NCHHSTP Project Determination & Approval

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
([email protected]) 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.
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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

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Project Title: LGBTQ Inclusivity Toolkit Demonstration Project
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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: LGBTQ Inclusivity Toolkit Demonstration Project
NCHHSTP Project Number:

Division: Divsion of Adolescent and School Health

Project Location/Country(ies):
Atlanta GA, USA

Telephone: (404) 718-6785

CDC Project Officer or CDC Co-Leads:

Leigh Szucs (DASH) and Nick Suarez ((DASH)

Project Dates:
Start 08/01/2022
End 08/31/2023
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.
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Project Title: LGBTQ Inclusivity Toolkit Demonstration Project
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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:*

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Project Title: LGBTQ Inclusivity Toolkit Demonstration Project
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Supported institution/entity FWA Number:* ICF IRB FWA00002349
FWA expiration date:* 10/13/2025
Expiration date of IRB approval:* 11/22/2023
*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).

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Project Title: LGBTQ Inclusivity Toolkit Demonstration Project
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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: LGBTQ Inclusivity Toolkit Demonstration Project

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:
Leigh Szucs (RAEB/DASH/NCHHSTP) - Lead Principal Investigator
Nick Suarez (RAEB/DASH/NCHHSTP) - Lead Principal Investigator

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

Leigh Szucs (RAEB/DASH/NCHHSTP)

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Michelle Carman-McClanahan (PDSB/DASH/NCHHSTP) - Subject Matter Expert &
Co-Investigator

4. Institution(s) or other entity(ies) funding the project:
N/A

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Project Title: LGBTQ Inclusivity Toolkit Demonstration Project
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5. Project goals:
The goal of this formative research study is to understand the extent to which a lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) inclusivity
toolkit, designed for district- and school-level staff, supports the adoption and implementation of strategies to create safe and supportive school environments for
students with LGBTQ identities in high school (grades 9-12). The study will explore the extent to which: (1) the LGBTQ inclusivity toolkit supports districts/high
schools in identifying areas for improvement in current LGBTQ inclusivity efforts, (2) the toolkit helps districts/high schools implement new or strengthen existing
strategies, (3) districts/high schools are able to diffuse policies/practices from the district to school-level implementation, (4) changes awareness of and support
for LGBTQ inclusivity and school climate across the district and select high schools, and (5) the toolkit assists in incorporating LGBTQ inclusivity strategies in
district and school-level diversity, equity, and inclusion (DEI) efforts. The study will also explore usability, feasibility, and acceptability information provided by
district and school-level staff using the draft LGBTQ inclusivity toolkit to help inform revisions following the pilot study. For this project, CDC will not be directly
involved in data collection activities, as all activities will be facilitated by ICF (contractor) following successful approval from their IRB.

6. Project objectives:
The study will use a mixed-methods evaluation design with participation from three U.S. school districts during the 2022-2023 academic year. Two
participating school districts will each select two high schools (grades 9-12), with one high school in each district serving as an intervention site and
one high school in each district serving as a control site for the outcome evaluation during the study; the remaining school district will select one high
school for a process evaluation. All three districts will receive the LGBTQ inclusivity toolkit and district and school-level staff will participate in action
planning, implementation, and data collection activities. To meet study objectives, two school districts will participate in a full outcome evaluation,
while the remaining school district will participate in process evaluations. The full outcome evaluation sites will include the following information
collections: 1) pre-post qualitative school climate interviews with district and school staff, 2) pre-post quantitative self-report surveys with school staff,
3) monthly progress reports on toolkit implementation, and 4) post-pilot feedback interviews. The process evaluation sites will include 1) pre-post
qualitative school climate interviews with district and school staff, 2) monthly progress on toolkit implementation, and 3) post-pilot feedback interviews.

7. Public health (program or research) needs to be addressed:
Through the LGBTQ Inclusivity Toolkit Demonstration Project, CDC/DASH will gain valuable information about the
extent to which an inclusivity toolkit can support the adoption and implementation of strategies to create safe and
supportive school environments for students with LGBTQ identities in U.S. high school (grades 9-12). Findings
from this study will help record understand usability, feasibility, and acceptability of toolkit domains and tailored
resources, including information needed for future refinements following the formative pilot study. Further, results
from this project will enable CDC/DASH to strengthen their guidance and technical assistance provide directly to
schools and school districts to improve safe and supportive environments for students with LGBTQ identities.

8. Population(s) or groups to be included:
For self-report staff surveys and in-depth interviews: District and school-level staff (i.e.,
individuals employed with the school district or school) whose role involves administration,
planning, or direct provision of student services, programs and activities, or classroom
instruction from each of the participating school districts (3) are eligible.

9. Project methods:
This pilot study will begin in spring 2022 and continue through the 2022-2023 academic year. ICF (CDC's Contractor) will coordinate the evaluation in collaboration with Charlotte-Mecklenburg Schools (NC), Boone County School District (KY), and Richardson Independent School District
(TX). Charlotte-Mecklenburg Schools and Boone County School District will each select two high schools: one intervention school where the district will work with school administrators to select activities (e.g., staff professional development) and pilot the toolkit during the 2022-2023
academic year and one control school that will only participate in evaluation data collections. Richardson ISD will select one high school to pilot the toolkit implementation. A draft of the LGBTQ inclusivity toolkit will be provided to each school district following Phase 1 of the study (see
additional details below). The mixed-method evaluation design allows for measurement of district, and school staff outcomes before the toolkit is implemented (pre/baseline), collection of information about toolkit implementation, measurement of outcomes following the 2022-2023 academic
year (post), and collection of feedback about the toolkit post-implementation. The study will evaluate both process and outcome measures, and selection of evaluation measures and methods is based on each school district’s capacity to participate in evaluation activities. Evaluation data
collection will take place in the following phases:
• Phase 1- Spring/Summer 2022- All Districts (3) - Outcome Evaluation - Pre-Pilot LGBTQ Inclusivity Toolkit School and District Staff Climate Interviews (60 minutes) (Attachment 1) with district and school staff at the intervention high school in each district (n=6-8) to gather qualitative data
about the district/school climate before using the toolkit.
• Phase 2- Fall 2022- Charlotte-Mecklenburg Schools and Boone County School District - Outcome Evaluation (2) - Quantitative LGBTQ Inclusivity Toolkit Pre-Post Staff Survey (15 minutes) (Attachment 2) to assess school staff perceptions and experiences of the school climate. The
school staff survey will be administered via an email invitation linking directly to the electronic survey for staff at intervention and comparison schools (approximately n=200 per district). School staff identifying information will be collected only for recruitment purposes.
• Phase 3- Fall 2022-Spring 2023- All Districts (3) - Process Evaluation - The point-of-contact in each district will complete the LGBTQ Inclusivity Toolkit Monthly Report Form (30 minutes) (Attachment 3) to track toolkit activities and strategy implementation.
• Phase 4- Spring 2023- Charlotte-Mecklenburg Schools and Boone County School District- Outcome Evaluation (2) - Repeat LGBTQ Inclusivity Toolkit Pre-Post Staff Survey (15 minutes) (Attachment 2) at intervention and comparison schools (approximately n=200 per district)(repeat of
Phase 2).
• Phase 5- Spring 2023- All Districts (3) - Outcome Evaluation - Post-Pilot LGBTQ Inclusivity Toolkit School and District Staff Climate Interviews (60 minutes) (Attachment 1) at intervention schools (n=6-8) (repeat of Phase 1).
• Phase 6- Spring/Summer 2023- All Districts (3) - Process Evaluation - LGBTQ Inclusivity Toolkit Post-Pilot Feedback Interviews (60 minutes) (Attachment 4) with district and school staff from intervention high schools (n=2-3) who participated in the pilot to gather qualitative data about the
utility of the toolkit and offered suggestions for improvement.

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10. Selection, inclusion, or sampling of participants (persons or entities):
LGBTQ Inclusivity Toolkit Pre-Post Staff Survey (Attachment 2): All school staff employed in each of the selected high schools in the school districts whose role involves administration, planning, or direct provision of student services, programs and
activities, or classroom instruction are eligible and will receive an email invitation to take the self-report survey, including the informed consent statement in SurveyMonkey. School staff may consent to participate and gain access to the web-based survey or
decline participation. LGBTQ Inclusivity Toolkit School and District Staff Climate Interviews (Attachment 1): For the school climate interviews, the study team will obtain a list of email addresses for the school staff at the pilot high school and for the district
department involved in the toolkit pilot for each district. The email list will be stratified by staff role: instructional, administration, and support. All staff on the list will receive an email inviting them to participate in a one-on-one school climate interview. The
email clarifies that the staff recipient need only reply if they are interested in participating in the interview, and that if they are not interested, they do not need to reply. The email addresses of all school and district staff who indicate their interest by replying
to the email will be placed on a list that will be used to randomly select a total of 10 emails that will include four instructional staff, three administrative staff, and three support staff. The study team will send emails inviting these individuals to participate in the
climate interview. The first seven staff members who respond will be scheduled to participate in the interview. If seven staff members do not respond within two weeks, up to 10 additional emails will be randomly selected using the same process. This
process will continue until seven staff interviews are scheduled. The study team expects the random selection process to not take more than one month. The interview participant recruitment process and procedural steps will be repeated for the post pilot
LGBTQ Inclusivity Toolkit School and District Staff Climate Interviews (Attachment 1) conducted in spring 2023. Different school and district staff may be selected to participate in the spring 2023 interviews. LGBTQ Inclusivity Toolkit Post-Pilot Feedback
Interviews (Attachment 4): The study team will follow a similar process as the LGBTQ Inclusivity Toolkit School and District Staff Climate Interviews (Attachment 1) for the LGBTQ Inclusivity Toolkit Post-Pilot Feedback Interviews (Attachment 4) using a list
of email addresses for all pilot high school and district staff who used the toolkit during the study period. For these interviews, the email list will be stratified by district staff or school staff. The study team will randomly select four district and three school staff
to invite to the interviews and schedule a total of five for the interviews.

11. Incentives to be provided to participants:
Incentives will be provided to school staff participants in the form of a $25 gift certificate for participating in each of the following
interviews: LGBTQ Inclusivity Toolkit School and District Staff Climate Interview (Attachment 1); and the LGBTQ Inclusivity Toolkit
Post-Pilot Feedback Interview (Attachment 4). Staff members who complete the fall LGBTQ Inclusivity Toolkit Pre-Post School Staff
Survey (Attachment 2) will be entered into a drawing to win a $50 gift certificate. Similarly, staff members who complete the spring
LGBTQ Inclusivity Toolkit Pre-Post School Staff Survey (Attachment 2) will be entered into another drawing to win a $50 gift certificate.
Each district (Charlotte-Mecklenburg Schools and Boone County School District) will have their own separate drawings for gift
certificates for the fall and spring administrations of the LGBTQ Inclusivity Toolkit Pre-Post School Staff Survey (Attachment 2).

12. Plans for data collection and analysis:
Data from the LGBTQ Inclusivity Toolkit Pre-Post Staff Survey (Attachment 2) will be collected through SurveyMonkey. The primary
goal of the staff survey is to assess school staff perceptions and experiences of the school climate. In-depth staff interviews will be
conducted in-person or virtually (e.g., Microsoft Teams, Zoom) with the primary goal of understanding the school climate and, for
those who used the toolkit, to obtain staff feedback on toolkit implementation (see LGBTQ Inclusivity Toolkit School and District
Staff Climate Interview (Attachment 1). The interviews will employ open-ended prompts and tailored probes to capture participant
perceptions and experiences related to LGBTQ inclusivity. The data will be analyzed in the following ways: 1) examining items
descriptively from the staff survey, and 2) thematic content analysis of interview transcripts to identify salient themes.

13. Confidentiality protections:
ICF will ensure confidentiality of all information collected, including written feedback, interview audio recordings and notes, and
transcriptions on secure, firewall-protected equipment and networks. Any written documentation will be stored in a secured
location until scanned and saved to secure, firewall-protected equipment and networks; at which time documentation will be
shredded by confidential shredding services. Written feedback on study instruments in addition to information gathered through
interviews does not aim to evaluate individual responses. As such, no sensitive or personal information will be collected in
survey or interview responses. Staff contact information (name, e-mail) will only be used for study communications (e.g.,
recruitment) and will not be linked to survey or interview data. Findings shared in final reports from ICF to CDC/DASH will be
de-identified.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
The following steps will be taken to minimize the risk of breach of privacy during the study:
Participants' names and business emails will be used for communication and incentive purposes
only. This information will be kept separate from all written/electronic survey data, interview
audio-recordings, notes and transcripts, and final report documentation. No sensitive or personal
information from participants will be displayed on written or electronic surveys collected and the
study team will not share participant information with CDC/DASH.
15. Projected time frame for the project:
School/district review of study instruments and materials; and administration of in-depth staff
interviews, and staff surveys will be completed between May-August 2022. During the
2022-2023 academic year (August-June) toolkit implementation will take place in select high
schools. Data analysis, revisions to study instruments and the LGBTQ Inclusivity Toolkit, and
final report documentation will be completed by the study team between September
2023-September 2024.
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16. Plans for publication and dissemination of the project findings:
Findings from this study will be disseminated through final report documentation prepared by
ICF. Additional dissemination may occur through presentations at conferences, regionally and
nationally, and through articles published in peer-reviewed journals.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Att 1_LGBTQ Inclusivity Toolkit School and District Staff Climate Interview Guide
Att 2_LGBTQ Inclusivity Toolkit Pre-Post School Staff Survey
Att 3_LGBTQ Inclusivity Toolkit Monthly Report Form
Att 4_LGBTQ Inclusivity Toolkit Post-Pilot Feedback Interview Guide
Att 7_IRB Approval
Att 8_Privacy Impact Assessment
Att 9_Consent-School Staff Survey
Att 10_Consent-District Staff Climate Interview
Att 11_Consent-School Staff Climate Interview
Att 12_ Consent-Post-Pilot Feedback Interview

18. References (to indicate need and rationale for project):
1. Centers for Disease Control and Prevention. (2019). Sexual Risk Behaviors Can Lead to HIV, STDs, & Teen Pregnancy. Retrieved December 22, 2021, from:
https://www.cdc.gov/healthyyouth/sexualbehaviors/index.htm
2. Centers for Disease Control and Prevention (2019). Sexually Transmitted Diseases; Adolescents and Young Adults. Retrieved December 22, 2021, from:
https://www.cdc.gov/std/life-stages-populations/adolescents-youngadults.htm
3. U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2016). Adolescent Health. Retrieved January 7, 2022, from:
http://www.healthypeople.gov/2020/topics-objectives/topic/Adolescent-Health/objectives
4. Centers for Disease Control and Prevention (CDC). 1991-2019 High School Youth Risk Behavior Survey Data. Available at http://yrbs-explorer.services.cdc.gov/. Accessed on November 30,
2021.
5. Kosciw, J. G., Clark, C. M., Truong, N. L., & Zongrone, A. D. (2020). The 2019 National School Climate Survey: The experiences of lesbian, gay, bisexual, transgender, and queer youth in our
nation’s schools. New York: GLSEN.
6. Kann L., et al (2016). Sexual Identity, Sex of Sexual Contacts, and Health-Related Behaviors Among Students in Grades 9-12 – United States and Selected Sites, 2015. MMWR Surveill Summ
2016; 65(9): 1-202.
7. David-Ferdon C., et al (2021). Vital Signs: Prevalence of Multiple Forms of Violence and Increased Health Risk Behaviors and Conditions Among Youths — United States, 2019. MMWR Morb
Mortal Wkly Rep 2021;70:167–173. DOI: http://dx.doi.org/10.15585/mmwr.mm7005a4
8. Robin L, Timpe Z, Suarez N, et al. Local education agency impact on school environments to reduce health risk behaviors and experiences among high school students. J Adol Health. 2021;
S1054-139. https://10.1016/j.jadohealth.2021.08.004.
9. Goldenkoff R. Using focus groups. In: Wholey JS, Hatry HP, Newcomer KE, eds. Handbook of practical program evaluation 2nd ed. San Francisco, CA: Jossey-Bass; 2004; 340-362.
10. Quinn Patton M. Qualitative Research and Evaluation Methods 3rd ed. Thousand Oaks, CA: Sage; 2002.
11. Krueger RA, Casey MA. Focus groups. A practical guide for applied research. Thousand Oaks, CA: Sage; 2009.

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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

X

Branch Chief or Branch Science Officer

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

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Project Title: LGBTQ Inclusivity Toolkit Demonstration Project
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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: LGBTQ Inclusivity Toolkit Demonstration Project

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:

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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: LGBTQ Inclusivity Toolkit Demonstration Project

X

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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