Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01, Clinical Trial Optional)

Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01, Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). This initiative supports investigator-initiated research on genetic counseling processes and practices in genomic medicine.

Expired RFA-HG-20-048: Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01, Clinical Trial Optional) 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 National Cancer Institute ( NCI ) National Human Genome Research Institute ( NHGRI ) Funding Opportunity Title Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01 Clinical Trial Optional) R01 Research Project Grant September 01, 2020 - Notice of Applicant Information Webinar and Frequently Asked Questions (FAQs) for Investigator-Initiated Research on Genetic Counseling Processes and Practices Request for Applications (RFAs): RFA-HG-20-048 and RFA-HG-20-049.

See Notice NOT-HG-20-057 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-HG-20-049 , R21 Exploratory/Developmental Grant Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this initiative is to support investigator-initiated research on genetic counseling processes and practices in genomic medicine.

Research is needed to optimize the genetic counseling process in the context of limited resources.

Applications will assess, innovate, scale, and/or research the implementation of novel genetic counseling practices to address the need for more healthcare professionals trained in genetic counseling; the uneven access to in-person genetic counseling across U.S. health care systems; and the challenges of effective and efficient communication of genomic findings to clinicians, patients, and families.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date October 28, 2020 and July 8, 2021 All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission AIDS Application Due Date(s) February/March 2021 and October/November 2021 May 2021 and January 2022 It is critical that applicants follow the Research (R) Instructions (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 Purpose: The purpose of this initiative is to support investigator-initiated research on genetic counseling processes and practices in genomic medicine. Research is needed to optimize the counseling process in the context of limited resources.

Applications will assess, innovate, scale, and/or research the implementation of novel genetic counseling practices to address the need for more healthcare professionals trained in genetic counseling; the uneven access to in-person counseling across U.S. health care systems; and the challenges of effective and efficient communication of genomic findings to clinicians, patients, and families.

As medical practice shifts to include genetics and/or genomics in clinical testing, and clinical genetics simultaneously moves to include genomic sequencing and treat growing numbers of patients, investigator-initiated research to assess, innovate, scale, and refine genetic counseling processes and outcomes could have significant impact on the field.

Genetic counseling includes a wide range of essential processes such as education of patients about the risks and benefits of genetic/genomic tests including how results may affect patients and their families; negotiation with payers; interpretation of laboratory reports; return of a growing array of results; communication of appropriate content; negotiation of boundaries between research and clinical care; and patient referral and follow-up.

However, the practice of genetic counseling has received little explicit research attention. Current research often focuses either on what results to return or downstream health outcomes. Research is needed on methods to optimize the genetic counseling process for genomic testing, particularly in the context of limited resources.

In addition, the strategies necessary for counseling may vary by who returns the results (e.g., genetics specialist vs. non-genetics provider), when disclosure occurs during the process of clinical care, and in what mode results are returned (e.g., face-to-face, online, or tele-counseling).

Just as clinical sequencing and annotation processes have been studied as they transition to genomic approaches, this key part of the clinical genomic pipeline may benefit from exploration The substantial growth of genomic medicine relative to the limited increase of professionals trained in genetic counseling also suggests that research on alternative, less labor-intensive methods of genetic counseling (e.g. automated triage, chatbots, health professionals training, telemedicine) may be important and timely.

Research is needed to explore whether and in what contexts these methods may have benefit. Finally, further examination of the post-test period is needed to understand how patients comprehend and potentially act on information conveyed through different modes of counseling. NHGRI is committed to maximizing the utility of genomics for all populations.

Racial and ethnic minority populations, underserved populations, and populations who experience poorer medical outcomes have been vastly underrepresented in genomic research to date. Increasing access to genomic medicine and genetic counseling represents a key step in helping patients and families appreciate how genomics, in addition to the environment, impacts their health.

Specialized tools and methods may improve the counseling process for diverse patients and patients with specific needs (e.g. lower literacy, non-English-speaking, differing cultures or values, clinically urgent settings). Projects are strongly encouraged to not only include diverse and underrepresented participants but also strategies that impact ancestrally diverse and underrepresented populations.

Investigator-initiated research focused on genetic counseling practices and processes in genomics will generate innovative and improved methods adaptable to multiple settings, institutions, and types of healthcare providers. It is important to evaluate how changes to existing practices impact stakeholders of the genetic counseling process.

In addition, the research should facilitate a broader integration of genomic medicine into clinical care. This funding opportunity would support investigator-initiated research on genetic counseling practices and processes in support of genomic medicine.

This could include studies of counseling practiced by a range of healthcare providers including genetic counselors, clinical geneticists, nurses, nurse practitioners, and primary care physicians. Investigator(s) with substantial experience in genetic counseling including identifying and overcoming challenges in the genetic counseling process should be an integral part of the project.

Projects should also be broadly applicable to genomic medicine as a field; projects studying a specific disease or disease area would have to yield generalizable findings. Applicants should include a plan to validate and disseminate methods shown to optimize the counseling process to enable wide distribution and implementation.

Research focused primarily on the ethical, legal and social implications (ELSI) of genetic counseling processes and practices will not be considered responsive to this RFA.

Applicants interested in ELSI research related to genetic counseling practices should inquire about applying to the ELSI Examples of research that could be pursued under this FOA include, but are not limited to studies that achieve the following: Develop and evaluate innovative or automated processes to triage communication of clinical genomes to clinicians and patients.

This includes systems that differentiate between levels of genetic counseling needed for different variants, such as limited counseling for some findings (e.g., pharmacogenomics) and very extensive for others (e.g. untreatable monogenic diseases) Implement and assess alternatives to in-person, one-on-one counseling that might address the shortage and uneven geographical distribution of genetic counselors, including evaluation of proposed technical solutions Assess the need for, develop, test, or measure efficacy of methods to increase capacity for genetic counseling in underserved areas Evaluate and improve strategies for communicating complex genomic findings (e.g. multiple genomic findings at once, de novo findings, gene-environment interactions, non-Mendelian risks, polygenic risk scores, pleiotropic effects, incomplete penetrance, and variants of unknown significance) and updating patients and families when variant interpretations Evaluate and improve communication of genomic results to patients and families, including strategies for cascade screening in a variety of Understand the needs of patients and relatives in the communication of genomic information and the potential impact of genetic counseling processes on patient outcomes Evaluate and improve the effectiveness of solutions for diverse populations including patients and research participants who vary in access to technology, ability to use digital instruments and/or health literacy Evaluate, improve and implement processes for follow-up care after communication of genomic results to patients and families Evaluate and research implementation strategies for training and involvement of health professionals other than genetic counselors such as clinical geneticists, nurses, nurse practitioners, and primary care physicians in the genetic Evaluate strategies and solutions for implementation of genetic counseling processes in both the clinical and research workflows, including challenges related to billing, insurance and licensing NCI is specifically interested in applications that address managing germline findings in the context of tumor testing.

In addition, NCI is interested in cancer focused applications that consider utilization of remote or mobile-ready genetic counseling approaches; methods to assess the behavioral and psychosocial impact of genetic counseling and testing on the individual and/or family to optimize clinical decision making; and strategies for training and supporting a workforce capable of improving case ascertainment, cascade screening, and follow-up care in healthcare systems.

To increase synergy, an annual meeting of grantees to share research findings will be funded either as a small supplement to one of the grants each year, or organized as a satellite meeting at a professional conference (e.g. National Society of Genetic Counselors, American Society of Human Genetics, or American College of Medical Genetics and Genomics). VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The following NIH components intend to commit the following amounts in FY 2021: NHGRI, up to $4M total costs, 3-5 awards NCI, up to $800K total costs, 1 award Application budgets are limited to $500,000 direct Application budgets need to reflect the actual needs of the The scope of the proposed project should determine the project period. The maximum project period is 4 years.

NIH grants policies as described Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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 possible. The NIH 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 late 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) 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 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 to register in eRA Commons.

Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration, but all registrations must be in place by time of submission. 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 submit an application.

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 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 (R&R) This FOA does not require cost sharing as defined in the NIH Grants 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 (A1) 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 1.

Requesting an Application The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system 2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , 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 review.

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: National Human Genome Research Institute 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 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: As part of the significance section, applicants should describe the generalizability and broader relevance of the proposed research to genomic medicine beyond any targeted genes, diseases, or clinical settings included in their specific application.

As part of the innovation section, applicants should describe the novelty of their research, how the proposed strategy is thought to improve the practice of genetic counseling and in turn genomic medicine, how it is distinct from existing research efforts and how successful achievement of the research aims will move the field of genetic counseling forward.

In the approach section, applicants should describe how they will validate and compare their proposed strategies to current genetic counseling processes and practices in the field of genomic medicine. Applicants should detail how the proposed strategy, methodology, and analyses will be applicable to all populations and generalizable beyond the disease or clinical setting being studied.

Applications should also include a plan to evaluate how the proposed strategy affects patients comprehension and actions. Stakeholder engagement can enhance the translation of research results into clinical care and public health and address disparities in health and healthcare.

Investigators are encouraged to solicit and be responsive to input of stakeholders such as professional societies, payers, public health and regulatory agencies, communities, patients, patient groups, or caregivers regarding study design, conduct, and outcomes, and to collaborate with relevant stakeholders throughout the research process.

If relevant to study aims, applicants are encouraged to provide a plan to include stakeholders in the process of prioritizing, designing, and conducting research. Applicants are encouraged to include population groups that are traditionally under-represented in genomic medicine.

Applications that include population groups traditionally under-represented in genomic medicine research should clearly identify the scientific questions that will be addressed within the population(s) and how the proposed research strategy will benefit the population(s).

Applications should also describe how their study design meets the needs of the populations they aim to recruit and any prior experience working with the population(s). As grantees are expected to attend one annual grantee meeting per year, applications should include plans to participate actively and openly in grantee meetings and in ways that contribute substantially to advancement of the field.

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 include a Data Sharing Plan.

Applications proposing to generate human genomic data should adhere to the NHGRI expectations for implementation of the NIH Genomic Data Sharing Policy ( https://www. genome. gov/about-nhgri/Policies-Guidance/Genomic-Data-Sharing ).

Applicants proposing datasets including participants from European nations or derived from European sources should address the extent to which the General Data Protection Regulation (GDPR) will impact data sharing and collaborative analyses proposed in this FOA.

Applications involving development of methods, software, or other tools for genetic counseling should include detailed plans with timelines for dissemination to the community Methods, tools, and software should be well-documented and where applicable, made available via public repositories. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide onset does NOT apply to a study that can be described but will not start immediately All instructions in the SF424 (R&R) Application Guide PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions.

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 4. Submission Dates and Times 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 . 7.

Other Submission Requirements 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 process, Apply Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section 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 the National Human Genome Research Institute and National Cancer Institute, NIH.

Applications that are incomplete, non-compliant and/or nonresponsive Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the Section V.

Application Review Information Only the review criteria described below will be considered Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review in addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.

Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each.

An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Does the project address an important problem or a critical barrier to progress in the field?

Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is the described research project designed to generate generalizable findings that will be broadly applicable to the field of genomic addition, for applications involving clinical trials Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the application include investigator(s) with substantial experience in genetic counseling as an integral part of the project?

addition, for applications involving clinical trials With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics?

For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Would successful achievement of the aims advance the process of genetic counseling in transformative and addition, for applications involving clinical trials Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?

Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Does the application provide preliminary evidence