Informed Consent for Clinical Research

Emory University
INTERVENTION

RESEARCH STUDY: HIV/STI Testing and Risks among Two Chinese MSM Cohorts: A Pilot Intervention

PROJECT DIRECTION/PRINCIPAL INVESTIGATOR: Frank Y. Wong, Ph.D. CO-PRINCIPAL

INVESTIGATOR IN CHINA: Na He, MD., PhD

TELEPHONE NUMBERS: Dr. Frank Y. Wong 01 (202) 687-0333 Dr. Na He (021) 54237519

INSTITUTIONS: Emory University (EU) School of Public Health (SPH), Fudan University School of
Public Health, and the National Institutes of Health (NIH)

INTRODUCTION

You are invited to consider participating in this research study. The study is called “HIV/STI Testing and
Risks among Two Chinese MSM Cohorts: A Pilot Intervention”. Please take your time to make your
decision. Discuss it with your family and friends. It is important that you read and understand several
general principles that apply to all who take part in our studies:

(a) Taking part in the study is entirely voluntary;

(b) Personal benefit to you may or may not result from taking part in the study, but knowledge may be gained
from your participation that will benefit others;
(c) You may withdraw from the study at any time without any of the benefits you would have received normally
being limited or taken away.

The purpose and nature of the study, possible benefits, risks, and discomforts, other options, your rights
as a participant, and other information about the study are discussed below. Any new information
discovered, at any time during the research, which might affect your decision to participate or remain in
the study will be provided to you. You are urged to ask any questions you have about this study with the
staff members who explain it to you. You are urged to take whatever time you need to discuss the study
with your physician, hospital personnel and your family and friends. The decision to participate or not is
yours. If you decide to participate, please sign and date where indicated at the end of this form. (Please
note that you do not have to sign using your real name. You may use an alias if you wish.)

The study is being sponsored by the National Institutes of Health (NIH), which is a U.S. government
research institute. The NIH is called the sponsor and the Emory University (EU) School of Public Health
(SPH) and Fudan University School of Public Health are being paid by the NIH to conduct this study.
The researchers in charge of this study are Frank Y. Wong, Ph.D. and Na He, M.D., Ph.D.
WHY IS THE STUDY BEING DONE?
You are being asked to participate in this study because you are a member of the Chinese MSM (men who have sex
with men) community.

You may not participate in this study if any of the following apply to you:

•You are not male

•You are younger than 18 years old
•You are not able to verbal and written consent (in Mandarin)
•You have never had sex with another man
•You currently do not identify yourself as an MSM

The purpose of this study is to learn more about issues such as HIV/STI testing, sexuality, and substance use
among Chinese men who have sex with men.

This research is being done because although researchers know little about HIV and STIs among MSM in China, the
MSM community is now considered to be a high-risk group for HIV infection. This study will be the first systematic,
long-term study of HIV risks, combined with a ‘pilot intervention’, among MSM in China.

Our hope is that information from this study will help in creating effective prevention programs.

HOW MANY PEOPLE WILLTAKE PART IN THE STUDY?

Participants in the study are referred to as subjects.

About 800 subjects will take part in this study. They will be recruited from throughout the Capital Areas of
Chengdu and Hefei.

WHAT IS INVOLVED IN THE STUDY?

The intervention will take place over four consecutive weekends within a month. You will talk and learn about issues
like family obligations, sexuality, communication skills, HIV, STIs, and alcohol and drug abuse.

Please advise the researchers of any medications you are taking. In addition, if you are taking any overthe-counter
drugs or herbal supplements, you should advise the researchers.
HOW LONG WILL I BE IN THE STUDY?
Each of the eight intervention sessions should take about one and a half hours to complete. The sessions will be
held during four consecutive weekends within a month.

WHAT ARE THE RISKS OF THE STUDY?

During the intervention, being asked questions of a very personal nature can cause some people to become very
anxious or uncomfortable. The research staff will keep your information private – they are sworn to not tell others
about your visit and anything you have shared.
For more information about risks and side effects, ask the researcher or contact Dr. Na He at (021) 54237519.

ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY?

You may not directly benefit from participating in this study. Please note that this study is not intended to provide
treatment to you. The information you provide may benefit the population of Chinese gay/bisexual men and/or men
who have sex with men in the prevention of HIV/AIDS.

We cannot promise that you will experience medical benefits from participating in this study. We hope the
information learned from this study will benefit others in the future.
WHAT OTHER OPTIONS ARE THERE?

You may choose to not participate in this study.

WHAT ABOUT CONFIDENTIALITY?

Efforts will be made to protect your research questionnaire and other personal information to the extent allowed by
law. However, we cannot guarantee absolute confidentiality. Research records of study participants are stored and
kept according to legal requirements in China. Copies of these research questionnaires will be transferred to the U.S.
You will not be identified in any reports or publications resulting from this study. Organizations that may request to
inspect and/or copy your research questionnaire for quality assurance and data analysis include groups such as:
•National Institutes of Health (NIH) (in U.S.)
•Food and Drug Administration (U.S.)
•Emory University School of Public Health (U.S.)
•Fudan University School of Public Health (in China)
•Emory University Institutional Review Board (IRB) (U.S.)
•Fudan University IRB (China)
•Other research oversight government agencies (China and U.S.)

Please note that the research records of study participants are stored and kept according to legal requirements in
China. Also, administrative personnel in China who are involved in processing your payment for participation
will be aware of your identity.

DATA SECURITY
Data collected will be identified with an ID number only and will be kept in locked files and password-entry computer
files, separate from any personal contact information. These files will be stored in the offices of the Fudan University
School of Public Health. Duplicates of these files also will be transferred to the offices of the Emory University School of
Public Health.

WHAT ARE THE COSTS?

Taking part in this study may lead to added costs for you or your insurance company. Please ask about any
expected added costs or insurance problems. You or your insurance company will be charged for continuing
medical care and/or hospitalization that are not a part of the study.

POLICY/PROCEDURES FOR RESEARCH RELATED INJURY

The Policy and Procedure for the Sponsor National Institutes of Health are as follows:

In seeking informed consent, the following information concerning research-related injury shall be provided to
each subject: An explanation of whom to contact for answers to pertinent questions about the research and
research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

The Policy and Procedure for Emory University are as follows:

We will make every effort to prevent study-related injuries and illnesses. If you are injured or become ill while
you are in the study and the illness or injury is due to your participation in this study, you will receive necessary
medical care at the usual charge. The costs of this care will be charged to you or to your health insurer. No
funds are available from Emory University, Emory University Hospital, MedStar Research Institute, or their
affiliates, the District of Columbia government or the federal government to repay you or compensate you for a
study related injury or illness.

The Policy and Procedure for Fudan University are as follows:

We will make every effort to prevent study-related injuries and illnesses. This study will be conducted
according to the laws and regulations of the government of the People’s Republic of China and will be strictly
monitored by the Fudan University Institutional Review Board. However, if you are injured or become ill
while in the study and the injury or illness is due to your participation in the study, you will receive the
necessary medical care at the usual charge. The costs of this care will be charged to you. No funds are
available from Fudan University, the Shanghai Municipal Government, or the Central Government to repay or
compensate you for a study-related injury or illness.

PAYMENT FOR PARTICIPATION

You should not expect anyone to pay you for pain, worry, lost income, or non-medical care costs that occur from
taking part in this research study.
WHAT ARE MY RIGHTS AS A PARTICIPANT?

Taking part in this study is voluntary. You may choose to not take part in or leave the study at any time. If you choose to
not take part in or to leave the study, your regular care will not be affected nor will your relations with your physicians,
other personnel and the hospital or university. In addition, you will not lose any of the benefits to which you are entitled.
 We will tell you about new information that may affect your health, welfare, or participation in this study.

A Data Safety and Monitoring Board, an independent group of experts, will be reviewing the data from this research
throughout the study. We will tell you about the new information from this or other studies that may affect your
health, welfare, or willingness to stay in this study.

By signing this form you do not lose any of your legal rights.
NEW FINDINGS
Throughout the study, we will tell you about new information we receive about treatments that may be appropriate
for you, about the experimental treatments under investigation in this study, and any information that may affect
your interest in remaining in the study.

WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?

For questions about the study or a research-related injury, any problems, unexpected physical or psychological
discomforts, or if you think that something unusual or unexpected is happening, call Dr. Na He at (021) 54237519.
Be sure to inform the physician of your participation in this study.

If you have questions about your rights as a research participant, contact the Emory University IRB Office.
Direct your questions to:

Institutional Review Board at:

Address: Emory University Institutional Review Board 1599 Clifton Road, 5th Floor East, Atlanta, Georgia 30322
Telephone: (404) 712-0720

WITHDRAWAL BY INVESTIGATOR, PHYSICIAN, OR SPONSOR

The investigators, physicians or sponsors may stop the study or take you out of the study at any time should they
judge that it is in your best interest to do so, if you experience a study-related injury, if you need additional or
different medication, or if you do not comply with the study plan. They may remove you from the study for various
other administrative and medical reasons. They can do this without your consent.

RESEARCHER’S STATEMENT

I have fully explained this study to the subject. As a representative of this study, I have explained the purpose, the
procedures, the benefits and risks that are involved in this research study. Any questions that have been raised have been
answered to the individual’s satisfaction.
Signature of person obtaining the consent Print Name of Person Date

I, the undersigned, have been informed about this study’s purpose, procedures, possible benefits and risks, and I have
received a copy of this consent. I have been given the opportunity to ask questions before I sign, and I have been told that
I can ask other questions at any time. I voluntarily agree to participate in this study. I am free to withdraw from the study
at any time without need to justify my decision. This withdrawal will not in any way effect my future treatment or medical
management and you will not lose any benefits to which you are otherwise entitled. I agree to cooperate with (name of
principal investigator) and the research staff and to inform them immediately if (I / the patient name) experience any
unexpected or unusual symptoms.

_____________________ _____________________ _________________

Signature of Subject Print Name of Subject Date

CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY version 05/01/2008

Page 6
研究编号: 2004-130项目负责人（PI）: Frank Wong博士和 Gary Simon博士项目名称: 亚洲男
性人群的 HIV检测研究

针对非英语对象的知情同意书范本同意加入本研究

乔治城（Emory）大学

亚洲男性人群的 HIV检测（MATH）研究

我们希望你能参加我们的一项研究。

在您同意之前，研究者必须告诉你(i) 研究的目的、程序和研究的期限； (ii) 试验（尝试）性的程序； (iii)

研究中任何可预见的危险、不适甚至益处； (iv) 任何可能更合适的其它方法和治疗；以及 (v) 研究的保密机
制。

在适当的时候，研究者还必须告诉你 (i) 伤害发生时的任何赔偿和治疗； (ii) 不可预见危险的可能性； (iii)

什么情况之下研究者将终止对您的研究； (iv) 研究对您增加的任何成本； (v) 如果你退出研究会发生什
么； (vi) 影响您继续参与研究与否的结果何时会反馈给您；以及 (vii) 多少人会加入到这个研究中。

如果同意参加，您将会给予一个经过您署名的本文档的复印件和本研究的摘要。

任何时候，您都可以就研究中的任何问题联系 Frank Wong博士（202-687-0333）。

在研究过程中，如果您对您拥有的权利有疑问，或者当你受到伤害不知如何做时，你也可以联系 Gary
Simon博士（202-741-2234）。

您加入本研究完全是自愿的，您将不会因为拒绝参加或退出而受到惩罚或损失利益。

签署本文件即意味着调查员已经口头向您描述了本研究和上面提及的信息，也意味着您自愿同意参加本研
究。

参加者签名日期

证明人签名日期
 Informed Consent for Clinical Research

Emory University
SEMI-STRUCTURED INTERVIEW

RESEARCH STUDY: HIV/STI Testing and Risks among Two Chinese MSM Cohorts: A Pilot Intervention

PROJECT DIRECTION/PRINCIPAL INVESTIGATOR: Frank Y. Wong, Ph.D. CO-PRINCIPAL

INVESTIGATOR IN CHINA: Na He, MD., PhD

TELEPHONE NUMBERS: Dr. Frank Y. Wong 01 (202) 687-0333 Dr. Na He (021) 54237519

INSTITUTIONS: Emory University (EU) School of Public Health (SPH), Fudan University School of
Public Health, and the National Institutes of Health (NIH)

INTRODUCTION

You are invited to consider participating in this research study. The study is called “HIV/STI Testing and
Risks among Two Chinese MSM Cohorts: A Pilot Intervention”. Please take your time to make your
decision. Discuss it with your family and friends. It is important that you read and understand several
general principles that apply to all who take part in our studies:

(a) Taking part in the study is entirely voluntary;

(b) Personal benefit to you may or may not result from taking part in the study, but knowledge may be gained from your
participation that will benefit others;
(c) You may withdraw from the study at any time without any of the benefits you would have received normally being
limited or taken away.

The purpose and nature of the study, possible benefits, risks, and discomforts, other options, your rights
as a participant, and other information about the study are discussed below. Any new information
discovered, at any time during the research, which might affect your decision to participate or remain in
the study will be provided to you. You are urged to ask any questions you have about this study with the
staff members who explain it to you. You are urged to take whatever time you need to discuss the study
with your physician, hospital personnel and your family and friends. The decision to participate or not is
yours. If you decide to participate, please sign and date where indicated at the end of this form. (Please
note that you do not have to sign using your real name. You may use an alias if you wish.)

The study is being sponsored by the National Institutes of Health (NIH), which is a U.S. government
research institute. The NIH is called the sponsor and the Emory University (EU) School of Public Health
(SPH) and Fudan University School of Public Health are being paid by the NIH to conduct this study.
The researchers in charge of this study are Frank Y. Wong, Ph.D. and Na He, M.D., Ph.D.
WHY IS THE STUDY BEING DONE?

You are being asked to participate in this study because you are a member of the Chinese MSM (men who have sex
with men) community.

You may not participate in this study if any of the following apply to you:

•You are not male

•You are younger than 18 years old
•You are not able to verbal and written consent (in Mandarin)
•You have never had sex with another man
•You currently do not identify yourself as an MSM

The purpose of this study is to learn more about issues such as HIV/STI testing, sexuality, and substance use
among Chinese men who have sex with men.

This research is being done because although researchers know little about HIV and STIs among MSM in China, the
MSM community is now considered to be a high-risk group for HIV infection. This study will be the first systematic,
long-term study of HIV risks, combined with a ‘pilot intervention’, among MSM in China.

Our hope is that information from this study will help in creating effective prevention programs.

HOW MANY PEOPLE WILLTAKE PART IN THE STUDY?

Participants in the study are referred to as subjects.

About 800 subjects will take part in this study. They will be recruited from throughout the Capital Areas of
Chengdu and Hefei.

WHAT IS INVOLVED IN THE STUDY?

The researchers would like to interview you about issues related to HIV/ STIs, alcohol, drugs, sex, and other matters.
Your answers during the interview will help this study’s researchers design an intervention program that is intended to
help people reduce their chances of being infected with HIV or other STIs.

Please advise the researchers of any medications you are taking. In addition, if you are taking any overthe-counter
drugs or herbal supplements, you should advise the researchers.
HOW LONG WILL I BE IN THE STUDY?

The interview should take about two hours to complete.

WHAT ARE THE RISKS OF THE STUDY?

During the interview, being asked questions of a very personal nature can cause some people to become very anxious
or uncomfortable. The research staff will keep your information private – they are sworn to not tell others about
your visit and anything you have shared.
For more information about risks and side effects, ask the researcher or contact Dr. Na He at (021) 54237519.

ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY?

You may not directly benefit from participating in this study. Please note that this study is not intended to provide
treatment to you. The information you provide may benefit the population of Chinese gay/bisexual men and/or men
who have sex with men in the prevention of HIV/AIDS.

We cannot promise that you will experience medical benefits from participating in this study. We hope the
information learned from this study will benefit others in the future.
WHAT OTHER OPTIONS ARE THERE?

You may choose to not participate in this study.

WHAT ABOUT CONFIDENTIALITY?

Efforts will be made to protect your research questionnaire and other personal information to the extent allowed by
law. However, we cannot guarantee absolute confidentiality. Research records of study participants are stored and
kept according to legal requirements in China. Copies of these research questionnaires will be transferred to the U.S.
You will not be identified in any reports or publications resulting from this study. Organizations that may request to
inspect and/or copy your research questionnaire for quality assurance and data analysis include groups such as:
•National Institutes of Health (NIH) (in U.S.)
•Food and Drug Administration (U.S.)
•Emory University School of Public Health (U.S.)
•Fudan University School of Public Health (in China)
•Emory University Institutional Review Board (IRB) (U.S.)
•Fudan University IRB (China)
•Other research oversight government agencies (China and U.S.)

Please note that the research records of study participants are stored and kept according to legal requirements in
China. Also, administrative personnel in China who are involved in processing your payment for participation
will be aware of your identity.
DATA SECURITY
 Data collected will be identified with an ID number only and will be kept in locked files and password-entry computer
files, separate from any personal contact information. These files will be stored in the offices of the Fudan University
School of Public Health. Duplicates of these files also will be transferred to the offices of the Emory University
School of Public Health.

WHAT ARE THE COSTS?

Taking part in this study may lead to added costs for you or your insurance company. Please ask about any
expected added costs or insurance problems. You or your insurance company will be charged for continuing
medical care and/or hospitalization that are not a part of the study.

POLICY/PROCEDURES FOR RESEARCH RELATED INJURY

The Policy and Procedure for the Sponsor National Institutes of Health are as follows:

In seeking informed consent, the following information concerning research-related injury shall be provided to
each subject: An explanation of whom to contact for answers to pertinent questions about the research and
research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

The Policy and Procedure for Emory University are as follows:

We will make every effort to prevent study-related injuries and illnesses. If you are injured or become ill while
you are in the study and the illness or injury is due to your participation in this study, you will receive necessary
medical care at the usual charge. The costs of this care will be charged to you or to your health insurer. No
funds are available from Emory University, Emory University Hospital, MedStar Research Institute, or their
affiliates, the District of Columbia government or the federal government to repay you or compensate you for a
study related injury or illness.

The Policy and Procedure for Fudan University are as follows:

We will make every effort to prevent study-related injuries and illnesses. This study will be conducted
according to the laws and regulations of the government of the People’s Republic of China and will be strictly
monitored by the Fudan University Institutional Review Board. However, if you are injured or become ill
while in the study and the injury or illness is due to your participation in the study, you will receive the
necessary medical care at the usual charge. The costs of this care will be charged to you. No funds are
available from Fudan University, the Shanghai Municipal Government, or the Central Government to repay or
compensate you for a study-related injury or illness.

PAYMENT FOR PARTICIPATION

You will be paid for participating in this portion of the study. You will receive $40US for finishing the interview
and be reimbursed for local travel expenses. The researchers determined these compensation amounts based on
extensive consultation with community leaders and experience in a prior study.

You should not expect anyone to pay you for pain, worry, lost income, or non-medical care costs that occur from
taking part in this research study.
WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary. You may choose to not take part in or leave the study at any time. If you choose
to not take part in or to leave the study, your regular care will not be affected nor will your relations with your
physicians, other personnel and the hospital or university. In addition, you will not lose any of the benefits to which
you are entitled.

We will tell you about new information that may affect your health, welfare, or participation in this study.

A Data Safety and Monitoring Board, an independent group of experts, will be reviewing the data from this research
throughout the study. We will tell you about the new information from this or other studies that may affect your
health, welfare, or willingness to stay in this study.

By signing this form you do not lose any of your legal rights.
NEW FINDINGS
Throughout the study, we will tell you about new information we receive about treatments that may be appropriate
for you, about the experimental treatments under investigation in this study, and any information that may affect
your interest in remaining in the study.

WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?

For questions about the study or a research-related injury, any problems, unexpected physical or psychological
discomforts, or if you think that something unusual or unexpected is happening, call Dr. Na He at (021) 54237519.
Be sure to inform the physician of your participation in this study.

If you have questions about your rights as a research participant, contact the Emory University IRB Office.
Direct your questions to:

Institutional Review Board at:

Address: Emory University Institutional Review Board Telephone: (404) 712-0720 3900 1599 Clifton Road, 5th
Floor East, Atlanta, Georgia 30322

WITHDRAWAL BY INVESTIGATOR, PHYSICIAN, OR SPONSOR

The investigators, physicians or sponsors may stop the study or take you out of the study at any time should they
judge that it is in your best interest to do so, if you experience a study-related injury, if you need additional or
different medication, or if you do not comply with the study plan. They may remove you from the study for
various other administrative and medical reasons. They can do this without your consent.

RESEARCHER’S STATEMENT
I have fully explained this study to the subject. As a representative of this study, I have explained the purpose, the
procedures, the benefits and risks that are involved in this research study. Any questions that have been raised have been
answered to the individual’s satisfaction.

Signature of person obtaining the consent Print Name of Person Date

I, the undersigned, have been informed about this study’s purpose, procedures, possible benefits and risks, and I have
received a copy of this consent. I have been given the opportunity to ask questions before I sign, and I have been told that
I can ask other questions at any time. I voluntarily agree to participate in this study. I am free to withdraw from the study
at any time without need to justify my decision. This withdrawal will not in any way effect my future treatment or medical
management and you will not lose any benefits to which you are otherwise entitled. I agree to cooperate with (name of
principal investigator) and the research staff and to inform them immediately if (I / the patient name) experience any
unexpected or unusual symptoms.

Signature of Subject Print Name of Subject Date

CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY version 05/01/2008

Page 6
 Informed Consent for Clinical Research

Emory University
SURVEY (Respondent Driven Sampling – RDS)

RESEARCH STUDY: HIV/STI Testing and Risks among Two Chinese MSM Cohorts: A Pilot Intervention

PROJECT DIRECTION/PRINCIPAL INVESTIGATOR: Frank Y. Wong, Ph.D. CO-PRINCIPAL

INVESTIGATOR IN CHINA: Na He, MD., PhD

TELEPHONE NUMBERS: Dr. Frank Y. Wong 01 (202) 687-0333 Dr. Na He (021) 54237519

INSTITUTIONS: Emory University (EU) School of Public Health (SPH), Fudan University School of
Public Health, and the National Institutes of Health (NIH)

INTRODUCTION

You are invited to consider participating in this research study. The study is called “HIV/STI Testing and
Risks among Two Chinese MSM Cohorts: A Pilot Intervention”. Please take your time to make your
decision. Discuss it with your family and friends. It is important that you read and understand several
general principles that apply to all who take part in our studies:

(a) Taking part in the study is entirely voluntary;

(b) Personal benefit to you may or may not result from taking part in the study, but knowledge may be gained from your
participation that will benefit others;
(c) You may withdraw from the study at any time without any of the benefits you would have received normally being
limited or taken away.

The purpose and nature of the study, possible benefits, risks, and discomforts, other options, your rights
as a participant, and other information about the study are discussed below. Any new information
discovered, at any time during the research, which might affect your decision to participate or remain in
the study will be provided to you. You are urged to ask any questions you have about this study with the
staff members who explain it to you. You are urged to take whatever time you need to discuss the study
with your physician, hospital personnel and your family and friends. The decision to participate or not is
yours. If you decide to participate, please sign and date where indicated at the end of this form. (Please
note that you do not have to sign using your real name. You may use an alias if you wish.)

The study is being sponsored by the National Institutes of Health (NIH), which is a U.S. government
research institute. The NIH is called the sponsor and the Emory University (EU) School of Public Health
(SPH) and Fudan University School of Public Health are being paid by the NIH to conduct this study.
The researchers in charge of this study are Frank Y. Wong, Ph.D. and Na He, M.D., Ph.D.
WHY IS THE STUDY BEING DONE?

You are being asked to participate in this study because you are a member of the Chinese MSM (men who have sex
with men) community.

You may not participate in this study if any of the following apply to you:

•You are not male

•You are younger than 18 years old
•You are not able to verbal and written consent (in Mandarin)
•You have never had sex with another man
•You currently do not identify yourself as an MSM

The purpose of this study is to learn more about issues such as HIV/STI testing, sexuality, and substance use
among Chinese men who have sex with men.

This research is being done because although researchers know little about HIV and STIs among MSM in China, the
MSM community is now considered to be a high-risk group for HIV infection. This study will be the first systematic,
long-term study of HIV risks, combined with a ‘pilot intervention’, among MSM in China.

Our hope is that information from this study will help in creating effective prevention programs.

HOW MANY PEOPLE WILLTAKE PART IN THE STUDY?

Participants in the study are referred to as subjects.

About 800 subjects will take part in this study. They will be recruited from throughout the Capital Areas of
Chengdu and Hefei.

WHAT IS INVOLVED IN THE STUDY?

RDS - Now that you have been recruited as a prospective subject for the study, this step will help to confirm your
eligibility and allow you to decide whether to give your informed consent to participate.
If you do give your informed consent, you then will complete a paper-and-pencil survey/questionnaire that will ask
specific questions about your attitudes, beliefs, and behaviors related to alcohol, drugs, sexual risk, and other
activities. The survey will take about one hour to finish. Some of questions will be of very sensitive and personal
nature. They will ask about your use of alcohol and drugs as well as sexual behavior that might put you at risk for
HIV/AIDS. If there are questions that you do not want to answer, you may skip them.
 Once you finish the survey, you will be given information on how to refer people you know or meet into the study.
If you have been recruited into this study by someone else, you must bring their recruitment card in order for them to
receive payment from us for recruiting you. Also, you will be paid by the research staff for recruiting another person
into the study ONLY after the person you referred has undergone a study visit.

You also may be selected randomly to take part in the next stage of the study. Your participation is completely
voluntary and, if you choose to participate you may withdraw at any time.

After finishing the survey, you will be asked if you would like to be tested for HIV and STIs (chlamydia, gonorrhea,
and syphilis) testing. If you agree, we will schedule your tests for a specific time.

Please advise the researchers of any medications you are taking. In addition, if you are taking any overthe-counter
drugs or herbal supplements, you should advise the researchers.

HOW LONG WILL I BE IN THE STUDY?

The survey should take about one hour to complete.

The researcher may decide to take you off this study if it is found to be in your best interest, if funding is stopped,
if HIV/STI testing should be unavailable for some reason, or another circumstance should arise that would
necessitate your being dropped from the study.

At two later times – six months and 12 months after taking the survey – you will be asked to return to take
another survey that asks about similar topics. If you take that survey, you will receive $15US.

You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to
talk to the researcher and your regular doctor first.

WHAT ARE THE RISKS OF THE STUDY?

1Questionnaire: Being asked questions of a very personal nature can cause some people to become very anxious or
uncomfortable. The research staff will keep your information private, unless you test positive for HIV, in which case we
must report your test results to the Shanghai Centers for Disease Control (CDC). They are sworn to not tell others about
your visit and anything you have shared.
2Referrals: It is possible that the individual who referred you into the study may find out that you participated. However,
this would ONLY happen if they gave a recruitment card to you and no one else. They would know you brought the card
in when they check to see if they are entitled to compensation for recruiting another person into the study. However, we
are prohibited by law from revealing to him any of personal information that would identify you.

For more information about risks and side effects, ask the researcher or contact Dr. Na He at (021) 54237519.

ARE THERE ANY BENEFITS TO TAKING PART IN THE STUDY?

 You may not directly benefit from participating in this study. Please note that this study is not intended to provide
treatment to you. The information you provide may benefit the population of Chinese gay/bisexual men and/or men
who have sex with men in the prevention of HIV/AIDS.

We cannot promise that you will experience medical benefits from participating in this study. We hope the
information learned from this study will benefit others in the future.
WHAT OTHER OPTIONS ARE THERE?

You may choose to not participate in this study.

WHAT ABOUT CONFIDENTIALITY?

Efforts will be made to protect your research questionnaire and other personal information to the extent allowed by
law. However, we cannot guarantee absolute confidentiality. Research records of study participants are stored and
kept according to legal requirements in China. Copies of these research questionnaires will be transferred to the U.S.
You will not be identified in any reports or publications resulting from this study. Organizations that may request to
inspect and/or copy your research questionnaire for quality assurance and data analysis include groups such as:
•National Institutes of Health (NIH) (in U.S.)
•Food and Drug Administration (U.S.)
•Emory University School of Public Health (U.S.)
•Fudan University School of Public Health (in China)
•Emory University Institutional Review Board (IRB) (U.S.)
•Fudan University IRB (China)
•Other research oversight government agencies (China and U.S.)

Please note that the research records of study participants are stored and kept according to legal requirements in
China. Also, administrative personnel in China who are involved in processing your payment for participation
will be aware of your identity.
DATA SECURITY
Data collected will be identified with an ID number only and will be kept in locked files and password-entry computer
files, separate from any personal contact information. These files will be stored in the offices of the Fudan University
School of Public Health. Duplicates of these files also will be transferred to the offices of the Emory University
School of Public Health.

WHAT ARE THE COSTS?

Taking part in this study may lead to added costs for you or your insurance company. Please ask about any
expected added costs or insurance problems. You or your insurance company will be charged for continuing
medical care and/or hospitalization that are not a part of the study.

POLICY/PROCEDURES FOR RESEARCH RELATED INJURY The Policy and Procedure for the Sponsor
National Institutes of Health are as follows:
 In seeking informed consent, the following information concerning research-related injury shall be provided to
each subject: An explanation of whom to contact for answers to pertinent questions about the research and
research subjects' rights, and whom to contact in the event of a research-related injury to the subject.

The Policy and Procedure for Emory University are as follows:

We will make every effort to prevent study-related injuries and illnesses. If you are injured or become ill while
you are in the study and the illness or injury is due to your participation in this study, you will receive necessary
medical care at the usual charge. The costs of this care will be charged to you or to your health insurer. No
funds are available from Emory University, Emory University Hospital, MedStar Research Institute, or their
affiliates, the District of Columbia government or the federal government to repay you or compensate you for a
study related injury or illness.

The Policy and Procedure for Fudan University are as follows:

We will make every effort to prevent study-related injuries and illnesses. This study will be conducted
according to the laws and regulations of the government of the People’s Republic of China and will be strictly
monitored by the Fudan University Institutional Review Board. However, if you are injured or become ill
while in the study and the injury or illness is due to your participation in the study, you will receive the
necessary medical care at the usual charge. The costs of this care will be charged to you. No funds are
available from Fudan University, the Shanghai Municipal Government, or the Central Government to repay or
compensate you for a study-related injury or illness.

PAYMENT FOR PARTICIPATION

You will be paid for participating in this portion of the study. You will receive $40US for finishing the survey and
will be reimbursed for local travel expenses. The researchers determined these compensation amounts based on
extensive consultation with community leaders and experience in a prior study.

If you continue to take part in this study, you will be compensated again. After six months and 12 months, you will be
asked to take another survey that asks about similar topics. If you take that survey, you will receive another $15US
each time.

You also will be paid $15 for each people you recruit in the study (up to three people).

You should not expect anyone to pay you for pain, worry, lost income, or non-medical care costs that occur from
taking part in this research study.
WHAT ARE MY RIGHTS AS A PARTICIPANT?
Taking part in this study is voluntary. You may choose to not take part in or leave the study at any time. If you choose
to not take part in or to leave the study, your regular care will not be affected nor will your relations with your
physicians, other personnel and the hospital or university. In addition, you will not lose any of the benefits to which
you are entitled.

We will tell you about new information that may affect your health, welfare, or participation in this study.
 A Data Safety and Monitoring Board, an independent group of experts, will be reviewing the data from this research
throughout the study. We will tell you about the new information from this or other studies that may affect your
health, welfare, or willingness to stay in this study.

By signing this form you do not lose any of your legal rights.
NEW FINDINGS
Throughout the study, we will tell you about new information we receive about treatments that may be appropriate
for you, about the experimental treatments under investigation in this study, and any information that may affect
your interest in remaining in the study.

WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?

For questions about the study or a research-related injury, any problems, unexpected physical or psychological
discomforts, or if you think that something unusual or unexpected is happening, call Dr. Na He at (021) 54237519.
Be sure to inform the physician of your participation in this study.

If you have questions about your rights as a research participant, contact the Emory University IRB Office.
Direct your questions to:

Institutional Review Board at:

Address: Emory University Institutional Review Board Telephone: (404) 712-0720 3900 1599 Clifton Road, 5th
Floor East, Atlanta, Georgia 30322

WITHDRAWAL BY INVESTIGATOR, PHYSICIAN, OR SPONSOR

The investigators, physicians or sponsors may stop the study or take you out of the study at any time should they
judge that it is in your best interest to do so, if you experience a study-related injury, if you need additional or
different medication, or if you do not comply with the study plan. They may remove you from the study for various
other administrative and medical reasons. They can do this without your consent.

RESEARCHER’S STATEMENT

I have fully explained this study to the subject. As a representative of this study, I have explained the purpose, the
procedures, the benefits and risks that are involved in this research study. Any questions that have been raised have
been answered to the individual’s satisfaction.

Signature of person obtaining the consent Print Name of Person Date

CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY version 05/01/2008

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I, the undersigned, have been informed about this study’s purpose, procedures, possible benefits and risks, and I have
received a copy of this consent. I have been given the opportunity to ask questions before I sign, and I have been told that
I can ask other questions at any time. I voluntarily agree to participate in this study. I am free to withdraw from the study
at any time without need to justify my decision. This withdrawal will not in any way effect my future treatment or medical
management and you will not lose any benefits to which you are otherwise entitled. I agree to cooperate with (name of
principal investigator) and the research staff and to inform them immediately if (I / the patient name) experience any
unexpected or unusual symptoms.

Signature of Subject Print Name of Subject Date

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