Human-Animal Interaction (HAI) Research (R01 Clinical Trial Optional)

Human-Animal Interaction (HAI) Research (R01 Clinical Trial Optional) is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and National Institute of Nursing Research (NINR). This funding opportunity solicits Research Project Grant (R01) applications for research to study the impact of human-animal interaction (HAI) on children's health and development and to test the efficacy of therapeutic uses of HAI with children.

Expired RFA-HD-09-031: The Role of Human-Animal Interaction in Child Health and Development (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Institutes of Health (NIH), ( http://www.

nih. gov ) Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ( http://www. nichd.

nih. gov ) National Institute of Nursing Research (NINR) ( http://www. ninr.

nih. gov ) Title: The Role of Human-Animal Interaction in Child Health and Applications (RFA) Number: RFA-HD-09-031 NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants. gov ( http://www.

grants. gov ) using the SF424 Research and Related (R&R) forms and the SF424 BE SUBMITTED IN PAPER FORMAT. in conjunction with the application guidelines included with this announcement for Grants (hereafter called Grants.

gov/Apply). is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV .

Domestic Assistance Number(s) Release/Posted Date: August 11, Opening Date: October 19, 2009 (Earliest date an application may be submitted to Grants. gov) NOTE: On-time submission requires that applications be successfully submitted to Grants. gov no later than 5:00 p.

m. local time (of the applicant institution/organization). Application Due Date(s): November 19, Due Date(s): Not applicable Date(s): February/March 2010 Earliest Anticipated Start Date(s): Information to Be Available Date (Activation Date): Not Applicable Purpose .

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Nursing Research (NINR) solicits Research Project Grant (R01) applications from institutions/ organizations that propose to study the impact of human-animal interaction (HAI) on children's health and development and to test the efficacy of therapeutic uses of HAI with children.

In 2008 NICHD and The WALTHAM Centre for Pet Nutrition, a division of Mars, Incorporated, entered into a public-private partnership to explore the interaction between humans and animals. The partnership encourages research on Human-Animal Interaction (HAI), especially as it relates to child development, health and the therapeutic use of animals with children and adolescents.

This shared interest resulted in The WALTHAM donating funds to NICHD to enhance NICHD’s ability to support research in this field .

The purpose of this FOA is to build an empirical research base on how children perceive, relate to and think about animals; how pets in the home impact children's social and emotional development and health (e.g. allergies, the immune system, asthma, mitigation of obesity); and whether and under what conditions therapeutic uses of animals is safe and effective. Mechanism of Support.

This FOA will utilize the NIH Research Project Grant (R01) grant mechanism and runs in parallel with a FOA of identical scientific scope, RFA-HD-09-030 that solicits applications under the NIH Small Research Grant (R03) mechanism. Funds Available and Anticipated Number of Awards. The total amount of funding that NIH expects to award through this announcement is $2 million per year, with $500,000 from NINR, $1.

5 million from NICHD, of which $250,000 has been donated by The WALTHAM Centre for Pet Nutrition, a division of Mars, Incorporated, as part of a public-private partnership with the NICHD. The anticipated number of awards is 3-4. Budget and Project Period.

Budgets for direct costs of up to $500,000 per year and a project duration of up to 4 years may be requested for a maximum of $2 million in direct costs over a 4-year project period. Institutions/Organizations. Institutions/organizations listed in Section III, 1.

A. are eligible Eligible Project Directors/Principal Investigators (PDs/PIs). I ndividuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ 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. Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application.

of Applications. Applicants may submit more than one application, provided each application is scientifically distinct. applications are not pe rmitted in response to Renewals .

Renewal applications are not permitted in response to this FOA. Special Date(s). This FOA uses non-standard due dates.

See Receipt, Review and Anticipated Start Dates . Materials. See Section IV.

1 for General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites: (R&R) Application and Electronic Submission Information: http://grants. nih.

gov/grants/funding/424/index. htm information on Electronic Submission of Grant Applications: http://era. nih.

gov/ElectronicReceipt/ Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936 Part I Overview Information Part II Full Text of Announcement Section I. Funding Opportunity Section II.

Award Information Section III. Eligibility Information 2. Cost Sharing or Matching 3.

Other-Special Eligibility Criteria Section IV. Application and 1. Request Application Information 2.

Content and Form of Application Submission 3. Submission Dates and Times A. Receipt, Review, and Anticipated B.

Submitting an Application Electronically to the NIH C. Application Processing 4. Intergovernmental Review 6.

Other Submission Requirements Section V. Application Review Information 2. Review and Selection Process A.

Additional Review Criteria B. Additional Review Considerations C. Resource Sharing Plan(s) Anticipated Announcement and Award Dates Section VI.

Award Administration 2. Administrative and National Policy Requirements Section VII. Agency Contacts 1.

Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/Grants Management Contact(s) Section VIII.

Other Information - Required Federal Citations - Full Text of Announcement Section I.

Funding Opportunity Description The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Nursing Research (NINR) solicits Research Project Grant (R01) applications from institutions/ organizations that propose to study the impact of human-animal interaction (HAI) on children's health and development and to test the efficacy of therapeutic uses of HAI with children.

The purpose of this FOA is to establish Human -Animal Interaction (HAI) as an important field of inquiry by encouraging both basic and applied studies that focus on the interaction between humans and animals and the impact of HAI in three major areas: (1) foundational studies of the interaction itself and its impact on typical development and health, including basic research on biobehavioral markers of suitable behavioral traits for HAI and for using domesticated companion animals as models for identifying gene-behavior associations in humans; (2) applied studies (to include but not limited to clinical trials of the therapeutic use of animals); and (3) population level studies of the impact of animals on public health (prevalence/incidence studies, etc.), social capital, and the cost-effectiveness of using pets/animals in reducing/preventing disease and Nearly 75% of US households have pets.

The decreasing size of families, with the disappearance of younger siblings, babies, and elderly from family homes, means that many children may be more likely to grow up with an animal than with a younger sibling or grandparent in the home. It has been documented in the literature that pets offer a source of emotional support to children, and studies suggest they may be helpful to prevent allergies, ease anxiety and encourage exercise.

However, most of the studies focusing on how animals affect children's health, development and well-being are small, and stop short of providing answers to key developmental questions. An empirical research base is needed focusing on information about how children perceive, relate to and think about animals and how pets in the home impact children's social and emotional development.

In addition, research is needed on the impact of pets in the home on children's health (e.g. allergies, the immune system, asthma, mitigation of obesity). On a practical level, such issues as when and how parents select pets for their families/children is important to child health and safety, e.g. how best to prevent injury or disease from pets. There is a need for evidence-based advice for parents and child care professionals.

In addition, dogs, cats and even other species such as monkeys are being used to assist those with disabilities and as adjuncts to therapeutic interactions. An increasing number of therapeutic interventions involve HAI, often based on anecdotal evidence and short-term observation. Despite the call for more research after a 1987 NIH conference, very little is known about the role pets play in children's growth, health, and wellbeing.

More information is needed about the physical and psychological health benefits that can accrue both in daily life and in To begin to address this need, in 2008 NICHD and The WALTHAM Centre for Pet Nutrition, a division of Mars, Inc., entered into a public-private partnership.

The partnership encourages research on Human-Animal Interaction (HAI), especially as it relates to child development, health and the therapeutic use of animals with children and adolescents.

This shared interest donating funds to NICHD to enhance NICHD’s ability to support research in In October 2008, the partners co-hosted a meeting of more than 40 of the world’s leading scientists in the field of HAI and related disciplines.

The workshop, Directions in Human-Animal Interaction Research: Child Development, Health and Therapeutic Interventions, was the first on HAI research held at NIH in more than 20 years, and the first to expand our scientific understanding and to tap the potential for HAI to improve the health and well-being of children and adolescents. Additional information about the workshop can be found at: www. anthrozoology.

org/HAIworkshop . program of research is to encourage interdisciplinary studies of HAI in terms of the impact of pets in the home on child and adolescent health and development, and therapeutically, through experimental trials of the use of HAI in treatment of behavioral problems, stress, anxiety, and other emotional or social development problems.

Projects should be theoretically based and seek to answer questions that address key developmental, health and safety issues regarding the interactions of children and youth with animals in the home or therapeutic settings. Research to identify biobehavioral markers also is encouraged.

Such work could inform the field about traits that make particular animals more suitable for interaction with individuals in certain settings, and also be useful in identifying animal models of gene-behavior associations in humans.

Physiologic measures (e.g. neuroendocrines, genetic, heart rate, neuroimaging), as well as direct or observational measures of behavioral, cognitive, psychosocial, and/or psychoeducational outcomes are encouraged . Research is needed to better understand the nature of interactions between people and various types of animals, as well as the contexts and conditions under which these interactions occur.

Studies are encouraged which address why relationships with pets are more important to some children than to others and to explore the quality of child-pet relationships, noting variability of human-animal relationships within a family.

It has been noted that abusive individuals often have a history of animal abuse prior to abusive behavior toward other humans; on the other hand, the presence of pet may be a solace to a maltreated child. Displaced families, whether displaced by disasters or through seeking shelter from abusive situations, may not be able to keep pets with them, which can have traumatic effects on children.

Developmental studies are needed which examine child-pet interactions and relationships as they change over time and within changing family dynamics. Community-level and social benefits of pets also should be considered, beyond the benefits of the There are several critical public health issues facing children today for which HAI may have direct impacts.

These include but are not limited to childhood obesity, mental health issues, attention deficit, and depression. It will be important to determine empirically which situations, under what conditions and for whom HAI can offer the greatest public health benefits and to examine the cost-effectiveness of such interactions or treatments.

Both formal and informal situations, i.e. pet ownership and formal therapeutic interactions, should be studied for potential health impacts. In designing studies to address these questions, it will be important to determine what outcome measures are needed to demonstrate a causal relationship between animal interaction and improved health.

Cost-effectiveness analysis indicating potential societal benefits such as decreased hospitalizations or reduced length of stay in hospitals, lower risk of childhood obesity, or lower incidence of problem behaviors, should be included The use of animals in interventions must be empirically studied.

A clinical trial approach using experimental or quasi-experimental methods is desirable; however mixed methods are also appropriate to understand whether an intervention is effective, why, and under what conditions.

While randomized controlled trials are a gold standard, it is recognized that there may be times when such a design cannot be fully implemented; where it can be used, it should, and where it cannot, the next most rigorous design should be used. Dose-response issues should be carefully targeted in research designs wherever possible.

There is a need to examine the role of pets in the treatment of at-risk children as well as those with confirmed diagnoses, such as children with autism spectrum disorder, developmental disabilities, and behavioral disturbances.

Primary prevention research through population studies is needed, including the development of survey instruments and/or adjunct studies taking advantage of ongoing large-scale studies where this is feasible given the time constraints.

Collaborating with population-based studies aimed at studying health and development offers a cost-effective way of gathering important information about pets in the home and community and their impact on health and development for children, adults, and families.

While this information can be useful and informative in cross-sectional population studies, it is also important to gain information longitudinally on the same subjects where possible, with attention given to collaborating with studies that have appropriately diverse samples. Ethical considerations must be kept in mind as HAI research is designed and conducted.

Protection for both parties should be in place for any research conducted on HAI. Gathering information ethically and responsibly from children who are particularly vulnerable and for whom parental consent may be difficult to obtain (e.g. foster care) is a challenge that must be carefully addressed.

Animal welfare is important and must be considered at all times, especially when animals are working with children who are emotionally disturbed or are placed in potentially abusive In the studies reporting health or therapeutic effects of HAI to date, few, if any, have examined the extent to which the relationship between pet ownership and health varies by race or socioeconomic status (SES).

Minorities and members of low SES groups consistently exhibit higher rates of negative health behaviors, morbidity, and mortality. Investigators are encouraged to ensure that their studies have a sufficient number of minorities and variation in SES to bolster our knowledge regarding the role of pets across racial/ethnic and SES groups.

These efforts will provide key information necessary for health promoting strategies and interventions that may ultimately inform policies. The following are examples of key questions that need to be addressed and methods utilized within the study of HAI.

This is not an exhaustive list however in all such studies, the focus must be on the interaction between the human and animal, the influence or impact of that interaction, or the efficacy of HAI as an intervention or adjunct to intervention in therapeutic settings.

multifactorial studies of HAI in foundational areas of child development do ethnic and cultural aspects of HAI influence child development and the child’s relationship to a pet in the home or the use of an animal in a important is the timing of children’s exposure to pets?

That is, is there a sensitive period for children to be exposed to pets for optimal relationship building between children and animals, and what impact does earlier or later exposure may have on health (allergies, immune is the role of pets as a buffer in family dynamics?

Such studies would bring together knowledge of pet behavior and child development, to better understand the mutual influences of human and animal, studying the feedback loop of cues that influence HAI and child-parent interactions, examining both behavioral and neurobiological responses.

impact does /can having and interacting with a pet have on the social, emotional and cognitive abilities of children with developmental disabilities, and what are the special conditions that might pertain to children with developmental disabilities and their families in terms of can pet behavioral response be recognized and managed within human-animal interaction to maximize safety for child and animal?

Do animal responses, e.g. dogs or cats, respond differentially to children/people of different ages? Descriptions of pet behavioral responses are needed, to reduce risk of injury from animals, e.g., can we prevent dog bites which are more prevalent among preschool children; can we predict cat stress to reduce both stress in the animal and risk of injury to pet owners?

can professional service providers best determine whether, in what context, and with what frequency animals might play a beneficial role in delivering therapeutic services to children who, e.g. have suffered traumatic events or have developmental or physical disabilities?

and genetic research, in both animal models and human studies, examining stress and social behavior: effects of parental or human caregiver care on epigenetic regulation of hippocampal glucocorticoid receptor expression seen in companion animals raised in abusive or neglected environments and when such animals are rescued, can these biological effects be modified?

In humans, can a companion animal modify the effect of non-nurturing or abusive experiences on epigenetic regulation of the hypothalamic-pituitary-adrenal (HPA) stress responses? neuroendocrine responses in both animals and humans vary during their interaction? What is the role of oxytocin and arginine vasopressin in the animal human bond?

For example, different polymorphisms of the vasopressin 1A receptor gene is linked to pair bonding and found in a variety of species. Is pair bonding between species also linked to this gene? Furthermore, could this gene be useful in the identification of pets for HAI activities?

impact does HAI have on women during pregnancy, in terms of stress reduction, and what role might this play in preventing or moderating gestational hypertension in pregnant women, including in particular young or teenage can interactions with a companion animal modulate the behavioral and stress response effects of childhood adversity and the interaction with genetic variations of the Monoamine oxidase-A (MAOA) gene, the 5-HTT polymorphism, or the vasopressin 1a polymorphism?

Do children behave and react differently to animal-human interaction depending upon their variant of these genes? canine genome has been available for the last three years. Gene-behavior associations relevant to identifying suitable companion dogs have just begun to be investigated.

Could such investigations be able to identify gene-behavior traits in canines such as sociability and trainability of the pet and ability that we have a canine genome and dogs have the potential to model various aspects of human socio-emotional behaviors such as attachment, temperament, and self-regulation, could dogs be an appropriate model for understanding human gene-behavior associations?

For example, Guanylate cyclase (in humans and dogs) has a possible link between loss in early life experiences children and late depression/anxiety, and the repeat polymorphism of the DRD4 gene, associated with ADHD in humans, is present in certain breeds of dogs exhibiting high activity-impulsivity depending upon their environmental conditions.

Are there genetic candidates in the dog for studying various social and emotional behaviors expressed by humans? nutritional support from sources such as Omega 3 have a role in improving human and animal adaptive behaviors? Could there be a synergistic effect of nutritional support and animal-assisted therapy in children with maladaptive behaviors?

Can aggressive dogs be managed through nutritional support? research on the use of animals to influence children’s development and/or to demonstrate the efficacy of animal-assisted intervention (AAI) in therapeutic settings for children with specific health problems or developmental disabilities: rewards are used in pets but not all pets are overweight; why is this different in children?

Is there a relationship between weight status perceptions by parents of children and of pets? How do children perceive the presence of pets mitigate shyness or inhibition for timid children? Is there an optimal or minimal age at which such a relationship or interaction might be most effective?

HAI help increase self-esteem and self-regulation in children with animal-assisted therapeutic intervention influence the ability of children with autism spectrum disorder to engage with and relate to humans?

Does a child with autism spectrum diagnosis react differently when looking at a dog vs. human face or to eye contact with dogs vs. training appropriate behaviors with animals translate to more socially appropriate behaviors in children with poor social skills? AAI modulate stress in children?

Is AAI effective in the treatment of post-traumatic stress disorder (PTSD), and if so for whom, under what AAI change perception of pain, other physical symptoms, and sense of well-being in children undergoing painful procedures and in post-treatment situations? a low-cost intervention such as dog-walking support rehabilitation, e.g. following radiation therapy?

What is the role of voluntary exercise in repairing damage from cancer therapy? To what extent can dog walking facilitate the benefits afforded by community contacts (social facilitation effect leading to greater social capital) for those recovering from medical treatment or those with chronic illness?

cancer treatment in children, does using companion animals and/or pets support rehabilitation, both physically (exercise, physiological healing) and cognitively (learning disabilities are a known side effect in many pediatric cancer treatments).

What are the social and emotional can information about animal behavior be used to prevent injury or illness related to pets (e.g., dog bites are a frequent cause of ER visits in preschool children)?

development of tools/methods to further the study of HAI including, but not limited to the following: methods of measuring animal-human activity, that can be used both cross-sectionally and longitudinally, which might also be applicable to the development of behavioral phenotypes.

questionnaires on pet ownership/exposure, for use in large scale public health studies and in epigenetic studies and surveys, both prospective and retrospective, in children and adults. pair-bonding: New methodologies to identify and classify pair bonding between children and pets and social traits in dogs and cats.

of dog-human eye tracking to help to determine the role of eye contact in the developing relationship between child and pet. See Section VIII, Other Information - Required Federal Citations , for policies related to this FOA will use the NIH Research Project Grant (R01) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide ) . It also uses the modular as well as the non-modular budget formats http://grants. nih.

gov/grants/funding/modular/modular. htm ) . Specifically, a U.S. organization submitting an application with direct costs in each year of $250 ,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component. The total amount of funding that NIH expects to award through this announcement is $2 million per year, w ith $500,000 from NINR, $1.

5 million from NICHD, of which $250,000 has been donated by The WALTHAM Centre for Pet Nutrition, a division of Mars, Incorporated, as part of a public-private partnership with the NICHD. The anticipated number of awards is 3-4 . The anticipated number of awards is 3-4.

Budgets for direct costs of up to $500,000 per year and a project duration of up to 4 years may be requested for a maximum of $2 million in direct costs over a 4-year project period. the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004 . grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in Section III.

Eligibility Information organizations/institutions are eligible to apply: Controlled Institutions of Higher Education Institutions of Higher Education Hispani c-serving Institutions Historically Black Colleges Tribally Controlled Colleges Alaska Native and Native Hawaiian Serving with 501(c)(3) IRS Status (Other than Institutions of Highe r Education) without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Organizations (Other than Small Businesses) American Tribal Governments (Federally Recognize d) American Tribally Designated Organizations Housing Authorities/Indian Housing Authorities U.S. Territory or Possession Indian /Native American Tribal Governments (Other than Federally (non-U.S.) Entities (Foreign Organizations) Agencies of the Federal Government or Community-based Organizations Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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 More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model.

Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants. nih. gov/grants/multi_pi .

All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era. nih. gov/ElectronicReceipt/preparing.

htm The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below.

When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.

Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants. nih.

gov/grants/multi_pi . This program does not require cost sharing as defined in the current NIH Grants Policy Statement . of Applications.

Applicants may submit more than one application, provided each application is scientifically distinct. Resubmission applications are not permitted in response to this FOA. applications are not permitted in response to this FOA.

Section IV. Application and Submission Information download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www. grants.

gov/Apply/ and follow the directions provided on that Web site. A one-time registration is required for institutions/organizations at both: Grants. gov ( http://www.

grants. gov/applicants/get_registered. jsp ) eRA Commons ( http://era.

nih. gov/ElectronicReceipt/preparing. htm ) PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

additional separate actions are required before an applicant can submit an electronic application, as follows: Organizational/Institutional Registration in Grants. gov/Get Registered Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants. gov registration process.

If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration. The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.

Direct questions regarding Grants. gov registration to: Business Hours: M-F 7:00 a. m.

- 9:00 p. m. Eastern Time 2) Organizational/Institutional Registration in the eRA Commons To find out if an organization is already Commons-registered, see Organizations Registered in NIH eRA Commons.

Direct questions regarding the Commons registration to: Phone: 301-402-7469 or 866-504-9552 (Toll Free) Business hours M-F 7:00 a. m. 8:00 p.

m. Eastern Time Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official ( AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.

When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons. This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image. the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.

gov and the Commons . The NIH will accept electronic applications only from organizations that have completed all 1. Request Application Information download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.

gov/Apply . Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected] .

for the hearing impaired: TTY: (301) 451-5936 Content and Form of Application Submission applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants. gov/Apply . Application Guide is critical to submitting a complete and accurate application