7 Biospecimen Use Annual Progress Report

0925-0744-NEW_DASH_ATTACHMENT A.2-7_BIOSPECIMEN USE ANNUAL PROGRESS REPORT (APPROVED OMB NUMBER: 0925-0744)

NICHD DATA AND SPECIMEN HUB (DASH)

Annual Biospecimen Use Progress Report

1. Guidelines for Reporting NICHD Biospecimen Use

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the NICHD Data and Specimen Hub (DASH) as a data sharing mechanism that enables investigators to organize, store, and access de-identified data from NICHD-funded research studies for the purpose of secondary research use. Many of these studies also involved the collection of biospecimens that are stored in the NICHD Biorepository. DASH stores and provides de-identified biospecimen inventories for studies that have associated study data in DASH, and facilitates access to biospecimens for secondary research use.

As part of the agreement for using the biospecimens stored in the NICHD Biorepository, the Recipient of the biospecimens is required to submit annual reports during the validity of the Material Transfer Agreement (MTA), which is a period of three years (as noted in clause 14 of the MTA). The purpose of the annual report is to:

1. Verify that the Recipient is conducting research according to the Research Plan as indicated in the Biospecimen Request Form

2. Provide information to DASH summarizing research accomplishments, including a list of oral or written presentations, disclosures, abstracts, or publications resulting from the use of the biospecimens

3. Provide the publication number of any patent applications for newly discovered or developed technologies

The Annual Biospecimen Use Progress Reports will help NICHD to determine how best to use its resources to foster biospecimen sharing.

OMB Control Number: 0925-0744

Expiration Date: 01/31/2022

2. 

   1. Public reporting burden for this collection of information is estimated to average ten minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925- 0744). Do not return the completed form to this address.

   Annual Biospecimen Use Progress Report

NICHD DASH – Annual Biospecimen Use Progress Report

1. Report Year

Report Year

2. Material Transfer Agreement (MTA) Information

Request ID

Project/Study Title

Biospecimens Requested from DASH Study

MTA Effective Date

MTA Expiration Date

3. Biospecimen Recipient Information

Name

Job Position/Job Title

Institution

Division/Center/Branch

Email Address

Phone Number

4. Project/Study Information* ¹

4A. Were there any changes to your Research Plan from what you provided in the DASH Biospecimen Request Form (shown below)?

Yes ___ No ___

Project/Study Title

Research Plan

Design and Analysis Plan

4B. If Yes to 4A, have you submitted a separate biospecimen request, including a new Biospecimen Request Form and signed a new Material Transfer Agreement for the new Research Plan?

Yes ___ No ___

4C. If No to 4B, please provide an explanation as to why a new biospecimen request was not submitted.

Please note: As per clause 4 of the Material Transfer Agreement you signed, “Biospecimens obtained from the NICHD Biorepository listed in Appendix B will be used by the Recipient for studies and analysis specifically indicated and described in the Research Plan. The Recipient agrees that Biospecimens will not be used in any research that is not approved by the NICHD DASH Biospecimen Access Committee as part of the Research Plan. The Recipient must submit a separate and completed MTA for each Research Plan for which Biospecimens are requested.”

5. Requester

Name

Role on Project

6. Collaborators*

6A. Were there any new Collaborators added to your study this past year?

Yes ___ No ___

6B. If Yes to 7A, have all the Collaborators submitted a separate biospecimen request in DASH, including a Biospecimen Request Form and signed a Material Transfer Agreement with NICHD before receiving access to the biospecimens, as required by the Material Transfer Agreement (Clause 14)?

Yes ___ No ___

6C. If No to 7B, please list below the Collaborators and ensure that they have submitted a separate biospecimen request in DASH including a Biospecimen Request Form and signed a Material Transfer Agreement with NICHD before submitting this Annual Report.

Name

Institution/Branch

Role on Project

Comment

7. Summary of Research Accomplishments

7A. Peer Review Publication(s)*

Publication Title

Date of Publication

Journal

Link (e.g., PubMed)

Impact Factor

Publication Title

Date of Publication

Journal

Link (e.g., PubMed)

Impact Factor

Additional Publications?

Please add an Appendix for additional publications

7B. Patent(s)

Patent Number

Provisional/ Patent Application Number

Description of newly discovered/ developed tool or technology

Additional Patents?

Please add an Appendix for additional patents

7C. List of Presentations: Please provide a list of oral or poster presentations and abstracts resulting from the use of the Biospecimens.

Title	Presentation Type (Oral, Poster, Abstract)	Date of Presentation	Conference/Seminar

7D. Other outputs or outcomes generated from the use of biospecimens received from DASH?

8. Was the data generated from the research use of requested biospecimens submitted into DASH, as required by the Material Transfer Agreement (Clause 10)?

Yes ___ No ___

If No, please approximate the date you plan to submit the data into DASH: MM/ YY

9. Was the quality of the biospecimens provided appropriate for the proposed research purpose?

Yes ___ No ___

If No, please provide feedback below on the quality of the biospecimens received from DASH.

10. Biospecimen Recipient Signature²

Signature of the Biospecimen Recipient

Recipient Name

Date

1*Indicates mandatory field

2

NICHD DASH – Annual Biospecimen Use Progress Report 6

Version: 01/06/21