NICHD/DIPHR Biospecimen Repository Access and Data Sharing (BRADS)

BRADS Manual of Operations

Table of Contents

Introduction
Summary of BRADS
BRADS Committee Roster
Description of BRADS Website
Disposition of Data
Biospecimen and Data Requests
Proposal Instructions and Procedures
Proposal Evaluation Criteria
Proposal Submission
Approved Proposals
Progress Reports
Proposed Costs for Acquiring Biospecimens and Accessing Ancillary Data
Deposition of Results and Samples

INTRODUCTION

Summary of BRADS

The Division of Intramural Population Health Research (DIPHR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) maintains an extensive repository of datasets from completed studies, including biospecimens and ancillary data. To promote access to these resources the Division has established an internal committee, the BRADS Committee (BRADSC), which has implemented specific procedures and guidelines consistent with the National Institutes of Health (NIH) Data Sharing Policy.

BRADSC Roster

Jennifer Weck, Ph.D. – BRADSC Chairperson and Repository Contact
Sung Duk Kim, Ph.D.
Pauline Mendola, Ph.D.
Tonja Nansel, Ph.D.
Neil Perkins, Ph.D.

DESCRIPTION OF BRADS WEBSITE

A link to studies included in BRADS can be access from the DIPHR website (http://www.nichd.nih.gov/about/org/diphr/pages/research.aspx or found directly at https://brads.nichd.nih.gov/. The home page of the BRADS website contains information for obtaining access to biospecimens and data from the Division’s research portfolio. There are four main links that provide additional detailed information.

    1. BRADS Program Synopsis (a detailed summary of available studies, proposal instructions, etc.)
    2. General Information about Requesting Biospecimens (a detailed overview of the biospecimen request process)
    3. Study related Biospecimens and Current Data (a detailed overview of all available studies including abstracts and related references)
    4. Register for Access to Data and/or Biospecimens (All requesters/investigators must register in order to gain access to available data/biospecimens; this link provides instructions needed to register).
    The BRADSC Roster and a link to a direct BRADS email box are also provided on the home page.

DISPOSITION OF DATA

The BRADS program enables compliance with the NIH datasharing policy while ensuring oversight regarding the dissemination of data. The BRADSC recommends that DIPHR researchers make data publically available through BRADS after papers addressing the primary and proposed secondary outcomes are published.

BRADS requires all data submitted are de-identified. Documentation illustrating that the data were collected under proper consents and, where applicable, with a certificate of confidentiality, is required.

DIPHR investigators who deposit their data on BRADS should submit a publication policy as well as a copy of the final study proposal and a codebook defining variables in the dataset for BRADS files.

Additional supporting documentation should include references citing original findings and an abstract or statement to define the study that will help potential users determine if the data set is appropriate for their research question.

If investigators create a new index or variable, these measures should be made publically available if they are included in the primary publications. Otherwise, investigators have no obligation to provide additional analytic measures in the publically available data files.

BIOSPECIMEN AND DATA REQUESTS

Proposals for using data or samples can be submitted on an ongoing basis. Technical panels for reviews will be assembled ad hoc or by January 1, May 1, or September 1 so that proposals can be evaluated in advance of federal funding deadlines. Samples are projected to be distributed within one month of demonstrable proof of applicant IRB approval and receipt of payment to cover repository costs and shipping.

All proposals for biospecimens and access to ancillary data will be evaluated by an ad hoc technical review panel for scientific merit. For ethical review, the BRADSC will generally rely on the investigators’ approval of their proposal by their respective institutional review board (IRB). The BRADSC reserves the right to have the NICHD IRB review any proposal even if the requesting investigators have already have IRB approval from their institution.

For proposed studies where the results of new laboratory analyses of existing biospecimens will be linked only to existing datasets and that require no contact (or contact is not possible) with the original study participants, an expedited institutional review may be sufficient, as long as the rationale for this decision is clearly stated. However, for proposed studies that involve any re-contact of the original study participants, are part of an on-going follow-up of original participants, or where new linkages are being made with other publically available databases, a full IRB review is required. Specimens will not be released from the repository without documentation of review, institutional approval, and upon receipt of full payment for repository costs.

If a DIPHR researcher obtains outside funding for a project that is dependent on accessing BRADS data or specimens, the proposal submitted to that funding body will be sufficient for the BRADS committee to review

As biospecimens are a limited resource, proposals should clearly state how much material is necessary to complete the proposed analysis, with emphasis on using the least amount of material possible. Examples of proper documentation include standard laboratory SOPs for proposed analysis as well as peer-reviewed publications defining methods.

Only research projects that propose laboratory results or findings in the ancillary data that do not have immediate clinical significance will be deemed acceptable. Applicants should address this clearly in the research proposal. Clinical significance for laboratory studies is defined by the following criteria:

    The findings are valid and performed by a CLIA-certified laboratory, and
    The findings may have significant immediate implications for the subjects’ health concerns, and
    A course of action to ameliorate or treat the concerns is readily available.

Clinical significance for ancillary findings is defined by:

    The findings may have significant immediate implications for the subjects’ or their family’s health concerns, and
    A course of action to ameliorate or treat the concerns is readily available.

PROPOSAL INSTRUCTIONS AND PROCEDURES

All investigators must submit a proposal for use of biospecimens and data.

A Material Transfer Agreement (MTA) must be completed before any specimen or data can be transported to requesting investigator. A copy of this agreement is located on the Division’s website. Any changes, amendments, or modifications to the MTA must be approved by the NIH/NICHD Technology Development Coordinator (Charlotte Mcguinness, 240-276-5497) prior to any materials being delivered.

Proposals are limited to a maximum of ten (10) single-spaced typed pages, excluding figures and tables, using 12 cpi type density (font).

Proposals should be comprehensive and tailored to the request.

The proposal cover page should include the name, address, phone number, and email address of the Principal Investigator (PI) and the name of the institution where the laboratory analysis will be done if applicable; the same information is needed for all participating investigators.

All proposals must be emailed in MS WORD or pdf to the BRADSC chairperson at the address specified on the DIPHR website.

Proposals should include the following categories and address the defined evaluation critera

  • Specific Aims
  • Background and public health significance
  • Research design and methods
  • Clinical significance or results
  • Qualifications
  • Period of performance (specify the project period)
  • Funding

Proposal Evaluation Criteria

  • Relevance of the study question to current research
  • Adequacy of the study design to address the question
  • Feasibility and appropriateness of the requested data or biospecimen to accomplish the proposed study
  • If biospecimens are requested, appropriateness of the assay including evidence that the analyte is stable given the storage conditions for available samples
  • Experience of the investigators in conducting similar studies.

Proposal Submissions

Proposals should be emailed to the BRADSC chairperson at the address specified on the DIPHR website.

Upon receipt, proposals will be reviewed for completeness by the BRADSC. Incomplete proposals will be returned to the requestor without further consideration. Proposals that are complete and follow the defined instructions will be evaluated and reviewed for scientific and technical merit by an ad hoc committee consisting of at least three external reviewers as appointed by the BRADSC.

If the project involves biologic specimens, the BRADSC and the external reviewers will consider the amount of sample requested and weigh the significance of the research against the amount of sample requested and that remaining. Investigators are encouraged to request the smallest amount of sample possible consistent with best scientific practices and aims of their study.

The evaluation will be in accordance with the review criteria stated in the proposal instructions. The review group will address and consider each of these criteria and assign an overall score. The proposal does not need to be strong in all categories to be judged likely to have major scientific impact. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Reviewers will be asked to evaluate the following aspects of the proposals:

SIGNIFICANCE: Does the concept protocol address an important problem? If the aims of the application are achieved, how will they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field?

APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

INNOVATION: Does the concept protocol employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and to that of other researchers?

ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

APPROVED PROPOSALS

Upon approval of a proposal, a data use agreement will be sent via email to the primary investigator. This document can also be found on the BRADS web site. The Data Use Agreement is valid for three years. Investigators who need more time should contact the BRADSC. After receipt of a signed data use agreement, login information for datasets will be provided to investigators. Secondary analysts can be designated approved users and thus access the data using the login information provided to primary investigators with the understanding that the primary investigators are responsible for overseeing the approved users and maintaining compliance with all regulations. A list of approved users should be submitted to BRADS in each annual report.

Approved projects will be provided specimens upon receipt of funds to the biospecimen repository to cover the cost of accessing, preparing and shipping specimens.

Approved and funded projects will be posted by title and abstract on the DIPHR website once specimens have been shipped.

All specimens will be distributed blinded, with no identifiers.

Progress Report

An annual progress report must be submitted via email to the BRADSC Chairperson. It is the responsibility of the requesting investigator to keep track of when progress reports are due. The annual progress report must contain an updated list of all approved users of the disseminated data as well as references of publications resulting from access to BRADS data.

Proposed Cost Schedule for Acquiring Biospecimens and Accessing Ancillary Data

Procedures and cost schedules vary depending on the age and nature of samples and the complexity of the request for data or samples. The BRADSC reserves the right to amend procedures and costs schedules as necessary to address unique conditions under which specimens were collected. DIPHR does not provide monetary resources for data or sample requests, analyses or data management

A usual fee of $8.00 - $16.00 per sample plus express shipping costs is anticipated for each sample requested. This is an estimated pricing fee that includes pulling and aliquotting specimens. The actual price will be determined after the proposal is accepted and will be made aware to the requester prior to initiation of the data sharing agreement. Payment in full for all costs associated with a specimen request must be made to the Biospecimen Repository prior to shipment of the specimens.

Deposition of Results and Residual Samples

All relevant data (laboratory values and metadata) generated through the use of BRADS biospecimens should be submitted to the BRADSC in a usable database form (SAS or Excel) upon publication of the primary goals of the project as outlined in the proposal. Updates regarding progression of the project should be included in each annual report.

The BRADSC assumes every attempt will be made to publish papers addressing the primary goals prior to publishing papers using data generated from BRADS biospecimens that address secondary or ancillary hypotheses.

No sample provided can be used for any purpose other than those specifically requested in the proposal and approved by the technical panel. No sample can be shared with others, including other investigators, unless specified and so approved in the proposal.

Any unused samples must be either discarded or returned to the DIPHR Repository, per instructions provided by the BRADSC upon completion of the approved project.

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