2 HIV Questionaire Informed Consent

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0925-0596. The time required to complete this information collection is estimated to average 2 minutes per response, including the time to review instructions, search existing data sources, gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0596). Do not return the completed form to this address.

OMB Number: 0925-0596

OMB Expiration Date: XX/XX/XXX

Consent form for the follow-up protocol for:

RECIPIENT EPIDEMIOLOGY AND DONOR EVALUATION STUDY-III (REDS-III)

HIV RISK FACTOR STUDY

The authority to collect this information is under 42 USC National Heart, Lung, and Blood Institute (NHLBI) – 42 USC 285b.

RETROVIRUS EPIDEMIOLOGY DONOR STUDY-III (REDS-III)

HIV RISK FACTOR QUESTIONNAIRE

You are being asked to take part in a research survey which is jointly conducted by __________ Blood Center, Institute of Blood Transfusion (of Chinese Academy of Medical Sciences), the Johns Hopkins School of Medicine and the United States National Institute of Health. The objective of this survey is to learn about the risk factors for HIV infection among blood donors. Results from this survey will be used to design more effective mechanisms to further improve blood safety.

Information provided by our volunteer blood donors is very valuable in further improving blood safety. We appreciate your participation in the questionnaire study. We would like to ask you some questions about your health and lifestyle. It will take about 20 minutes to complete these questions. In order to protect your confidentiality, your name and other personal identifiable information will not be asked. You are assigned a study number. Your answers will be identified by your study number, not by any of your personal information. All of the data sent to and analyzed by RTI International, the REDS-III U.S.-based Coordinating Center, will not contain any of your identifying information. Protecting donors’ privacy is a very important goal of our work.

This study protocol has been reviewed and approved by research ethic committees at Chinese Academy of Medical Science, Johns Hopkins School of Medicine, and RTI International. OMB CONTROL NUMBER:____________；Expiration Date:___________。

Your participation is voluntary. You have the right to not answer any question or withdraw at any time. But we would like you to be as complete and truthful as possible for those questions you do answer. After you finish the questionnaire, please mail it directly to us using the enclosed pre-addressed, postage-paid return envelope. To protect your privacy, please do not write down your name on the questionnaire or the envelope. Instead of filling this form, you may also complete this survey online at our website: __________(to be provided).

Please be aware that the questionnaire is only used for the purpose of identifying risk factors for HIV, and not for any other purposes, such as disease diagnosis. This survey includes donors who may or may not have abnormal results from donor testing. The CDC office is responsible for notifying you if you have an abnormal test result. In this case, please follow CDC office’s advice for further follow-up.

Thank you for taking the time to help us with this important study. Please accept the RMB 100 as a token of our gratitude for your effort after completion of the survey. If you have any question about the study, please call your blood center at _______________. Thanks for your contribution to blood safety.

Date: __ __/__ __/__ __ __ __ (D D/ M M / Y Y Y Y)

Study identification number: __ - __ __ __ __ __ __ __ - __