Human Subjects Determination

DATE:

December 20, 2019

TO:

Kristen Cincotta; Bhuvana Sukumar

FROM:

Carole Harris, IRB Chair

SUBJECT:

152691.0.008.01.30

PROJECT NAME:
Assessment

Get Ahead of Sepsis Consumer and Healthcare Professional (HCP)

ICF’s IRB has reviewed the description and supporting materials submitted for the project referenced
above and determined that the activities qualify for the Exemption identified below.
Please note that this Exempt determination eliminates the Continuing Review requirement. However,
the following communications with the IRB are still required:
•
•

Submit a Protocol Modification form to the IRB prior to implementing any changes to your
study as changes may alter your Exempt status.
Submit an Adverse Event/Unanticipated Problem/Protocol Deviation form to the IRB within 2
business days of an event.
2018 Common Rule Exemptions

Research involving children is allowed in categories 1, 4, 5, 6, 7, & 8. Limitations/exclusions of children apply in
categories 2, 3. Research involving prisoners is allowed under all categories only when prisoners are incidentally
included. To qualify for exemption, the research must align with the following categories and involve only minimalrisk1 to subjects.
Category

Exemption

☐ 1.

Research involving education practices. Research involving normal education practices and instructional
techniques used in classroom management; conducted in established education settings.

45 CFR
46.104.1
☒ 2.
45 CFR
46.104.2

Research involving only educational tests, surveys, interviews, observation of public behavior. (1, 2, or 3
must apply)
☐ 1. Recorded information cannot readily identify the
subject (directly or indirectly/linked)
☒ 2. Any disclosure of responses outside of the research
would NOT reasonably place subject at risk (criminal,
civil liability, financial, employability, educational
advancement, reputation)

Minimal risk: defined as the probability and magnitude of physical or psychological harm that is normally encountered
in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons
1

9300 Lee Highway • Fairfax, VA 22031 • 703-934-3000 • 703.934.3740 fax • icfi.com

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2018 Common Rule Exemptions
Research involving children is allowed in categories 1, 4, 5, 6, 7, & 8. Limitations/exclusions of children apply in
categories 2, 3. Research involving prisoners is allowed under all categories only when prisoners are incidentally
included. To qualify for exemption, the research must align with the following categories and involve only minimalrisk1 to subjects.
Category

Exemption
☒ 3. Recorded information includes identifiers (and may be
sensitive) but adequate privacy and confidentiality
protections are in place.

☐ 3.
45 CFR
46.104.3

Benign behavioral interventions. Research with adults limited to verbal or written responses, data entry
or audiovisual recordings where adults prospectively agree.
☐ 1. Recorded information cannot readily identify the
subject (directly or indirectly/linked)

☐ 2. Any disclosure of responses outside the research would
NOT reasonably place subject at risk (criminal, civil
liability, financial, employability, educational
advancement, reputation)
☐ 3. Recorded information includes identifiers (and may be
sensitive) but adequate privacy and confidentiality
protections in place.
☐ 4.
45 CFR
46.104.4

Secondary research use of identifiable Information or identifiable biospecimens. Data were (or will be)
collected for other research. Consent for current project not required.
☐ 1. Biospecimens or information are publically available.
☐ 2. Recorded information/biospecimens cannot readily
identify the subject (directly or indirectly/linked)

☐ 3. Use of data is regulated under HIPAA as healthcare
operations, research, or public health research

☐ 4. Research is conducted by/on behalf of federal agency
using data collected for non-research purposes

☐ 5.

Public benefit or service programs.

45 CFR
46.104.5

Research designed to study, evaluate, improve or examine public benefit/service programs, if the
research is conducted by or supported by a federal department or agency

☐ 6.

Taste and food quality. Research limited to food taste and food quality evaluation and consumer
acceptance studies.

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2018 Common Rule Exemptions
Research involving children is allowed in categories 1, 4, 5, 6, 7, & 8. Limitations/exclusions of children apply in
categories 2, 3. Research involving prisoners is allowed under all categories only when prisoners are incidentally
included. To qualify for exemption, the research must align with the following categories and involve only minimalrisk1 to subjects.
Category

Exemption

45 CFR
46.104.6

☐ 1. Consumption of wholesome foods without additives

☐ 2. Food contains food ingredient(s) at or below the level
found to be safe, or agricultural chemical or

environmental contaminant at or below the level found
to be safe, by the FDA, EPA, USDA.
☐ 7.

Storage or maintenance of identifiable private information or biospecimens. Can only be used with:

45 CFR
46.104.7

☐ 1. Broad consent from subjects for storage, maintenance,

☐ 8.

Secondary research with identifiable private information or biospecimens. Can only be used with:

45 CFR
46.104.8

and secondary use of their materials.

☐ 1. Broad consent from subjects for storage, maintenance,
and secondary use of their materials.

☐ 2. Documentation of consent was obtained.

☐ 3. Individual results are not returned to subjects.

List of Reviewed Project Materials:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.

IRB Project Information Form
Attachment D_GAOS Informed Consent_Consumer Pilot Assessment v3 2019.12.20 revised
Attachment D_GAOS Informed Consent_HCP Pilot Assessment v3 2019.12.20 revised
Attachment B_GAOS Consumer Assessment Research Questions - Updated 12.15.2019
Attachment B_GAOS HCP Assessment Research Questions - Updated 12.15.2019
Attachment A_GAOS Pilot Assessment Overview_Consumers
Attachment C_GAOS Consumer Recruitment Invitation
Attachment E_GAOS Consumer Survey_11.22.2019
Attachment A_GAOS Pilot Assessment Overview_HCPs
Attachment C_GAOS HCP Recruitment Invitation
Attachment E_GAOS HCP Survey_11.22.2019

If you have any questions regarding this finding, please email IRB@icf.com.

(Revised 02/2019)

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