H3Africa: Ethical, Legal, and Societal Issues (ELSI) Research Program (U01)

H3Africa: Ethical, Legal, and Societal Issues (ELSI) Research Program (U01) is sponsored by NIH Common Fund, National Human Genome Research Institute (NHGRI), Fogarty International Center. This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-RM-16-013: Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Research Program (U01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations This Funding Opportunity Announcement (FOA) is a Common Fund initiative ( http://commonfund. nih. gov ) through the NIH Office of the Director, Office of Strategic Coordination ( http://dpcpsi.

nih. gov/osc/ . The FOA will be administered by a trans-NIH team led by the National Human Genome Research Institute ( NHGRI ).

Funding Opportunity Title Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Research Program (U01) U01 Research Project Cooperative Agreements September 19, 2017 - This RFA has been reissued as RFA-RM-17-021 . September 15, 2016 - Notice of Change in Award Information for RFA-RM-16-013. See Notice NOT-RM-16-030 .

September 02, 2016 - Notice of New Expiration Date for RFA-RM-16-013. See Notice NOT-RM-16-029 . September 01, 2016 - Notice of Technical Assistance Webinars for Human Heredity and Health in Africa (H3Africa).

See Notice NOT-RM-16-028 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-RM-16-014 U54 Specialized Center- Cooperative Agreements RFA-RM-16-015 U01 Research Project Cooperative Agreements RFA-RM-16-016 U54 Specialized Center- Cooperative Agreements RFA-RM-16-017 U24 Resource-Related Research Projects Cooperative Agreements RFA-RM-16-011 U24 Resource-Related Research Projects Cooperative Agreements RFA-RM-16-012 U2R International Research Training Cooperative Agreements Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) encourages applications to study the ethical, legal and societal issues (ELSI) of human genome research in African populations. Of particular interest are projects that propose focused bioethical, legal, and social science analyses of new or emerging issues.

This FOA is complementary to the H3Africa: ELSI Collaborative Centers ( RFA-RM-16-014 ). Open Date (Earliest Submission Date) Letter of Intent Due Date(s) November 15, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) November 15, 2016, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. New Date November 16, 2016 per issuance of NOT-RM-16-029 .

(Original Expiration Date: November 16, 2017 ) It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description In 2012, the NIH in partnership with the Wellcome Trust, and with advice from the African Society of Human Genetics, initiated the Human Heredity and Health in Africa Program (H3Africa).

At the NIH, H3Africa is a component of the NIH Common Fund’s Global Health Initiative, and several Institutes and Centers have joined the Common Fund to support it.

Recognizing that African researchers and populations have been, and still are, substantially underrepresented in genomics and environmental research, and disproportionately affected by some environmental exposures, H3Africa is designed to provide new opportunities to African scientists to lead research on the genetic and environmental contributors to health and disease issues of importance to Africa through the use of genomics and other cutting-edge approaches.

In this document, the term genomics and other cutting-edge approaches is used broadly and is intended to include approaches such as genetic epidemiology, phenotyping, biomarker development, pre-clinical research including the use of model organisms, and research on clinical utility, among others.

For further background on the origin and development of H3Africa, see the article Research Capacity: Enabling the Genomic Revolution in Africa Science (2014) 344: 1346-1348, and the H3Africa web site http://www. h3africa. org .

In order to enhance the capacity for genomics and environmental health research, in Africa by African scientists, and to understand the genetic and environmental factors that determine disease susceptibility, H3Africa has three interrelated, interdependent objectives: To support human genomics and genetics research that will not only generate important findings and discoveries relevant to human health, but will also serve as a vehicle to improve the research capacity of African laboratories and provide research opportunities for young scientists at the institutions where the research is carried out.

To expand expertise and experience in genomics-based biomedical research and environmental epidemiology in Africa through research experience, skills development, and enhanced collaborations with regional, national, and To improve infrastructure including bioinformatics and biorepository capacity needed to support genomics-based and environmental research and associated data and sample sharing.

These objectives have been addressed through a set of awards to African institutions from the two funding partners using several different funding mechanisms, awarded primarily in 2012 and 2013.

In its initial five-year phase, the Wellcome Trust has supported collaborative research projects and NIH has supported H3Africa Collaborative Centers (U54), H3Africa individual research projects (U01; including studies in the area of the ethical, legal, and societal issues of genomics in Africa), H3Africa Biorepositories (UH3), and a bioinformatics network, H3ABioNet (U41).

This Funding Opportunity Announcement (FOA) is being issued to solicit applications for research projects addressing ethical, legal, and social issues related to genomics research.

Related H3Africa FOAs include announcements for and ELSI Collaborative center (RFA-RM-16-014), biomedical research projects (RFA-RM-16-015 and RFA-RM-16-016), a Bioinformatics network (RFA-RM-16-011), an H3Africa Administrative Coordinating Center (RFA-RM-16-017), and Research Training The H3Africa program is an initiative of the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact.

Investigators are invited to develop bold and innovative approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. Common Fund programs are limited to a maximum of 10 (ten) years in length.

The NIH H3Africa program will complete its first five years in 2017; therefore, activities proposed in applications submitted in response to this FOA should (a) be framed in terms of what can realistically be accomplished in the remaining five years of the program (2017 2021) and (b) discuss how activities will be sustained after 2021, when Common Fund support for the Investigators funded by the H3Africa program operate as a highly collaborative Research Consortium.

The Research Consortium meets regularly in person and by teleconference. The H3Africa Consortium has developed a number of overall policies and guidelines (see http://www. h3africa.

org/consortium/documents ). These policies will be referred to at appropriate places in this document and all applicants are expected to recognize and adopt these policies or provide justification as to why a particular policy cannot be followed.

This FOA solicits applications for research projects that identify, examine and address the ethical, legal and societal issues raised by genomic research and technology that pertain to individuals, families, communities and societies throughout Africa. These applications should be for self-contained research projects.

Of particular interest are projects that propose bioethical, legal, and social science analyses of new or emerging issues.

Examples of possible research questions to be addressed in studies proposed in response to this FOA include, but are not limited to, the What are the views, conceptions, expectations, etc. of various stakeholders (communities, community leaders, religious leaders, families, researchers, policy makers, etc.) regarding genetic and genomic research?

What are the ethical, legal, and societal issues involving privacy and confidentiality for different communities in Africa? What are the ethical, legal and societal issues of government regulations in African countries that are relevant to genetic and genomic research, including but not limited to regulations on specimen and/or data sharing, data and samples access, shipment and ownership, biorepositories for future research, etc.?

What are the ethical, legal, and societal issues surrounding collection of and use of data and samples in genetic/genomic research in Africa? What are the ethical, legal, and societal issues surrounding sharing of data and samples in genetic/genomic research in Africa? What are the ethical, legal, and societal issues of potential stigmatization of individuals and/or families affected by a genetic disorder?

What are the ethical, legal and societal issues involving potential community harm specific to African communities? What are the ethical, cultural, religious and socioeconomic factors that are likely to affect conduct of genetic/genomic research or application of findings derived from the genomic research?

What are the ethical, legal, and societal issues of disclosing individual genetic What are the attitudes toward personal genomics testing in African communities? What ethical, legal, and societal issues may be raised by genetic research using new genomic technologies? What are the beliefs surrounding genetic inheritance and transmission of genetic diseases in African communities?

What are the cultural, social and religious beliefs on donating blood for use in genetic What is the appropriate use of consent forms:, i.e. appropriate language (with translation verifications) and means of getting consent without coercion, confirming consent in communities with high illiteracy rates, use of thumbprint or acceptability of community consent, What strategies are likely to be most effective for educating the public about genetic research findings and their implications for As noted in the Purpose section, there are several specific objectives that the H3Africa Program is trying to achieve.

Successful applicants will become members of the H3Africa Consortium, and will be expected to adhere to these policies, unless adequate justification can be provided. H3Africa Consortium Participation : H3Africa is organized as a research consortium that brings participants together in a highly collaborative and synergistic effort.

The H3Africa Consortium includes all participants of research and infrastructure projects funded through H3Africa, as well as responsible Wellcome Trust and NIH staff. Groups funded under this initiative will be expected to participate in the H3Africa Research Consortium and to collaborate effectively with each other to maximize the chances of overall success of the program.

Each funded applicant is expected to participate directly or via proxy in consortium Working Groups that establish rules, guidelines, and resources for the Consortium (a list of H3Africa Working Groups can be found at www. h3africa. org ).

Each project is expected to comply with applicable consortium data and sample sharing and other policies and procedures (found at www. h3africa. org ).

In addition the PD/PI(s) will be active members of the H3Africa Steering Committee, which meets regularly by teleconference. The H3Africa Consortium generally holds two meetings per year, usually in Africa.

Engagement : H3Africa recognizes ongoing community engagement and the building of trust relationships with research participants as an essential feature of ethical biomedical and population-based genomics research involving human subjects ( www. h3africa. org/consortium/documents ).

Community engagement can include a variety of activities, such as broad consent for sharing of samples and data, recontact of research participants, return of results to individual participants, or other relevant topics.

One of the major goals of the H3Africa Initiative is to facilitate opportunities for collaboration between and among investigators within Africa, in order to help build a larger African scientific community, which will in turn lead to more research opportunities and cutting-edge science on the continent. Intra-continental collaborations will also contribute to sustainability of African genomics programs.

It is expected that research project members will participate in consortium-wide research collaborations as well as forging new collaborative partnerships within and outside of the the next generation of African researchers with opportunities in genomics . Establishing the next generation of African researchers to take advantage of genomic approaches to health research is a primary objective of the H3Africa program.

H3Africa projects provide a variety of career enhancement opportunities for students, postdoctoral researchers, and/or young investigators, such as attending seminars and scientific meetings, writing papers, and giving talks.

Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities are objectives of the All applicants are strongly encouraged to contact NIH Staff early in the application process to discuss the alignment of their proposed work with the goals of this FOA, and with the H3Africa Project.

Technical Assistance Sessions and teleconferences will be held for potential applicants to this FOA and companion FOAs. NIH staff will be available to answer questions related to this FOA. Location, time, date, and dial in information will be announced in an NIH Guide Notice and will be posted on the H3Africa website: http://www.

h3africa. org . During the Information Sessions, NIH staff will present an overview of these FOAs and answer questions from prospective applicants.

The Information Sessions are open to all prospective applicants, but participation is not a prerequisite to applying. VIII. Other Information for award authorities and regulations.

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The NIH Common Fund intends to commit up to a total of $600,000 per year for up to 3 years. NIH intends to fund an estimate of 5-7 awards.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to $100,000 direct costs per year but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period.

The maximum period is 3 years. Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Non-domestic (non-U.S.) Entities (Foreign Institutions), African Public/State Controlled Institutions of Higher Education African Private Institutions of Higher Education Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 The PD/PI should be an established investigator in their field and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.

The PD/PI should have research experience in Africa, particularly in the country where the proposed research program will be established. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD/PI has responsibility for the program and appointing members of an Advisory Committee, as appropriate, and using their recommendations to modify the overall direction, management, administration, and evaluation of the program.

The contact PD/PI must be affiliated with the LMIC African institution submitting the application where the proposed research program will be established and must have citizenship in an LMIC African country. Other Multiple PDs/PIs with relevant expertise from partner institutions in Africa, U.S. or other high income country (HIC) institutions may be proposed.

Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed program. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide , including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide Travel Funds: The budget should include funds to support travel for the PD/PI and an additional staff member to Consortium meetings.

All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Aims : A concise set of specific aims that clearly state the research objectives and explain the overall goals and expected outcomes of the research Strategy: The application should describe a well-conceived plan for the investigation of one or more ELSI topics related to genomic research.

The application should provide a description of the impact of the focus of their research in Africa, and the relationship (if any) to similar issues in other parts of the world. The applicant should present a well-considered plan for accomplishing the goals of the research application and give timelines and milestones, where applicable.

The research strategly should discuss, but is not limited description of qualitative and/or quantitative data to be management and analysis of the data; and how the research proposed will lead to an improved understanding of the ELSI questions considered in the African context. of Research Participants.

The research plan must include a detailed plan for sample acquisition (where applicable), storage, preparation of material needed etc. In particular, when collecting new samples, investigators are required to obtain consent for the broad sharing of samples and data; detailed justification must be provided if archived samples and data cannot be shared or only shared in a limited manner.

A document entitled "H3Africa Guidelines for Informed Consent" may be helpful to applicants in writing their informed consent documents; this can be found at http://h3africa. org/consortium/documents . A timeline for developing and implementing an informed consent process, including obtaining IRB/REC approval, must be included in the application.

Applicants should also include a community engagement plan which includes ongoing and future community engagement activities and specifically addresses the benefit to the community.

of the major goals of the H3Africa program is to enable African investigators to become more productive and develop skills that will lead them to becoming internationally competitive for support in the future, increase the number of high quality publications, and become leaders in genomics, genetics and ELSI research. It is hoped that this will in turn lead to increased investment in research by African governments and private sources.

Applicants should discuss the issue of future sustainability of their ELSI research program beyond the H3Africa program. of Support : Applications should include letters of support from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) from all collaborating institutions to substantiate the institutions commitment to the proposed plan.

Each institution should also state its commitment to overcoming any administrative obstacles to the implementation of the application. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. Where applicable, the letter should address institutional commitment to any faculty who participate in associated skill-building programs.

It should also address commitment to collaborating and sharing data as appropriate.

The letter should also briefly discuss the institution's plans for sustaining an active program of genomics related research subsequent to the end of the As the programmatic activities of this initiative may support national and international collaborations, letters of support from the related national ministries such as the Ministry of Science, Ministry of Health and/or Ministry of Education for each African country with a programmatic component should be provided with the application if possible; if letters are not provided with the application, they may be requested from the applicant at a later date.

The letter should briefly describe the national policy concerning the development of a national scientific research program and how the country is addressing the target that the African Union set in 2006 for each nation to spend 1% of its gross domestic product (GDP) on research and development Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The data sharing plan must be consistent with H3Africa Consortium policies (found at www. h3africa. org ).

Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application PHS Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide Foreign (non-U.S.) institutions must follow policies Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Part I. Overview Information contains information about Key Dates and times.

Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Policy on Late Application are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5.

Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission Electronically .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues . For assistance with application submission, contact the Application Submission Contacts in Section VII . All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package .

Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the National Human Genome Research Institute (NHGRI), Referral Office by email at bettie_graham@ nih. gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Use of Common Data Elements in NIH-funded Research Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use