The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Human Genome Research Institute (NHGRI) invite applications for administrative supplements to existing NICHD and NHGRI awards to assess the ethical, legal and social implications (ELSI) of obtaining pediatric tissue from generally healthy decedents (under 18 years old) in a post-mortem setting.

There are special circumstances and sensitivities surrounding the sudden loss of an otherwise healthy child. Therefore, unique ethical considerations must be taken into account when approaching family decision-makers for consent to donate pediatric tissue for research purposes in a manner that would be acceptable to grieving parents. The purpose of this NOSI is to announce the availability of administrative supplements to existing NICHD and NHGRI awards to encourage ELSI research into the attitudes and concerns of potential study participants, particularly those with diverse racial, ethnic, socioeconomic and religious backgrounds; the effectiveness of consent processes in informing participants of the risks and benefits of the study and ensuring informed decisions; best practices for obtaining broad consent from grieving families for the procurement of multiple pediatric tissues for future research purposes and the return of general research results; and the psychosocial impact of participation in the study on families and healthcare staff. It is expected that teams of specialists, potentially including bioethicists, clinicians working in intensive care or emergency settings, and experts in organ procurement or medical examination, would be most responsive to this supplement request.

Specific Areas of Research Interest

Examples of research areas include, but are not limited to, the following:

• Best strategies for and effectiveness of approaching and obtaining broad consent from grieving parents and other family decision-makers for post-mortem pediatric tissue donation for research, from generally healthy neonates, children, and adolescents, including in settings where organ donation may also be a consideration
• The attitudes and concerns of family decision-makers around pediatric tissue donation for research and their perceptions on its utility, particularly from donors with diverse racial, ethnic, socioeconomic and religious backgrounds, and strategies to address these cultural differences
• The attitudes and concerns of healthcare providers around pediatric tissue donation for research, particularly from healthcare teams providing care for eligible donors
• Strategies to guide bereaved family decision-makers through a complex consent process including concepts such as the collection of multiple tissue types, broad sharing of data, unspecified future use of research samples, and potential familial implications of genomic data
• Approaches to address the possibility of return of results to families, including moral/legal responsibilities, family preferences and expectations, clinical/pathological findings, and secondary/non-medical/non-genomic findings
• Research to address the unique needs and expectations of bereaved parents and to develop procedures for follow-up with families regarding study activities and general research outcomes

Projects that only support the development of training and educational materials and do not involve a research question are NOT eligible for this NOSI.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Budget

To be eligible, the parent award must be able to receive funds in FY 2020 (Oct. 1, 2019 - Sept. 30, 2020) and not be in the final year or in a no-cost extension period at the time of the award.

One-time supplement budget requests cannot exceed $100,000 direct costs for one year of total support. The number of awards will be contingent on availability of funds and receipt of meritorious applications. It is currently anticipated that 2-3 awards will be made.

Eligible Activity Codes:

Administrative supplement requests may be submitted for the following activity codes: R01, RL1, RM1, R21, U01, UG1, U24, P01, P50, K23

Administrative Evaluation Process

Administrative Supplements do not receive peer review. NIH will conduct administrative review of applications. The most meritorious applications will be evaluated by a panel of NICHD and NHGRI staff and supported based upon availability of funds. Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award to discuss whether the supplement falls within the scope of the parent award and meets the needs of the NOSI.

The criteria described below will be considered in the administrative evaluation process:

1. Is the work proposed within the scope of the active award?
2. Is the work proposed focused specifically on pediatric tissue donors in the post-mortem setting?
3. How well does the proposed work address the goals of the NOSI?
4. Is there appropriate expertise to accomplish the goals of the work proposed?

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date(s) May 15, 2020, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-HD-20-012 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for one year of support only.
• The Research Strategy section of the application is limited to 6 pages.
• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains FORMS-E-ADMINSUPP . In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Applicants are encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.
• As part of the application, investigators should submit a one-page abstract of the proposed research that describes the relevance to the parent award and the responsiveness to the goals of the NOSI. Place the abstract in the Project Summary/Abstract section of the SF424 (R&R) form.