NIH Grant Application Involving Human Subject Research
Section 8.e, Human Subjects Research
Therapeutic Research Application
Page Numbers –
PHS 398
Instructions
18
19
20
20
20
PHS 398 Instruction Headers
Special Populations
Protection of Human Subjects
1. Risks to the Subjects
Human Subjects Involvement and
Characteristics
o Anticipated number
o Age range
o Health status
o Rationale for involvement of
subpopulations
Protection of Human Subjects
1. Risks to the Subjects
Sources of Materials
Protection of Human Subjects
1. Risks to the Subjects
Potential Risks
o Physical, psychological, social, legal,
other
o Alternative treatments and procedures
Protection of Human Subjects
2. Adequacy of Protection Against
Risks
Recruitment and Informed
Consent
o Plans for recruitment of subjects
o Process for obtaining informed consent
o
Method of documenting consent
Related IRB Application Sections
o
o
Section II.6 (children)
Section II.10 (vulnerable subjects)
o
o
o
o
Section II.3 (target accrual)
Section II.5 (adults) and II.6 (children)
Section II.8 (inclusion) and II.9 (exclusion)
Section II.10 (vulnerable subjects)
o
Section II.11 (methods)
o
Section II.14 (potential risks)
o
Section II.19 (alternatives)
o
o
Section II.24 (method of subject identification and recruitment)
Section II.27 (process of informed consent), II.28 (subject/representative
comprehension), and II.29 (information purposely withheld)
Section II.31 (documentation of consent/assent)
o
Comments
UNMC’s IRB
letter will cite
federal regulation
that allows
inclusion of
special
populations
Page 1 of 5
NIH Grant Application Involving Human Subject Research
Section 8.e, Human Subjects Research
Therapeutic Research Application
Page Numbers –
PHS 398
Instructions
20
20
20
22
24
PHS 398 Instruction Headers
Protection of Human Subjects
2. Adequacy of Protection Against
Risks
Protection Against Risk
o Planned procedures for protecting against
or minimizing potential risks
o Risks to confidentiality
o Plans for ensuring necessary medical or
professional intervention in the event of
adverse effects to the subjects
Protection of Human Subjects
3. Potential Benefits of the Proposed Research
to the Subjects and Others
o Potential benefits to the subjects
o Potential benefit to others
o Risks to subjects are reasonable in
relation to the anticipated benefits to
subjects and others
Protection of Human Subjects
4. Importance of the
Knowledge to be Gained
o Risks to subjects in relation to the
importance of knowledge
o Test article and the FDA
Information to be Provided for All Clinical
Research Studies
o A description of the subject selection criteria
o Rationale for proposed exclusion of any
sex/gender
o Rationale for proposed exclusion of any
racial/ethnic group
o Description of proposed outreach programs
for recruiting women and minorities in clinical
research settings
Additional information to be Provided for NIHDefined Phase III Clinical Trials
Related IRB Application Sections
o
Section II.16 (protection against risks)
o
o
Section II.13 (data storage and confidentiality)
Look for discussion of stopping rules in:
 Sponsor protocol
 Scientific Review Committee protocol
 Methods section of IRB application
o
o
o
Section II.17 (benefits to subjects)
Section II.18 (benefits to society)
Section II.20 (risk/benefit relationship)
o
o
Section II.17(benefits to subjects), II.18(benefits to society), and II.20
(risk/benefit relationship)
Section II.12 (drugs and devices)
o
o
Section II.8 (inclusion criteria)
Section II.4 (gender)
o
Section II.7 (racial and ethnic origin)
o
Section II.24 (subject identification and recruitment)
o
Section II.11 (methods)
Comments
Page 2 of 5
NIH Grant Application Involving Human Subject Research
Section 8.e, Human Subjects Research
Non-Therapeutic Research Application
Page Numbers –
PHS 398
Instructions
18
19
20
20
20
20
PHS 398 Instruction Headers
Special Populations
Protection of Human Subjects
1. Risks to the Subjects
Human Subjects Involvement and
Characteristics
o Anticipated number
o Age range
o Health status
o Rationale for involvement of
subpopulations
Protection of Human Subjects
1. Risks to the Subjects
Sources of Materials
Protection of Human Subjects
1. Risks to the Subjects
Potential Risks
o Physical, psychological, social, legal,
other
o Alternative treatments and procedures
Protection of Human Subjects
2. Adequacy of Protection Against Risks
Recruitment and Informed Consent
o Plans for recruitment of subjects
o Process for obtaining informed consent
o Method of documenting consent
Protection of Human Subjects
2. Adequacy of Protection Against
Risks
Protection Against Risk
o Planned procedures for protecting against
or minimizing potential risks
o Risks to confidentiality
Related IRB Application Sections
o
o
Section II.6 (children)
Section II.10 (vulnerable subjects)
o
o
o
o
Section II.3 (target accrual)
Section II.5 (adults) and II.6 (children)
Section II.8 (inclusion) and II.9 (exclusion)
Section II.10 (vulnerable subjects)
o
Section II.11 (methods)
o
Section II.14 (potential risks)
o
Section II.19 (alternatives)
o
o
o
Section II.21 (method of subject identification and recruitment)
Section II.23 (process of informed consent), II.24 (subject/representative
comprehension), and II.25 (information purposely withheld)
Section II.27 (documentation of consent/assent)
o
Section II.15 (protection against risks)
o
Section II.12 (data storage and confidentiality)
Comments
Page 3 of 5
NIH Grant Application Involving Human Subject Research
Section 8.e, Human Subjects Research
Non-Therapeutic Research Application
Page Numbers –
PHS 398
Instructions
20
20
22
24
PHS 398 Instruction Headers
Protection of Human Subjects
3. Potential Benefits of the Proposed Research
to the Subjects and Others
o Potential benefits to the subjects
o Potential benefit to others
Protection of Human Subjects
4. Importance of the
Knowledge to be Gained
o Risks to subjects in relation to the
importance of knowledge
Information to be Provided for All Clinical
Research Studies
o A description of the subject selection criteria
o Rationale for proposed exclusion of any
sex/gender
o Rationale for proposed exclusion of any
racial/ethnic group
o Description of proposed outreach programs
for recruiting women and minorities in clinical
research settings
Additional information to be Provided for NIHDefined Phase III Clinical Trials
Related IRB Application Sections
o
o
Section II.16 (benefits to subjects)
Section II.17 (benefits to society)
o
Section II.16 (benefits to subjects), II.17 (benefits to society)
o
Section II.8 (inclusion criteria)
o
Section II.4 (gender)
o
Section II.7 (racial and ethnic origin)
o
Section II.21 (subject identification and recruitment)
o
Comments
Section II.11 (methods)
Page 4 of 5
NIH Grant Application Involving Human Subject Research
Section 8.e, Human Subjects Research
Non-Therapeutic Research Involving Existent Left-Over (Excess) Human Biological Material
Page Numbers – PHS
398 Instructions
20
21
PHS 398 Instruction Headers
Related IRB Application Sections
Protection of Human Subjects
1. Risks to the Subjects
Sources of Materials
Exempt Human Subjects Research
Sources
o Specimens
o
o
Section II.3 (nature of biological materials)
Section 11.4 (source of biological materials)
o
Section II.4 (source of biological materials)
NIH Grant Application Involving Human Subject Research
Section 8.e, Human Subjects Research
Exempt Educational Behavioral Social Science and Medical Research Application
Page Numbers –
PHS 398
Instructions
20
21
21
PHS 398 Instruction Headers
Exempt Human Subjects Research
General
Exempt Human Subjects Research
Population Sample
o Characteristics of the subject population
o Anticipated number
o Age range
o Criteria for inclusion/exclusion of any
subpopulation
o Rationale for involvement of special classes of
subjects
Exempt Human Subjects Research
Sources
o Data or records
Related IRB Application Sections
o
IRB application approval letter lists exemption category(ies)
o
o
o
o
Section II.7 (inclusion criteria)
Section II.3 (target accrual)
Section II.5 (age range)
Section II.7 (inclusion)
o
Section II.2 (background and rationale), II.4 (gender), and II.5 (age range)
o
Section II.10 (description of procedures)
Comments
UNMC’s IRB
determines
whether exempt
and selects
appropriate
categories
Prepared by Sponsored Programs Administration
and the Office of Regulatory Affairs
Page 5 of 5