Guidance for Completing IRB Applications for Recruitment Registries or Repositories that Store Data and/or Tissue

Version Date: July 27, 2016

The purpose of this guidance is to explain what research teams should consider when completing IRB applications for Registry or Repository studies in ARROW. If you have not already done so, please view our guidance on Data Repositories, Recruitment Registries, and Tissue Repositories.

Tips for Completing a Recruitment Registry Application

Tips for Completing a Data Repository Application

Tips for Completing a Tissue Repository Application

Tips for Completing a Recruitment Registry Application

  • Select Application Type: Initial Review Application: Full Review
  • Study Summary: The IRB typically expects a stand-alone protocol to be provided to outline the operational procedures for the recruitment registry. Information required in the protocol is similar to that described below for the Research Design General description.
  • Research Design General: Describe the purpose and aims of the recruitment registry. Provide an overview of how subjects will be recruited and how data will be collected and where and how data will be stored.
    • Clarify what, if any, health information you will store along with contact information.
      • Consider NOT including health information that is likely to go “stale,” such as medication use, as long-term retention of such changeable information is unlikely to be useful.
      • Keep in mind that any study recruiting subjects from this registry will have its own eligibility screening process. In light of this, try to only keep information that is unlikely to change (e.g., date of birth).

    • Identify the individuals who will have access to data collected on this registry and indicate whether review of registry data will be limited to key personnel on this study.
    • If your subject population is vulnerable (e.g., children, people lacking decision-making capacity), clarify whose information will be entered into the database (e.g., the subjects’ or that of their guardian/caregiver) Address whether any information about the guardians/caregivers will be collected, or whether they will merely provide information about subjects. [If identifiable and private data about guardians/caregivers is collected, they will constitute subjects.]
    • Describe how these subjects will learn about new research studies for which they might be eligible. For example, in some cases all contact occurs through the Principal Investigator (PI) and the PI’s study team managing the recruitment registry protocol.
    • Explain how research teams will gain access to the recruitment registry. For example, will everyone who wants to use it be given access to the file containing the Registry data? Or, will a designated person on the Registry PI’s study team pull information out of the registry based on a new study’s eligibility criteria, and provide a list of names and contact information to the recipient PI? Please be clear about how research teams seeking to recruit subjects out of your registry will access the information in your database.
    • Clarify whether recipients of data will make any progress reports to the PI of the registry, and, if so, give a general idea of what they will include (e.g., the number of subjects recruited and enrolled from the list provided by the recruitment registry).

  • Study Location: If you are contributing subject information to a recruitment registry housed outside UW-Madison, you will need to complete the multi-site section of the protocol.
  • RB Ratio:

    • 4.1: Address whether any sensitive information will be stored along with subjects’ contact information, such as genotype or other biomarkers, illicit drug use, etc.
    • 4.2: Make a general statement about data security, given that breach of confidentiality is likely the primary risk. [Granular details will be addressed later in the application.]

  • Subjects: General: Describe the subject population and eligibility criteria. If you are targeting a particular gender, race, or ethnic group, you will need to justify this. If you are targeting a vulnerable population, you will need to indicate this in the Vulnerable Checklist and justify their inclusion on the following page.
  • Subject Identification and Recruitment:

    • If you will be screening subjects for eligibility, see Subject Recruitment and Screening Procedures for guidance.
    • Many research teams that maintain recruitment registries enroll people who screen-failed eligibility screenings for other specific protocols. If you plan to do this, please include this in the recruitment plan along with how screen failed subjects will be informed about the registry.

  • Privacy and Confidentiality: Be clear about how data will be labeled and securely stored. Remember that there is a difference between coded and de-identified data.
  • Consent:
    • Describe the consent process and upload the consent document(s).
    • If you will be using medical records to identify potentially eligible subjects prior to recruitment, you will need to request a waiver of informed consent for this process and complete the Consent Waiver page.

  • HIPAA:
    • In order to maintain a Recruitment Registry, you will need to obtain subjects’ HIPAA authorization in addition to their informed consent.
    • If the Recruitment Registry falls under the purview of the VA, please note that the VA also requires a waiver of authorization if you will be using medical records to identify potentially eligible subjects. You should complete the HIPAA Waiver page.

  • Review of Records/Data/Images: If you need to collect medical records data to put in the recruitment registry, select the Review of Records/Data/Images option on the Special Procedures page and complete the Records Review section accordingly.

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Tips for Completing a Data Repository Application

  • VA Status: If your study falls under the purview of the VA, please note that the VA has special requirements about repositories. If you have not already done so, be sure to consult with the VA Privacy Officer and Research Office about these requirements before completing the application in ARROW.
  • Select Application Type: Initial Review Application: Full Review
  • Study Summary: The IRB typically expects a stand-alone protocol be provided to outline the operational procedures for the data repository. Information required in a protocol is similar to that described below for the Research Design General description.
  • Research Design General: Describe the purpose and aims of the research repository in detail. Provide an overview of how subjects will be recruited (if applicable) and data collected and stored. If you are relying on previously-collected data, then provide an overview of the data that will be included in the repository. Describe the purpose of the database and confirm that all future projects using this database will be submitted for separate IRB review and approval or exemption.

    • If the data repository will include data that were initially collected under other research protocols, provide a list of the studies, identifying them by both Principal Investigator and IRB protocol ID number. If the study was reviewed by non-UW IRB, identify that IRB and provide a copy of that IRB’s approval notice.
    • If you plan to add data on a semi-regular basis (annually, quarterly), please state this and how often, and clarify the source(s) from which the data will come – medical records, ongoing research studies, etc.
    • If you plan to add data from other research studies into the data repository as new studies complete their data collection, clarify this in your description of the study. Typically, an assurance that you will submit a protocol change to this study before adding data from a new study would be sufficient.
    • Clarify whether the recipients of data will be limited to those listed as key personnel on this study, or whether you plan to disseminate data to other researchers, or even outside the UW-Madison, the Madison VA (Wm. S. Middleton VA Hospital), or UW Health.
    • Clarify who will query the repository, and how datasets will be distributed to investigators who want to use them. If you plan to disseminate data outside the UW that contains identifiers, even limited ones, consult with your IT department about the best way to ensure data security BEFORE submitting your application to the IRB.
    • Address whether new data generated by analyses will be added into this database for additional/future dissemination.

  • Study Location: If you are contributing subject information to a research database housed outside UW-Madison, you will need to complete the multi-site section of the ARROW application.
  • RB Ratio:

    • 4.1: Address whether any sensitive information will be stored along with subjects’ contact information, such as genotype or other biomarkers, illicit drug use, etc.
    • 4.2: Make a general statement about data security. [Granular details will be addressed later in the application.]
    • 4.4: Address how the investigator will communicate with study team members to ensure that the collection, transfer, and storage of data from various protocols/medical records will not result in breaches of confidentiality.

  • Subjects: General: If you will be recruiting subjects in order to include their data in the repository, describe the subject population and eligibility criteria. If you are targeting a particular gender, race, or ethnic group, you will need to justify this. If you are targeting a vulnerable population, you will need to indicate this in the Vulnerable Checklist and justify their inclusion on the following page.
  • Subject Identification and Recruitment, if applicable: If you will be screening subjects for eligibility, see Subject Recruitment and Screening Procedures for guidance.

  • Privacy and Confidentiality: Be clear about how data will be labeled and securely stored. Remember that there is a difference between coded and de-identified data.
  • Consent:

    • If applicable, describe the consent process in the informed consent section of the application and upload the consent document(s). If you will be using medical records to identify potentially eligible subjects prior to recruitment, you will need to request a waiver of informed consent for this process and complete the Consent Waiver page.
    • If only retrospective data is being collected and there is no interaction with research subjects, a waiver of consent may be appropriate. In this case, select the Waiver of Informed Consent option on the Informed Consent: General page and complete the Consent Waiver page to request a waiver of consent for the full study.
      • If using previously-collected research data, address whether those studies’ consent forms referred to the future use of data.

  • HIPAA:
    • Coded data linked to direct identifiers is still considered individually identifiable health information. If a “key” still exists, then you will need to request a waiver of authorization.
    • Datasets that are Limited Data Sets, or which include elements of dates, are considered protected health information (PHI). To use a Limited Data Set Within the UW Healthcare Component/ACE, a Certification for Use of a Limited Data Set Within the UWHCC or UW ACE must be completed.
    • Datasets that are Limited Data Sets, or which include elements of dates, are considered PHI, and a Data Use Agreement would be needed to share this data outside the UW Healthcare Component/ACE.

  • Review of Records/Data/Images: If you need to collect medical records data, data originally gathered under other research protocols, or data from a departmental QI database to put in the research database, then select the Review of Records/Data/Images option on the Special Procedures page and complete the Records Review section accordingly.
  • Supplemental Information: If utilizing data that were originally collected under research protocols, upload copies of the parent studies’ consent forms.

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Tips for Completing a Tissue/Specimen Repository Application

  • VA Status: If your study falls under the purview of the VA, please note that the VA has special requirements about repositories. If you have not already done so, be sure to consult with the VA Privacy Officer and Research Office about these requirements before completing the application in ARROW.
  • Select Application Type: Initial Review Application: Full Review
  • Study Summary: The IRB typically expects a stand-alone protocol to be provided to outline the operational procedures for the recruitment registry. Information required in a protocol is similar to that described below for the Research Design General description.
  • Research Design General: Describe the purpose and aims of the tissue repository in detail. Provide an overview of how subjects will be recruited (if applicable) and how biological specimens will be collected and stored. If you are relying on previously-collected specimens, then provide an overview of the specimens that will be included in the repository. Describe the purpose of the specimen repository and confirm that all future projects using materials stored in this specimen repository will be submitted for separate IRB review and approval.
    • If the specimen repository will also store data (e.g., age, disease type), then a description of data that will be included in the specimen repository should also be provided. In this case, please also review the Tips for Completing a Data Repository Application and incorporate that information into your application.
    • Describe the source(s) from which the biological specimens will come – direct collection from subjects, clinical pathology, ongoing research studies, etc.
      • If the specimen repository will include biological specimens that were initially collected under other research protocols, provide a list of the studies, identifying them by both Principal Investigator and IRB protocol ID number. If the study was reviewed by non-UW IRB, identify that IRB and provide a copy of that IRB’s approval notice.

    • If you plan to continuously add biological specimens as they become available, please state this and how often.
    • If you plan to add biological specimens from other research studies into the tissue repository as new studies complete their study procedures, clarify this in your description of the study. Typically, an assurance that you will submit a protocol change to this study before adding biological specimens from a new study to the database would be sufficient.
    • Describe whether the recipients of biological specimens will be limited to those listed as key personnel on this study, or whether you plan to disseminate specimens to other researchers, or even outside the UW.
    • Clarify whether each analysis project seeking to use biological specimens needs to be approved by an entity, in addition to the IRB, such as an executive review committee or the PI of the tissue repository protocol. Clarify what that entity will look for (e.g., scarce specimen resources, feasibility, scientific validity, a copy of their IRB approval, etc.).
    • Describe how biological specimens will be distributed to investigators who want to use them. If you plan to disseminate specimens linked with data outside the UW that contains identifiers, even limited ones, consult with your IT department about the best way to ensure data security BEFORE submitting your application to the IRB.
    • Address whether new data generated by analyses of tissue specimens will be added into this database for additional/future dissemination.

  • RB Ratio:

    • 4.1: Consider whether genetic testing may be performed on the biological specimens you are storing. If so, then you might want to explain in 4.2 the steps you are taking to mitigate the associated risks: Will you refrain from putting results into subjects’ medical records? Will you even receive the results of any analyses performed on the biological specimens in your bank? Will you reveal the results of any genetic testing to the subjects whose tissue is being analyzed?
    • 4.2: Make a general statement about data security. [Granular details will be addressed later in the application.]
    • 4.4: Address how the investigator will communicate with study team members to ensure that the collection, transfer, and storage of biological specimens will not result in breaches of confidentiality.

  • Subjects: General: If you will be recruiting subjects in order to include their biological specimens in the tissue repository, describe the subject population and eligibility criteria. If you are targeting a particular gender, race, or ethnic group, you will need to justify this. If you are targeting a vulnerable population, you will need to indicate this in the Vulnerable Checklist and justify their inclusion on the following page.
  • Subject Identification and Recruitment, if applicable: If you will be screening subjects for eligibility, see Subject Recruitment and Screening Procedures for guidance.
  • Privacy and Confidentiality: Be very clear about how the specimens and any associated data will be labeled and securely stored. Remember that there is a difference between coded and de-identified data.
  • Consent:
    • If applicable, describe the consent process in the informed consent section of the application and upload the consent document(s).
    • If you will be using medical records to identify potentially eligible subjects prior to recruitment, you will need to request a waiver of informed consent for this process and complete the Consent Waiver page.
    • If only existing biological specimens are being collected and there is no interaction with research subjects, a waiver of consent may be appropriate. In this case, select the Waiver of Informed Consent option on the Informed Consent: General page and complete the Consent Waiver page to request a waiver of consent for the full study.
    • If using previously-collected research biological specimens, address whether those studies’ consent forms referred to the future use of data.

  • HIPAA: Coded specimens and data linked to direct identifiers are still considered identifiable health information. If a “key” still exists, then you will need to either obtain HIPAA authorization from subjects or request that the IRB grant a waiver of authorization.
  • Review of Records/Data/Images: If you need to collect medical records data or data from a departmental QI database for inclusion in the tissue repository’s database, select the Review of Records/Data/Images option on the Special Procedures page and complete the Records Review section accordingly.
  • Supplemental Information: If utilizing biological specimens that were originally collected under research protocols, upload copies of the parent studies’ consent forms.
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See Also:




Keywords:registry, repository, recruitment, ARROW, application, data, tissue, specimens, databases   Doc ID:67390
Owner:Tesha Z.Group:Health Sciences IRBs
Created:2016-09-30 10:59 CSTUpdated:2016-10-05 08:49 CST
Sites:Health Sciences IRBs
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