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PHS Human Subject and Clinical Trials Form Information Guide

The Public Health Service (PHS) Human Subjects and Clinical Trials form is required for most National Institutes of Health (NIH) applications. It collects information on proposed human subjects research, clinical research, and/or clinical trials. To assist with the completion of this form, and the related study record (if applicable) in KR, please refer to the following guidance.

Q1. Does any of the proposed research in the application involve human specimens and/or data? (Answered within the Questionnaire option of the Proposal Development [PD] document.)

image of the questionaire option of the proposal development document

Q2. Are human subjects involved?1 (Answered by adding a Compliance entry with Human Subjects as the Type.)

image of the type dropdown menu under the compliance option of the document

If there’s uncertainty whether the project involves human subjects research, NIH has developed a decision tool to help make this determination.

If the answers to both of the above questions are 'No', this form is complete.

If the answer to Q1 is 'Yes' and the answer to Q2 is 'No', an attachment explaining why the human specimens and/or data is not considered human subjects research is required.

1. Go to the Attachments option of the PD:

image of the attachments option of the proposal development

2. On the Proposal tab, click the [+Add] button:

image of the attachments option of the proposal development

3. Select the Attachment Type "PHS_HumanSubjectsAndCT_InvolveHumanSpecExp" from the dropdown menu, select a Status ("Complete", or "Incomplete"), and click [Choose File]:

image of the attachments option of the proposal development

4. Once the file is added, click [Save].

If the answers to both Question 1 (Q1) and Question 2 (Q2) are 'Yes', at least one Delayed Onset explanation or Study Record is required.2 Please continue through the following questions:

1. Go to the Compliance Option of the PD and click [+Add compliance entry]:

image of the attachments option of the proposal development

2. Add a compliance entry for Human Subjects with an Approval Status of Pending (unless IRB approval has been obtained for this project).

image of the attachments option of the proposal development

3. Check the Delayed Onset box.

4. Add a Study Title.

5. Add a Human Study Attachment with the justification for why this study is delayed onset.

6. Click [Add Entry].

A Study Record is required.

1. From the Basics option, select the S2S Opportunity sub option, then choose the Forms tab. Click on the PHSHumanSubjectsandClinicalTrialsInfo form:

image of the attachments option of the proposal development

2. Answer 'Yes' to the question, “Are Human Subjects Involved?”

image of the attachments option of the proposal development

...then extract the Study Record from the downloaded form:

image of the attachments option of the proposal development

3. Complete the Study Record using the folowing Table as a guide:

Exempt Human Subjects Research
Section 1 - Basic Information Required  
1.1 Study Title Required  
1.2 Exempt? YES  
1.3 Exemption Number Required ➡ Should match selection on PHS Human Subjects and Clinical Trials Information form
1.4 Clinical Trial Questionaire At least one question NO ➡ 1.4.a "Does the study involve human participants?" defaults to Yes and is not editable
1.5 ClinicalTrials.gov Identifier    
 
  Exemption Number (1.3 above)  
  E41 ONLY All other Exemptions2  
    YES  
Section 2 - Study Population Characteristics Not Required Required  
2.1 Conditions of Focus of Study   Required ➡ Up to 20 conditions, limited to 255 characters each
2.2 Eligibility Criteria   Required ➡ Use dash+space for bulleted list
2.3 Age Limits   Required  
2.3.a. Inclusion of Individuals Across the Lifespan   Required  
2.4 Inclusion of Women and Minorities   Required  
2.5 Recruitment and Retention Plan   Required  
2.6 Recruitment Status   Required  
2.7 Study Timeline   Optional  
2.8 Enrollment of First Participant   Required unless Inclusion Enrollment Report is using an existing dataset  
2.9 Inclusion Enrollment Report(s) Not Required Required ➡ Up to 20 reports can be added per study record
1. Inclusion Enrollment Report Title   Required  
2. Existing Dataset or Resource?   Required  
3. Enrollment Location Type   Required  
4. Enrollment Country(ies)   Optional ➡ Autopopulates to USA for domestic; multi-select from list
5. Enrollment Location(s)   Optional ➡ Type of location, not name
6. Comments   Optional  
Planned Table      
Cumulative (Actual) Table      
Section 3 - Protection and Monitoring Plans Required Required  
3.1 Protection of Human Subjects Required Required  
3.2 Multi-site study? Required Required ➡ Choose "N/A" for exempt
Single IRB plan attachment      
3.3 Data and Safety Monitoring Plan Optional Optional  
3.4 Data and Safety Monitoring Board? Optional Optional  
3.5 Overall Structure of Team Optional Optional  
Section 4 - Protocol Synopsis Do not complete Do not completed  
Section 5 - Other Clinical Trial-related Attachments Do not complete Do not complete  
  ⬇
Finished.
Attach to PHS Human Subjects and Clinical Trials Information form.		 ⬇
Finished.
Attach to PHS Human Subjects and Clinical Trials Information form.		  

1 Exemption 4 ONLY
2 Any exemption other than E4 only, or any compination of exemptions including E4.

Guidelines are generally applicable to NIH R-series proposals; please refer to the FOA for specific instructions.

 

Refer to the NIH Application Guide Section G.500 (link below) for details and content requirements:
grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.500-phs-human-subjects-and-clinical-trials-information.htm

4. Go to the Compliance Option of the PD and click [+Add compliance entry]:

image of the attachments option of the proposal development

5. Add a compliance entry for Human Subjects with an Approval Status of Exempt.

6. Select the Exemption # applicable to the study.

image of the attachments option of the proposal development

7. Attach the completed Study Record.

8. Click [Add Entry].

A Study Record is required.

1. From the Basics option, select the S2S Opportunity sub option, then choose the Forms tab. Click on the PHSHumanSubjectsandClinicalTrialsInfo form:

image of the attachments option of the proposal development

2. Answer 'Yes' to the question, “Are Human Subjects Involved?”

image of the attachments option of the proposal development

...then extract the Study Record from the downloaded form:

image of the attachments option of the proposal development

3. Complete the Study Record using the folowing Table as a guide:

Clinical Trial
Section 1 - Basic Information Required  
1.1 Study Title Required  
1.2 Exempt? NO  
1.3 Exemption Number    
1.4 Clinical Trial Questionaire All questions YES ➡ 1.4.a "Does the study involve human participants?" defaults to Yes and is not editable
1.5 ClinicalTrials.gov Identifier Optional  
Section 2 - Study Population Characteristics Required  
2.1 Conditions of Focus of Study Required ➡ Up to 20 conditions, limited to 255 characters each
2.2 Eligibility Criteria Required ➡ Use dash+space for bulleted list
2.3 Age Limits Required  
2.3.a. Inclusion of Individuals Across the Lifespan Required  
2.4 Inclusion of Women and Minorities Required  
2.5 Recruitment and Retention Plan Required  
2.6 Recruitment Status Required  
2.7 Study Timeline Required  
2.8 Enrollment of First Participant Required unless Inclusion Enrollment Report is using an existing dataset  
2.9 Inclusion Enrollment Report(s) Required ➡ Up to 20 reports can be added per study record
1. Inclusion Enrollment Report Title Required  
2. Existing Dataset or Resource? Required  
3. Enrollment Location Type Required  
4. Enrollment Country(ies) Optional ➡ Autopopulates to USA for domestic; multi-select from list
5. Enrollment Location(s) Optional ➡ Type of location, not name
6. Comments Optional  
Planned Table Required if NOT using an existing dataset or resource  
Cumulative (Actual) Table Required if using an existing dataset or resource  
Section 3 - Protection and Monitoring Plans Required  
3.1 Protection of Human Subjects Required  
3.2 Multi-site study? Required ➡ If YES, contact IRB office to develop sIRB Plan (irb@ora.msu.edu)
Single IRB plan attachment Not required if NIH ➡ If AHRQ and 3.2 is YES, attach IRB Plan (for NIH, plan will be reqired at JIT stage)
3.3 Data and Safety Monitoring Plan Optional  
3.4 Data and Safety Monitoring Board? Optional  
3.5 Overall Structure of Team Optional  
Section 4 - Protocol Synopsis Required  
4.1a Detail Description Required ➡ Up to 32,000 characters
4.1.b Primary Purpose Required  
4.1.c Interventions Required ➡ Up to 20 interventions allowed
4.1.d Study Phase Required ➡ Select Y/N NIH Phase III
4.1.e Intervention Model Required  
4.1.f Masking Required ➡ aka Blinding; if Yes, select types(s)
4.1.g Allocation Required  
4.2 Outcome Measures Required ➡ At least 1, up to 50 allowed
4.3 Statistical Design and Power Required  
4.4 Subject Participation Duration Required  
4.5 FDA-regulated intervention? Required ➡ If yes, 4.5a explanation required
4.6 Applicable clinical trial under FDAAA? Required  
4.7 Dissemination Plan Required ➡ Same can be used for multiple studies; filename must be unique for each study record
Section 5 - Other Clinical Trial-related Attachments Only include per FOA  
  ⬇
Finished.
Attach to PHS Human Subjects and Clinical Trials Information form.		  

Guidelines are generally applicable to NIH R-series proposals; please refer to the FOA for specific instructions.

Refer to the NIH Application Guide Section G.500 (link below) for details and content requirements:
grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.500-phs-human-subjects-and-clinical-trials-information.htm

4. Go to the Compliance Option of the PD and click [+Add compliance entry]:

image of the attachments option of the proposal development

5. Add a compliance entry for Human Subjects with an Approval Status of Pending (unless IRB approval has been obtained for this project).

6. Check the Clinical Trial box.

image of the attachments option of the proposal development

7. Attach the completed Study Record.

8. Click [Add Entry].

A Study Record is required.

1. From the Basics option, select the S2S Opportunity sub option, then choose the Forms tab. Click on the PHSHumanSubjectsandClinicalTrialsInfo form:

image of the attachments option of the proposal development

2. Answer 'Yes' to the question, “Are Human Subjects Involved?”

image of the attachments option of the proposal development

...then extract the Study Record from the downloaded form:

image of the attachments option of the proposal development

3. Complete the Study Record using the folowing Table as a guide:

Non-Exempt Human Subjects Research
Section 1 - Basic Information Required  
1.1 Study Title Required  
1.2 Exempt? NO  
1.3 Exemption Number    
1.4 Clinical Trial Questionaire At least one question NO ➡ 1.4.a "Does the study involve human participants?" defaults to Yes and is not editable
1.5 ClinicalTrials.gov Identifier    
Section 2 - Study Population Characteristics Required  
2.1 Conditions of Focus of Study Required ➡ Up to 20 conditions, limited to 255 characters each
2.2 Eligibility Criteria Required ➡ Use dash+space for bulleted list
2.3 Age Limits Required  
2.3.a. Inclusion of Individuals Across the Lifespan Required  
2.4 Inclusion of Women and Minorities Required  
2.5 Recruitment and Retention Plan Required  
2.6 Recruitment Status Required  
2.7 Study Timeline Optional  
2.8 Enrollment of First Participant Required unless Inclusion Enrollment Report is using an existing dataset  
2.9 Inclusion Enrollment Report(s) Required ➡ Up to 20 reports can be added per study record
1. Inclusion Enrollment Report Title Required  
2. Existing Dataset or Resource? Required  
3. Enrollment Location Type Required  
4. Enrollment Country(ies) Optional ➡ Autopopulates to USA for domestic; multi-select from list
5. Enrollment Location(s) Optional ➡ Type of location, not name
6. Comments Optional  
Planned Table Required if NOT using an existing dataset or resource  
Cumulative (Actual) Table Required if using an existing dataset or resource  
Section 3 - Protection and Monitoring Plans Required  
3.1 Protection of Human Subjects Required  
3.2 Multi-site study? Required ➡ If YES, contact IRB office to develop sIRB Plan (irb@ora.msu.edu)
Single IRB plan attachment Not required if NIH ➡ If AHRQ and 3.2 is YES, attach IRB Plan (for NIH, plan will be required at JIT stage)
3.3 Data and Safety Monitoring Plan Optional  
3.4 Data and Safety Monitoring Board? Optional  
3.5 Overall Structure of Team Optional  
Section 4 - Protocol Synopsis Do not complete  
Section 5 - Other Clinical Trial-related Attachments Do not complete  
  ⬇
Finished.
Attach to PHS Human Subjects and Clinical Trials Information form.		  

Guidelines are generally applicable to NIH R-series proposals; please refer to the FOA for specific instructions.

Refer to the NIH Application Guide Section G.500 (link below) for details and content requirements:
grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.500-phs-human-subjects-and-clinical-trials-information.htm

4. Go to the Compliance Option of the PD and click [+Add compliance entry]:

image of the attachments option of the proposal development

5. Add a compliance entry for Human Subjects with an Approval Status of Pending( unless IRB approval has been obtained for this project).

image of the attachments option of the proposal development

6. Attach the completed Study Record.

7. Click [Add Entry].

NOTES:

1 Response to "Are Human Subjects Involved?" must match the response on the R&R Other Project Information.
2 A proposal may include both Delayed Onsets and Study Records. Complete the appropriate sections for each portion of the project.
3 See NIH definition of a clinical trial: grants.nih.gov/policy/clinical-trials/definition.htm

These guidelines are generally applicable to R-series proposals. Please refer to the FOA for specific instructions. See also the NIH Application Guide Section G.500 for details on this form.

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