NOT-MH-19-040: Notice of Change to the Cooperative Agreement in RFA-MH-19-149, BRAIN Initiative Cell Census Network (BICCN) Specialized Collaboratory on Human and Non-Human Primate Brain Cell Atlases (U01 Clinical Trial Not Allowed)

Notice of Change to the Cooperative Agreement in RFA-MH-19-149, BRAIN Initiative Cell Census Network (BICCN) Specialized Collaboratory on Human and Non-Human Primate Brain Cell Atlases (U01 Clinical Trial Not Allowed)

Notice Number: NOT-MH-19-040

Key Dates
Release Date: August 2, 2019

Related Announcements
RFA-MH-19-149

Issued by
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this notice is to change the cooperative agreement language in RFA-MH-19-149, " BRAIN Initiative Cell Census Network (BICCN) Specialized Collaboratory on Human and Non-Human Primate Brain Cell Atlases (U01 Clinical Trial Not Allowed).

Currently Reads:

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches and to plan and conduct the proposed research. She/he will assume responsibility and accountability to the applicant organization and to the NIMH for performance and proper conduct of all research, including the NIH intramural component, if applicable, in accordance with the Terms and Conditions of Award.

The Principal Investigator will be a member of the Steering Committee and will be responsible for scheduling Steering Committee meetings and disseminating meeting notes to all participants within 2 weeks of each meeting (see below under Collaborative Responsibilities).

The Awardee Institution and/or Research Project Leader's Institution will retain primary custody of and have primary rights to data as specified under the NIMH approved Intellectual Property Patent Rights Agreements for New Chemical Entities or the data and research resource sharing plans (described below). The PD/PI will provide to the NIMH Program Official and Project Scientist(s) access to data generated under this cooperative agreement to allow them to periodically review the data consistent with current DHHS, PHS, and NIH policies.

Timely publication of major findings by the Steering Committee members is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIMH support, including the assigned cooperative agreement award number.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist(s) interacts scientifically with the funded PIs and the collaborators on their cooperative agreement grants, and may provide appropriate assistance, including: 1) assisting in research planning, 2) suggesting studies within the scope of the cooperative agreement objectives and research activities, 3) presenting experimental findings from published sources or from relevant contract projects, 4) participating in the design of experiments, 5) participating in the analysis of results, and 6) advising in management and technical performance.

The Project Scientist(s) will be a member(s) of the Steering Committee.

FIH, EFS, Phase Ib and Phase II/PoC studies will be reviewed by an appropriate NIMH Data and Safety Monitoring Board (DSMB) to ensure the safety of participants and the validity and integrity of the data. The study protocol(s) and consent form(s) will be reviewed by the DSMB prior to initiation of the project. The DSMB will review study reports on a regular basis to monitor subject enrollment and retention, safety, quality of data collection, and integrity of the study. Applicants should refer to NIH’s policy on data and safety monitoring (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) as well as the NIMH Guidelines for Data and Safety Monitoring (http://www.nimh.nih.gov/funding/grant-writing-and-application-process/nimh-policy-on-data-and-safety-monitoring-in-extramural-investigator-initiated-clinical-trials.shtml.

Additionally, an NIMH Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including monitoring implementation of the data and research resource sharing plans and will be named in the award notice.

As noted previously, both NIMH Project Scientist and Program Official will be given access to the data generated under this cooperative agreement, which will allow them to periodically review the data to ensure consistency with current DHHS, PHS, and NIH Policies.

Participation of NIH Intramural Scientists:

An NIH intramural scientist may not serve as the PD(s)/PI(s) but may participate as a collaborator, or consultant. However, an Intramural scientist may not receive salary, equipment, supplies, or other remuneration from awards resulting from this FOA. The Intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project. The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research. The participation of an intramural scientist is independent of and unrelated to the role of the NIMH Project Scientist. For applications that include NIH intramural components, the intramural resource level will be included in the total cost of the overall application. The involvement of Intramural scientists needs to be consistent with NIH Policy. http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm

Intramural research scientists participating as collaborators have the same rights and responsibilities as other researchers who are participating investigators in the funded cooperative agreement grants. Most often these investigators will be members of the Steering Committee, since they will likely be considered as key personnel.

Areas of Joint Responsibility include:

A governing Steering Committee composed of the PD(s)/PI(s), a CRO lead or CTSA lead (as applicable), key personnel, NIMH Project Scientist(s), and NIMH Program Official will be established to assist in monitoring and developing the scientific content and direction of the program. The total membership by NIMH staff will not exceed one-third (1/3) of the membership of the Steering Committee. In all cases, the role of NIMH will be to assist, participate in deliberations, and facilitate discussion and not to direct activities.

Steering Committee will serve as the governing board for awardees. All awardees under this initiative program are bound by the policies and procedures developed by the Steering Committee; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the Steering Committee.

Membership in the Steering Committee will include the PD(s)/PI(s) of each U01 award, or a designated representative in the case of Multiple PD/PI award. Each member will have one vote.

The NIMH Project Scientist will be a voting member of the Steering Committee.

The chair will be chosen by a majority vote of the Steering Committee, with years of service as chair determined by the committee. The chair is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to Steering Committee members within 30 days of the meeting. Virtual meetings are appropriate. The NIMH Project Scientist may not serve as the Chair of the Steering Committee.

The Steering Committee members will meet periodically to review progress, plan and design research activities, and establish priorities. The frequency of meetings, not fewer than two per year, will be determined by the PD(s)/PI(s) who will be responsible for scheduling the time and place (generally at one of the performance sites) and for preparing concise proceedings or minutes (action items and one-two page summary) which will be delivered to the members of the Committee within 2 weeks of the meeting.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Intellectual Property and Patent Rights for New Chemical Entities or Devices

Since the development of new pharmacological treatments for psychiatric disorders is a major objective of this effort and active involvement by pharmaceutical laboratories is encouraged and would be facilitated by the existence of appropriate patent coverage, it is expected that applicants provide plans to address the handling of intellectual property for new chemical entities or devices under this FOA.

Under the earlier National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction program, successful applicants were required to supply the following confidential materials to the NIMH Program Official listed under Section VII. Agency Contacts. Similar to the NCDDG, applicants are expected to address the three items noted below under this FOA, consistent with achieving the goals of this program:

1. Each applicant are expected to provide a detailed description of the approach to be used for handling intellectual property and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Procedures are expected to be described for resolution of legal problems should they arise, consistent with achieving the goals of the program. Your attention is drawn to the NIH Extramural Technology Transfer Policies and Documents [https://grants.nih.gov/grants/intell-property.htm].

2. A formal statement of Intellectual Property among the PD(s)/PI(s) and their institutions as well as a detailed description of procedures to be followed for resolution of legal problems which may develop, is expected to be signed and dated by the organizational official authorized to enter into intellectual property arrangements for each PD(s)/PI(s) and their institution(s). The signed agreement is expected to be submitted prior to award to the appropriate NIMH staff at the addresses provided under Section VII. Agency Contacts.

3. Prior to the award, the PD(s)/PI(s) is expected to provide a signed statement of acceptance of the participation of NIMH staff during performance of the award as outlined under "NIH Staff Responsibilities" in Section VI.2 - Cooperative Agreement Terms and Conditions of Award.

Note: Do NOT submit documents 1-3 above with the application. However, awards will not be made until these documents are received and approved by NIMH.

Progress Reviews

Progress of the project will be reviewed annually by the NIMH Project Officer at the time of each non-competing continuation application to assure that satisfactory progress is being made in achieving the project objectives, especially with respect to enrollment and quality of data collection, timely data sharing as appropriate and consistent with achieving the goals of the program, and to ensure the site is following the procedures recommended and approved by the project Steering Committee.

By acceptance of these awards, the awardees agree to abide by decisions and policies of the project Steering Committee and the other terms and conditions listed above or referenced in the Notice of Grant Award.

Modified to Read:

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply) , and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibilities as described below:

Define the details for the project within the guidelines of this FOA.
Oversee and perform the scientific activities.
Administratively manage the Collaboratory grant.
Accept close coordination, cooperation, and participation of NIH BRAIN program staff in the scientific, technical, and administrative management of the BICCN. Inform the NIH program official of all major interactions with other members of the Steering Group.
Provide milestones and cost for the Collaboratory operation to the NIH BRAIN program staff as requested (usually at the outset of the award and annually thereafter, but also at other times as requested by the program staff).
Use common brain samples, common coordinate systems, and standard nomenclature to generate and integrate the data, metadata, and knowledge.
Demonstrate capability and flexibility for modifying brain regions of study, data formats and metadata.
Ensure that the products of the production effort meet the quality standards.
Share data and resources according to the data release and resource sharing policies developed for and by this project as appropriate and consistent with achieving the goals of the program.
Share Specific Aims and Research Strategy of the project with other members of the BICCN for the purpose of collaboration and coordination.
Fully disclose algorithms, software source code to the other members of the Network for the purpose of scientific evaluation.
Not disclose confidential pre-public information confidential information obtained from other members of the Network.
Submit data for quality assessment and/or validation in any manner specified by the Steering Group, the External Scientific Panel, and/or the NIH BRAIN program to ensure scientific rigor;
Adhere to NIH policies regarding intellectual property and other policies that might be established during the course of this activity. Awardees will retain custody of and have primary rights to the data and resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
Participate in BICCN activities, including periodic meetings to report the Collaboratory’s progress, and coordinate publication of research results.
Coordinate and collaborate with other U.S. and international groups that may be generating relevant cell census datasets;
Serve as a member of the BICCN Steering Committee.
Submit periodic progress reports as agreed upon by the Steering Committee.
Accept and implement the common guidelines and procedures approved by the Steering Committee, External Scientific Panel, and NIH.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A Program Officer will be assigned to this award. The Program Officer will be responsible for normal scientific and programmatic stewardship and guidance for the overall project within the NIMH and will ensure that the generation of cell census datasets and resources are relevant to the diverse research community served by the NIH Institutes and Centers. The Program Officer will be responsible for milestone negotiations to ensure that the milestones are achieved and goals are being met. In addition, the NIH Program Officer is responsible for monitoring and implementing the Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/index.htm). The NIH Program Officer may attend Steering Group meetings as a non-voting participant. The NIH Program Officer will be named in the award notice.
One or more extramural NIH program staff member will be assigned as the Project Scientist(s) for this award. The same person may serve as the Project Scientist for multiple BRAIN Initiative awards. The Project Scientist(s) will interact scientifically with the PDs/PIs and other named personnel of that award, as a partner in the research, including providing technical assistance, advice, and coordination for the BICCN and its component parts. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the BICCN Steering Committee and that NIH staff will be given the opportunity to offer input to this process.
An NIH BRAIN Project Team will be composed of Program Officials and other relevant extramural staff from NIH Institutes and Centers and the Project Scientist(s). Its primary role is to ensure that the datasets and resources generated represent the diverse interests of the participating NIH Institutes and Centers, advise on brain cell census activities relevant to their individual Institute/Center mission, monitor overall progress, attend Steering Group meetings as required, and report back to their Institute/Center.
The NIH BRAIN Project Team will establish an External Scientific Panel (ESP) to help evaluate the progress of the BICCN.
NIH intramural scientists involved in the BICCN will have the same rights and responsibilities as the comparable extramural Project Scientists involved in the BICCN. An intramural scientist may not receive salary, equipment supplies, or other remuneration from awards resulting from this FOA. The intramural scientist must obtain written approval of his/her NIH Institute Scientific Director for the amount of resources that may be allocated to the project. The approval must also specify that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy on vertebrate animal research. The participation of an intramural scientist is independent of and unrelated to the role of the NIH Project Scientist(s). The involvement of intramural scientists needs to be consistent with NIH Policy. http://sourcebook.od.nih.gov/ethic-conduct/ethical-conduct-toc.htm

Areas of Joint Responsibility include:

BRAIN Cell Census Network (BICCN) Steering Committee:

The Steering Committee will be composed of the PD(s)/PI(s), NIH program staff member(s) and External Scientific Panel members (experts to be named after award). The Steering Committee will be established to help monitor progress, encourage improvements, and coordinate the production of brain cell census datasets and resources through the BICCN. It is anticipated that additional coordination mechanisms will be set up with other U.S. and international groups that may join this effort. The BICCN Steering Committee members will meet periodically to plan and design activities, review and discuss progress, and establish priorities and policies. A chair and a co-chair will be designated on a rotating basis as needed. Each PD(s)/PI(s), and external scientific advisor will have one vote each and the NIH will have one vote through the participation of the Project Scientist(s). Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The BICCN Steering Committee will:

Discuss progress in meeting the research community's need for cell census datasets.
Facilitate the development of uniform procedures and policies, for example for data standards, quality measures and assessment, nomenclature and annotation conventions for data depositions, and so forth.
Awardee members of the Steering Group will be required to accept and implement the common guidelines and procedures approved by the Steering Group.
Coordinate and improve cell census data production, for example by reporting progress, disseminating best practices and collectively evaluating new procedures, resources, and technologies.
Establish subcommittees as needed to address particular issues. Subcommittees will include representatives from the BICCN, the NIH BRAIN Project Team, and possibly other experts. Subcommittees may be formed to: 1) develop and implement data production and analysis standards including spatial and semantic standards for integrating heterogeneous data sets and information; 2) address data submission, management, and analysis issues; 3) develop quality standards and methods for quality control and assurance; and 4) develop common reagents and informatics tools. In these cases, common policies, uniform practices (as needed), and data exchange will be critical to the success of the effort and will enable harmonization and eliminate duplication/overlap.

External Scientific Panel (ESP):

The ESP will provide recommendations to the NIH BRAIN Project Team and BICCN about the progress and scientific direction of all components of the program. The ESP will be composed of four to six senior scientists who represent broad research community and have relevant expertise, although the membership may be enlarged permanently or on an ad hoc basis as needed. The ESP will meet twice a year; some meetings may be conducted by telephone conference. At least once a year, there will be a joint meeting with the Steering Committee for the members of both ESP and Steering Committees to interact directly. The ESP will make recommendations regarding progress of the BICCN and present advice to the NIH BRAIN Project Team about changes, if any, that may be necessary in the BICCN program.

Dispute Resolution:

Inquiries

Please direct all inquiries to:

Yong Yao, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-6102
Email: yyao@mail.nih.gov