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.)

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

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.

➤ To add this attachment: (expand to show instructions)

1. Go to the Attachments option of the PD:

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

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

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:

➤ Is the study Delayed Onset? (If yes, expand for more information. If no, continue to next question.)

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

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

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].

➤ Is the study Exempt? (If yes, expand for more information. If no, continue to next question.)

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:

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

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

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]:

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

6. Select the Exemption # applicable to the study.

7. Attach the completed Study Record.

8. Click [Add Entry].

➤ Is the study a Clinical Trial?³ (If yes, expand for more information. If no, continue to Non-Exempt Human Subjects Research.)

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:

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

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

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.

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

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.

7. Attach the completed Study Record.

8. Click [Add Entry].

➤ Non-Exempt Human Subjects Research (expand to show instruction)

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:

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

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

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.

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

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

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.

Skip to Content Options:

PHS Human Subject and Clinical Trials Form Information Guide

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.

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:

A Study Record is required.

A Study Record is required.

A Study Record is required.

NOTES:

Resources/Training

Site Management

Skip to Content Options:

PHS Human Subject and Clinical Trials Form Information Guide

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.

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:

A Study Record is required.

A Study Record is required.

A Study Record is required.

NOTES:

Resources/Training

Site Management

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: