/ Establishing a Registry and Repository / Document Number:
Effective Date:
9-Sep-07
PURPOSE / To provide guidance on establishing a Registry and Repository (R&R) that allows researchers the ability to access data and specimens in a manner that fosters the greatest flexibility and most efficient avenue for accessing these samples in the highest ethical and regulatory complaint fashion.
SCOPE / Applies to all researchers wishing to a) establish one or more Registries and Repositories, b) researchers that wish to use samples from pre-existing and future Registries and Repositories c) external researchers that wish to use samples collected from BRI patients.
ACCOUNTABILITY / The Principal Investigator (PI), Recipient Investigator (RI),Unit Director (UD), Unit Manager (UM), BRI Institutional Review Board (IRB), and Clinical Research Program (CRP).
DEFINITIONS / See the ‘Glossary of Terms’ (GCP 0002) for a complete list of definitions.
REGISTRY AND Repository (R&R)–this includes any study (i) where the only activity is to store data and/or tissues and to release to investigators for research use (under appropriate IRB approvals and gatekeeper procedures) or (ii) any activity which will store either data or tissues for research use/potential research use outside of the scope of that particular study. If the storage of data is only to be used for one unique study and does not fit under the “Repository” definition above, it would not be considered a “Repository”.
R&Rs activities involve three components: (i) the collectors of tissue samples; (ii) the repository storage and data management center; and (iii) the recipient investigators requesting the samples for research purposes.
Recipient Investigator(RI) -person responsible for the conduct of aresearch projectthat is requesting coded or anonymous specimens from an R&R. If the project is conducted by a team of individuals, the recipient investigator is the responsible leader of the project group.
PROJECT REQUEST PROTOCOL – This is a research project bucket, which is designed to allow multiple researchers’ access to data and specimens from an R&R in an efficient manner without any personal identifiers “PHI” attached to the samples. A Gatekeeper will establishthis Project Request Protocol to assure no PHI is transferred.
GATEKEEPER – This person will be considered the Principal Investigator for the Project Request Protocol. They will assist the recipient investigators in being responsible for; (i) establishing, monitoring, and maintaining sample requests, (ii) submitting project requests to the IRB (iii) requesting and retrieving samples from the R&R once IRB approval has been granted.
MATERIAL TRANSFER AGREEMENT(MTA)– a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials being transferred.
CertificateS of Confidentiality – these protect subjects from compelled disclosure of identifying information from a study. They do not prevent the voluntary disclosure of identifying characteristics of research subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research subjects, such as evidence of child abuse or a subject's threatened violence to self or others.
If a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this. They do not prevent other types of intentional or unintentional breaches of confidentiality. See OHRP guidance on Certificates of Confidentiality:
http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm
POLICY / This research requires access to blood and/or samples from people with the underlying disease(s) being studied, and those who do not have these diseases (control groups). R&Rs established at BRI may be modular in nature, subdivide based on subject/disease type.
The IRB and Benaroya Research institute is responsible for oversight of the operation of these registries and repositories.
Main Registry and Repository (R&R) Protocol submission:
1)Separate IRB approvals are required for each disease-specificmodule, unless otherwiseindicated in the protocol. A clinical researcher will serve as principle investigator (PI) for each module.
2)A standardized consent form will be provided to all clinical researchers who enroll subjects in the R&R.
3)The clinical PI will be responsible for collection of data and samples in accord with IRB approved protocols.
4)Each subject enrolled in an R&R will be associated with the appropriate clinical modules(s), and assigned coded numbers based on the protocol specific coding system.
5)The department running the R&R and the clinical investigator(s) designated as the PI(s) for specific modules control the use of repository samples and registry data.
6)Certificates of Confidentiality should to be obtained to protect confidentiality of repository specimens and data per OHRP guidance.
Individual Project Request Protocol submission:
7)A generic registry and repository Project Request Protocol will be submitted to the IRB for review. This protocol will:
  1. Allow recipient investigators to pull samples from multiple R&R disease modules.
  2. Establish Gatekeeping procedures to assure no PHI is transferred to recipient investigators form the main R&R.
  3. Outline the procedures for recipient investigators requesting samples from the R&R.
8)Research data generated by laboratory investigation projects is entered into the database by coded number for future use. Access to laboratory data is limited; and specific results are available only to clinical researchers who have password access to personal information.
Recipient Investigators (RI) requesting samples:
9)Internal BRI researchers who require repository samples for laboratory-based studies will contact the department head running the R&R to request the use of samples for a project. The researcher will describe the study, the reason for use of human tissue, and the expected results. No PHI will be disseminated to the RI.
10) If approved, the Director of the department will assess the request for funding and feasibility issues.
11) Once final sign-off is received by the recipient investigator, the RI or Gatekeeper will complete aRepository Project Research modification form and submit it to the IRB.
12) If approved, samples will be distributed and then tracked in the database. All approval forms are filed with the regulatory documents of the appropriate module. These forms will be included in annual IRB review of each module to document use of the samples.
13)IRB approved modification forms for each project will be filed under the Project Request Protocol and reviewed on an annual basis per regulations.
14) Internal Investigators with “dual” interests in both sample use and management of the R&R or ongoing clinical studies may not approve sample use for their own studies. Such request must be reviewed and approved by and uninvolved investigator.
External Investigators:
15)External Investigators who wish to procure specimens form BRI R&R modules will need to complete and submit a Human Tissue Material Transfer Agreement (MTA) for each project request. The signed MTA is filed with the regulatory documents associated with the module form which the samples were taken. The MTA will be included in the IRB annual review for each module.
16)Any publications making use of this repository will acknowledge the specific R&R at BRI and will note the sample source.
RELATED DOCUMENTS / Principal Investigator Roles & Responsibilities (GCP 0003)
BRI Investigator Compact Form (FRM 0030)
AUTHOR(S) / Chris Weir, CIP, Clinical Research Program Specialist
IMPLEMENTATION / Document will be circulated to all clinical research staff via e-mail and posted on the BRI website for reference.
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