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




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Criteria


Human Subjects Research Yes

Exemption Yes or No

Clinical Trial Yes or No

NIH-Defined Phase III Clinical Trial Yes or No

Instructions and Required Information


In rare situations, applications are submitted with the knowledge that human subjects will be involved during the period of support, but plans are so indefinite that it is not possible to describe the involvement of human subjects in the application. The kinds of activities that lack definite plans are often institutional awards where the selection of specific projects is the institution's responsibility, research training grants, and projects in which the involvement of human subjects depends upon completion of instruments, animal studies, or purification of compounds.

If the involvement of human subjects cannot be fully described, create a heading entitled “Protection of Human Subjects” and provide a detailed explanation why it is not possible to develop definite plans at this time. The explanation should be specific and directly related to the Specific Aims in the application. If the involvement of human subjects depends upon information that is not presently available (e.g., completion of instruments, animal studies, purification of compounds), be explicit about the information and the factors affecting the availability of the information. Describe the information that will be necessary in order to develop definite plans for the involvement of human subjects, why that information is not currently available, and when the information is expected to become available during the course of the project.

If an award is made, prior to the involvement of human subjects the grantee must submit to the NIH awarding office for prior approval either (1) detailed information as required in the Research Plan, Protection of Human Subjects (addressing risks to the subjects, adequacy of protection against risks, potential benefits of the proposed research, importance of the knowledge to be gained, and data and safety monitoring plan if applicable) and certification of IRB approval, OR (2) if all of the research meets the criteria for one or more exemptions, identification of which exemption(s) is/are applicable to the research, and a justification for the exemption with sufficient information about the involvement of human subjects to allow a determination that the claimed exemption is appropriate. For NIH-defined clinical research, the request for prior approval must also address the inclusion of women and minorities, the inclusion of children, and provide completed targeted/planned enrollment tables as required in the Research Plan.

Under no circumstance may human subjects be involved in research until approval is granted by the awarding entity, and certification of IRB approval has been accepted by the agency.

In the application narrative for paper PHS398 applications, create a section entitled Protection of Human Subjects and a subheading for each of the following items. For electronic SF424 (R&R) applications, provide the required information for each of the following topics below as a separate file. Save each of the four files as a .pdf file and attach in lines 6-9 of the PHS 398 Research Plan (for K applicants, items 14-17 of the PHS 398 Career Development Award Supplemental Form; for F applicants, items 9-12 of the PHS Fellowship Supplemental Form - Research Training Plan).

Follow the instructions that are identified for each of the following topics and EITHER provide as much of the information that is requested as possible, OR describe why it is not possible to provide the information due to delayed-onset of human subjects research:

Protection of Human Subjects - Section 4.1 - 4.1.4

If the research will include a clinical trial, include a Data and Safety Monitoring Plan - Section 4.1.5, and address the ClinicalTrials.gov requirements if applicable – Section 4.1.6.

Inclusion of Women and Minorities - Section 4.2

Targeted/Planned Enrollment Table(s) - Section 4.3

Inclusion of Children - Section 4.4

Scenario E: Clinical Trial

Criteria


Human Subjects Research Yes

Exemption Yes or No

Clinical Trial Yes

NIH-Defined Phase III Clinical Trial No

Instructions and Required Information


In the application narrative for paper PHS398 applications, create a section entitled “Protection of Human Subjects” and include the following statement below the heading: “This Human Subjects Research meets the definition of a clinical trial.” (See definition of "clinical trial" under Part III.3.) Create a subheading for each of the following items below. For electronic SF424 (R&R) applications, provide the required information for each of the following topics below as a separate file. Save each of the four files as a .pdf file and attach in lines 6-9 of the PHS 398 Research Plan (for K applicants, items 14-17 of the PHS 398 Career Development Award Supplemental Form; for F applicants, items 9-12 of the PHS Fellowship Supplemental Form - Research Training Plan).

Follow the instructions that are identified for each of the following topics and provide the required information:

Protection of Human Subjects - Section 4.1 - 4.1.6

Inclusion of Women and Minorities - Section 4.2

Targeted/Planned Enrollment Table(s) - Section 4.3

Inclusion of Children - Section 4.4

If the research involves collaborating sites or subprojects, provide the information identified above for each participating site.

Scenario F: NIH Defined Phase III Clinical Trial

Criteria


Human Subjects Research Yes

Exempt No

Clinical Trial Yes

NIH-Defined Phase III Clinical Trial Yes

Instructions and Required Information


In the application narrative for paper PHS398 applications, create a section entitled “Protection of Human Subjects” and include the following statement below the heading: “This Human Subjects Research involves an NIH-Defined Phase III Clinical Trial.” (See definition of "NIH defined Phase III Clinical Trial" in Part III.3.).Create a subheading for each of the items below. For electronic SF424 (R&R) applications, provide the required information for each of the following topics below as a separate file. Save each of the four files as a .pdf file and attach in lines 6-9of the PHS 398 Research Plan (for K applicants, items 14-17 of the PHS 398 Career Development Award Supplemental Form; for F applicants, items 9-12 of the PHS Fellowship Supplemental Form - Research Training Plan).

Follow the instructions that are identified for each of the following topics and provide the required information:

Protection of Human Subjects - Section 4.1 - 4.1.6

Inclusion of Women and Minorities - Section 4.2

Additional Instructions and Requirements when NIH-Defined Phase III Clinical Trials are Proposed - Section 4.2.1

Targeted/Planned Enrollment Table(s) - Section 4.3

Inclusion of Children - Section 4.4

If the research involves collaborating sites or subprojects, provide the information identified above for each participating site.


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