Research determination

2017-017c

CGH HSR Tracking #:________________
Request for Project Determination & Approval – Center for Global Health (CGH)
Use this form to submit proposals to the CGH Office of the Associate Director for Science/Laboratory Science (ADS/ADLS) for
research/nonresearch determination and requirements for IRB review/approval.
Approval Chain: Investigator → Branch Chief/Country Director →Division ADS → CGH Human Subjects Mailbox
✔ Amendment
New Request
Project Title: Parasitic infections in children living in the Mississippi Delta

CDC Principal Investigator's Richard Bradbury (SEV#9576)
name and SEV#:
Division: DPDM

CDC Primary Contact's name
Susan Montgomery (SEV#13572)
and SEV# (Leave blank if same as PI):

CDC PI or PC Email: [email protected]

Project start date (mm/dd/yyyy): 01/01/2016

Laboratory Submission
Project Location/Country(ies): United States

Telephone: 4047184731

Project end date (mm/dd/yyyy): 01/01/2021

Collaborating Institutions (List other collaborating institutions in the protocol or in a separate document)
CoAg Grant ✔ contract #: 75D30118C02930
Original Award Year if CoAg:
Current Budget Year if CoAg:
Title (CoAg, Grant, or Contract): BAA FY2018-OADS, 7.1 Determination of prevalence of select parasitic diseases
Supported Institution Name: University of Mississippi Medical Center
Supported Institution FWA#: FWA00003630
FWA Exp. Date (if applicable): 10/26/2022
Check appropriate category and subcategory
I. Activity is NOT human subjects research. Primary intent is public health practice or a disease control activity (Check all that apply)
A. Epidemic or endemic disease control activity; if applicable, Epi-AID #
B. Routine surveillance activity (e.g., disease, adverse events, injuries)
C. Program evaluation activity*
D. Public health program activityΩ
E. Laboratory proficiency testing
* Evaluation of a new intervention for effectiveness and comparison of different interventions are research under CDC policy.
Ω e.g., service delivery; health education programs; social marketing campaigns; program monitoring; electronic database construction and/or support; development of patient
registries; needs assessments; and demonstration projects intended to assess organizational needs, management, and human resource requirements for implementation.

II. Activity is research but does NOT involve human subjects (Check all that apply)
A. Activity is research involving collection or analysis of data about health facilities or other organizations or units (NOT persons).
B. Activity is research involving data or specimens from deceased persons.
C. Activity is research involving unlinked or anonymous data or specimens collected for another purpose.
D. Activity is research involving data or specimens from animal subjects. §
§Note: Approval by CDC Institutional Animal Care and Use Committee (IACUC) may be required for certain animal research. Institution must also have assurance with the
Office of Laboratory and Animal Welfare at NIH.
✔
III. Activity is research involving human subjects but CDC involvement does not constitute “engagement in human subject research.” CDC
employees or agents will not intervene or interact with living individuals or have access to identifiable information for research purposes. Appropriate IRB
or ethics committee approval is required prior to approval. (Check all that apply)
A. This project is funded under a grant/cooperative agreement/contract award mechanism.
B. CDC staff provide technical support that does not involve possession or analysis of identifiable data or interaction with
participants from whom data are being collected (No CDC Supportβ).
C. CDC staff are involved only in manuscript writing for a project that has closed. For the project, CDC staff did not interact with
participants and were not involved with data collection (No CDC Support).
✔
D. Activity is research involving linked data, but CDC non-disclosure form 0.1375B is signed.∞

β See definition of support on page 3.
∞ Access to linked data is permitted under any of the above sub-categories if CDC investigators and the holder of the key linking the data to identifiable human subjects enter
into an agreement using CDC form 0.1375B, prohibiting the release of the key to CDC investigators under any circumstances. The purposes of the planned research do not
contradict the terms of consent under which the information or specimens were collected, whether that consent was documented or not documented.

IV. Activity is research involving human subjects that requires submission to CDC Human Research Protection Office (Check one) α
A. Full Board Review (Use forms 0.1250, 0.1370-research partners)
B. Expedited Review (Use same forms as A above)
C. Exemption Request** (Use forms 0.1250X, 0.1370-research partners)
D. Reliance¥
1. Request to allow CDC to rely on a non-CDC IRB (Use same forms as A above, plus 0.1371)
2. Request to allow outside institution to rely on CDC IRB (Use same forms as A above, plus 0.1372)
α There are other types of requests not listed under category IV, e.g., continuation of existing protocol, amendment, incident reports.
¥ Exemption and reliance request is approved by CDC Human Research Protection Office (HRPO).

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CGH HSR Tracking #:________________
Public Access and Data Sharing
A.

Type of data collected or generated: 7. Owned by partner and has an agreement restricting data sharing
Instructions: From the dropdown list, select the types of data that will be collected that best fits this project. Categories 1, 2, and 3 are data covered by CDC Policy.
Categories 4 and 5 are data covered by CDC Policy but release or sharing may be restricted or limited. Categories 6, 7 and 8 are data NOT covered by CDC Policy. The
numbering and categories correspond to the categories described in CDC Policy (see info section on page 8 for exact wordings and link to the CDC Policy). Use the
lowest number when the data falls under more than one type.
Provide a 2-3 sentences description of the data that will be collected in this project:
Demographic and risk for infection data will be collected. Participants will provide specimens, stool and/or dried blood spots, for parasitic infection
testing.

B.

Data ownership: University of Mississippi Medical Center
Instructions: Provide the name of the organization that will own the public health data for this project. If there are multiple organizations involved, provide the name
of the organization that will retain and provide long-term control over the access and use of the data. Provide data steward’s name and contact information if available.

C.

Public access level: 1. Public – dataset or summary data tables made available without restriction after data availability date
Instructions: From the drop-down list, select the data release category that will best fits how data will be available after data availability date.

Rights: Other (describe in the text box below)
Instructions: From the dropdown list, select the justification when the public access level is “restricted public” or “non-public.”
Provide a brief description (1-3 sentences) according to the instructions for the option selected:
Data collected under a contract.

D.

Anticipated data availability date (mm/yyyy):

Instructions: Provide the anticipate date that the public health data will become available.

Amendment
If this request is an amendment to an existing project determination. Please include a brief description of the substantive change or
modification below and attach both clean and marked copies of the amended protocol or project outline.
The amendments to the protocol include collecting demographic information, stool and blood samples from children aged 0-18 years (expanded from school
age only) at two additional venues, UMMC Pediatrics Clinics and UMMC School of Nursing Health Fairs. At these new sites, this study will enroll a
convenience sample of 2000 children with parental consent who will be tested for soil transmitted helminth infection using both microscopic and molecular
methods and evaluated for anemia and possible impact of infections on growth. In addition to the two new venues for enrollment, testing now include for
other childhood infections and three stool samples will be collected instead of one sample in the previous version of the protocol. Community mobilization
now includes active partnering with the communities through education and outreach and ongoing communications, particularly with key community
stakeholders. The amendment now includes compensation for time and inconvenience by provision of store gift cards to parents.

Submission: Attach a protocol if one exists. If not, provide a separate project description (See suggested
format below) in sufficient detail to justify the proposed category. Submit your request to your branch chief (or
country director or designee for country staff).
CGH ADS/ADLS Review

✔

Date received in CGH ADS /ADLS office:

Project does not require human subject research review beyond CGH at this time. Local IRB Exp. Date (if applicable):
Project constitutes human subject research that must be routed to CDC HRPO.

Comments/Rationale for Determination:
). This is request to amend the approval for non-engaged participation in a research protocol, broadening the scope of the
project from the perspective of enrollee age, location of enrolment, and testing being done.
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CGH HSR Tracking #:________________

Approvals and Signatures
Date:
Richard Bradbury -SR1
(Affiliate)

Remarks:

Digitally signed by Richard Bradbury -SR1
(Affiliate)
Date: 2018.12.07 10:43:33 -05'00'

Investigator
Stephanie R. Bialek -S9

Digitally signed by Stephanie R. Bialek -S9
Date: 2018.12.07 14:03:33 -05'00'

Branch Chief/Country Director
signed by Barbara Marston -S
Barbara Marston -S Digitally
Date: 2019.02.26 14:46:24 -05'00'

Division Human Research Protection Coordinator
Division ADS/ADLS or Director

Barbara J. Tomczyk -S

Digitally signed by Barbara J. Tomczyk -S
Date: 2019.02.28 16:17:28 -05'00'

CGH Human Research Protection Coordinator
CGH ADS/ADLS or Deputy ADS/ADLS
Note: Although CDC IRB review is not required for certain projects (categories I,II & III) approved under this determination, CDC investigators and
project officers are expected to adhere to the highest ethical standards of conduct and to respect and protect to the extent possible the privacy,
confidentiality, and autonomy of participants. All applicable country, state, and federal laws must be followed. Informed consent may be appropriate
and should address all applicable elements of informed consent. CDC investigators should incorporate diverse perspectives that respect the values,
beliefs, and cultures of the people in the country, state, and community in which they work.

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CGH HSR Tracking #:________________
Definitions
Agent – A nonemployee of CDC who conducts research under CDC’s FWA. This generally includes all persons
cleared for access to CDC networks and who use CDC networks or physical facilities for human research activities.
Epidemic disease control (aka, emergency response) – A public health activity undertaken in an urgent or
emergency situation, usually because of an identified or suspected imminent health threat to the population, but
sometimes because the public and/or government authorities perceive an imminent threat that demands immediate
action. The primary purpose of the activity is to document the existence and magnitude of a public health problem in
the community and to implement appropriate measures to address the problem (Langmuir, Public Health Reports
1980; 95:470-7).
Engagement – An institution becomes engaged in human subjects research when its employees or agents (i) obtain
data about living individuals through intervention or interaction with them for research purposes; (ii) obtain
individually identifiable private information about living individuals for research purposes; or (iii) obtain the
informed consent of human subjects (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-onengagement-of-institutions/index.html). Furthermore, an institution is automatically considered to be engaged in
human subjects research whenever it receives a direct HHS award to support such research, even where all activities
involving human subjects are carried out by a subcontractor or collaborator.
Human subject or participant – is defined as a living person about whom an investigator conducting research
obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (e.g.,
medical records, employment records, or school records).
Private information includes information about behavior that occurs in a context in which an individual can
reasonably expect that no observation or recording is taking place, and information which has been provided for
specific purposes by an individual and which the individual can reasonably expect will not be made public (for
example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is
or may readily be ascertained by the investigator or associated with the information) in order for obtaining the
information to constitute research involving human subjects.
Program evaluation – is the systematic collection of information about the activities, characteristics, and outcomes
of programs to make judgments about the program, improve program effectiveness, and/or inform decisions about
future program development. Program evaluation should not be confused with treatment efficacy which measures
how well a treatment achieves its goals which can be considered as research.
Public health data – is digitally recorded factual material commonly accepted in the scientific community as a basis
for public health findings, conclusions, and implementation. Public health data could be quantitative, qualitative,
imaging, or genomic output. Public health data includes those from research and nonresearch activities.
Research – is defined as a systematic investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute
research, whether or not these activities are conducted or supported under a program which is considered research
for other purposes. For example, some demonstration and service programs may include research activities.
Support - Pertaining to Federal agencies, provision of funding, identifiable private information, or supplies,
products, drug, other tangible support (does not include mere provision of Federal staff time and assistance absent
other forms of financial or material support).
Surveillance – The ongoing systematic collection, analysis and interpretation of health data, essential to the
planning, implementation and evaluation of public health practice, closely integrated to the dissemination of these
data to those who need to know and linked to prevention and control.

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CGH HSR Tracking #:________________
Table: Determining Public Health Research from Nonresearch±
Research

Practice (nonresearch)

“...systematic investigation, including
The purpose of the activity is to identify
research development, testing, and
and control a health problem or improve
evaluation, designed to develop or contribute a public health program or service;
to generalizable knowledge.” (ref. 45 CFR Intended benefits of the project are
46)
primarily or exclusively for the
participants (or clients) or the
The purpose of the activity is to develop or participants’ community; Data collected
contribute to generalizable knowledge to
are needed to assess or improve the
improve public health practice; intended
program or service, the health of the
benefits of the project can include study
participants or the participants’
participants, but always extend beyond the community; Knowledge that is generated
study participants, usually to society; and
does not extend beyond the scope of the
data collected exceed requirements for care activity; and project activities are not
of the study participants or extend beyond the experimental. May use scientific methods
scope of the activity.
to identify and control a health problem
with benefits for the study participants or
their communities.
Primary Purpose To generate new or generalizable knowledge To benefit study participants or the
(information that can be applied in other
communities from which they come
settings)
Scientific principles and methods used
Scientific principles and methods may be
Methodology
used.
Hypothesis testing/generating
Hypothesis testing/generating
Knowledge is generalizable
Knowledge may be generalizable
Examples
Requested data are broad in scope (and may Regular, ongoing collection and analyses
Surveillance
involve as yet unproven risk factors)
to measure occurrence of health problem
Projects
Definition

Comparison of different surveillance
approaches

Scope of data is health condition or
disease, demographics, and known risk
factors

Hypothesis testing

Emergency
Response

Subsequent studies planned using cases
identified
Samples stored for future use
Additional analyses performed beyond
immediate problem

Program
Evaluation

Investigational drugs tested
Test an untried intervention
Systematic comparison of standard and
nonstandard interventions, in any
combination

Invokes public health mechanisms to
prevent or control disease or injury
Solves an immediate health problem
No testing of methods or interventions

Assess success of established
intervention
Evaluation information used for feedback
into program (management)

± Adapted from 2010 CDC Policy on “Distinguishing Public Health Research and Public Health Nonresearch”
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CGH HSR Tracking #:________________
Quick Reference Guide for Development of Scientific Protocol
for Project Determination and Approval
Purpose
Investigators have responsibilities to provide complete and accurate information in order for reviewers to make
informed-decision regarding the research/nonresearch and requirements for IRB review/approval. The general rule
of thumb is to include all available supporting documents for review when submitting a project for
research/nonresearch determination. If a protocol already exists, submit the protocol instead of a summary.
Summary of protocol may omit crucial information. Additionally, all supporting documents, such as local
institutional review board (IRB) approval and/or a letter of local ministry of health (MOH) concurrence, study tools,
and informed consent documents should be submitted with the protocol for review. Protocol and all supporting
documents must be in English. Investigators should discuss study issues with co-investigators, division ADSs, and
other relevant partners prior to submission in order to determine appropriate category and subcategory and avoid
delay in processing their request.
If a protocol has not already been written, the following outline, based on the CDC Protocol Development Guide,
provides the minimal information needed for reviewer to make an informed-decision and assess the scientific and
ethical merits of a study. Note that if the study is deemed human subjects research requiring IRB approval, a more
detailed protocol may be requested for submission to the IRB. CDC Excellence in Science Committee has developed
a protocol development guide that should be used in preparing protocols for submission to the IRB. The guide can
be found at http://intranet.cdc.gov/od/oads/osi/hrpo/guides/protdev.pdf.
General Outline
I. Overview
• Title: A project title should provide the main idea of the study and include country name(s). Be specific and
avoid general title that tells little about the actual study.
• Project summary: Give a concise overview of the project. Describe the purpose of the study, including
problem to be investigated and hypothesis(es) to be tested, the population, and the methods that will be used.
Avoid the use of acronyms. Include the expected benefit of the study.
• Investigators/collaborators/funding mechanism(s)/Federalwide Assurance numbers: Include the names
and degrees of all investigators (CDC and collaborators); include SEV# for CDC investigators, their roles,
responsibilities, and interaction with participants in the project. Include the following information for each
collaborator: funding mechanism, award number, FederalWide Assurance number if applicable.
• OMB/PRA information: Describe the proposed information collection, how the information will be
collected, by whom, and what role CDC staff member will have. Note that any standardize data collection on
10 or more people where CDC activities include approving, directing, managing, and owning the data will
require OMB approval.
• Sponsoring institution(s): Identify the sponsoring institution(s) if not CDC (Note that if this is blank, it is
assumed that CDC is the sponsoring institution).
II. Introduction/Background
• Literature review/current state of knowledge about project topic: Discuss relevant information about the
subject of the project based on a review of the literature. Provide citation of the sources and include a
reference in the appendix.
• Justification for study: Explain the public health and scientific importance of the study. In the context of
previous studies, describe the contribution this study will make.
• Location(s): Identify the study location(s).
• Intended/potential use of study findings: Define the primary target audience(s) and discuss the expected
applicability of study findings.
• Goals/Objectives: Clearly and concisely, list the goals and/or objectives that the project will address.
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•

CGH HSR Tracking #:________________
Hypotheses or questions: Describe the question(s) that the study will answer. State the type of
hypothesis(es) that will be explored or tested.

III. Methods
• Study design/timeline: Describe the methods to be used, the duration of participants’ involvement. Describe
whether the approach used will be descriptive, exploratory (hypothesis-generating), confirmatory
(hypothesis-testing), or developmental (focused on corrective action).
• Study population(s): Describe the study population, number of participants, sampling frame, case
definitions, inclusion/exclusion criteria, recruitment, and justification for involving vulnerable populations.
• Study procedures: Describe training, number of staff and roles, data collection activities, adverse
event/protocol deviation reporting, monitoring plan, etc.
• Data analysis: Describe key variables that will be collected and how data will be analyzed, data storage, and
quality assurance.
• Data management plan: There is substantial overlap between a data collection plan (protocol, statement of
work, SOP) and the data management plan. Reference can be made to other section of the protocol or other
related documents, but this section should include documentation on the following:
 Descriptions of the data to be produced in the proposed project;
 How access will be provided to the data (including provisions for protection of privacy,
confidentiality, security, intellectual property, or other rights);
 Use of data standards that ensure all released data have appropriate documentation that describes the
method of collection, what the data represents (data dictionaries), and potential limitations for use;
 Plans for archival and long-term preservation of the data, or explaining why long-term preservation
and access cannot be justified.
• Dissemination/Reporting of Results: Describe any plan for notifying participants and other stakeholders of
study findings. Describe any publication plan.*
IV. Ethical considerations:
• Risks/Benefits: Describe the potential risks (physical and mental) and benefits to study participants
• Informed Consent/Assent/Permission: Describe the informed consent/assent procedures, waiver of
informed or written consent, assent of children, parental permission,
• Other ethical considerations: Describe confidentiality/privacy protection, autonomy, safeguard for
vulnerable population, reporting of adverse events, and culture, values, and beliefs. Describe conflicts or
potential conflicts of interest if any.
• HIV Notification Policy: If individuals will be consented and tested for HIV, describe the plan to inform
individuals of their test results, including providing appropriate counseling according to HHS Policy -http://www.hhs.gov/ohrp/policy/hsdc88jun.html.
References: List of references cited.
Appendices: Include all relevant materials, such as study tools, informed consent document, local IRB approval,
confidentiality agreement, material/data transfer agreement, and other supporting documents.
*Publications produced under a CDC grant support project must comply with the “Public Access to CDC Funded Publications” a policy
which was established to ensure that full-text versions of peer-reviewed journal manuscripts by any CDC author be made available within
12 months after publication. To access the policy please click here: http://isp-v-maso-apps.cdc.gov/Policy/Doc/policy596.pdf.

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CGH HSR Tracking #:________________
Public Access and Data Sharing
Purpose
The purpose of “CDC Policy on Public Health Research and Nonresearch Data Management and Access,” is to
ensure that CDC manages public health data and provide access to such data for public-use. The policy applies to
public health research and nonresearch data, intramural and extramural, collected or generated using CDC funds.
Public health data, as defined in the definitions section of this document, could be quantitative, qualitative, imaging,
or genomic output (for example, genome sequencing, arrays, gene expression, etc.). Public health data do not
include preliminary analyses, drafts of scientific papers, plans for future research, reports, grantee progress reports,
communications with colleagues, or physical objects, such as laboratory notebooks or laboratory specimens.
The numbering and types of data in the dropdown list in part A of the “Public Access and Data Sharing” section (top of
page 2) of this form correspond to the descriptions provided by the CDC Policy below.
Public health data covered by the policy are those:
1. Collected or generated by CDC
2. Collected or generated by other agencies or organizations funded or co-funded by CDC (for example,
through mechanisms such as grants, cooperative agreements, contracts, or other funding mechanisms). When
CDC funds another federal agency, an interagency agreement should indicate who would be responsible for
the data
3. Reported to CDC by another entity (for example, by state health departments) that become a part of a CDC
data collection system (for example, CDC surveillance systems)

Public health data covered by the policy, but which release or sharing may be limited includes those:
4. Protected from disclosure by applicable laws and regulations (for example, the Privacy Act [6,7], the Trade
Secrets Act [8], Section 308(d) of the Public Health Service Act [9])
5. Deemed not shareable due to the potential of dual-use research of concern [10]
Public health data not covered by this policy includes those:
6. Collected and generated by other organizations but that are shared with CDC
7. Provided to CDC by a license agreement with restrictions on the use and sharing of the data
8. Provided to CDC by another federal agency (for example the Centers for Medicare and Medicaid Services)
under restricted terms of use and sharing of the data
Links
• CDC Human Research Protections Policy (2010): http://aops-mas-iis.cdc.gov/Policy/Doc/policy556.pdf
• CDC Distinguishing Public Health Research and Public Health Nonresearch (2010): http://aops-masiis.cdc.gov/policy/Doc/policy557.pdf
• CDC Scientific Ethics Verification # database (intranet): http://scientificethics.cdc.gov/reprint/
reprintmenu.asp
• HHS Title 45 Code of Federal Regulations Part 46, Protection of Human Subjects (Revised 2009):
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
• OHRP Guidance on Engagement of Institutions in Human Subjects Research:
http://www.hhs.gov/ohrp/policy/engage08.html
• OHRP Guidance on Research Involving Coded Private Information or Biological Specimens:
http://www.hhs.gov/ohrp/policy/cdebiol.html
• OHRP FederalWide Assurance number database: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc
• CDC Policy on public health research and nonresearch data management and access: http://aops-masiis/Policy/Doc/policy385.pdf
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