1 I have a Special Award

3 Special Awards SBIR/STTR

Research involving human material or data is classified into three categories: non-exempt human subjects research for studies involving an interaction or intervention with subjects or that have access to identifiable private information; exempt human subjects research for studies that meet one (or more) of the six exemption categories; or not human subjects research for studies that make use of human specimens or data without identifiable information that was not collected specifically for the study. If you are awarded an NIH grant through the Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) program and your research involves human subjects you must remain compliant with the Federal Regulations for the Protection of Human Subjects (45 CFR 46). [See the Investigator section for additional information for human subjects during specific periods of the award cycle.] This includes:

• If you checked “Yes” to Human Subjects in your application, you must submit a complete PHS Human Subjects and Clinical Trial Information Form (complete instructions).
• If awarded and will be conducting non-exempt human subjects research you will need to provide your funding Institute or Center (IC) with a Federal wide Assurance Number (FWA) for your institution, IRB approval of your study, and certification of human subject's education by all key personnel.
• If awarded and will be conducting research that meets the definition of one of the Federal exemptions, you will need to submit to your IC certification of human subject's education by all key personnel.
• For the duration of your award, if conducting non-exempt human subjects research, you will need to keep your FWA current and receive annual IRB approval of your study. Any new key personnel involved in the conducting of human subjects research will need to complete human subjects education.

FWA

The Federal wide Assurance (FWA) is the only type of assurance currently accepted and approved by the Office of Human Research Protections (OHRP). Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46. OHRP has guidance available for obtaining an FWA; for FWA FAQs see http://grants.nih.gov/grants/policy/hs/faqs_aps_assurances.htm. In general, if an institution has been awarded NIH funding to conduct research involving human subjects, the institution will need to have its own FWA. An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP. Before obtaining an FWA, an institution must either register its own IRB, (an “internal” IRB), or designate an already registered IRB operated by another organization, (an “external” IRB), after establishing a written agreement with that other organization.

IRB

Department of Health and Human Services (HHS) regulations at 45 CFR 46 require that research supported by the NIH that involves non-exempt human subjects research be reviewed and approved by an Institutional Review Board (IRB). The IRB can approve, require modifications to secure approval, or disapprove all research activities covered by the regulations. Many small businesses do not have their own IRB. Many partner with local universities or hospitals that do have IRBs (an external IRB) and have their research reviewed and approved by the external IRB. Or, a small business may choose to use a commercial IRB. IRB approval is required annually for all non-exempt human subjects research.

If you are having difficulties obtaining an FWA or IRB contact your Program Officer or OHRP.

Clinical Trials

If your study involves a clinical trial you will need to include a Data and Safety Monitoring Plan (DSMP) with your NIH application. The DSMP should address the PI’s plan for ensuring the safety of participants and the validity and integrity of the data for all clinical trials. The establishment of a Data and Safety Monitoring Board (DSMB) is required for multi-site clinical trials involving interventions that entail potential risk that is greater than minimal to participants and most NIH-defined Phase III clinical trials. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). The level of monitoring should be commensurate with risks; the method and degree of monitoring needed is related to the degree of risk involved. See ClinicalTrials.gov for information on registering your clinical trial and FDAAA.

Human Subjects Education

Individuals who will be involved in the design or conduct of NIH-funded human subjects research must fulfill the human subjects education requirement. Individuals considered to be "Key Personnel" on NIH awards involving human subjects research include the Principal Investigator(s), all individuals responsible for the design or conduct of the study, and those individuals identified as key personnel of consortium participants or alternate performance sites. Also see the NIH Guide Notices of June 5, 2000 and September 5, 2001 for additional information on the Requirement for Education on the Protection of Human Subjects. 

For more information about the NIH’s SBIR/STTR program see https://sbir.nih.gov/.

If you are unsure whether your study involves human subjects use our quick determination tool.

3 Special Awards Fellowships

If you are awarded an NIH grant through a fellowship or mentoring program and your research involves human subjects you must remain compliant with the Federal Regulations for the Protection of Human Subjects (45 CFR 46). [See the Investigator section for additional information for human subjects during specific periods of the award cycle.] This includes:

• If you checked “Yes” to Human Subjects in your application, you must submit a complete PHS Human Subjects and Clinical Trial Information Form (complete instructions).
• If awarded and will be conducting non-exempt human subjects research you will need to provide your funding Institute or Center (IC) with a Federalwide Assurance Number (FWA) for your institution, IRB approval of your study, and certification of human subjects education by all key personnel.
• If awarded and will be conducting research that meets the definition of one of the Federal exemptions, you will need to submit to your IC certification of human subjects education by all key personnel.
• For the duration of your award, if conducting non-exempt human subjects research, you will need to keep your FWA current and receive annual IRB approval of your study. Any new key personnel involved in the conducting of human subjects research will need to complete human subjects education.

FWA

The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by the Office of Human Research Protections (OHRP). Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46. OHRP has guidance available for obtaining an FWA. You must provide your institution’s valid FWA number during the Just-in-Time collection of information. You can find your institution’s FWA number on the OHRP website.

IRB

Department of Health and Human Services (HHS) regulations at 45 CFR 46 require that research supported by the NIH that involves non-exempt human subjects research be reviewed and approved by an Institutional Review Board (IRB). The IRB can approve, require modifications to secure approval, or disapprove all research activities covered by the regulations. IRB approval is required annually for all non-exempt human subjects research.

Your mentor should be your first source of information regarding the FWA and IRB review. However, if you have additional questions you can contact your NIH Program Officer.

Clinical Trials

If your study involves a clinical trial you will need to include a Data and Safety Monitoring Plan (DSMP) with your NIH application. The DSMP should address the PI’s plan for ensuring the safety of participants and the validity and integrity of the data for all clinical trials. The establishment of a Data and Safety Monitoring Board (DSMB) is required for multi-site clinical trials involving interventions that entail potential risk that is greater than minimal to participants and most NIH-defined Phase III clinical trials. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). The level of monitoring should be commensurate with risks; the method and degree of monitoring needed is related to the degree of risk involved. See ClinicalTrials.gov for information on registering your clinical trial and FDAAA.

Special Considerations

With Fellowships many awardees are conducting secondary analysis of specimens or data obtained for a previous study or other purpose. It can be unclear whether or not the fellow’s research involves human subjects. If a fellow is conducting a secondary analysis of specimens or data not collected specifically for the study and anyone one the research team, including co-investigators, collaborators, consultants, or mentors, has the ability to link specimens or data to the private identifiable information of human subjects then the fellow is conducting non-exempt human subjects research. Examples of private identifiable information include name, social security number, medical record number, and address. For example, a fellow is studying the most recent flu pandemic. Her mentor, a clinician, provides her with coded participant data from his flu study. The fellow never interacts with subjects and the data is de-identified and coded. If the mentor is able to link the coded data back to participant names or medical record numbers then the fellow is conducting non-exempt human subjects research.

If you are unsure whether your study involves human subjects use our quick determination tool.

3 Special Awards Training Grants

Training grants provide resources to trainees to prepare qualified predoctoral and/or postdoctoral trainees for careers that have a significant impact on the health-related research needs of the Nation. The training grant can offer financial support to trainees and link them with research opportunities but often the training grant does not support the research being conducted by the trainee. For training awards where the training plans include or potentially will include trainees assigned to projects that involve human subjects at any time during the proposed project period that will be supported by other research grants (with their own IRB approval) the applicant should check “Yes” to Human Subjects on the application. If awarded, the grantee will need to provide the Federalwide Assurance (FWA) to the funding IC during Just-in-Time. IRB approval dates are not required for these awards. (However, if any trainee is involved in any human subjects research projects that study must have IRB approval. The awardee institution is responsible for ensuring compliance with this requirement.)

If trainees are conducting research involving human subjects that is being supported by the training grant, then the trainee and the awardee must remain compliant with the Federal Regulations for the Protection of Human Subjects (45 CFR 46). [See the Investigator section for additional information for human subjects during specific periods of the award cycle.] Otherwise, for those training grants that support trainees working on mentored projects:

• The applicant should checked “Yes” to Human Subjects if trainees will be working on mentored projects that involve human subjects research. 
• You will not be able to complete the PHS Human Subjects and Clinical Trial Information Form.
• If awarded and will be conducting non-exempt human subjects research you will need to provide your funding Institute or Center (IC) with a Federalwide Assurance Number (FWA) for your institution.
   
• If research conducted by any trainee is supported by the training grant, please speak with the IC Program Officer to make sure that the grant is properly managed.

3 Special Awards Foreign Awards

If you are at a foreign institution and receive an award from NIH and your research involves human subjects you must remain compliant with the Federal Regulations for the Protection of Human Subjects (45 CFR 46). [See the Investigator section for additional information for human subjects during specific periods of the award cycle.] This includes:

• If you checked “Yes” to Human Subjects in your application, you must submit a complete PHS Human Subjects and Clinical Trial Information Form (complete instructions).
• If awarded and will be conducting non-exempt human subjects research you will need to provide your funding Institute or Center (IC) with a Federalwide Assurance Number (FWA) for your institution, IRB approval of your study, and certification of human subjects education by all key personnel.
• If awarded and will be conducting research that meets the definition of one of the Federal exemptions, you will need to submit to your IC certification of human subjects education by all key personnel.
• For the duration of your award, if conducting non-exempt human subjects research, you will need to keep your FWA current and receive annual IRB approval of your study. Any new key personnel involved in the conducting of human subjects research will need to complete human subjects education.

FWA

The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by the Office of Human Research Protections (OHRP). Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46. OHRP has guidance available for obtaining an FWA. In general, if an institution has been awarded NIH funding to conduct research, the institution will need to have its own FWA. An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP. Before obtaining an FWA, an institution must either register its own IRB, (an “internal” IRB), or designate an already registered IRB operated by another organization, (an “external” IRB), after establishing a written agreement with that other organization.You can find your institution’s FWA number on the OHRP site. Many foreign institutions have their own FWAs with OHRP. You must provide your institution’s valid FWA number during the Just-in-Time collection of information. You can find your institution’s FWA number on the OHRP website.

IRB

Department of Health and Human Services (HHS) regulations at 45 CFR 46 require that research supported by the NIH that involves non-exempt human subjects research be reviewed and approved by an Institutional Review Board (IRB). The IRB can approve, require modifications to secure approval, or disapprove all research activities covered by the regulations. The HHS regulations state that non-exempt human subjects research must be reviewed by the IRB at least annually. Foreign institutions must comply with the minimum requirements. Therefore, if the requirements of your country require IRB review every 6 months; you will remain in compliance. However, if the IRB requirement in your country is every 3 years, you must have your IRB review your NIH-funded study annually.

If you are having difficulties obtaining an FWA or IRB contact your Program Officer or OHRP.

Clinical Trials

If your study involves a clinical trial you will need to include a Data and Safety Monitoring Plan (DSMP) with your NIH application. The DSMP should address the PI’s plan for ensuring the safety of participants and the validity and integrity of the data for all clinical trials. The establishment of a Data and Safety Monitoring Board (DSMB) is required for multi-site clinical trials involving interventions that entail potential risks to the participants and most NIH-defined Phase III clinical trials. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). The level of monitoring should be commensurate with risks; the method and degree of monitoring needed is related to the degree of risk involved. See ClinicalTrials.gov for information on registering your clinical trial and FDAAA.

Special Considerations

In general, your institution can monitor human subjects activities more conservatively than that required by the HHS regulations. However, your institution cannot be less conservative than the requirements. For instance, the HHS regulations do not consider research involving specimens or identifiable data from deceased individuals to be considered human subjects research. Some countries require IRB review and approval for studies that use specimens or identifiable data from deceased individuals.

If you are unsure whether your study involves human subjects use our quick determination tool.

3 Special Awards R&D Contracts

If you are awarded NIH funding through an R&D contract mechanism and your research involves human subjects you must remain compliant with the Federal Regulations for the Protection of Human Subjects (45 CFR 46). [See the Investigator section for additional information for human subjects during specific periods of the contract award cycle.] This includes:

• If you selected “Yes” to Human Subjects in your proposal, you must submit a complete PHS Human Subjects and Clinical Trial Information Form (see the solicitation for complete instructions).
• If awarded and will be conducting non-exempt human subjects research you will need to provide your funding Institute or Center (IC) with a Federalwide Assurance Number (FWA) for your institution, IRB approval of your study, and certification of human subjects education by all key personnel.
• If awarded and will be conducting research that meets the definition of one of the Federal exemptions, you will need to submit to your IC certification of human subjects education by all key personnel.
• For the duration of your award, if conducting non-exempt human subjects research, you will need to keep your FWA current and receive annual IRB approval of your study. Any new key personnel involved in the conducting of human subjects research will need to complete human subjects education.

FWA

The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by the Office of Human Research Protections (OHRP). Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46. OHRP has guidance available for obtaining an FWA. In general, if an institution has been awarded NIH funding to conduct research, the institution will need to have its own FWA. An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP. Before obtaining an FWA, an institution must either register its own IRB, (an “internal” IRB), or designate an already registered IRB operated by another organization, (an “external” IRB), after establishing a written agreement with that other organization.

IRB

Department of Health and Human Services (HHS) regulations at 45 CFR 46 require that research supported by the NIH that involves non-exempt human subjects research be reviewed and approved by an Institutional Review Board (IRB). The IRB can approve, require modifications to secure approval, or disapprove all research activities covered by the regulations. Offerors may not have their own IRB. Many partner with local universities or hospitals that do have IRBs (an external IRB) and have their research reviewed and approved by the external IRB. Or, an Offeror may choose to use a commercial IRB. IRB approval is required annually for all non-exempt human subjects research.

If you are having difficulties obtaining an FWA or IRB contact your Contracting Officer or OHRP.

Clinical Trials

If your study involves a clinical trial you will need to include a Data and Safety Monitoring Plan (DSMP) with your NIH application. The DSMP should address the PI’s plan for ensuring the safety of participants and the validity and integrity of the data for all clinical trials. The establishment of a Data and Safety Monitoring Board (DSMB) is required for multi-site clinical trials involving interventions that entail potential risks to the participants and most NIH-defined Phase III clinical trials. The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). The level of monitoring should be commensurate with risks; the method and degree of monitoring needed is related to the degree of risk involved. See ClinicalTrials.gov for information on registering your clinical trial and FDAAA.

If you are unsure whether your study involves human subjects use our quick determination tool.