Attachment 13 - CDC IRB Approved Protocal Chapter Requesting Parental Waiver

2. DESIGN
The pilot study is designed as an implementation of an anonymous, cross-sectional survey of HIVrelated behaviors and prevention experiences, using ACASI software. The pilot will be conducted in
a consistent fashion in four different MSA. This design will afford the opportunity to compare and
contrast the performance of the sampling plan, the recruitment strategy, interviewer training, and
questionnaire administration across the four locations. The experience of the pilot will help in the
development of methods and instruments for a larger scale surveillance effort among transgender
persons. The pilot data will also be useful locally for understanding the spread of current HIV
prevention efforts among the transgender participants.

Stakeholder Participation
Stakeholders in THBS cover a wide gamut of health professionals, program administrators, social
service providers, health risk behavior researchers, and individuals living in transgender
communities, and will be found at the national, state and local levels. Local stakeholders in THBS
include: the state or local health department, community-based organizations that provide HIV
prevention services to transgender persons, the HIV community planning group, transgender service
organizations, and the transgender populations.
Opportunities for stakeholder participation have been built into all stages of the THBS pilot study development, implementation, and dissemination. During the development stages, CDC held a
meeting of researchers who had conducted similar behavioral surveys among transgender
populations. At this meeting, strategies for asking about sexual behaviors, gender identity, and
sampling of transgender persons were discussed. Recommendations from this meeting were
considered while creating the protocol and questionnaire for this pilot. In addition to this meeting,
CDC also consulted with researchers who were unable to attend the meeting. Prior to
implementation, CDC will conduct cognitive interviews and focus groups among minority male-tofemale transgender persons to get their input on the questionnaire. In addition, in order to apply for
funding to conduct THBS, the four project areas will need to seek input on implementing the survey
from their local transgender communities. During implementation, the THBS staff will collect
information from transgender participants. Given that the interview will be conducted in ACASI
format, a series of questions at the conclusion of the interview will provide respondent feedback on
the instrument. These findings, along with others, will be summarized in a final report about THBS
at the conclusion of data collection.
Dissemination of THBS findings will engage a broad audience as well. Each project area is
expected to share local THBS findings with their local stakeholders. The data should be shared with
local stakeholders in a forum that allows feedback on the project. CDC will be responsible for
overseeing reporting of multi-site data to its stakeholders and to the general public.
The input received during each stage: development, implementation, and dissemination will be used
to refine future protocols and questionnaires used to collect HIV-related behavioral data from
transgender populations. In addition, findings and lessons learned from conducting the THBS pilot
will be incorporated as appropriate into similar behavioral surveys conducted by CDC.

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Survey time line
Implementation of the activities described in this protocol is planned for the Fall of 2008. Prior to
implementation, project sites will submit protocols to their local IRB. Data collection will not be
performed until local IRB has been approved. Initial THBS results are expected in the Spring of
2009.

Potential Risks and Anticipated Benefits
Participation in THBS presents no more risks to respondents than that which might occur outside of
the context of surveillance. These non-surveillance contexts include participation in individual or
group HIV prevention activities, and interactions with HIV prevention and health-care providers in
public or clinical settings. Similar to these contexts, participating in THBS might cause discomfort
to those participants whose risks for HIV/STD infection are not fully recognized. Although privacy
will be protected to the greatest extent possible, some acquaintances may recognize respondents who
enter field site location and choose to participate.
Participants may benefit from participating in the THBS survey by better recognizing their own risks
for HIV infection, speaking to trained staff about how to reduce those risks, learning more about
local HIV prevention efforts, and obtaining prevention materials and referrals for health care, drug
treatment, or HIV/STD testing and prevention services. Participating in THBS also benefits
communities by helping prevention planners to better direct state and local HIV prevention efforts.

Voluntary Participation
Participation in THBS is completely voluntary. Participants can refuse to participate in the THBS
survey. Once participants have started the survey, they can refuse to answer any question or end the
survey at any time without penalty.

Anonymity and Privacy Protections
As a component of HIV/AIDS surveillance, THBS data at CDC are protected by the Assurance of
Confidentiality (Section 308(d) of the Public Health Service Act, 42 U.S.C. 242 m(d)). This
assurance prohibits the disclosure of any information that could be used to directly or indirectly
identify individuals. A copy of the Assurance of Confidentiality for HIV/AIDS Surveillance Data is
provided in Appendix A.
In accordance with the Assurance of Confidentiality requirements, each project area will adhere to
the existing standards of its pertinent State or local health department for protecting the security and
confidentiality of HIV/AIDS surveillance data to THBS data, because these are approved by the
Overall Responsible Party (ORP) at the health department. They may need to write a data security
policy based upon these local guidelines for the THBS staff to follow. For guidance on developing
data security policies for HIV surveillance data, they will consult the Technical Guidance for
HIV/AIDS Surveillance Programs, Volume III: Security and Confidentiality Guidelines (available
online at http://www.cdc.gov/hiv/topics/surveillance/resources/guidelines/guidance/ ). This
document establishes the minimum data security standards for protecting HIV/AIDS surveillance
data.
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The written policy developed by the THBS project area should describe:
• Standard operating procedures and policies for maintaining the security of THBS data,
•

Data release policy describing the provisions for protecting against access to raw data or data
tables containing small-denominator populations that could be indirectly identifying, and

•

Evaluation of the data security measures outlined in the document.

Anonymity protections
Participation in THBS is anonymous. Participants will not be required to provide their names or
other personal identifiers as a condition for participation. Instead, potential participants will be
assigned an anonymous survey number which can be used to link recruitment and survey data. No
personal identifiers will be on any survey forms. The CDC protocol does not require participants to
sign consent forms. If a local IRB requires consent forms to be signed, the forms will not have a
Survey ID number that could be linked to survey responses. If participants voluntarily disclose their
names or personal identifiers, these will not be maintained by THBS project staff nor linked with
any survey data.
Privacy protections
THBS staff will always conduct surveillance activities using procedures to protect the privacy of
participants. All federal, state, and local staff will adhere to the ethical principles and standards by
respecting and protecting, to the maximum extent possible, the privacy, confidentiality, and
autonomy of participants.
Paper copies of THBS consent forms or other forms will be stored in locked filing cabinets that are
maintained in secure office environments with limited and controlled access. Laptop computers used
to administer the CDC-developed interview program will be password protected. Computers and
networks where data will be downloaded and stored will also be password protected. Only
authorized project staff will have access to completed survey data and study files. All project staff
whowill have access to the THBS data must undergo local security and confidentiality training and
must sign a statement of confidentiality.

Institutional Review Board Approval
This protocol is submitted for review by CDC’s Institutional Review Board (IRB). RTI and local
project areas will also follow their procedures for obtaining IRB approval.
Waiver of Documentation of Informed Consent
For this protocol, a waiver of documentation of informed consent is requested from the CDC IRB.
The only record linking the subject and the research would be the consent document and the
principal risk would be the potential harm resulting from a breach of confidentiality. This protocol
presents no more than minimal risk of harm to subjects. Participation involves the completion of an
anonymous self-administered risk behavior questionnaire. The interviewer will document consent by
recording in the laptop computer used for conducting interviews that consent was obtained for the
survey. If local IRB review is required, then local project areas should request a waiver of
documentation of informed consent and allow the use of oral consent (see Appendix B).
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Waiver of Parental Permission for Participants Aged 15 to 17
For this protocol, a waiver of parental permission for participants aged 15 to 17 years is requested
from the CDC IRB. Federal Regulations Title 46, Section 408, Requirements for permission by
parents or guardians and for assent by children, paragraph (c) specifies that “for a subject population
for which parental or guardian permission is not a reasonable requirement to protect the subjects, it
may waive the consent requirements … provided an appropriate mechanism for protecting the
children who will participate as subjects in the research is substituted, and provided that the waiver
is not inconsistent with Federal, state, and local law.”
Requiring transgender youth to obtain parental consent to participate in this survey requires them to
be forthcoming with their parents about their gender. Asking transgender youth to reveal their
gender variance to their parents or guardians may needlessly jeopardize their security, domestic
stability, and welfare. Youth in this age group often are dependent on their parents and guardians for
care, shelter, financial support, and other needs. However, parents of transgender youth may have
difficulty accepting their child’s gender variance (Brown & Rounsley, 1996; Ettner, 1996). As a
result, these youth may experience psychological and physical harm and abandonment if their
parents learn about their public expression of their preferred gender. This may explain why
transgender youth face a dilemma between seeking family support and risking rejection (Kruks,
1991).
In addition, most state and local laws allow persons as young as 15 years to consent to HIV testing
services without parental permission. Routine counseling with HIV testing involves reviewing risk
behaviors like the ones on the THBS survey. Therefore, participating in the THBS survey will pose
no more of a risk than participating in HIV testing services. However, to protect young participants
in THBS, it is recommended that each local project area identify a person who is not affiliated with
the survey to serve as a child advocate; participants younger than 18 years in age should be offered
the option of conferring with this person prior to providing their consent. The local IRB will also
determine whether waiving of parental permission and mechanisms for protecting young participants
is allowable given local law and policies regarding including minors in research.

Staffing Roles and Responsibilities
The following staff are recommended for the THBS pilot. Strong leadership abilities, good
communication skills, and a marked enthusiasm for the project are essential attributes for THBS
pilot staff. Participating THBS project areas are encouraged to tailor these recommendations to meet
their local staffing situation.
Principal Investigator
The principal investigator is expected to provide scientific and administrative oversight to the local
THBS team. This person would be responsible for hiring local THBS staff.
Project Coordinator
A successful Project Coordinator must have considerable knowledge of the local transgender
community, broad knowledge of HIV/AIDS, excellent leadership skills and experience, and attention
to detail. S/he performs all managerial and administrative aspects of THBS. S/he is responsible for
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maintaining all necessary administrative records which will require knowledge of computer
programs such as word processing, spreadsheets, and file management. S/he will be responsible for
using and teaching others to use Coupon Manager, RDS Analysis Software (RDSAT) and
Questionnaire Development System (QDS). The Project Coordinator will develop the local
Institutional Review Board (IRB) application, participate in CDC site visits, train and supervise
THBS staff, serve as the community’s contact person, and coordinate with local stakeholders.
Interviewers
Interviewers will be responsible for screening recruits for eligibility and conducting the interviews.
These individuals should be highly motivated and able and willing to work outside the office and
outside normal business hours, which may include evening and weekend hours. Interviews will be
conducted using ACASI technology; interviewers must be very competent in this regard.
Interviewers will be knowledgeable about HIV/AIDS, familiar with transgender issues, willing to
work with transgender persons, and culturally competent in terms of gender and race/ethnicity. To
the extent possible, interviewers should be representative of the racial and ethnic minority
populations in the MSA. If local transgender communities are small, interviewers from outside the
immediate transgender community will be sought to help ensure that the anonymity of participants is
maintained.

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