںv83/PK!\drs/downrev.xmlDAO0 Hȓt;@UMhh* .ݐkK{"{[F׋h=+M ĭז;m "&dgRp+i:M8V4TR֐8q}p:(C9@kCaSݤrzo_nsMyTf2>>H4Vg(n2\PK-![Content_Types].xmlPK-!Z,[ _rels/.relsPK-!\drs/downrev.xmlPK``8B 8 c $1#"@PK![Content_Types].xml|N0 HC+jS8 @:Q۸ ??\o<7p]V޷O(I'6E=, ){Ō4>I)q7UuDހǏ)}nL"Mᴸ&g0eSA)΄2';2 WYu7{ɯΒzŘqFrj9K*(]mOlPK!Z,[ _rels/.relslj0 ``t_Pƈ[>,dgzjǎ?I'f#®Pb-\/Ƿ0Z]nLnp__3.iJV KQBiDžrL,Vʌ/7р4`ANar+m;E/'3U Aںv83/PK!\drs/downrev.xmlDAO0 Hȓt;@UMhh* .ݐkK{"{[F׋h=+M ĭז;m "&dgRp+i:M8V4TR֐8q}p:(C9@kCaSݤrzo_nsMyTf2>>H4Vg(n2\PK-![Content_Types].xmlPK-!Z,[ _rels/.relsPK-!\drs/downrev.xmlPK `8B 8 c $1#"@PK![Content_Types].xml|N0 HC+jS8 @:Q۸ ??\o<7p]V޷O(I'6E=, ){Ō4>I)q7UuDހǏ)}nL"Mᴸ&g0eSA)΄2';2 WYu7{ɯΒzŘqFrj9K*(]mOlPK!Z,[ _rels/.relslj0 ``t_Pƈ[>,dgzjǎ?I'f#®Pb-\/Ƿ0Z]nLnp__3.iJV KQBiDžrL,Vʌ/7р4`ANar+m;E/'3U Aںv83/PK!\drs/downrev.xmlDAO0 Hȓt;@UMhh* .ݐkK{"{[F׋h=+M ĭז;m "&dgRp+i:M8V4TR֐8q}p:(C9@kCaSݤrzo_nsMyTf2>>H4Vg(n2\PK-![Content_Types].xmlPK-!Z,[ _rels/.relsPK-!\drs/downrev.xmlPK ` 33___PPT10i.=ܚ+D=' = @B +" )N 0(@(  @ @ fѿ?6Slide Number Placeholder 5^ `  r*(   ; @  rс0e0eRectangle 2 `}   u+Overview of Applicable Regulations/Policies, ,0,  t @  rЌс0e0eRectangle 3 `  F How Does 45 CFR Part 46 Apply to Research Repositories and Databases?6 F 0F0G   33___PPT10i.1`[+D=' = @B +" N 'H(  H H fѿ?6Slide Number Placeholder 4^ `  r*(   > H  rс0e0eRectangle 2 `}   x.Definition of a Human Subject: 45 CFR part 46 / /$/  h H Nч?Rectangle 3t0`XP___PPT92*  Human Subject A living individual about whom an investigator conducting research obtains: Data through intervention or interaction with the individual; or (2) Identifiable private information [45 CFR 46.102(f)] [45 CFR 46.102(f)]P] B L ]BL    33___PPT10i.7IP+D=' = @B +"N P(  P P fѿ?6Slide Number Placeholder 5^ `  r*(   c P  rс0e0eRectangle 2    G Research Repositories & Databases 3 Paths to Human Subjects Research $H  F$H    P  rpс0e0eRectangle 3   Z0Creating a research repository/database through intervention or interaction with individual Creating a research repository/database by obtaining identifiable private information Obtaining identifiable private information from a research repository/database. (Slide courtesy of J. Kaneshiro, OHRP)  PRl KP P' P P(5(.+''1   33___PPT10i.]0+D=' = @B +"(N /'0X(  X X f ѿ?6Slide Number Placeholder 5^ `  r*(   R X  r@с0e0eRectangle 2   BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C  \ X  r0с0e0eRectangle 3"~~    Guidance on Research Involving Coded Private Information or Biological Specimens Defines when research involving data or specimens does not involve human subjects http://www.hhs.gov/ohrp/humansubjects/ guidance/cdebiol.pdf S R '  RR'   33___PPT10i.6I +D=' = @B +"N  P`(  ` ` fѿ?6Slide Number Placeholder 5^ `  r*(   R `  r0с0e0eRectangle 2 `}   BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C   `  rс0e0eRectangle 3     Definition of  Coded : (1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens. >     33___PPT10i.9I4C+D=' = @B +"N  ph(  h h f@ѿ?6Slide Number Placeholder 4^ `  r*(   R h  rс0e0eRectangle 2 `}   BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C   h  r΁0e0eRectangle 3@  <  In general, OHRP considers private information or specimens to be individually identifiable as defined at 45 CFR 46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. However, the OHRP coded specimens policy allows exceptions under certain conditions.\X ZTX   33___PPT10i.8I@ܕ+D=' = @B +"N pw(  p p f@ο?6Slide Number Placeholder 5^ `  r*(   R p  r΁0e0eRectangle 2 `}   BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C   p  r΁0e0eRectangle 3 `    Conversely OHRP considers private information or specimens not to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly through coding systems. "    33___PPT10i. eҚ+D=' = @B +"N  t(  t t fο?6Slide Number Placeholder 5^ `  r*(   R t  r΁0e0eRectangle 2   BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C  & t  r`΁0e0eRectangle 3  ` Research involving only coded information or specimens is not considered to involve human subjects if the following conditions are both met: (1) the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; AND (2) the investigator(s) cannot readily ascertain the identify of the individual(s) to whom the coded private information or specimens pertain. V P   33___PPT10i.:I5+D=' = @B +"N  |u(  | | f@ο?6Slide Number Placeholder 5^ `  r*(   R |  r΁0e0eRectangle 2 `}   BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C   |  rp΁0e0eRectangle 3 r NF___PPT9(   Examples of When Coded Data/Biologic Specimens Are Not Individually Identifiable to Investigators: the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceasedHe   d  P@ 33___PPT10i.9IdW.+D=' = @B +"N  (    fο?6Slide Number Placeholder 5^ `  r*(   R   r΁0e0eRectangle 2    BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C  0   r΁0e0eRectangle 3@  j Examples of When Coded Data/Biologic Specimens Are Not Individually Identifiable to Investigators: (b) there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or (c) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased. Z P Pcs   33___PPT10i.;Ic*+D=' = @B +";N B:"(    f ο?6Slide Number Placeholder 5^ `  r*(   R   rp΁0e0eRectangle 2    BOHRP Guidance on Coded Private Information or Biological SpecimensC C$C  o   r΁0e0eRectangle 3     Only applies if: 1. Person(s) doing coding of data/specimens and person(s) holding codes are not part of the research team; AND 2. Specimens/data are not being obtained for the specific research in question by an interaction or intervention with living individuals.j Zh   33___PPT10i.;I^+D=' = @B +"N  (    fPο?6Slide Number Placeholder 3^ `  r*(     |A??OHRP ModelPicture 2OHRP ModelP 33y___PPT10Y+D=' = @B +"N @(    fpο?6Slide Number Placeholder 5^ `  r*(       r΁0e0eRectangle 2 `}   F 0  B   r0΁0e0eRectangle 3 `  |" How do the FDA Regulations Apply?(# 0"0#   33___PPT10i.2&+D=' = @B +"N `(    fPYп?6Slide Number Placeholder 5^ `  r*(   @   rpYЁ0e0eRectangle 2 `}   z0How Do the FDA Human Subjects Regulations Apply?1 1(1  X   rYЁ0e0eRectangle 3`  21 CFR Part 50: Informed consent 21 CFR Part 56: IRB review 21 CFR Part 812: Investigational Device Exemption (IDE) Apply to all clinical investigations regulated by FDA Biomedical research involving an unapproved drug, device or biologic and certain studies of approved products B o  o   33___PPT10i.'mP+D=' = @B +";N B:"(    fDž?6Slide Number Placeholder 5^ `  r*(   1   rƅ0e0eRectangle 2 `}   k!FDA Definition of a Human Subject" "("     rpƅ0e0eRectangle 3 `   FDA Human who participates in research either as a recipient of the test article or as a control. A healthy human or a patient. (21 CFR 50.3(g) and 56.102(e)) Subject is an individual on whom or on whose specimen an investigational device is used. (21 CFR part 812)  Z Z Z Z5      33___PPT10i.(mP6___PPT9 hKey points to remember: Authorization must be specific for the research use and disclosure of PHI from repositories, but authorization may be obtained to create and maintain a research repository Authorization is NOT required for the subsequent use or disclosure from the repository of de-identified data or a limited dataset pursuant to a data use agreementx " PP P]]i   33___PPT10i.>o+D=' = @B +"N (    fPԿ?6Slide Number Placeholder 5^ `  r*(      rԁ0e0eRectangle 21   MModel 1     ZA ??Object 3   ZA ??Object 4 ~F  33___PPT10i.)R+D=' = @B +"N v(    fԿ?6Slide Number Placeholder 5^ `  r*(      r@ԁ0e0eRectangle 2   MModel 2   d 0 s A ?5%8c8c    ?Object 3"@ (    ZA ??Object 40 `V   33___PPT10i.)2+D=' = @B +"N v(    fԿ?6Slide Number Placeholder 5^ `  r*(      rԁ0e0eRectangle 2   MModel 3   d 0 s A ?5%8c8c    ?Object 3"p (    ZA ??Object 4 `&   33___PPT10i.)Pg2+D=' = @B +"N v(    fвԿ?6Slide Number Placeholder 5^ `  r*(      rPԁ0e0eRectangle 2    MModel 4   d 0 s A  ?5%8c8c    ?Object 3" (    ZA ??Object 4 ~   33___PPT10i.)h+D=' = @B +"0N 7/ (      fԿ?6Slide Number Placeholder 5^ `  r*(       rԁ0e0eRectangle 2 `}   R Other Laws         rԁ0e0eRectangle 3 `  |Genetic Information Non-Discrimination Act (GINA) HITECH Act State Laws Genetic information, testing Medical records privacy*H 5 H5}   33___PPT10i.P+D=' = @B +"cN jbJ(    f Կ?6Slide Number Placeholder 5^ `  r*(   '   r0ԁ0e0eRectangle 2 `}   aRisks and Risk Assessment      r`ԁ0e0eRectangle 3     How do you assess risk for research involving human specimens and data? When is research using human specimens and data greater than minimal risk?6 P P   33___PPT10i.2&+D=' = @B +"7N NF0.(    fԿ?6Slide Number Placeholder 5^ `  r*(      rpԁ0e0eRectangle 2 `}   MRisks      r0ԁ0e0eRectangle 3  nf___PPT9H@ ~Physical risks Psychosocial risks Anxiety Loss of privacy of personal information/research data Loss of employment or insurability Risks associated with unvalidated research data Group harms " > # <   ">#>    33y___PPT10Y+D=' = @B +"YN  `XP @(      f`Կ?6Slide Number Placeholder 5^ `  r*(   )    rРԁ0e0eRectangle 2 `}   cAssessment of Level of Risk       rЗԁ0e0eRectangle 3   jb___PPT9D< ~Risk assessment critical to determine if waiver of informed consent is appropriate National Bioethics Advisory Commission1 recognized that specimen research may be considered minimal risk if it: protects confidentiality protects privacy includes plan for whether and how to reveal findings to the subject 1 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, 1999 Pn P  P[ Py I<" Y     33___PPT10i.+D=' = @B +"*N! A9p(!(  ( ( fԿ?6Slide Number Placeholder 5^ `  r*(   ) (  rԁ0e0eRectangle 2 `}   cAssessment of Privacy Risks    (  rԁ0e0eRectangle 3Ib >6___PPT9 Identifiability Sensitivity of identifiable data Nature of the research Likelihood of disclosure of research or subject information Systems and policies in place to protect privacy and confidentiality Assessment based on probability and magnitude of harmZ ZE Z7 ZE7   33y___PPT10Y+D=' = @B +"N" 0(  0 0 fԿ?6Slide Number Placeholder 5^ `  r*(   Z 0  rԁ0e0eRectangle 2 `}   @Repository Subject Protections: Multiple Levels of IRB Review "A ?((A   0  rpԁ0e0eRectangle 30 b >6___PPT9 Review of repository operating procedures and policies Review of individual research protocols for use of identifiable specimens and data >7  " T    33___PPT10i.@+D=' = @B +"N# 8(  8 8 fԿ?6Slide Number Placeholder 5^ `  r*(   R 8  rԁ0e0eRectangle 2P   BRepository Subject Protections: Policies, Governance and OversightC C$C   8  rPԁ0e0eRectangle 3P ^V___PPT980 DOperating policies and procedures Procedures for obtaining informed consent Procedures for protecting privacy/confidentiality; access to specimens/data Policies and procedures for return of research results (if and under what conditions) Governance and oversight Steering and/or oversight committees, ethics advisory boards t"   > ">E   33___PPT10i.P_Q+D=' = @B +"N$ @(  @ @ fԿ?6Slide Number Placeholder 5^ `  r*(   R @  rԁ0e0eRectangle 2`}   BRepository Subject Protections: Privacy/Confidentiality ProceduresC C$C   @  r0ԁ0e0eRectangle 3  ^V___PPT980 .Anonymization of specimens/data Coding of specimens/data Links maintained by repository but identifying information never released to investigators Encryption Limited access/secure storage/data security  Honest Broker systems Certificates of Confidentiality (where appropriate) t9 [   9[   33___PPT10i.+D=' = @B +" N% H(  H H fԿ?6Slide Number Placeholder 5^ `  r*(   R H  rԁ0e0eRectangle 2`}   BRepository Subject Protections: Privacy/Confidentiality ProceduresC C$C   H  rԁ0e0eRectangle 3P   ,Employee confidentiality agreements  I understand that in my role as an employee of the XYZ Tissue Bank, I may have access to confidential information such as patient names or patient-identifying information, patient demographics, medical records, etc. I understand that my access to this information is strictly for the purposes of carrying out my employee responsibilities and that any disclosure to third parties or other misuse of this confidential information is strictly prohibited. A breach of confidentiality may result in the termination of my employment with the XYZ Tissue Bank. P$ P P0 P P%1V   33___PPT10i.@4+D=' = @B +"N& P(  P P fԿ?6Slide Number Placeholder 5^ `  r*(   L P  r`ԁ0e0eRectangle 2 `}   <Repository Subject Protections: Investigator User Agreements= =$=  ( P  r@ԁ0e0eRectangle 3@ `r NF___PPT9(  Address: Use of specimens/data Human subjects protections Sharing of specimens with third parties Commercial use of specimens Biohazards IndemnificationB    z   33y___PPT10Y+D=' = @B +"}N |0Xd(  X X fԿ?6Slide Number Placeholder 5^ `  r*(    X  rԁ0e0eRectangle 2 `}   XInformed Consent    X  r`ԁ0e0eRectangle 3 `  Informed consent required when there is intervention/interaction with a living individual or private identifiable information is being collected and/or used, unless waived by the IRB Should be clear and understandable    33___PPT10i.kם2+D=' = @B +"PN WO@\7(  \ \ fԿ?6Slide Number Placeholder 5^ `  r*(   > \  r0ԁ0e0eRectangle 2 `}   x$Additional Informed Consent Content "% #((%   \  rлԁ0e0eRectangle 3 `  XMust meet requirements of human subjects regulations In addition, should also include: Description of specimens/data and process used for collecting them Risks, including risks to privacy and confidentiality, and methods to protect risks Description of the purpose of the collection and conditions for sharing Types of research to be conducted HW Z Z ZWY   33___PPT10i.l`+D=' = @B +"N  P`(  ` ` fԿ?6Slide Number Placeholder 5^ `  r*(   3 `  rԁ0e0eRectangle 2 `}   m#Additional Informed Consent Content$ $($  X `  rpԁ0e0eRectangle 3`  Statement of the right to withdraw Whether results will be returned Plans for re-contact, if any As appropriate: Information on the consequences of DNA typing What will happen to specimens/data when no longer useful, when repository loses support, or is transferred to others Details about where the specimens will be stored (particularly relevant for international research) Use of  tiered consentBa Z Z Za   33___PPT10i.oP#+D=' = @B +"N `d(  d d fpԿ?6Slide Number Placeholder 5^ `  r*(   P d  rԁ0e0eRectangle 2 `}   @Consent for Collections Established from Existing Specimens/DataA A$A  1 d  rpԁ0e0eRectangle 3   kIs use consistent with initial consent under which specimens/data were collected? If not, can informed consent be waived: no more than minimal risk to the subjects; the waiver will not adversely affect the rights and welfare of the subjects; the research could not practicably be carried out without the waiver; and whenever appropriate, the subjects will be provided with additional pertinent information after participation. Is new consent required? pz Z5 Z ZzZ   33___PPT10i.o C+D=' = @B +"UN \Tph<(  h h fԿ?6Slide Number Placeholder 5^ `  r*(   6 h  rԁ0e0eRectangle 2 `}   p&Specimen/Data Access and Dissemination' '$'   h  rԁ0e0eRectangle 3 `  Procedures for determining that research use is scientifically appropriate and consistent with consent Procedures for prioritizing requests for access Systems in place to reduce risk of harms to groups Specimens/data distributed without identifiers Receipt of documentation of IRB approval from recipient investigators (where appropriate) Compliance with HIPAA Privacy Rule, where applicable $     33___PPT10i.z@'+D=' = @B +"N l(  l l fԿ?6Slide Number Placeholder 5^ `  r*(    l  rԁ0e0eRectangle 2 `}   T Other Issues      l  rԁ0e0eRectangle 3 `  VFinancial Issues Reasonable cost recovery generally appropriate Tracking Systems to document location, distribution and use of specimens/data Systems to track the types of research for which consent was givenT /   /    33___PPT10i.|У+D=' = @B +"3N :2p(  p p f Կ?6Slide Number Placeholder 5^ `  r*(    p  rԁ0e0eRectangle 2 `}   T Other Issues      p  r ԁ0e0eRectangle 3 `  KResource Sharing/IP Considerations Material Transfer Agreements specify the rights and obligations of both the provider and the recipient, including any IP terms and publication rights consistent with NIH Research Tools Policy Benefit Sharing Annual reports, newsletters, summaries of general research findings Technology transfer \# Z Z ZY Z#YL   33___PPT10i.|hl+D=' = @B +"N t(  t t f@Կ?6Slide Number Placeholder 5^ `  r*(    t  rԁ0e0eRectangle 2 `}   >   R t  rԁ0e0eRectangle 3 `  6 What should be in the protocol submitted to the IRB?$7 $507   33___PPT10i.e`?f+D=' = @B +"N x(  x x f@Կ?6Slide Number Placeholder 5^ `  r*(   c x  rԁ0e0eRectangle 2`}   SPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewT T T   x  r`ԁ0e0eRectangle 3   nName, purpose, and overall goals of repository Administration and oversight of repository Who is responsible; oversight mechanisms in place Procedures for specimen and data collection Identification of subjects or previously existing specimens; study populations Information collected with the specimen, especially identifiers Ongoing subject interactions, if any x[ 2 ,   [2,o   33___PPT10i.bD+D=' = @B +"4N ;3|(  | | fԿ?6Slide Number Placeholder 5^ `  r*(   c |  rԁ0e0eRectangle 2`}   SPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewT T T  W |  rԁ0e0eRectangle 3 `  1Recruitment and Informed Consent Who, how and when Consent process and form If waiver is requested, justification Plans for obtaining consent when a child reaches age of consent for research; or request for waiver Procedure for subjects to withdraw their consent and what will be done with specimens/data .! Z Z!2   33___PPT10i.+D=' = @B +"TN [S;(    fPԿ?6Slide Number Placeholder 5^ `  r*(   c   rԁ0e0eRectangle 2   SPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewT T T  w   r`ԁ0e0eRectangle 3 `  #Specimen and Data Storage/Retention Linkage to subject identities, if any Who will have access to identifying information? How will specimens/data be coded? Procedures for secure storage How long will specimens/data be retained? Specimen derivation and processing Cell lines, DNA/RNA, etc.\$ Z Z# Z Z$#$   33___PPT10i.Cg+D=' = @B +"N (    f`Կ?6Slide Number Placeholder 5^ `  r*(   c   rԁ0e0eRectangle 2   SPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewT T T     rԁ0e0eRectangle 3 `  BSpecimen and Data Distribution What specimens and data will be provided? Processes in place for assuring appropriate access Policy regarding secondary distribution Investigator usage agreements/MTAs Policy regarding commercial use*     33___PPT10i. +D=' = @B +"N $(    fԿ?6Slide Number Placeholder 3^ `  r*(   W   rԁ0e0eRectangle 2 }   SPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewT T T  L   rԁ0e0eRectangle 3   2Protection of subject autonomy, privacy, confidentiality Who has access to identifiers and keycode Policies and procedures in place to protect subjects Policy regarding release of personal identifiers Policies for assuring uses are consistent with consent How will repository comply with HIPAA Privacy Rule.9 Z Z93   33___PPT10i.j+D=' = @B +"2N 91(    fԿ?6Slide Number Placeholder 5^ `  r*(   c   rԁ0e0eRectangle 2 }   SPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewT T T  U   rԁ0e0eRectangle 3 `   Return of Research Results Policy regarding when, if ever, individual research results will be returned to subjects Policy regarding return of aggregate, generalized research findings Other Issues Plans if PI leaves institution or repository loses financial supportT   E  E    33___PPT10i.2+D=' = @B +"N (    fԿ?6Slide Number Placeholder 4^ `  r*(   -   rԁ0e0eRectangle 2p `    gChallenging/Unresolved Issues 6   33___PPT10i.bA+D=' = @B +"N  (    fԿ?6Slide Number Placeholder 5^ `  r*(   (   rPԁ0e0eRectangle 2 `}   bReturn of Research Results   *   rԁ0e0eRectangle 3 `  dWhen should individual research results be returned to subjects? Tension between perspectives on the rights of individuals to information about themselves vs. harms associated with inappropriate return of research results Harms associated with return of individual results that have not been analytically and clinically validated or are of unknown clinical significance Stress, anxiety, and even physical harms if used inappropriately for medical decision makingdA P P P] PA]   33___PPT10i.t`? +D=' = @B +"`N g_0G(    fԿ?6Slide Number Placeholder 5^ `  r*(   (   rԁ0e0eRectangle 2 `}   bReturn of Research Results      rԁ0e0eRectangle 3 `  TClinical Laboratory Improvement Amendments (CLIA) 1988 Prohibits return of results for clinical care if tests not performed in CLIA approved labs Informed consent should address if and under what circumstances individual results will be returned to subjects May be appropriate to provide generalized, aggregate research findings to subjectsr7 [  7[  U   33___PPT10i.t`h+D=' = @B +"[N bZ@B(    fԿ?6Slide Number Placeholder 5^ `  r*(   ?   rԁ0e0eRectangle 2 `}   y/Unresolved Issue: Ownership/Control of Samples0 0(0     r@ԁ0e0eRectangle 3 `  (Moore v. Regents of the University of California Greenberg et al. v. Miami Children s Hospital Catalona v. Washington University Havasupai Case 1  .  2   a2    33___PPT10i.c +D=' = @B +"N Ps(    fԿ?6Slide Number Placeholder 5^ `  r*(      r ԁ0e0eRectangle 2 `}   VCustodianship       rԁ0e0eRectangle 3 `P  0rDifferent from ownership  Caretaking responsibility 1 Governance, management and oversight Conditions for access and use Documented plans for disposition of specimens and data Plans if repository/bank closes Plans for transfer if PI leaves institution 1(NCI Best Practices for Biospecimen Resources, June 2007) 7 z M < 4 zM : :   33___PPT10i._` 7+D=' = @B +"N ~`f(    fԿ?6Slide Number Placeholder 5^ `  r*(   &   r ԁ0e0eRectangle 2 `}   `Other Challenging Issues      r0ԁ0e0eRectangle 3 `  Banking specimens from children Identifiability Differing definitions Impact of emerging genetic technologies and extent and availability of databases containing patient/subject information*0  0   33___PPT10i.`I!+D=' = @B +"}N' |pd(    fԿ?6Slide Number Placeholder 5^ `  r*(      rPԁ0e0eRectangle 2 `}   YBest Practices  (     rԁ0e0eRectangle 3@   International Society for Biological and Environmental Repositories (ISBER) Best Practices For Repositories: Collection, Storage, Retrieval and Distribution of Biological Materials for Research Cell Preservation Technology, March 2008 issue; http://www.isber.org/ibc.html NCI Best Practices for Biospecimen Resources http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf  N - J  lT.f-JF    .  H    >(` 33___PPT10i.Lp!+D=' = @B +"*N 1)(    fԿ?6Slide Number Placeholder 5^ `  r*(   9   rԁ0e0eRectangle 2 `}   s)Ongoing Efforts to Address the Challenges* *$*  w   r@ԁ0e0eRectangle 3 `  Clinical Research Policy Analysis and Coordination Program (CRpac) Trans-NIH policy for repositories currently under development Trans-HHS taskforce (HELPs) to streamline and harmonize policies related to research using human specimens and data Other NIH efforts NCI NHGRI/ELSI NHLBIdC Z Z Z ZC   33___PPT10i.d[+D=' = @B +"N (  7   rԁ0e0eRectangle 2 `}   q)Ongoing Efforts to Address the Challenges**$*  J   rԁ0e0eRectangle 3 `  ,Secretary s Advisory Committee on Human Research Protections (SACHRP) Subpart A Subcommittee is exploring informed consent issues related to specimens&FQFQ   3380___PPT10.cER"N (    f Կ?6Slide Number Placeholder 5^ `  r*(   1   rPԁ0e0eRectangle 2 `}   k!Tools to Help (See also Handouts)" "$"  C   rpԁ0e0eRectangle 3 `  }Clinical Research Policy Analysis and Coordination Program (CRpac) http://www.crpac.od.nih.gov Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group Report http://www.primr.org lC  k   Ck   33___PPT10i.f!3+D=' = @B +"N (    fԿ?6Slide Number Placeholder 5^ `  r*(   !   rԁ0e0eRectangle 2 `}   [Contact Information   O   r@ԁ0e0eRectangle 3 `  ;Marianna J. 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՜.+,D՜.+,  $ , 0On-screen Show (4:3)NationalCancer Institute$ D( JArialTimes New RomanTimes WingdingsDefault Design Bitmap ImageCHuman Specimen & Data Repositories: Legal and Ethical Challenges DisclaimerOverview of PresentationNTIME Magazines Top 10 Ideas Changing the World Right Now The Simplest Repository ModelA More Complex ModelTypes of banks/repositories,Overview of Applicable Regulations/Policies/Definition of a Human Subject: 45 CFR part 46 H Research Repositories & Databases 3 Paths to Human Subjects Research COHRP Guidance on Coded Private Information or Biological SpecimensCOHRP Guidance on Coded Private Information or Biological SpecimensCOHRP Guidance on Coded Private Information or Biological SpecimensCOHRP Guidance on Coded Private Information or Biological SpecimensCOHRP Guidance on Coded Private Information or Biological SpecimensCOHRP Guidance on Coded Private Information or Biological SpecimensCOHRP Guidance on Coded Private Information or Biological SpecimensCOHRP Guidance on Coded Private Information or Biological SpecimensPowerPoint PresentationPowerPoint Presentation1How Do the FDA Human Subjects Regulations Apply?"FDA Definition of a Human Subject&FDA Requirements for Informed ConsentFDA Guidance PowerPoint Presentation4Use or Disclosure of PHI for Research Repositories GUse or Disclosure of PHI to Create the Research Repository or DatabaseBSubsequent Use or Disclosure of PHI From Repository for Research IWhen the specific research is unknown at the time the data are collectedModel 1Model 2Model 3Model 4 Other LawsRisks and Risk AssessmentRisksAssessment of Level of RiskAssessment of Privacy RisksARepository Subject Protections: Multiple Levels of IRB Review CRepository Subject Protections: Policies, Governance and OversightCRepository Subject Protections: Privacy/Confidentiality ProceduresCRepository Subject Protections: Privacy/Confidentiality Procedures=Repository Subject Protections: Investigator User AgreementsInformed Consent%Additional Informed Consent Content $Additional Informed Consent ContentAConsent for Collections Established from Existing Specimens/Data'Specimen/Data Access and Dissemination Other Issues Other IssuesPowerPoint PresentationTPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewTPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewTPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewTPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewTPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewTPoints to Consider: Information to Include in a Repository Protocol for IRB ReviewChallenging/Unresolved IssuesReturn of Research ResultsReturn of Research Results0Unresolved Issue: Ownership/Control of SamplesCustodianship Other Challenging IssuesBest Practices *Ongoing Efforts to Address the Challenges*Ongoing Efforts to Address the Challenges"Tools to Help (See also Handouts)Contact Information  Fonts UsedThemeEmbedded OLE Servers Slide TitlesD 8@ _PID_HLINKSA$<http://www.time.com/time/magazine/0,9263,7601090323,00.htmlhttp://www.isber.org/ibc.htmlIhttp://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf<http://www.time.com/time/magazine/0,9263,7601090323,00.htmlhttp://www.isber.org/ibc.htmlIhttp://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf_   !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~      !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~Root EntrydO)PicturesCurrent UserSummaryInformation(PowerPoint Document(| DocumentSummaryInformation8