Dyadic renewal a program for developing ongoing relationships

Investigators are expected to certify the quality of all data generated by grants funded under this FOA prior to submission to NDA and review their data for accuracy after submission. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately i.

Foreign non-U. See Part 1. Section III. 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 business day. Organizations must submit applications to Grants. NIH and Grants. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. This initiative is not subject to intergovernmental review. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply — Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed. 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 of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.

Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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 policy.

Only the review criteria described below will be considered in the review process. 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 project proposed.

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? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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? 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? 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? 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 adequately address the following, if applicable. Is the trial appropriately designed to conduct the research efficiently?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate?

Is there a plan to obtain required study agent s? Does the application propose to use existing available resources, as applicable? Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site s or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed?

Is there a plan to complete data analysis within the proposed period of the award? Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application adequately address the capability and ability to conduct the trial at the proposed site s or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources e. Are potential challenges and corresponding solutions discussed e. For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1 risk to subjects, 2 adequacy of protection against risks, 3 potential benefits to the subjects and others, 4 importance of the knowledge to be gained, and 5 data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1 the justification for the exemption, 2 human subjects involvement and characteristics, and 3 sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: 1 description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; 2 justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; 3 interventions to minimize discomfort, distress, pain and injury; and 4 justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals.

Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.

Reviewers will assess the information provided in this section of the application, including 1 the Select Agent s to be used in the proposed research, 2 the registration status of all entities where Select Agent s will be used, 3 the procedures that will be used to monitor possession use and transfer of Select Agent s , and 4 plans for appropriate biosafety, biocontainment, and security of the Select Agent s.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group s convened by the Center for Scienctific Review, in accordance with NIH peer review policy and procedures , using the stated review criteria.

As part of the scientific peer review, all applications will receive a written critique. Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit generally the top half of applications under review will be discussed and assigned an overall impact score. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

The following will be considered in making funding decisions:. A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official. Awardees must comply with any funding restrictions described in Section IV. Funding Restrictions. Selection of an application for award is not an authorization to begin performance.

Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. This includes any recent legislation and policy applicable to awards that is highlighted on this website. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies clinical trials to ensure the safety of participants and the validity and integrity of the data. Recipients of federal financial assistance FFA from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.

This includes ensuring programs are accessible to persons with limited English proficiency. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.

The Federal Funding Accountability and Transparency Act of Transparency Act , includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY or later.

In accordance with the regulatory requirements provided at 45 CFR The recipient must also make semiannual disclosures regarding such proceedings.

Proceedings information will be made publicly available in the designated integrity and performance system currently FAPIIS. This is a statutory requirement under section of Public Law , as amended 41 U.

To assess your ability to: identify the characteristics of social relationships in the workplace define self-disclosure identify alternatives to self-disclosure identify elements of interpersonal deception identify the elements in the listening process identify common barriers to effective listening. Work through the questionnaire with a person with whom you have a significant personal relationship. Select three to four significant components that you learned about yourself, the assignment partner, the relationship that you share or the concept of interactive listening.

Create a four to five page paper that provides an analysis of the encounter. Cindy and I have always been very good at self-disclosure. When talking one-on-one, we take time to listen to each other, showing positive reciprocity. The more we got to know each other, the more comfortable we felt divulging information. This is because we came to count on a supportive environment, where our thoughts and feelings are respected.

Being able to talk through situations and be supportive gives us self-clarification and self-validation. Often this happens when one of us is feeling unsure about something, and the other is able to provide a soundboard and support, where others might try t. Our talks do not always have to do with the present. We often talk about things in our life that have shaped who we are. Often these things still weigh on our mind, and can be a source of doubt.

By talking about them, we give these things less power over us. It serves as a catharsis, and allows us to see that we are not the only one who deals with issues from the past. Even though Cindy comes from a close-knit family, she understands and empathizes with me when I talk about problems in my own family. This ability to share our thoughts and doubts makes us closer and enhances our friendship.

Even with an open dialogue, we still have boundaries. It seems like we are both mindful in what we say, and how it will affect the other. By gauging an appropriate amount of disclosure, we are able to stay open without crossing a line. Creating an atmosphere that is open and supportive makes it easy to be open and honest. Because we have supported each other before in the past, and not been judgmental, there is no fear of rejection, negative impressions, decrease in relational satisfaction, loss of influence, or hurting the other person.

This kind of atmosphere also makes it easier to reject alternatives that could harm our friendship. Being able to convey your feelings when you do not disagree with someone makes it possible to work through disagreements. By using Assertiveness Techniques, we can work through a problem without placing blame or shutting down emotionally. The progression of Assertiveness Techniques goes as follows:. These steps can often diffuse a tense situation. Often, someone might not realize how his or her behavior bothers you until you explain how you interpret it.