The definitions for registries and repositories tend to vary among researchers, but involve the collection and/or retention of subject data or specimens for future analysis. Within the office, we differentiate them as described here in the Investigator’s Manual.

Generally, these should be thought of as frameworks that will save researchers time in future projects by regulatorily organizing valuable human subjects data and/or biospecimens. The ultimate goal for such an application would be for a research team to establish clear processes that anticipate the research needs of their investigators, that has carefully considered what is feasible for their group to reliably provide, and allows them to confidently respond to inquiries about how their materials could be accessed or analyzed.

Registries and repositories also generally offer a greater degree of autonomy to research participants whose data and/or biospecimens are used, as they will ideally be prospectively informed that their materials are being used (and offered a choice regarding this), how they are likely to be used, and any risks associated with these usages.

• Registries are:
  • Often set up by departments or research groups with ongoing recruitment initiatives for many different studies and find it useful to have a pool of potential subjects likely to be eligible for them. These can save researchers time when they recruit for new studies.
  • Information varies widely, and can be limited to name and contact information, or could include preliminary screening information.
  • Under VA regulations, retaining a subject list is considered a recruitment registry.
• Registries are not:
  • “A list in a drawer” – Maintaining a one-time list of subjects who participated in a particular research study and are willing to be contacted for future research does not typically constitute a recruitment registry. Rather, this should be reflected in the IRB application and consent form of the particular research study. 
    • However, if this list will be added to over time, used by more than one researcher, and/or subjects are specifically recruited to be on the list, then it likely constitutes a recruitment registry and should be reviewed as such. 
      
      
• Repositories / Banks are:  
  • Often set up by researchers who have (or want to collect) a valuable longitudinal dataset, with or without accompanying biospecimens. Both the data and the biospecimens may be collated retrospectively, collected prospectively, or both. Materials could come from other research protocols, clinical sources, or other sources. 
         
• Repositories / Banks are not:  
  • QI/QA data repositories: Some repositories collate information within an institution with a primary intent to improve system performance at a clinic or department level. Although data from these repositories may be used for research, their creation does not constitute a research activity when the primary intent is clinical use. Generally, IRB review is not required for the creation and maintenance of clinical Quality Improvement/Quality Assurance (QI/QA) data repositories. However, the subsequent use of data from these repositories for research purposes requires IRB review. See the Program Evaluation / Quality Improvement or Assurance Projects guidance in the Investigator’s Manual. 
    •  A clinical database that contains PHI should be registered with the HIPAA Privacy Officer using the Database Registration and Preparatory to Research Certification for Database Custodian form (See: “Database Forms and Tools”).  

• Generally require IRB approval, both for the creation and maintenance of the registry itself, as well as for future projects that wish to use a registry as a recruitment method.  
• We expect a PBA. If they have no template, encourage use of HRP-503a. We can’t require people to use our protocol templates. Regardless of what they submit, you can evaluate the content using HRP-503a. 
• Staff reviewer should expect an informed consent process, and that it address what information will be stored,  as well as setting expectations for being contacted about future research opportunities. 
• Under the HIPAA Privacy Rule, permission is required for use of individually identifiable health information (aka protected health information). Staff reviewer should expect authorization be obtained from subjects for storage and use of their protected health information in the recruitment registry. 
• It is rare for these submissions to include a section on analysis but it is permissible if they do.

Subsequent use of registries 

• Recruitment materials pertaining to a new study should be reviewed under THAT study. Do not submit it to the registry application. 
• No changes to the registry protocol when new studies recruit “out of” it unless something about their processes will change.    

Can researchers contact previous subjects without a formal registry? 

• Yes, if the previous and new studies are both “theirs”
  • For example, both the same group of researchers
  • If the above is not the case, subjects would most likely expect to be contacted by researchers who already have their information for research purposes
    • IM states, “you may not share names of previous research participants with other researchers without permission from the participants.”
  • If subjects may be contacted for all sorts of research, a separate recruitment registry may be more appropriate

• If the primary intent of the repository is for use in future research projects, IRB approval is required.  
• An investigator can obtain IRB review of a repository either through a stand-alone application (e.g. for the creation and maintenance of a bank) or, if the specimen collection occurs in conjunction with a specific research project, by explicitly building into the IRB application the intent to store data and/or tissue for future use. 
• We expect a PBA. If they have no template, encourage use of HRP-503a. We can’t require people to use our protocol templates. Regardless of what they submit, you can evaluate the content using HRP-503a. 
• Staff reviewer should typically expect informed consent be obtained to include an individual’s information and/or biospecimens in the research repository prospectively. However, a waiver of informed consent may be granted in certain situations in which the data and/or biospecimens are being collected retrospectively.  
• VA regulations include additional requirements for maintaining a research repository. 
• Under the HIPAA Privacy Rule, permission is required for use of individually identifiable health information. Staff reviewer should expect written authorization be obtained from subjects for storage and use of their protected health information in the research repository. Authorization from subjects for each new use of their PHI for research purposes in conjunction with the tissue must be obtained or a waiver of such authorization sought from the IRB for a use for which written authorization was not previously obtained. 
• IRB approval is generally required both for the creation of a research repository, as well as any future projects that wish to access the repository. The latter is most commonly submitted separately from the Research Repository application for IRB review and approval, but some PIs insist on keeping everything in one protocol. In these cases, those requesting use of materials must be added as key personnel.  
• The IRB reviews most subsequent research involving banked data and/or specimens to determine whether the use of the data or source of specimens raises any ethical concerns and whether explicit consent and HIPAA authorization was obtained from the individuals for the use of their data in research and the particular research that is proposed.      

Subsequent use of repository materials 

• In some VERY specific cases, review might not be required (this is very rare)
  • In order for this to be the case, data must TRULY be de-identified: as determined by an honest broker (e.g. TSB BioBank, commercial source) 
  • Usually data and specimens are never truly deidentified: more valuable with identifiers (connecting tissue and data) 
  • If investigators are collaborating that is considered research and review is required, sometimes investigators are just being good stewards of research and just sharing de-identified data (this does not require review) 
• Please view “Biospecimen and Data Research – IRB Review Requirements” in the Investigator’s Manual for more information about when review is needed. 
• New submission is most likely required 
  • In the application, secondary use of information would most likely need to be selected, and identifiability and informed consent would be addressed there. 
  • Could be considered: NHSR, category 4 exemption, expedited, full 
    • Most likely an nPBA unless subjects are recruited for additional procedures 
    • Review type affected by: identifiability, whether new PI was involved in collection, whether registry/repository PI involved in new analysis 
  • Can researchers use data/tissue for future research if original study is silent on banking? 
    • Probably yes 
      • Parent protocol would need to be updated to describe sharing/use 
      • Ideally the consent form includes banking language 
      • If not, check to see that the consent doesn’t contradict sharing/using 

Add-on registries and repositories: main protocol has a specific objective/question that it’s trying to answer but data and/or tissue may be banked for future use 

• PBA 
  • Standalone protocol should include information from section 19 of HRP 503 (Biomedical Protocol Template) 
• nPBA 
  • In the ARROW application, under privacy and confidentiality, retention of data and or specimens should be indicated 
    • Sometimes the privacy and confidentiality section of the ARROW application will be affected, for example level of identifiability 
  • While this may not always be the case, researchers could share data/tissue with external collaborators; the sharing data page in the application should be completed 
         

When does a registry/repository need to be submitted separately instead of an add-on? 

Depends on the aims and objectives of a study/when it starts affecting the original regulatory determinations

Can have processes approved for collection and state that they will submit a change to include dissemination plan prior to giving out any data and/or tissue. 

• OHRP Guidance on Coded Private Information or Specimens Use in Research (2008) 
• SACHRP’s FAQ on Informed Consent for Use of Biospecimens and Data 
• FDA’s Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable