Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015



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1.17 Transparency Act Reporting


The Federal Funding Accountability and Transparency Act of 2006 (FFATA), ensures that the public can access information on all entities and organizations receiving Federal funds. Central to the law was the development of www.USASpending.gov, a publicly available Web site with searchable information on each Federal grant and contract over $25,000. Moving one step further, reporting on executive compensation and first-tier subawards has been implemented as of October 1, 2010 with the development of the Federal Subaward Reporting System (FSRS). While NIH is responsible for providing award information to USASpending, grantees are responsible for entering their executive compensation and subaward information into FSRS.gov.

For additional information regarding subaward and executive compensation reporting requirements, please see NIH Guide Notice NOT-OD-11-005.


2. Assurances and Certifications


Each application to the PHS requires that the assurances and certifications in this section be verified by the signature of the Official Signing for Applicant Organization on the Face Page of the application. For electronic SF424 (R&R) applications, this is verified by checking the “I agree” box on line 17 of the SF424 (R&R) Cover Component.

PD/PI (including Fellowship Applicant) and SO Verification


After the PD/PI and SO successfully submit an application electronically through Grants.gov, they will receive an automatically generated e-mail requesting them to view and verify (or reject) the application on-line in the Commons. To do this, the PI and SO need to:

1. Make sure they can log onto the eRA Commons. Before they receive the e-mail, they should be sure to know their Commons account names and passwords.

2. Verify the electronic grant application via the eRA Commons. Complete instructions on the verification process are in the Applicant Package.

All assurances listed below may or may not be applicable to the project, program, or type of applicant organization. Applicants and grantees must comply with a number of additional public policy requirements. Refer to the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm) for additional information.


2.1 Human Subjects Research


(See also Part II: Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan.)

The DHHS regulations for the protection of human subjects provide a systematic means, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the DHHS. The regulations stipulate that the awardee organization, whether domestic or foreign, bears responsibility for safeguarding the rights and welfare of human subjects in DHHS-supported research activities. The regulations require that all organizations engaged in nonexempt human subjects research supported or conducted by the DHHS hold a Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP), and establish appropriate policies and procedures for the protection of human subjects. These regulations, 45 CFR part 46, Protection of Human Subjects, are available from OHRP, Department of Health and Human Services, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD; telephone: 1-866-447-4777 (toll-free) or (240-) 453-6900; e-mail: ohrp@osophs.dhhs.gov. In general OHRP considers organizations that receive direct support from DHHS for the conduct of nonexempt human subjects research to be engaged in human subjects research. (For more information on whether an institution is engaged in human subjects research, refer to: http://www.hhs.gov/ohrp/policy/engage08.html.) When a research project is conducted by multiple organizations each organization that is engaged in nonexempt human subjects research must hold an FWA and comply with the regulations at 45 CFR 46.

Nonexempt research involving human subjects may only be conducted under a DHHS award if the engaged organization(s) is operating in accord with an approved FWA and provides verification that an Institutional Review Board (IRB) that is registered under the specific FWA has reviewed and approved the proposed activity in accordance with the DHHS regulations. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the DHHS regulations. Foreign applicant organizations must also comply with the provisions of the regulations unless a determination of equivalent protections is made in accord with 45 CFR 46.101(h).

Under DHHS regulations to protect human subjects, certain research areas are exempt. (See Exemption Categories). With the exception of research projects that meet the criteria for Exemption 4, studies that are exempt from the human subjects regulatory requirements must still address the inclusion of women, minorities, and children in the study design.

Regulations of the Food and Drug Administration (21 CFR 50; 21 CFR 56) generally apply to biomedical research involving an unapproved drug, device or biologic, and may apply to certain studies of approved products. Additional information on FDA regulations is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm. If work falls under FDA’s regulatory requirements, the grantee must follow both DHHS and FDA human subject protection regulations.

Research involving the use of coded private information or biological specimens may not constitute human subjects research. Refer to the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens to clarify when such research is or is not research involving human subjects: http://www.hhs.gov/ohrp/policy/cdebiol.html. For additional help determining whether research that involves the use of human data or biological specimens is human subjects research, please refer to this Web site: http://grants.nih.gov/grants/policy/hs/.


Vulnerable Populations


Investigators who conduct research involving pregnant women, human fetuses and neonates, prisoners (including subjects who become prisoners after the research has started), or children, must follow the provisions of the regulations in Subparts B, C, and D of 45 CFR part 46, respectively. The subparts describe the additional protections required for conducting research involving these populations. Relevant information may be obtained at the OHRP Web site (http://www.hhs.gov/ohrp/policy/index.html).

REMINDER: DHHS regulations at 45 CFR part 46, Subpart C describe requirements for additional protections for research involving prisoners as subjects or individuals who become prisoners after the research has started. Refer to: http://www.hhs.gov/ohrp/policy/prisoner.html for complete instructions.

Exemptions 1-6 (see Exemptions under Human Subjects Research Definitions and Terms, Part III.3) do not apply to research involving prisoners or subjects who become prisoners (see Subpart C). Although Exemptions 1 and 3-6 apply to research involving children (see Subpart D), Exemption 2 can only be used for research involving educational testing or observations of public behavior when the investigator(s) do not participate in the activities being observed.

Data and Safety Monitoring


For each proposed clinical trial, NIH requires a data and safety monitoring plan that describes oversight and monitoring to ensure the safety of participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks and the size and complexity of the clinical trial. Prior to the accrual of human subjects, a detailed data and safety monitoring plan must be submitted to the applicant’s IRB and to the funding entity for approval. Adverse Events must be reported to the IRB, the NIH funding Institute or Center, and other appropriate offices or agencies. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.

NIH Policy specifically requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials. A DSMB also may be appropriate for clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.

Summary reports of adverse events must be provided to the NIH funding IC and to individual IRBs in order for them to address reports related to the site for which they have responsibility. Grantees should address questions on this subject to the NIH Program Official.

Further information concerning these requirements is contained in several NIH Guide for Grants and Contracts notices (http://grants.nih.gov/grants/guide/notice-files/not98-084.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html).


Required Education in the Protection of Human Research Participants


NIH requires education on the protection of human research participants for all individuals identified in PHS applications as senior/key personnel who will be involved in the design or conduct of human subjects research, before funds are awarded for applications or contract proposals involving human subjects. For information relating to this requirement, see the following notices: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html, and Frequently Asked Questions at http://grants.nih.gov/grants/policy/hs_educ_faq.htm. Prior to award, applicants will be required to provide a description of education completed in the protection of human subjects for all senior/key personnel involved in the design or conduct of human subjects research. Although NIH does not endorse specific programs, curricula are available and provide guidance or can be modified to provide training in this area. See http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp for computer-based training developed for NIH that can be downloaded at no charge. For information on facilitating education and developing curricula, see http://www.nih.gov/sigs/bioethics.

2.1.1 Research on Transplantation of Human Fetal Tissue


In signing the application Face Page (or for electronic applications, in checking the “I agree” box on line 17 of the SF424 (R&R) Cover Component), the Authorized Organization Representative of the applicant organization certifies that if research on the transplantation of human fetal tissue is conducted, the applicant organization will make available, for audit by the Secretary, DHHS, the physician statements and informed consents required by section 498A (b)(2) and (c) of the Public Health Service Act, 42 U.S.C. 289g (b)(2) and (c), or ensure DHHS access to those records, if maintained by an entity other than the applicant organization.

2.1.2 Research Using Human Embryonic Stem Cells


In signing the application Face Page (or for electronic applications, by checking the “I agree” box on line 17 of the SF424 (R&R) Cover Component), the Authorized Organization Representative of the applicant organization certifies that if research using human embryonic stem cells is proposed, the applicant organization will identify hESCs to be used from the NIH Registry (http://stemcells.nih.gov/research/registry/), or, if a specific cell line cannot be referenced at the time of application, certify that one from the NIH Registry will be used, in accord with the NIH Guidelines on Human Stem Cell Research (http://stemcells.nih.gov/policy/2009guidelines.htm). The AOR further certifies that the hESCs will be used in accordance with any restrictions associated with the line as cited on the Registry (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-029.html). See also http://stemcells.nih.gov/index.asp for additional guidance on stem cells and http://stemcells.nih.gov/policy/guidelines.asp for Federal policy statements and guidelines on federally funded stem cell research.

2.1.3 NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research


NIH policy requires that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving NIH-defined clinical research unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant IC Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an IC Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. This policy applies to research subjects of all ages.

The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The Research Plan should describe the composition of the proposed study population in terms of sex/gender, race, and ethnicity, and provide the rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. See http://grants.nih.gov/grants/funding/women_min/women_min.htm.


2.1.4 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research


See NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research in Part II, 5.8.

The Office of Management and Budget (OMB) defines minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all grant, contract, and intramural proposals and for all active research grants, cooperative agreements, contracts, and intramural projects. The minimum standards are described in the 1997 OMB Directive 15, http://www.whitehouse.gov/omb/fedreg_1997standards.

The standards were revised in 1997 and include two ethnic categories (Hispanic or Latino, and Not Hispanic or Latino) and five racial categories (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White). The categories in this classification are social-political constructs and should not be interpreted as being anthropological in nature. NIH is required to use these definitions to allow comparisons to other Federal databases, especially the census and national health databases. Federal agencies will not present data on detailed categories if doing so would compromise data quality or confidentiality standards.

Collection of this information and use of these categories is required for research that meets the NIH definition of clinical research. See Part II, 5.8 for additional information.


2.1.5 NIH Policy on Inclusion of Children


Research involving children (see definition of “child”) must comply with the NIH Policy and Guidelines on the Inclusion of Children in Clinical Research. Investigators should obtain full copies of the Policy and Guidelines from NIH staff, or from http://grants.nih.gov/grants/funding/children/children.htm.

NIH policy requires that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH unless there are clear and compelling reasons not to include them. Therefore, applications proposing clinical research must include a description of plans for including children. If children (or a subset of children) will be excluded from the research, the application or proposal must include an acceptable justification for the exclusion.

The involvement of children as subjects in research must be in compliance with all applicable subparts of 45 CFR part 46 as well as with other pertinent Federal laws and regulations.

IRBs have special review requirements to protect the well-being of children who participate in research. These requirements relate to risk, benefit, parental/guardian consent, and assent by children, and to research involving children who are wards of the state or of another institution. The local IRB approves research that satisfies the conditions set forth in the regulations.


2.1.6 ClinicalTrials.gov


In signing the application Face Page (or for electronic applications, in checking the “I agree” box on line 17 of the SF424 (R&R) Cover Component), the Authorized Organization Representative of the applicant organization assures compliance with Public Law 110-85, enacted 09/27/2007, if applicable (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid= f:publ085.110.pdf). The law amends the Public Health Service Act to expand the scope of clinical trials that must be registered in ClinicalTrials.gov. It also increases the number of registration fields that must be submitted, requires certain results information to be included, and sets penalties for noncompliance.

The trials that must be registered are called “applicable clinical trials.” Under the statute these trials generally include: (1) Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and (2) Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric postmarket surveillance. NIH encourages registration of ALL trials whether required under the law or not.

When registering clinical trials in the ClinicalTrials.gov Protocol Registration System, if applicable, enter the NIH Grant Number associated with the trial in the “Secondary ID” field; include activity code, institute code and 6-digit serial number (example: R01CA054321).

The entity responsible for registering the trial is the “responsible party.”

For the complete statutory definitions of “responsible party” and “applicable clinical trial,” refer to Elaboration of Definitions of Responsible Party and Applicable Clinical Trial.

Additional information can be found on the ClinicalTrials.gov Web site (http://grants.nih.gov/ClinicalTrials_fdaaa/).





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