CDC Research Project Determination Form

Att 6b. CDC HumanSubject Project Determination_2017.10.06.pdf

Formative Research and Tool Development

CDC Research Project Determination Form

OMB: 0920-0840

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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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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 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: Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)
NCHHSTP Project Number:

Division: DASH

Project Location/Country(ies):
United States

Telephone: (404) 718-8170

CDC Project Officer or CDC Co-Leads:

Richard Dunville

Project Dates:
Start 01/01/2017
End 12/31/2018
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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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:*
The Fenway Institute
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Supported institution/entity FWA Number:* 145
FWA expiration date:* 11/07/2021
Expiration date of IRB approval:* 10/04/2018
*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 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: Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)

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:
Richard Dunville and Catherine Rasberry, NCCHSTP/Division of Adolescent and School
Heath/Research Application and Evaluation Branch

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

Richard Dunville (Technical Lead) and Catherine Rasberry (COR), NCCHSTP/Division of
Adolescent and School Heath/Research Application and Evaluation Branch

3. Other CDC project members, branches, divisions, and other participating institutions, partners, and
staff:
Christopher Harper and Michelle Johns, NCCHSTP/Division of Adolescent and School
Heath/Research Application and Evaluation Branch

4. Institution(s) or other entity(ies) funding the project:
Funded through Minority AIDS Initiative

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5. Project goals:

The primary goal of this project is to conduct online and in-person focus groups with the least
studied segment of the MSM population - adolescent MSM 13 to 18 years old - as well as
transgender youth ages 13 to 24 years old. We also plan to ensure sufficient representation of
the full age range and ample representation of Black and Latino/a youth to inform prevention
efforts and produce evidence-based tools and guidance that work in this population.
6. Project objectives:
The primary objectives of this project are
-- Conduct 2 in-person focus groups with adolescent MSM ages 14-17, 2 online focus groups with adolescent MSM ages 13-18, and 2
online focus groups with transgender youth ages 13-24. The focus groups will explore fundamental aspects of sexual identity, gender
identity, sexual behavior, protective factors, and acceptability of HIV prevention strategies.
--Analyze youth focus group data from online and in-person groups.
--Translate research findings into tools and guidance for a variety of public health practitioner audiences that will support the implementation
of feasible and scalable public health strategies to increase HIV prevention among Black and Latino/a AMSM and transgender youth.

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

This project will translate the survey results into tools and guidance that a variety of public health
practitioners working in different settings can use to engage adolescent MSM and transgender
youth in HIV prevention interventions.

8. Population(s) or groups to be included:
Adolescents ages 13-18 who were born male and are attracted to males; transgender youth
ages 13-24

9. Project methods:
This project involves online and in-person focus groups. The focus group facilitator will follow a semi-structured focus group guide. Separate focus group guides have been created for the AMSM and transgender youth focus groups. Each focus group will be conducted with 8-12
individuals. Online focus groups will be conducted using an asynchronous bulletin board method of data capture consisting of 2 postings (morning and evening) of question sets over a 3 day period (6 postings, each taking approximately 30 minutes for a total of 3 hours).
IN-PERSON:
Staff at focus group sites will assist in recruitment of focus group participants at their respective sites. Study staff will screen potential participants using the screening tool. If they are eligible to participate, they will then be signed up for the focus groups and their contact
information will be collected. On the day of the focus group, participants will arrive at the site of the group which will take place in a private room in a public space. Study staff will then have participants complete the consent process using the information sheet and they will be asked to
complete a background survey. The focus group will then take place and will be recorded and later transcribed. Audio files from the focus group will be kept on a locked computer belonging to a member of the study staff at The Fenway Institute (TFI). The in-person focus groups are
confidential because information can be linked to screening information, the background survey, and focus group transcripts but are only seen by study staff and kept in a secure location.
ONLINE
The online focus groups will be conducted on a secure web based portal owned and operated by InsideHeads®. This research company facilitates qualitative online focus groups and owns and operates the focus group platform. They will obtain the participant contact information, provide
technologic support, and the procedural instructions for how to “attend” the online discussions (date/time/etc.). This company will also handle all compensation for participation. InsideHeads® does not have access to the actual focus group discussions. This way when the participant links to
the PI’s secure account on the focus group platform only the researcher will have access to the focus group data. The online focus groups are conducted in a secure virtual focus group web platform (similar to an online classroom). The virtual focus group web page is password protected
by the study staff and totally anonymous for participants. Participants will only use a pseudonym (screen name), ensuring forced anonymity. Each online focus group will be facilitated by a moderator. Moderators will be study staff and/or consultants trained in Human Subjects Protectio
(HSP). Focus groups will take place over the course of three days. Question sets of 4-10 prompts will be posted by moderators twice a day (morning and evening), and participants will be given time to respond to each question set. Participants will be able to see and access all question and
response threads, and are able to reply to other participants’ responses and comment. Moderators will monitor the discussion boards at all times during the three days and send probe questions when necessary to elicit clarification of participant responses. Should participants attempt to
share identifying information with each other (i.e., location, phone number), moderators will intervene. Moderators are also able to send participants private messages (“back channel”) to ask for clarification of a response or to remind participants to respond to a question set. Participants
have the option to not respond to any prompt they do not wish to answer. At the conclusion of the online focus group, all discussion board chat content will be downloaded and saved to a secure, password protected file that will only be accessible to authorized study staff.
IP addresses will not be collected as part of this study. To protect the participant’s confidentiality, transcripts will be cleaned to remove any names or otherwise identifying information. The focus group transcript will be kept in a password protected electronic folder on the Fenway secured
server and will only be accessible to authorized study staff. Participants will be made aware that the information provided may be used in future reports, but any identifying information will not be included. Focus group transcripts will be analyzed using traditional content analysis techniques.

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10. Selection, inclusion, or sampling of participants (persons or entities):
In-person Focus Groups
For in-person focus groups, we plan to collaborate with our partner organizations to recruit participants. We will utilize recruitment ads to post in the partner organization, on the social media accounts (Facebook,
Instagram, Twitter) of partner organizations, and to be handed out at
public events. The recruitment ads have been developed in partnership with our youth community advisory board (YCAB) to make culturally competent images that are attractive to youth.
Online Focus Groups
For online focus groups, we will use similar recruitment ads (attached). InsideHeads, the online focus group platform, also provides recruitment services. InsideHeads® is a marketing research company with over 17
years of experience recruiting participant panels and supporting platforms for online research. Potential participants recruited by InsideHeads®, from their panel of more than 100,000 consumers, will be directed to a
web page that explains the study purpose and
procedures, and provides the electronic information sheet. Those consenting will be directed to complete a brief demographic survey and then given procedural instructions of how to “attend”
the online focus group (e.g. date, time, login instructions). During the designated days/times the online discussion will begin in a discussion board format, and be moderated by the study staff.

11. Incentives to be provided to participants:

Participants will be compensated up to $30 for their participation in the online focus group, $10
for each day of participation up to 3 days. The in-person focus group will take place over 2 hours
and participants will be compensated with $50 for their participation. Participants will receive this
payment at the conclusion of the focus group either immediately for in-person groups or by email
within 2 business days for online groups.
12. Plans for data collection and analysis:

We will collect data from the screener, background survey, and transcripts of the focus groups.
Upon completion of the focus groups, analysis will be conducted by CDC and TFI and will be
used to develop peer reviewed publications and the sets of tools and guidance for HIV
prevention.

13. Confidentiality protections:
To reduce the risk that data could be unintentionally disclosed to unauthorized persons, all contact information for the study participants will be kept in a password protected location, with access restricted to study staff, and will not be connected to any data. Data will also be stored in a
physically secure environment, and all data files will have encryption and strong password protection. Only study staff members who require access to identifying data to complete their study-related roles will be allowed access. All members of the research team are trained in human
subjects’ protections, confidentiality, and all essential elements of the informed consent, assent and study procedures. From our experiences, these methods have proven to be effective to ensure the privacy and confidentiality of the study subjects. Responses in online focus groups will be
recorded anonymously. The names and contact information of participants will not be collected. Survey responses will remain anonymous and will not be linked to individual participant’s names or contact information at any point during the study. TFI will maintain all study documentation for
at least five years after the completion of the study.
We will also develop procedures to minimize indirect disclosure that a participant is participating in an HIV-related research study. For each mode of contact information, we will ask specifically whether anyone else potentially has access to that mode of communication, and if it is acceptable
to leave a non-specific message (e.g., general appointment reminder) about participation in a health study. No study-related messages will ever mention HIV or the nature of this research study.
The researchers and project staff will keep personal information and protected health information (PHI) confidential. All study data will be identified by participant unique ID only. To the extent allowed by law, no individual information will be released to anyone outside the study. All results
from the study will be described in such a way that no individual can be identified. Only study staff will have access to the password-protected, encrypted files including participant contact information – which will only be used for scheduling the focus groups as there will be no follow up
conducted. We will obtain verbal informed consents, which will include HIPAA authorization.
Although we will make every effort to protect participants’ privacy, complete privacy cannot be absolutely guaranteed because multiple people are participating in the study together. We have taken steps to minimize the chance of a breach of confidentiality happening. The consent form
states that focus group facilitators will ask participants to keep everything private that was discussed in the group. In addition, the facilitator will emphasize that all information about other participants should not be shared outside of the group, and will highlight this point during the
informed consent process and both at the beginning and end of the group. Further, it will be emphasized with participants during the consenting procedure and in the group to not reveal personal identifiers or discuss other identifying information about third parties (e.g., partners of
other people in their group) both in and outside of the group. In addition, during qualitative data collection, participants and the facilitator are asked to only use first name of choice when referring to participants during discussions. Individuals are also instructed that they do not have to share
personal information with which they are uncomfortable sharing, consistent with the nature of voluntary involvement.

14. Other ethics concerns (e.g., incentives, risks, privacy, or security):
We believe risks to the participants to be minimal:
There is no physical risk to participate. Consent will be obtained and will review the potential risks for participation. For participants under the age of 18, we will be using assent forms and parental consent will not be required. The online focus group format is completely anonymous and
maintains confidentiality; all participants are unaware of the identity of any other participant and have no way to identify others in the group. Potential risk may include experienced distress over questions related to sensitive topics.
If an online participant experiences distress during participation in the focus group, Holly Fontenot, a nurse/researchers and a member of the study team, will be present during the group and will be available to directly communicate with the participant. The InsideHeads platform
allows for a backroom chat between Holly and the participant, so that she can assess the needs of the participant. Holly Fontenot will also be available over the phone if necessary. Additionally, participants will be provided with contact information for the Trevor Lifeline, run by the Trevor
Project (1-866-488-7386). Participants can call this toll-free, confidential line that is available 24/7 if they are experiencing distress. Participants will be provided with this information during the consent process (see ICF). Additionally, the participant will be informed of our procedure for
reporting abuse if they disclose that information during the focus group. This procedure will also be detailed in the ICF.
Emotional Discomfort: Questions posed during the focus groups and quantitative assessment (such as sexual behavior, dating, relationships, and HIV prevention) may make some participants embarrassed or uncomfortable. Participants are told they can always
refuse to answer any questions, or share any information, or interrupt or stop the conversation at any moment (in participating in focus group).
Participants in focus groups experiencing significant distress or requesting services will be assisted immediately by the project staff and referred to the appropriate supportive services, as needed. It is unlikely that participants will be at any risk of physical harm as a result of study
participation. Participants will be informed that staff may report some behaviors (threats to self or others) to trained medical staff or, in certain cases, local authorities (hospital, police, or social services).
Social Harms: We will make every effort to protect participant confidentiality during the study. However, it is possible that others might learn of their participation and make them feel badly for being involved in this study. For example, if family, friends, or others learn that they are in this
study, they may react negatively or discriminate against them. If participants haven’t told these people that they are transgender or are men attracted to other men, they might find that out. Participants are asked to only talk about this study with people they feel comfortable with.
Privacy and Confidentiality: There is a risk that data could be seen by an unauthorized person. Risks to confidentiality also exist through disclosure of high risk behaviors. As in any study, there is a risk that these data could be unintentionally disclosed to someone not authorized to access
the data, compromising the privacy of the participant.
Participants in the focus group face risk of embarrassment or loss of privacy. The researchers will ask participants in the group to use only the name or pseudonym they decide to use during the group session. They are free to refuse to share personal and sexual information about
themselves during the group sessions and may terminate participation in the group sessions or the study at any time. Facilitators will also ask participants not to tell anyone outside the group what any particular person said in the group. However, the researchers cannot guarantee that
everyone will keep the discussions private.

15. Projected time frame for the project:

January 1, 2017-December 31, 2018 (includes time for focus groups, data analysis, and tool
development).

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16. Plans for publication and dissemination of the project findings:
Findings from the study will be presented at conferences and published in peer-reviewed
journals with the approval of CDC DASH COR.

17. Appendices — including informed consent documents, scripts, data collection instruments, focus
group guides, fact sheets, or brochures:
Appendix A--New Project Application
Appendix B--Protocol Summary
Appendix C--Full Protocol
Appendix D--Informed Consent (In-Person Focus Groups)
Appendix E--Informed Consent (Online Focus Groups)
Appendix F--Waiver Informed Consent
Appendix G--Waiver Parental Permission
Appendix H--Waiver HIPAA Authorization
Appendix I--Recruitment Language
Appendix J--Focus Group Recruitment Ads
Appendix K--AMSM Focus Group Guide
Appendix L--Transgender Youth Focus Group Guide
Appendix M--Screener (In-Person Focus Groups)
Appendix N--Screener (Online Focus Groups)
Appendix O--Background Survey
Appendix P--Procedure for Reporting Child Abuse
Appendix Q--The Fenway Institute IRB Approval letter

18. References (to indicate need and rationale for project):

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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

Lisa Barrios -S

Digitally signed by Lisa Barrios -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Lisa Barrios -S,
0.9.2342.19200300.100.1.1=1000764687
Date: 2016.10.11 13:36:07 -04'00'

Branch Chief or Branch Science Officer

X

Stephen
Banspach -S

Digitally signed by Stephen Banspach -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001274135,
cn=Stephen Banspach -S
Date: 2016.10.12 13:29:08 -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

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NCHHSTP ADS/DEPUTY ADS OR ADLS REVIEW AND APPROVAL
Project Title: Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)

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: Developing Tools to Engage Adolescent Men Who Have Sex with Men (AMSM)

X

Janella
Dodson

Digitally signed by Janella Dodson
DN: cn=Janella Dodson,
o=NCHHSTP, ou=OADS,
[email protected], c=US
Date: 2016.10.19 15:46:14 -04'00'

X

NCHHSTP ADS, Acting ADS, or Deputy ADS

NCHHSTP ADLS or Designee

Or

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File Typeapplication/pdf
File TitleNCHHSTP-Determination-Applicability-Human-Subjects-Regulations
SubjectCDC, Centers for Disease Control and Prevention, Coordinating Center for Infectious Diseases, CCID, ADS, Associate Director for
AuthorHHS/CDC/NCHHSTP
File Modified2017-10-06
File Created2016-01-07

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