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Policy & Procedures

NDAR Policy | Data Access Committee | Standard Operating Procedures

The NDAR research portal has been developed for the autism research community. The NDAR Policies, however, have multiple stakeholders with differing needs. The policy and procedures defined here address the needs of all NDAR stakeholders.

NDAR Policy

• NDAR Policy [ PDF, 72 KB ]
  Last updated: Feb 16, 2011
• Ongoing Study Policy Addendum [ PDF, 13 KB ]
  Last updated: Feb 20, 2009

The NDAR Policy is the primary overarching policy of NDAR addressing considerations for providing data to NDAR, outlining the requirements for data submission and the protection of research subjects.

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Data Access Committee

As defined by the NDAR Policy, an NDAR Data Access Committee (DAC) has been established to objectively and systematically review the requests for data submission and access to NDAR resources. Collectively, the NDAR DAC has overall responsibility for ensuring compliance with the NDAR Policy. Specifically, the NDAR DAC is responsible for the following:

1. Reviewing and approving of data submissions to the NDAR Central Repository in compliance with the NDAR policies.
2. Reviewing and approving of individuals requesting access to controlled NDAR resources (e.g. NDAR Central Repository) for broad access or for NDAR's Ongoing Study capability.
3. Agreeing to Memoranda of Understanding (MOUs) or agreements with entities interacting with NDAR, such as federated data resources.
4. Authorizing other groups, such as NDAR Staff, to perform specific tasks defined within this document (e.g. QA/QC procedures, security compliance, granting of access in NDAR based upon DAC decisions, etc.).
5. Approving the NDAR standard operating procedures (SOPs).

The NDAR DAC consists of a minimum of 3 federal government employees appointed by the NDAR Director. Currently, the NDAR Data Access Committee comprises the following individuals with expertise in science, policy or bioinformatics resources:

• Dr. Michelle Freund — Chair
• Dr. Lisa Gilotty
• Dr. Alice Kau
• Dr. Cindy Lawler
• Dr. Matthew McAuliffe
• Dr. Anne Sperling
• Dr. Patrick Bender

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Standard Operating Procedures

NDAR is a protected resource for autism data contributed by investigators, funded by the NIH and other organizations. Contained in the NDAR Central Repository are detailed research data derived from consenting human subjects. Operational procedures have been established to ensure that the data contained in NDAR are efficiently made available to qualified researchers according to the protections defined in NDAR and other federal policies.

The standard operating procedures (SOPs) described below are to be followed by NIH, their designees, and any users of NDAR. Note that these procedures often require an investigator to upload a document into their NDAR profile and possibly associate these documents with an NDAR Collection or NDAR Study. Only the investigator and NDAR staff will have access to these documents. For any other questions or feedback, please contact ndarhelp@mail.nih.gov.

• SOP-01 NDAR Account Request
• SOP-02 Data Submission Privilege Request
• SOP-03 NDAR Certification and Assurance to Operate
• SOP-04 Data Access Permission Request
• SOP-05 Quality Assurance and Quality Control
• SOP-06 Establishment of a Federated Data Resource
• SOP-07 Data Dictionary Definition
• SOP-08 GUID Generation Permission Request
• SOP-09 Request for Ongoing Study
• SOP-10 Request Time Extension for Sharing
• SOP-11 Deviations to Data Sharing Terms
• SOP-12 Administrative Access to NDAR
• SOP-13 Request to Submit Data to an NDAR Federated Repository

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SOP-01 NDAR Account Request

NDAR is a restricted access portal to research data relevant to autism. An NDAR account is required to submit or access autism-related data. Investigators and data managers at research sites are invited to request an account. To provide maximum protection for the confidentiality of research participants whose data is stored in NDAR, professional credentials are verified by NDAR Staff during the account request process.

Procedure

This procedure provides process steps for account request initiation, authorization, and validation. The entire procedure typically requires 1-3 business days.

Account Request Initiation

1. Point your browser to the NDAR portal at http://ndarportal.nih.gov.
2. Click the "Request an Account" link.
3. On the "Request an Account" page, fill in the required fields.
4. Click the [ Next ] button for a confirmation page.
5. Review and edit the information if needed.
6. Click the [ Submit ] button.
7. The NDAR portal notifies NDAR Staff that your request is awaiting review.

Account Request Review and Authorization

1. NDAR Staff review the information you provided in your request.
2. NDAR Staff look up your name in the NIH grants management system to see if you have applied for or received grant support. (Grant support is not required for an NDAR account.)
3. NDAR Staff verify that your Affiliated Institution is recognized by the NIH as a research organization.
4. NDAR Staff may contact you for more information about your intended use of the NDAR portal.
5. NDAR Staff summarize this information and provide it to the NDAR Data Access Committee (DAC).
6. The NDAR DAC reviews the information and authorizes the account request.
7. With authorization from the NDAR DAC, NDAR Staff establish a link between your NDAR account and NIH enterprise systems for the purpose of making grants and publications information available in the NDAR research portal.
8. The NDAR portal sends you an automated email message with instructions on how to validate your account.

Account Validation

1. Watch your email inbox for a message from "NDAR" with subject "NDAR Portal New User Account Request."
2. Click on your unique URL in the body of the e-mail message.
3. Establish a password in keeping with the NIH password policy.

To request additional privileges for your NDAR account, please refer to the following procedures:

• To submit data to NDAR, refer to SOP-02 Data Submission Privilege Request.
• To query and access data stored in NDAR, refer to SOP-04 Data Access Permission Request.
• To generate Global Unique Identifiers (GUIDs) to use as subject IDs for research participants, refer to SOP-08 GUID Generation Permission Request.

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SOP-02 Data Submission Privilege Request

To submit data to the NDAR research portal, an investigator is required to complete an NDAR Data Submission Agreement. With an approved submission request, an investigator can submit descriptive data, experimental data, and a variety of supporting documentation associated with a research study to an NDAR Collection — a virtual container for storing research data. To create an NDAR Collection, an investigator must have at least one current Data Submission Agreement uploaded to the NDAR portal.

The Data Submission Agreement must be signed by two parties:

1. The person responsible for collecting the data and
2. The NIH-recognized business official at the investigator's affiliated institution.

The person responsible for collecting the data is typically the Principal Investigator. Alternatively, it could be a co-Investigator who is responsible for data coordination for the study. The person who signs the form will create the NDAR Collection.

The NIH-recognized business official is the same person that signs off on grant applications at the research institution.

Procedure

This procedure provides process steps for data submission privilege request initiation, review and approval. The entire procedure typically requires 10 business days.

Data Submission Privilege Request Initiation

1. Download and complete the NDAR Data Submission Agreement.
2. Create an Adobe PDF file of the signed agreement.
3. Log in to your NDAR account at http://ndarportal.nih.gov.
4. Click on the "My Profile" link.
5. On the "Modify my Profile" page, scroll down to the "Account Privileges" section.
6. Check the "Create Collections" checkbox.
7. Under the "Administrative Files" section, click the [ Browse ] button to locate the PDF file of the signed agreement on your desktop.
8. Use the drop-down menu under "File Type" to choose "Data Submission Agreement."
9. Click the [ Add ] button.
10. Click the [ Submit ] button.
11. The NDAR portal notifies NDAR Staff that your request is awaiting review.

Data Submission Privilege Request Review and Approval

1. NDAR Staff review your Data Submission Agreement for completeness.
2. NDAR Staff ensure that the signing business official is recognized by the NIH.
3. NDAR Staff ensure that the Federal Wide Assurance (FWA) for the specified institution number is properly listed.
4. NDAR Staff set an appropriate agreement expiration date, generally 180 days following project end date. The agreement may be extended as necessary by contacting NDAR at ndarhelp@mail.nih.gov with a request.
5. NDAR Staff provide the agreement and a summary of the request to the NDAR Data Access Committee (DAC) for decision. The NDAR DAC meets twice a month to review these requests.
6. The NDAR DAC reviews the request and makes a decision based on the expectations outlined in the NDAR policy. NDAR Staff may contact you for additional information to support the decision.
7. Once your request is approved, NDAR Staff update your NDAR account privileges, permitting you to create an NDAR Collection and submit data.
8. The NDAR portal sends you an automated e-mail message notifying you of the change in your account privileges.

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SOP-03 NDAR Certification and Assurance to Operate

As a Federal Information System, NDAR will follow NIH Security Certification and Accreditation as defined at http://ocio.nih.gov/nihsecurity/NIH_System_CnA.htm. NDAR is rated at a Security Objective of Confidentiality and a Potential Impact Level of Moderate. This level of security is defined by NIST publication 800-18 Guide for Developing Security Plans for Federal Information Systems:

"The unauthorized disclosure of information could be expected to have a serious adverse effect on organizational operations, organizational assets, or individuals."

The NDAR Data Access Committee has authorized the NIH Center for Information Technology (CIT) to oversee its certification and accreditation utilizing objective third parties to perform NDAR's security certification and accreditation.

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SOP-04 Data Access Permission Request

The NDAR research portal will provide investigators with a single point of access to multiple autism-relevant data sources (e.g., AGRE, IAN, NIMH Genomics Repository) in addition to the shared data stored in the NDAR Central Repository.

For permission to query and access shared data stored in the NDAR Central Repository, an investigator is required to complete the following. Please refer to the Data Access Document Completion Instructions for more information.

1. The simplified SF-424 (R&R) form,
2. The Data Use Certification contained in the NDAR Data Access Request information packet and
3. The Data Access Document Completion Instructions.

Both forms must be signed by two parties:

1. The Principal Investigator responsible for collecting the data and
2. The NIH-recognized business official at the investigator's affiliated institution.

For permission to query and access shared data stored in data sources that are federated with NDAR, an investigator will be expected to complete access agreements specific to these data sources in addition to the SF-424(R&R) and Data Use Certification. Procedures for requesting access to specific federated data sources will be made available as these data sources come online. Until then, contact ndarhelp@mail.nih.gov with any questions.

For permission to query and access data stored in the NDAR Central Repository that have not been shared, please read SOP-09 Request Ongoing Study prior to performing these procedures.

Procedure

This procedure provides process steps for data access permission request initiation, review and approval. The entire procedure typically requires 10 business days.

Data Access Permission Request Initiation

1. Download the NDAR Data Access Request information packet for instructions on completing the simplified SF-424 (R&R) and Data Use Certification forms.
2. Complete the SF-424(R&R) and Data Use Certification forms.
3. Create an Adobe PDF file of each signed form.
4. Log in to your NDAR account at http://ndarportal.nih.gov.
5. Click on the "My Profile" link.
6. On the "Modify my Profile" page, scroll down to the "Account Privileges" section.
7. Check the "Query Shared Autism Data" checkbox.
8. Under the "Administrative Files" section, click the [ Browse ] button to locate the PDF file of the SF-424(R&R) on your desktop.
9. Use the drop-down menu under "File Type" to choose "SF-424R&R."
10. Click the [ Add ] button.
11. Click the [ Browse ] button to locate the PDF file of the signed Data Use Certification on your desktop.
12. Use the drop-down menu under "File Type" to choose "Data Access Agreement"
13. Click the [ Add ] button.
14. Click the [ Submit ] button.
15. The NDAR portal notifies NDAR Staff that your request is awaiting review.

Data Access Permission Request Review and Approval

1. NDAR Staff review your Data Access Agreement for completeness.
2. NDAR Staff provide the agreement and a summary to the appropriate authority for decision. For example, if the request is for the NDAR Central Repository the request is routed to the NDAR Data Access Committee. If the request is for access to a data resource federated with NDAR, the request is routed to the federated resource for a decision.
3. The NDAR DAC or federated resource will provide approval for access to their data through the NDAR portal.
4. The NDAR DAC or federated resource will determine the expiration date for access to its data.
5. Once access is approved, NDAR Staff update your NDAR account privileges to permit you to query and access data.
6. The NDAR portal sends you an automated e-mail message notifying you of the change in your account privileges.

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SOP-05 Quality Assurance and Quality Control

The quality of data within NDAR is crucial for ensuring its usefulness and reliability for research. Therefore, the NIH has implemented a multi-tiered quality control procedure for data contributed to NDAR.

Procedure 1: Validation of Data Elements Made Available by NDAR

Prior to a Data Dictionary release or the establishment of a federated data resource, NDAR Staff will certify that the fields defined do not include any information that can be reasonably used to identify a research subject, their specific geography or individuals associated with the research. Although not applicable to NDAR, the HIPAA Limited Dataset definition will be used as the basis for this certification. Specifically, NDAR staff will ensure that the following direct identifiers of the research subject or of relatives, employers, or household members associated with the research subject are removed:

1. Names;
2. Postal address information, other than town or city and State or 3 digit zip code;
3. Telephone numbers;
4. Fax numbers;
5. Email addresses;
6. Social Security numbers;
7. Medical record numbers;
8. Health plan beneficiary numbers;
9. Account numbers;
10. Certificate or license numbers;
11. Vehicle identifiers and license plate numbers;
12. Device identifiers and serial numbers;
13. URLs associated with an individual;
14. IP addresses;
15. Biometric identifiers; and
16. Full-face photographs and any comparable images.

Any potential discrepancies to this privacy rule (e.g., genomics data or images that could be transformed) will be documented and approved/denied by the NDAR Data Access Committee (DAC).

Procedure 2: Sharing of an NDAR Study or NDAR Collection

An NDAR Collection is a virtual container for research datasets contributed to the NDAR Central Repository or made available through federation. An NDAR Study contains references to specific participants either within the NDAR Central Repository or a federated data resource. Both NDAR Collections and NDAR Studies allow for supporting documentation to be uploaded and shared.

Investigators may create NDAR Collections or NDAR Studies many months prior to submitting data to them. As containers empty of research data, NDAR Collections and NDAR Studies contain only general information such as the project title, contributing investigators and funding source. These containers may be shared either to specific individuals through NDAR's Ongoing Study capability or broadly with other researchers. The decision to share an NDAR Collection or NDAR Study is based solely upon the discretion of the owner of the NDAR Collection or NDAR Study. No additional review is necessary.

Sharing an NDAR Collection or NDAR Study only makes general information available to others. Documentation contained in the NDAR Collection or NDAR Study or data contained in the NDAR Collection must follow specific data sharing procedures, defined below.

Procedure 3: Validation of Documents within an NDAR Collection or NDAR Study

For documentation uploaded to NDAR, the following procedure will be followed.

1. An individual with appropriate privilege uploads a document into an NDAR Collection or NDAR Study.
2. The account holder assures NDAR that the data contained in the document contains no identifying information.
3. The NDAR portal performs a virus scan on the document and accepts the document.
4. NDAR Staff are notified of the uploaded document and will perform a review of the document to verify that it contains no identifying information associated with research subjects.
5. The owner of the NDAR Collection or NDAR Study requests that the document be shared (e.g. for scientific collaboration using NDAR's Ongoing Study capability or broadly shared)
6. NDAR Staff notify the NDAR Data Access Committee (DAC) of the request for a decision to allow the document to be shared.
7. If the document is approved, the NDAR DAC authorizes NDAR Staff to allow the document to be shared with others.

Procedure 4: Validation and Sharing of an NDAR Dataset

Datasets contributed to the NDAR Central Repository are shared with those that have appropriate access. The same process is followed for data shared broadly or data shared through NDAR's Ongoing Study capability.

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SOP-06 Establishment of a Federated Data Resource

The NDAR portal has been designed to federate with external data sources, providing investigators with a single point of access to multiple autism-relevant data sources (e.g., AGRE, IAN, NIMH Genomics Repository) in addition to the shared data stored in the NDAR Central Repository.

The following procedure is required to establish a federated resource.

Procedure

1. NDAR Staff request NDAR Data Access Committee (DAC) approval to pursue data federation with a specific data resource.
2. NDAR Staff work with the prospective federated data resource and resolve issues associated with data definition, translation, security, and access.
3. The NDAR Director, working with NDAR Staff, will develop a data federation agreement between the prospective data resource and NDAR. The agreement will define the specific views of data to be made available and the persons or groups the federated resource has determined to have authority to grant access to those views.
4. The NDAR DAC and federated data resource approve the data federation agreement.
5. NDAR Staff perform data validation steps associated for each of the views established by the federated data resource.
6. The NDAR DAC authorizes the data resource (or specific views into that resource) to be available through NDAR as defined by the agreement.

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SOP-07 Data Dictionary Definition

These procedures will be developed in support of the NDAR Data Dictionary, when it becomes available. Contact ndarhelp@mail.nih.gov to help lead the autism research community in defining the NDAR Data Dictionary.

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SOP-08 GUID Generation Permission Request

In the NDAR Central Repository, research data associated with an individual participant are linked by means of a Global Unique Identifier (GUID) that protects personally identifiable information (PII) about the participant. GUIDs allow investigators to track participants longitudinally, across multiple research sites and across multiple studies.

The GUID is generated using a free software application installed at the research site. The software uses four items found on a typical birth certificate:

1. Full legal name of participant at birth (as it appears on the participant's birth certificate)
2. Participant date of birth
3. Gender
4. Town or municipality of birth (as it appears on the participant's birth certificate)

If all four items were not collected from participants, the software can be used to generate pseudo-GUIDs, which can be converted to valid GUIDs at a later date.

Participant GUIDs or pseudo-GUIDs are required to submit data to NDAR.

Procedure

This procedure provides process steps for GUID client request initiation, review, approval and verification. The entire procedure typically requires 4-5 business days.

GUID Client Request Initiation

1. Log in to your NDAR account at http://ndarportal.nih.gov.
2. Click on the "My Profile" link.
3. On the "Modify my Profile" page, scroll down to the "Account Privileges" section.
4. Check the "GUID Client" checkbox.
5. Enter the fully qualified domain name of the computer that will run the GUID client (i.e., somehost.example.com).
6. Enter the static IP address of the computer that will run the GUID client application. If the client machine has a dynamic IP address, then enter the current IP address and the subnet mask.
7. The NDAR portal notifies NDAR Staff that your request is awaiting review.

GUID Client Request Review and Approval

1. NDAR Staff approve the request or request more information.
2. Once access is approved, NDAR Staff update your NDAR account privileges to permit you to query and access data.
3. NDAR Staff initiate a request with NDAR Technical Staff to create two versions of the GUID client application configured to your computer:
   
   • GUID Demo client — to test the client using fake participant demographics
   • GUID Production client — to generate valid GUIDs for real research participants
4. NDAR Technical Staff create the application and send you an e-mail message with set-up procedures.

GUID Client Verification

1. Set-up the GUID Demo client on your computer according to the instructions.
2. Test the GUID Demo client specific to your institutional processes, using fake demographic data. DO NOT USE REAL DEMOGRAPHIC DATA.
3. If the client doesn't function properly, send an e-mail message to NDARHELP@mail.nih.gov for technical support. A new GUID Demo client may be created for you to set up and test.
4. Once the GUID Demo client functions properly, install the GUID Production client.
5. If the client does not function properly, send an e-mail message to NDARHELP@mail.nih.gov for technical support.

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SOP-09 Request for Ongoing Study

NDAR's Ongoing Study capability allows investigators to work collaboratively on research studies in progress; sharing data, tools, and standards through the NDAR portal before they are shared with the rest of the ASD community.

To request this capability, an investigator is required to review the Ongoing Study Policy Addendum to the NDAR Policy and communicate with potential collaborators to develop a request for an ongoing study. An Ongoing Study Request Template is provided, and includes:

1. A descriptive title for the project
2. The research problem and primary objectives
3. A primary point of contact, or lead investigator
4. Names of co-investigators who should receive access to the data
5. The expected date that data will be shared.

The lead investigator designated as primary point of contact is required to have an NDAR account with at least one current Data Submission Agreement uploaded. Co-investigators are required to have an NDAR account. Please refer to SOP-01 NDAR Account Request and SOP-02 Data Submission Privilege Request for these procedures.

Procedure

This procedure provides process steps for ongoing study request initiation, review and approval. The entire procedure typically requires 10 business days.

Ongoing Study Request Initiation

Lead investigators:

1. Develop an ongoing study abstract with consensus from co-investigators.
2. Create an Adobe PDF file of the ongoing study abstract.
3. Log in to your NDAR account at http://ndarportal.nih.gov.
4. Click on the "My Profile" link.
5. On the "Modify my Profile" page, scroll down to the "Administrative Files" section.
6. Click the [ Browse ] button to locate the PDF file of the ongoing study abstract on your desktop.
7. Use the drop-down menu under "File Type" to choose "Request for Ongoing Study."
8. Click the [ Add ] button.
9. Click the [ Submit ] button.
10. The NDAR portal notifies NDAR Staff that your request is awaiting review.

Co-investigators:

1. Initiate a Data Access Permission Request as described in SOP-04. Copy the descriptive title of the ongoing study from the abstract to the SF-424(R&R) form.
2. Once you have completed the process to initiate a request, the NDAR portal notifies NDAR Staff that your request is awaiting review.

Ongoing Study Request Review and Approval

1. NDAR Staff provide the ongoing study abstract and any related data access agreements to the NDAR Data Access Committee (DAC) for decision. The NDAR DAC meets twice a month to review these requests.
2. The NDAR DAC reviews the request and makes a decision based on the expectations outlined in the NDAR policy. NDAR Staff may contact investigators for additional information to support the decision.
3. Once approved, NDAR Staff send an e-mail message to the lead investigator with the decision.
4. NDAR Staff update co-investigator account privileges for data-sharing.
5. The NDAR portal sends automated e-mail messages notifying account holders of the change in account privileges.

Ongoing Study Participation

Lead investigators:

1. Log in to your NDAR account at http://ndarportal.nih.gov.
2. Click on the "Study" link.
3. Click on the name of the NDAR Study you wish to share.
4. On the "Study Overview" page, scroll down to the "Administrative Files" section.
5. Click the "Edit Study" link.
6. Use the drop-down menu under "Select File to Attach to Study" and choose the Request for Ongoing Study from the list.
7. Click the [ Associate File ] button.
8. Click the [ Save Changes ] button.
9. The NDAR portal updates the Study Status to "Ongoing Study."
10. The NDAR portal sends you an automated e-mail message with notification of the change in status.

As the owner of the NDAR Collection/Study, the lead investigator will then be free to assign particular individuals to the NDAR Collection or NDAR Study to allow them access to data and/or documents contained therein. Please refer to the procedures defined in SOP-05 Quality Assurance and Quality Control prior to sharing.

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SOP-10 Request Time Extension for Sharing

This request applies only to data contained in the NDAR Central Repository.

After an investigator has submitted data to the NDAR Central Repository, the NDAR policy defines a timeframe in which QA/QC activities are to be performed prior to data being made available for sharing. Investigators, please refer to the data-sharing policy associated with your specific research study to determine the length of time between data submission and data sharing.

The investigator may request an extension to this timeframe if, in the interest of science, there are reasons for which the release of data would be considered premature. Extensions will not be granted for the singular purpose of delaying QA/QC activities.

To request this extension, an investigator is required to develop a brief, written request to include:

1. The title of the NDAR Collection or Study for which you are requesting the extension
2. The scientific rationale for the extension
3. A description of the data requiring the extension
4. A schedule for the release of the data requiring the extension
5. A description of data that will be released in the original timeframe

For an extension supporting a longitudinal outcome, identify which time points may be provided (e.g., baseline) and which time points should be withheld.

Procedure

This procedure provides process steps for time extension request initiation, review and approval. The entire procedure typically requires 10 business days.

Time Extension Request Initiation

1. Develop a written request for extension for a specific NDAR Collection or Study.
2. Create an Adobe PDF file of the written request for extension.
3. Log in to your NDAR account at http://ndarportal.nih.gov.
4. Click on the "My Profile" link.
5. On the "Modify my Profile" page, scroll down to the "Administrative Files" section.
6. Click the [ Browse ] button to locate the PDF file of the written request for extension on your desktop.
7. Use the drop-down menu under "File Type" to choose "Request for Time Extension."
8. Click the [ Add ] button.
9. Click the [ Submit ] button.
10. The NDAR portal notifies NDAR Staff that your request is awaiting review.

Time Extension Request Review and Approval

1. If the data are associated with research funded by the NIH, the NDAR Data Access Committee will consult with the NIH Program Officer to decide whether to support the request.
2. NDAR Staff will then update the status of the request in NDAR based upon the decision.

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SOP - 11 Deviations to Data Sharing Terms

Over the course of research, circumstances may arise that necessitate a change in the data sharing terms associated with NIH funded research. In anticipation of this need, the following procedure has been developed.

Procedure

1. The investigator defines the need to deviate from the established terms of the research, defining the scientific need to deviate from the proposed terms and conditions.
2. The owner of the NDAR Collection will upload the file of the concern to their profile in PDF format, defining the document type as "Deviation to Data Sharing Terms" within NDAR and associate the request to the appropriate NDAR Collection(s).
3. NDAR Staff will forward the request to the NDAR Data Access Committee and appropriate NIH Program Officer.
4. The NDAR Data Access Committee and Program Officer will approve the request or consult with the investigator for clarification/modification.
5. Once approved, the NDAR Staff will then set the status of the request in NDAR to Approved and this deviation will be honored and included in the terms associated with subsequent awards.

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SOP - 12 Administrative Access to NDAR

NDAR Staff

NDAR technical and operational staff must have access to NDAR resources, including the ability to query and review research data within NDAR. The NDAR Director is responsible for granting individual access to those administering NDAR. The NDAR Director may choose to delegate the responsibility of granting access to other NDAR Staff.

Extramural Program Staff

Extramural program staff, or their designees, must be allowed to query NDAR data. Requests for such access will be approved by the NDAR Data Access Committee. The procedure for requesting such access will follow procedure SOP-04 Data Access Permission Request but require a document specifying the reason for the request in lieu of forms SF-424(R&R) and the NDAR Data Use Certification.

SOP - 13 Request to Submit Data to an NDAR Federated Repository

Beginning in fiscal year 2012, all NIH funded human subject research data related to autism is expected to be shared through the National Database for Autism Research (NDAR). For new projects, the data sharing terms will be included in the Notice of Grant Award (NGA) which will also include expected timelines for data submission. For projects enrolling new research subjects and collecting new data on those subjects, both descriptive and experimental data are expected to be deposited into NDAR. When experimental results are obtained from a dataset originating from an NDAR federated source (e.g. ATP, AGRE), only the newly derived experimental data are expected to be submitted to NDAR in an effort to avoid duplication. While most data are expected to be submitted directly into NDAR, there may be valid scientific and/or operational reasons for submitting data, either descriptive and/or experimental, into another repository and not NDAR. However, to ensure that data remains available to the research community, only repositories that are federated with NDAR, make the data generally available to the autism research community, and have a memo of understanding (MOU) in place with NDAR ensuring such data deposited remain available to the community in perpetuity, will be considered.

The following procedure should be followed for such cases.

Procedure

Investigators who wish to use another repository for data sharing should first consult with their Program Officer. If the Program Officer believes that it is appropriate for the investigator to submit to a repository other than NDAR, then the investigator should provide the following information to ndarhelp@mail.nih.gov:

• NIH grant information (title, PI, grant number, etc.)
• Background and reason for submitting into another repository
• Submission and data sharing schedule, if different from the terms of award
• Name of the federated repository proposed for data submission where the data will be made available.

NDAR Staff will provide the request to submit and share data through a federated repository and any related information to the NDAR Data Access Committee (DAC) for a decision. The NDAR DAC meets twice a month to review these requests. NDAR Staff may contact investigators and/or the Program Officer for additional information if required. The NDAR DAC reviews the request and makes a decision based on the information provided in the request. Final approval of the request to submit to another repository instead of NDAR is contingent upon approval from both the Program Officer and the DAC. Once approved, NDAR Staff will send an e-mail message to the lead investigator with the decision. The entire procedure typically requires 10 business days.

The Policies and Procedures listed here are reviewed and approved by the NDAR Leadership Team periodically, at a minimum of once per year.