Research Determination

12/18/2015

REQUEST FOR NCHHSTP PROJECT DETERMINATION & APPROVAL
NCHHSTP ADS/ADLS Office on behalf of CDC (New, Continuation, or Amendment)

This form should be used to request NCHHSTP/OD/ADS or ADLS office review and approval on behalf of
CDC of a new, continued, or amended project for those projects for which NCHHSTP staff/employees,
branches, divisions, and center/OD/ADS or ADLS office are responsible.
Any NCHHSTP activity that meets the definition of a project (see the following section) and represents
one of the four project categories must be approved by the respective NCHHSTP branch and division and
by the NCHHSTP/OD/ADS or ADLS office. Approval by the NCHHSTP ADS or ADLS office
(nchstphs@cdc.gov) of these projects indicates approval by CDC. This review and approval process
complies with obligations for adherence of projects to federal regulations, state laws, ethics guidelines,
CDC policies, and publication requirements.
For research that involves identifiable human subjects in which CDC/NCHHSTP is engaged, use CDC
Human Research Protection Office forms and submit them to CDC Human Research Protection Office
through the NCHHSTP ADS human subjects email box after approval at the branch and division levels.

RELEVANT INFORMATION
What is a project?
A project is defined as a time-limited activity that is funded for a specific period of time, an activity with
specified funds for a limited time, or as a limited time responsibility by specific CDC employees or staff,
including projects that might be ongoing or continuous for an extended period. A project has defined
objectives, tasks (e.g., essential public health services), dedicated resources, and is funded for a specified
time. NCHHSTP reviews and approves projects for the four project categories listed on this form. Every
project officer, project team and staff, NCHHSTP branch, and NCHHSTP division or office is responsible
for submitting this form for each project and for obtaining NCHHSTP OD/ADS or ADLS approval on behalf
of CDC before project initiation, continuation, or amendment. Such programs as surveillance are
approved and funded as specific projects for certain periods.

What is research?
The federal regulations and CDC/OD/ADS office define research as a systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable
knowledge. Activities that meet this definition constitute research, regardless if these activities are
conducted or supported under a program that is not considered research for other purposes. For
example, demonstration and service programs sometimes include research activities.

What is a human subject?
A human subject is a living individual about whom an investigator (whether professional or student)
conducting research obtains
1. data through intervention or interaction with the individual or
2. identifiable private information.

What is an intervention?
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Page 1 of 12

12/18/2015

What is private information?
Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is occurring and information that has been
provided for specific purposes by an individual and that the individual can reasonably expect will not be
made public (e.g., a medical record). Private information identifies individuals (i.e., the identity of the
person is or might be readily ascertained by the investigator or associated with the information) for the
information to constitute research involving human subjects.

What does being “engaged” mean?
An institution becomes “engaged" in human subjects research when its employees or agents intervene
or interact with living individuals for research purposes, or obtains individually identifiable private
information for research purposes. An institution is automatically considered to be engaged in human
subjects research whenever it receives funding or resources (e.g., a direct award) to support such
research. In such cases, the awardee institution has the ultimate responsibility for protecting human
subjects under the award.

What is surveillance?
CDC defines surveillance as “the ongoing, systematic collection, analysis, and interpretation of health
data essential to the planning, implementation, and evaluation of public health practice, closely
integrated with the timely dissemination of these data to those who need to know. The final link of the
surveillance chain is the application of these data to prevention and control. A surveillance system
includes a functional capacity for data collection, analysis, and dissemination linked to public health
programs.”

What is program evaluation?
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, or inform
or guide decisions about future program development. Program evaluation should not be confused with
treatment efficacy, which measures how well a treatment achieves its goals and that can be considered
research.

Sources (links)
 http://intranet.cdc.gov/od/oads/osi/hrpo/
 http://www.hhs.gov/ohrp/index.html

Page 2 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

PROJECT REQUEST
Project Stage
Choose one by selecting a checkbox:
■

New: Fill out entire form, even if a protocol is attached (approval is for work by CDC/NCHHSTP employees).
Continuation: For projects expected to continue beyond NCHHSTP approved date; include brief description
of changes and attach clean and marked copies of approved determination (approval is for continued work
by CDC/NCHHSTP employees).
Amendment: Include brief description of changes and attach relevant documentation and a copy of
approved project (approval is for continued work by CDC/NCHHSTP employees).

Project Information:
Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
NCHHSTP Project Number:

Division: DTBE

Project Location/Country(ies):
United States

Telephone: (404) 639-5019

CDC Project Officer or CDC Co-Leads:

Stephanie Johnston, DTBE/LB/LCT Team Lead

Project Dates:
Start 10/01/2016
End 12/31/2017
Laboratory Branch Submission:
If applicable, select the checkbox:

■

Project Categories
Select the corresponding checkbox to choose the category and subcategory.
I. Activity is not human subject research. The primary intent of the project is public health practice or a disease
control activity.
A. Epidemic or endemic disease control activity; collected data directly relate to disease control. If this
project is an Epi-AID; provide the Epi-AID number and documentation of the request for assistance,
per division policy. Epi-AID no.
B. Routine disease surveillance activity; data will be used for disease control program or policy
purposes.
C. Program evaluation activity; data will be used primarily for that purpose.
D. Post-marketing surveillance of effectiveness or adverse effects of a new regimen, drug, vaccine, or
device.
E. Laboratory proficiency testing.
Page 3 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015
■

II. Activity is not human subjects research. The primary intent is public health program activities.
A. Public health program activity (e.g., service delivery; health education programs; social marketing
campaigns; program monitoring; electronic database construction or support; development of patient
registries; needs assessments; and demonstration projects to assess organizational needs, management,
and human resource requirements for implementation).
■

B. Activity is purely administrative (e.g., purchase orders or contracts for services or equipment).
III. Activity is research but does NOT involve identifiable human subjects.
A. Activity is research involving collection or analysis of data about health facilities or other
organizations or units (i.e., not individual persons.)
B. Activity is research involving data or specimens from deceased persons.
C. Activity is research using unlinked or anonymous data or specimens: ALL (1–4) below are required:
1. No one has contact with human subjects in this project; and
2. Data or specimens are or were collected for another purpose; and
3. No extra data or specimens are or were collected for this project; and
4. Identifying information was (one of the following boxes must be checked)
a. not obtained;
b. removed before this submission, or before CDC receipt, so that data cannot be linked
or re-linked with identifiable human subjects; or
c. protected through an agreement (i.e., CDC investigators and the holder of the key
linking the data to identifiable human subjects enter into an agreement prohibiting
the release of the key to the investigators under any circumstances. A copy of the
agreement must be attached.)
IV. Activity is research involving human subjects, but CDC involvement does not constitute “engagement in
human subject research.” Select only one option by checking the box: A indicates the project has current
funding; B or C indicates no current funding is applicable.
A. This project is funded under a grant, cooperative agreement, or contract award mechanism. ALL of
the following 3 elements are required:
1. CDC staff will not intervene or interact with living individuals for research purposes.
2. CDC staff will not obtain individually identifiable private information.
3. Supported institution(s) must have a Federalwide Assurance (FWA), and the project must be
reviewed and approved by a registered IRB or an institutional office linked to the
supported institution’s FWA.*
Supported institution of primary investigator or co-Investigators/entity name:*

Page 4 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

Supported institution/entity FWA Number:*
FWA expiration date:*
Expiration date of IRB approval:*
*Attach copy of IRB approval letter(s) supporting project review and approval.
B. CDC staff provide technical support that does not involve possession or analysis of data or interaction
with participants from whom data are being collected (no current CDC funding).
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 current CDC
funding).

Page 5 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

Project Description
Participating project staff must complete all 18 elements of this section.
This is a required description from CDC employees or staff for review and approval of a project plan or
proposal (or for changes) for projects conducted by CDC or in which CDC is involved. All 18 elements
are required to standardize the review and approval process across NCHHSTP, document that all 18
elements have been addressed, expedite review and approval by the NCHHSTP ADS or ADLS office, and
minimize CDC/OD/ADS office audit requests for additional information. A protocol may be attached to
this form, but it does not eliminate the requirement to complete all 18 elements.
PROJECT TITLE: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment

Instructions: Use the following boxes to complete the 18 items. Each box will expand as you type, and you are not
limited in the length of your answers. Formatting features and symbols also may be used.
1. CDC Principal Investigator(s) or Project Directors and branch/division/office affiliations:
Angela Starks, DTBE/LB

2. CDC Project Officer(s) and each person’s role and responsibilities and affiliations:

Stephanie Johnston, DTBE/LB/LCT, oversight of assessment development, OMB approval of
questionnaire, and communication with public health TB laboratorians and APHL.

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Tracy Dalton, DTBE/LB/LCT
Beverly Metchock, DTBE/LB/LCT
Mitchell Yakrus, MS, DTBE/LB/LCT
Association of Public Health Laboratories (APHL)- Anne Gaynor and Paul Zell
California Microbial Diseases Laboratory- Ed Desmond and Grace Lin

4. Institution(s) or other entity(ies) funding the project:
CDC/NCHHSTP/DTBE/LB

Page 6 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

5. Project goals:
To assess customer satisfaction with the CDC/APHL Tuberculosis (TB) Drug Susceptibility Testing
(DST) Reference Center by collecting feedback from stakeholders to improve service delivery.
Information collected will determine if the recently-established DST Reference Center at the
California Microbial Diseases Laboratory in Richmond, CA is achieving its primary mission of
providing consolidated and quality-assured DST services for public health laboratories (PHL)
processing fewer than 50 DSTs per year of Mycobacterium tuberculosis complex (MTBC) isolates.

6. Project objectives:
Assess through a customer satisfaction data collection instrument whether the CA MDL TB DST
Reference Center is providing quality assured first-line DST for PHL with low volumes of DST
(<50 MTBC isolates/year). Secondarily, measure satisfaction with second-line DST and
molecular detection of drug resistance for the rapid detection of multi-drug resistant TB.

7. Public health (program or research) needs to be addressed:

Analysis of data and incorporation of suggestions from stakeholders will guide program changes
needed to improve delivery, quality, and turnaround time of DST services at the CA MDL DST
Reference Center.

8. Population(s) or groups to be included:
The respondent universe includes 24 state public health laboratory TB supervisors located in
low-volume laboratories who are eligible to enroll in the CDC/APHL DST TB DST Reference
Center for first-line and second-line DST and MDDR testing services.

9. Project methods:
A web-based questionnaire will be designed and administered by APHL using Qualtrics software. The questionnaire contains 25
multiple choice or fill in the blank questions. The questionnaire link, post OMB approval under PRA, will be emailed to 24 public
health laboratories supported, in part, by the CDC TB Elimination and Laboratory Cooperative Agreement. These laboratories
have low-volume DST testing, are eligible to submit MTBC isolates to the TB DST Reference Service, and may have enrolled in
the service. Responses will be submitted electronically and automatically compiled by Qualtrics. Data will be analyzed through
collaboration of APHL with the CDC project officer and/or CDC project team members and discussed internally within the
Laboratory Branch and DTBE as well as externally with APHL and CA MDL.

Page 7 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

10. Selection, inclusion, or sampling of participants (persons or entities):

Twenty-four U.S. public health laboratories who are eligible to enroll or have enrolled in the
CDC/APHL TB DST Reference Center, with volumes of less than 50 DST per year, will be
invited to participate. These laboratories are funded, in part, through the CDC TB Elimination
and Laboratory Cooperative Agreement.
11. Incentives to be provided to participants:

None

12. Plans for data collection and analysis:

Data will be collected and initially analyzed through the use of a web-based questionnaire using
Qualtrics software. Subsequent quantitative analysis to generate descriptive statistics and
qualitative analysis of free-text responses will be conducted.

13. Confidentiality protections:

Secure web-based software program- no personal identifying information is requested.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
None

15. Projected time frame for the project:
14 months (10/01/16- 12/31/17)

Page 8 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

16. Plans for publication and dissemination of the project findings:
Project findings will be reviewed within the Laboratory Branch, DTBE, APHL, and CA MDL. A
manuscript will be written and published through collaboration of the above parties. Data
collected may also be presented within DTBE and externally at meetings, conferences, etc.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendix 1- questionnaire that will be sent to TB public health laboratory officials.
Appendix 2- web shots of questionnaire that will be seen by TB public health laboratory officials.

18. References (to indicate need and rationale for project):
None

Page 9 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

PROJECT APPROVAL
Choose one of the following options (Division or Center/OD Project)
■

DIVISION PROJECT

NCHHSTP BRANCH AND DIVISION ADS REVIEW AND APPROVAL (Sign electronically by clicking next to the X
and following the prompts)

X

Angela Starks
-S

Digitally signed by Angela
Starks -S
Date: 2016.10.12 11:06:11
-04'00'

Branch Chief or Branch Science Officer

X

Carla Winston
-S

Digitally signed by Carla Winston -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Carla Winston -S,
0.9.2342.19200300.100.1.1=1000186839
Date: 2016.10.12 12:42:42 -04'00'

Division ADS, Acting ADS, or Deputy ADS

CENTER/OD PROJECT

NCHHSTP OD OFFICE REVIEWS AND APPROVALS (Sign electronically by clicking next to the X and following
the prompts)

X

X

Office Associate Director or Designee

NCHHSTP ADS or Designee

Page 10 of 12

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment
12/18/2015

NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment

Date received in NCHHSTP ADS or ADLS office:
Date received by NCHHSTP Deputy ADS or ADLS:
Select the checkbox for each applicable comment for Nos. 1–5 or select the checkbox for No. 6 if all of the comments apply.
Additional applicable comments may be added to No. 7. If additional information is required before approval can be
granted, select No. 8.

1. This project is approved by NCHHSTP/CDC and CDC (per CDC policies and federal regulations) for CDC staff
participation.
2. Participating partners and sites must obtain project review and approval, according to their institutional
policies and procedures and according to local, national, and international regulations and laws, including
45 CFR 46 regulations and state laws. CDC project officers must maintain a current copy of local sites’
approvals in project records.
3. CDC investigators and project officers need to adhere to the highest ethics standards of conduct and to
respect and protect the privacy, confidentiality, autonomy, data, welfare, and rights of participants and
integrity of the project. All applicable country, state, and federal laws and regulations must be followed.
4. Informed consent or script is needed as required by laws and regulations. Information conveyed in an
informed consent or script process needs to address all applicable required elements of informed consent.
Consent of employees in related projects about their institutions needs to include a statement that their
voluntary participation or withdrawal would not affect their employment status or opportunities.
5. OMB Paperwork Reduction Act determination by the NCHHSTP OMB/PRA Coordinator might be needed for
this project.
■

6. All previous comments apply.
7. Other applicable comments: Type your comment in the box. The space will expand as you type.

8. More information is required before approval is granted: Explain what additional information is requested by
typing in the box. The space will expand as you type.

Date Information was requested:
Date Information was received:

Page 11 of 12

12/18/2015

Approval must be granted by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Associate
Director for Science (ADS), Acting ADS, or Deputy ADS, or for laboratory-associated projects, by the Associate
Director for Laboratory Science (ADLS) or Acting ADLS.

Project Title: Tuberculosis Drug Susceptibility Testing Reference Center Customer Service Assessment

X

Janella
Dodson -S

Digitally signed by Janella Dodson -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Janella Dodson -S,
0.9.2342.19200300.100.1.1=1000626972
Date: 2016.10.13 16:11:03 -04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

Page 12 of 12