Consent - Chinese

Green Housing Study

Appendix F -Consent Form

Household ID # ______________

Green Housing Study

綠色住房研究

RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY AUTHORIZATION FORM

研究對象知情同意書及隱私授權書

Protocol Title: The Green Housing Study

研究名稱：綠色住房研究

IRB Protocol number: CDC IRB # 5587

機構審查委員會研究號：美國疾病控制預防中心研究號#5587

Sponsor: Centers for Disease Control and Prevention (CDC)

負責機構：美國疾病控制預防中心(CDC)

Principal Investigator for Boston Study Site: Gary Adamkiewicz, PhD MPH (Harvard)

首席研究員：Gary Adamkiewicz, PhD MPH 博士(哈佛大學)

Principal Investigator for National Study: Ginger L. Chew, ScD (CDC)

全國項目首席研究員：Ginger L. Chew, ScD 博士(美國疾病控制預防中心)

1. What you should know about this study:

你應該知道的有關該研究的情況：

• You are being asked to join a research study.

• 我們徵求你加入這項研究

• This consent form explains the research study and your part in the study.

• 這個研究對象知情同意書對該項研究和你所參與的研究部分進行解釋

• Please read it carefully and take as much time as you need.

• 請花你所需的時間仔細將其閲讀

• Please ask questions at any time about anything you do not understand. Ask the study team to explain any words or information in this informed consent that you do not understand.

• 如果有你在任何時候有任何不明之処，請提出來。如果你對這個知情同意書中的任何詞語或信息有疑問或不清楚，請讓研究團隊進行解釋

• You are a volunteer. If you join the study, you can change your mind later. You can decide not to take part or you can quit at any time. There will be no penalty or loss of benefits if you decide to quit the study.

• 你是一名志願者。如果你加入進這個研究，你可以改變你的決定。你可以決定在任何一個步驟或時間退出研究。如果你退出研究，你不會受到任何處罰或失去任何收益。

• During the study we will tell you if we learn any new information that might affect whether you wish to continue to be in the study.

• 在研究過程，如果有會影響到你參與研究的新信息，我們會通知你。

• Data collection is authorized under Section 301 of the Public Health Service Act

• 數據收集是根據公共健康服務法第301條授權

2. Why is this research being done? 爲什麽進行這項研究？

Some apartment buildings in your community are undergoing renovations and some homes are not undergoing renovations. This research is being done to see:

你所在社區裏有些公寓將會被翻新，有些不會被翻新。這項研究的目的是：

(1) If levels of chemicals and other agents (such as mold or dust) are different among apartments in your community and among similar homes in other communities, and

(1）如果水平的化學品和其他代理（如模具或灰塵）在您的社區和公寓之間在其他社區類似家庭之間的不同，

(2) If levels of chemicals and other agents (such as mold or dust) are different among apartments in your community and among similar homes in other communities, and

(2）如果水平的化學品和其他代理（如模具或灰塵）在您的社區和公寓之間在其他社區類似家庭之間的不同，

Please note that the renovations are not part of this research study. They would take place whether the research is conducted or not.

請注意公寓的翻新不是由這個研究提供的。這項研究進行與否不囘影響翻新的過程。

How many people will be in this study? We expect to test samples from residents of over 800 apartments across the country. Families with children with asthma (ages 7-12 years) will be invited to enroll. One eligible child from each home can be enrolled in the study. To be eligible, the children (age 7-12 years) must have experienced asthma-related symptoms (wheezing, slow play or night awakening) during the past 6 months and must have been diagnosed with asthma by a doctor at some time in his/her life.

我們預計來自全國各地的800多名公寓居民測試樣品。 （年齡7-12歲）患有哮喘的兒童的家庭將被邀請報名參加。一個符合資格的孩子可以從每個家庭參加了這項研究。兒童（年齡7-12歲）要符合資格，必須有經驗豐富的與哮喘有關的症狀（喘息，慢放或夜間覺醒）在過去6個月，並且必須已與哮喘醫生診斷，在一段時間在他/她的生命。

3. What will happen if you and your child join this study?

如果您和您的孩子參加這項研究中，會發生什麼事？

a. These are things that we will do in your home:

a. 這些都是在家裡做的事情，我們將：

We will measure the air inside your home for chemicals, temperature, and humidity (see examples in the attached brochure). The machines will be put in your child’s bedroom. The machines will run day and night for 5 days. When they run, they make no more noise than a pump in a fish tank. At the end of 5 days we will return to your home to remove the machines; we require that you or a designated adult be present during the pick-up. We will place small membrane badges in your child’s bedroom which detect additional chemicals in your air. We will also measure how air changes in your home. The air change measurement requires releasing a nontoxic chemical in your air and then measuring it with a detection membrane 5 days later. The relative humidity and temperature will be measured with small devices (see examples in the attached brochure) which will stay in your home for the same 5 days as the air change monitor. These devices are silent. We will also collect dust samples from the floor in your home and your bed, and your child’s bed to test for agents in the dust which might affect your child’s health.

All of these measurements will occur at the first visit before any renovation occurs in your apartment, the second visit after any renovation occurs (approximately 1 month after renovation), then 6 and 12 months (please see Table 1. for summary of data collection time points). If you are a control home, all of these measurements will occur at four visits which coincide with the time points for the renovated homes.

Table 1. Summary chart of environmental measurements in homes*家裏環境測量總結表

Type of assessment 測量種類	Start of study 研究開始	1-month follow-up 跟蹤第一個月	6-Month follow-up 跟蹤第六個月	12-Month follow-up 跟蹤第十二個月
Dust 灰塵 (for allergens and pesticides) 過敏原 殺蟲劑				
Air 空氣				
Temperature溫度				
Relative humidity對比適度				
Air change 通風速度				

* Dust sampling will occur in the children’s beds as well as the bed of the mother/primary caregivers. Except for the pesticide measurements in the kitchen, all other measurements will be limited to the child’s bedroom.

*兒童的床和母親/照顧人的床都會被收集粉塵。除殺蟲劑測量是在廚房，其它的測量都將在兒童的臥室進行。

我們將會用環境監測儀器（參見附加小冊子）對空氣和空氣污染進行採樣。監測器將會被放置到你/你小孩的臥室。監測器會不間斷工作5天。儅該儀器運作時，其發出的聲音不會比漁缸或者水族館的打水聲大。第5天結束的時候我們會到你家裏來提取儀器；我們需要你或者一個指定的成年人到時候在場。 我們會在你/你小孩的臥室裏放置用來偵察空氣中化學物的膠片章。同時我們還會在你家裏地上和床上採樣從而對粉塵中可能會影響你/你小孩健康的物質進行檢查。

以上的測量將會在第一次家訪也就是公寓翻新前進行。第二批測量將會在翻新后的一個月，6個月和12個月進行（請參考顯示所有數據收集步驟地圖表）。如果你的公寓被選為比較公寓，所有以上測量都囘在和翻新公寓相應的四次家訪期間進行。

在四次家訪時，我們會測量你家裏的通風情況和市内氣溫及濕度（請參考顯示所有數據收集步驟地圖表）。通風情況的測量需要在你家裏釋放無害的物質然後用偵查膠片在5天后測量其物質。 在同一個五天的時間，一個小型儀器將會用於測量室内氣溫和濕度（請參考顯示所有數據收集步驟地圖表）。這些儀器/測量工具都是無聲的。

2. These are things we will ask you (the mother/primary caregiver of the child) to do:

b.這些都是我們會要求您（母親/兒童的主要照顧者）做

Respond to Health and Home Surveys: During home visits, we will ask you questions about any breathing problems that your child may have. We will also ask questions about your child’s lung health, breathing medication use, and home environmental characteristics.

In addition, we will contact you by telephone (at 3 and 9 months) assess changes in your child’s breathing health. During the months when phone call or home visits are not scheduled, we will send you a series of brief text messages to ask about breathing problems that the child might have had in the past month.

回應保健和家庭調查：我們將會問你或者你小孩的呼吸方面的問題。我們同時也會問及和你小孩整體健康的情況，呼吸方面藥物的使用情況，以及家裏的環境情況。有一些問題是用來決定研究條件是否符合，我們同時也需要考慮可以反饋環境和健康的關係的問題。請參考顯示所有數據收集步驟地圖表。注：我們將會通過電話（在3個月和9個月時）來更新任何有關你的聯係方式以及評估呼吸情況的變化。在沒有電話聯係和沒有家訪的幾個月裏，我們將會通過你簡短的短訊來問你有關小孩在近幾個月的呼吸狀況。

Collect nose and throat swab samples from your child: You will be asked to collect nose and throat swabs from your child (see Figures A and B in the attached brochure) when your child experiences cold/flu symptoms. You will be given swabs and instructions how to collect and store the nose and throat swabs. You will also be asked to fill out a form about the symptoms and healthcare for each of the cold/ flu episodes that occur during the study. You will also be instructed about contacting study coordinator for specimen pick up.

鼻咽拭子標本收集來自您的孩子：你需要在你的還在出現發燒，鼻塞/流鼻涕，咳嗽，咽喉痛，背痛或乏力長達24小時的時候用棉簽在小孩的鼻子和喉嚨裏採樣（參考附加手冊裏的例圖A和B）。我們會為你提供棉簽和有關採樣和儲存的指導。在研究期間，針對每一次病症和醫療你需要填寫一張相關表格。我們也會告訴你怎麽聯係協調員來領取樣本。

2. These are things we will ask your child to do:

c.這些都是我們會問你的孩子做：

Provide height and weight measurements: We will measure height and weight which will be needed for input into the computer that does lung function tests. Please see Table 2. for summary of data collection points.

提供的身高和體重測量：我們將測量身高和體重將輸入到計算機，肺功能測試需要。請見表 2。數據採集點的總結。

Give a blood sample: We will take about 2 teaspoons of blood from a vein in the arm. This will be stored in 2 tubes. The blood will be sent to a laboratory to determine if the study participant has allergies.

舉一個血液樣本：我們將會從手臂上的靜脈抽大概兩 茶匙的血。抽出來的血會被保存在兩個專用管裏並被送到實驗室去進行過敏症狀的分析。

Perform breathing tests: We will ask your child to blow into machines that measures lung function and inflammation. In one test, your child will blow into a machine at least three times as hard as he/she can. In another test, your child will blow into a mouthpiece for about 6 to 10 seconds.

進行呼吸測試：我們會要求您的孩子吹機的措施，肺功能和炎症。在一次試驗中，您的孩子將打擊到一台機器至少三次硬如他/她可以。在另一項試驗中，你的孩子會打擊到一台機器大約6至10秒。

Give urine samples: We will ask your child to urinate in a cup at home. We will test the urine for chemicals (e.g., pesticides). We will not be testing for illegal drugs in the urine.

提供尿液樣本：我們會要求您的孩子在一個杯子在家小便。我們將測試的化學品（如農藥）的尿液。我們不會對尿樣裏的違禁藥品進行分析。

Have his/her nose and throat swabbed: When your child has cold/flu symptoms, his/her nose and throat will be swabbed by you (as described above). At the time when the nose and throat swabs are picked up from the home, the study technician will collect another nose swab and throat swab.

收集他/她的鼻子和咽喉拭子：你會被要求收集您的孩子鼻子和咽喉拭子（如上所述）。在協調員來領取樣本的時候，研究工作人員會為實驗室分析再對鼻子和咽喉進行一次採樣。

Table 2. Summary chart of clinical measurements 表2。分析圖表

Factor要素	Child with asthma (Age 7-12) 有氣喘的兒童 （7到12嵗）
Blood 血 Start of study研究開始	
Urine 尿 Start of study研究開始 1-mo. follow-up跟蹤第一個月 6-mo. follow-up跟蹤第六個月 12-mo. follow-up跟蹤第十二個月	   
Breathing tests 肺功能 Start of study研究開始 1-mo. follow-up跟蹤第一個月 6-mo. follow-up跟蹤第六個月 12-mo. follow-up跟蹤第十二個月	   
Respiratory Symptoms 呼吸症狀 Monthly每月	
Cold/ Flu assessment感冒/流感評估 When the child experiences at least 3 of the following: feverish, stuffy/runny nose, cough, sore throat, body aches or tiredness, for more than 24 hours. 兒童有持續24小時以上的 發燒，鼻塞/流鼻涕，咳嗽，喉嚨發炎，身體酸痛和乏力	

*Blood will be used for assessment of allergy status 血樣將用於過敏分析

** Urine will be used for assessment of environmental chemical exposures尿樣將用於環境裏化學成分的評估

Reporting of Results:

All study results will be provided to you. For mothers/primary caregivers of participating asthmatic children (ages 7-12), we will also provide breathing machine test results within a period of not more than 3 months. There are no government standards for residential levels for any of the environmental agents that we are measuring in your home. However, during your final home visit, we will: 1) give you the first environmental results that we collected from your home; 2) give you the first clinical results (blood and urine tests) that we collected from your child; 3) discuss the results with you; and 4) give you information (e.g. local health department phone numbers and a DVD and/or pamphlets) on how to lower environmental agents in your home. The rest of your results will be mailed to you within one year after you finish the study.

結果報告：

所有研究結果都囘提供給你。我們還會再3個月内提供呼吸器測量結果。現在國家沒有發佈任何有關住房環境物質分佈和量化的標準。在最後一次家訪時，我們會1）向你提供第一組對你家裏環境的測量結果，2）向你提供第一組擬小孩的臨床檢驗（血和尿樣）結果， 3）跟你討論這些結果， 並4）提供怎樣減少環境裏面的各種物質的信息（比如説本地衛生侷電話號碼，DVD和/或手冊）。其餘的結果會在研究結束后一年之内寄給你。

How long will you be in the study?

12 months if all study visits are completed on time.

你參與研究的時間長度？

如按計劃縂長度為12個月。

4. What are the risks or discomforts of the study? 參加研究有什麽風險？

Blood collection: Taking blood may cause pain, bleeding or bruising where the needle is placed. In rare

cases, it may result in fainting. There is a small risk of infection.

抽血：抽血可能由針頭引起疼痛，出血或淤血。非常罕見的情況下，有暈倒的可能性。感染的可能性非常小。

Breathing tests

• Your child may become dizzy.

• Occasionally minor chest soreness for several days after the testing.

肺功能

• 小孩可能出現頭昏

• 在少數情況下有在檢測完后幾天出現胸部發酸

Nose Swabs and Throat swabs: Nose swabs quickly rub the back portion of the nose and may feel uncomfortable for a second. Rarely, nose swabs may cause a small amount of bleeding. Throat swabs may feel uncomfortable for a second.

鼻子和喉嚨取樣：鼻子取樣過程中需要快速地在鼻子後方摩擦，可能有幾秒鐘的不舒服感。在罕見的情況下，鼻子取樣可能造成小出血。喉嚨取樣可能造成幾秒鐘的不舒服感。

The research team will comply with state and local law and will tell the local or state authorities if they suspect abuse or neglect of a child or dependent adult.

研究團隊會遵守當地和州法律，如發現忽視或虐待兒童將會匯報給相關政府部門。

5. Are there benefits to being in the study?

From the blood test, you will learn about any allergies your child might have had at the time of the blood draw. You will also learn about your child’s breathing function at the time that the breathing function tests were administered, and this information should be shared with the child’s healthcare provider to aid in the child’s overall asthma management. All households will receive information about how to decrease their exposures to chemicals and other agents which can be associated with breathing problems during their last home visit.

參加研究有什麽好處？

你會通過血樣分析了解到你小孩可能有的任何過敏情況。你會根據呼吸測試的結果了解到你小孩的呼吸功能情況，並且這個情況和測試結果應該爲了更好地改善小孩的氣喘情況而提供給醫療機構。 所有參與的家庭都會在最後一次家訪地侍候收到和呼吸問題有關的物質數量和暴露情況。

5. What are your options if you do not want to be in the study?

You do not have to join this study. If you do not join, your housing situation will not be affected. If your home has been scheduled to be renovated, it will still undergo the renovations.

如果你不想參加研究，有什麽其它的選擇？

你不是必須參加這項研究。如果你不參加，你住房的情況不會受到任何影響。如果你的房子被安排進行翻新，翻新過程一樣會進行。

5. Will it cost you anything to be in this study?

It will not cost you anything to be in the study. The costs of all of the measurements in the study are covered by the study.

如果參加研究有什麽花費？

參加這項研究不需要你任何花費。所有測量的費用都由研究來承擔。

5. What will you get if you join this study?

You will receive $50 for each of the home visits. You will be reimbursed $2 for each of the monthly text messages (month 1, 2, 4, 5, 7, 8, 10, and 11) and 3-month and 9-month phone calls (total = $20). If you complete all study activities, you will receive a total of up to $220.

參加研究會有報酬嗎？

每一次完成家訪，你會收到50圓美金的信用卡。同時，針對每月得電子短訊（跟蹤的第1，2，4，5，7，8，10和11個月）和簡短的健康電話跟蹤（跟蹤第3和第9個月）你還會收到每次2美金（總共20美金）。 如果你完成所有研究項目，你會獲得總價值220美金的報酬。

5. Can you leave the study early?

You can agree to be in the study now and change your mind later. If you wish to stop, please tell us right away. Leaving this study early will not stop you from getting regular medical care or affect your housing situation.

你可以提前退出研究嗎 ?

你現在可以同意加入研究然後改變主意。如果你希望停止，請第一時間告訴我們。提前退出這項研究不會影響你接受醫療服務和住房情況。

5. Why might we take you out of the study early?

You and your child may be taken out of the study:

• If it is in your or your child’s best interest to be taken out of the study.

• If you fail to follow instructions.

• If the study is cancelled.

• There may be other reasons that we don’t know at this time to take you out of the study.

爲什麽我們有可能提前讓你退出研究？

你和你的小孩可能被提前退出研究：

• 如果是為你和你小孩的利益著想

• 如果你不遵守程序和規定

• 如果研究被取消

• 還有其他我們現在不知道的原因

5. How will your privacy be protected?

怎樣保護你的隱私？

Information from the survey will be used for research purposes only. All answers you give will be kept private to the extent permitted by law. We do not plan to share your information with anyone other than CDC staff and its contractors. Data that identify you or where you live will not be included in any report. All information from the surveys will be kept in a locked file. Data will be stored separately from any personal identifiers.

從調查的信息將只用於研究目的。所有你所給出的的答案將被保密，在法律允許的範圍內。我們不打算與疾病預防控制中心的工作人員和其承包商以外的任何人分享您的信息。識別您的身份或你住的地方的數據將不包括在任何報告。從調查的所有信息將被保存在鎖定的文件。獨立於任何個人識別數據將被存儲。

The use of your information has no time limit. You can cancel your permission to use and disclose your information at any time by calling the Study Site Principal Investigator at HSPH, Dr. Gary Adamkiewicz at tel (617) 384-8852, emailing him at [email protected], or by sending him a letter \at the following address:

對有關你的信息的使用沒有時間限制。 你可以在任何時候取消分享信息的認可，如果是這樣，請致電波士頓首席研究員，哈佛大學的Gary Adamkiewicz博士，電話號碼：(617) 384-8852 或發郵件到:[email protected], 或寄信到以下地址：

Gary Adamkiewicz

Harvard School of Public Health

401 Park Drive

Landmark Center West Room 404K

Boston, MA 02215

If you cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

如果你選在取消分享信息的認可，你的參與將會被終止然後不會有進一步的數據收集。 取消分享認可對已經收集的數據沒有影響。

5. What treatment costs will be paid if you are injured in this study?

如果在研究過程中受傷有什麽補償？

CDC and HSPH do not have programs to pay you if your child is hurt or has other bad results from being in the study. The costs for any treatment or hospital care would be the responsibility of you or your insurance company.

美國疾病控制預防中心和哈佛大學公共衛生學院沒有受傷擔保項目。任何治療和醫院費用應由你或者你的保險公司承擔。

5. What other things should you know about this research study?

其它有關這項研究的信息

a. What is the Institutional Review Board (IRB) and how does it protect you?

The HSPH IRB is generally made up of: Doctors, Nurses, Scientists, and Non-scientists

什麽是機構審查委員會和該委員會如何保護你？

哈佛大學公共衛生學院機構審查委員會是由醫生，護士，科學家及非科學家組成。

The IRB reviews human research studies. It protects the rights and welfare of the people taking part in those studies. You may contact the IRB if you have questions about your rights as a research subject, please contact HSPH Office for Human Research Administration. They can be reached at 617-384-5480 or 1552 Tremont Street, Boston, Massachusetts 02120.

機構審查委員會審查有人參與的研究項目。機構審查委員會保護參與人的權益。如果有關于參與者權利方面的問題，你可以聯係哈佛公共衛生學院的機構審查委員會辦公室。致電(617) 384-5480 或到1552 Tremont Street, Boston, Massachusetts 02120

b. What do you do if you have questions about the study?

Call the study site principal investigator, Dr. Gary Adamkiewicz at the Harvard School of Public Health, at 617-384-8852 or the CDC principal investigator, Dr. Ginger Chew at 770-488-3992.

如果你對研究有問題怎麽辦？

致電給哈佛公共衛生學院的首席研究員 Gary Adamkiewicz博士：（617）384-8852

或者美國疾病控制預防中心的首席研究員Ginger Chew 博士：（770）488-3992

c. What should you do if you are injured or ill as a result of being in this study?

If you have an urgent medical problem you should call 911.

如果你因爲參與研究而受傷怎麽辦？

如果你需要任何緊急醫療救護，撥打911。

Call the study site principal investigator, Dr. Gary Adamkiewicz at the Harvard School of Public Health at 617-384-8852 or the CDC principal investigator, Dr.Ginger Chew at 770-488-3992, if you think you are injured or ill because of this study.

如果你覺得你因爲參與研究而生病或受傷，致電給哈佛公共衛生學院的首席研究員 Gary Adamkiewicz博士：（617）384-8852

或者美國疾病控制預防中心的首席研究員Ginger Chew 博士：（770）488-3992

d. What happens to data, blood, urine, and samples that are collected in the study?

研究所收集的數據，血樣，尿樣和其它測量結果都有何用途？

Scientists at CDC work to find the causes and cures of disease. The data, urine, blood and samples collected from you during this study are important to both this study and to future research.

美國疾病控制預防中心的科學家研究治療疾病的方法。研究所收集的數據，血樣，尿樣和其它測量結果對這個研究和將來的研究都有很重要的意義。

If you join this study:

• CDC and/or its outside partners in this research will own these collected data, blood, urine, and environmental samples.

• Scientists may study, test and use this material in future research only with your consent or with the approval of a special review board.

如果你參與研究：

• 美國疾病控制預防中心和其合作夥伴會擁有研究所收集的數據，血樣，尿樣和其它測量結果的所有權

• 在有你認可或機構審查委員會同意的情況下，科學家會研究，測試和使用這些東西

5. What does your signature on this consent form mean?

你在這個同意書上的簽名以爲著什麽？

• you understand the information given to you in this form

• you accept the provisions in the form

• you agree to join the study

You will not give up any legal rights by signing this consent form.

• 你明白這個文件裏的信息

• 你接受這個文件裏的條款

• 你同意加入這個研究

你不會因爲在這個同意書上簽字而喪失任何法律權利

WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM

我們會為你提供一個有簽名和日期的同意書的備份

Please initial here if it is okay for CDC to save my/my child’s samples collected in this study for future research purposes related to public health. The samples may be kept indefinitely. These samples will not be identified by my name; therefore they cannot be traced back to me. This also means that I will not receive any results from any of those future studies.

我同意美國疾病控制預防中心收集和保存我/我小孩的樣本並用于未來的公共衛生方面的研究。這些樣本可能被長久保存。 這些樣本不會被標有我的名字。這也意味著我不會受到未來研究所產生的結果。

簽名___________________

__________________________________________________________________________________________________________________________

Signature of Participant 參與人簽名 (Printed Name清楚填寫名字) Date 日期

_________________________________________________________________________________________

Signature of Person Obtaining Consent 獲取同意工作人員簽名 Date日期

________________________________________________________________________________________

NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR AND A COPY MUST BE GIVEN TO THE PARTICIPANT.

注：首席研究員和參與人應各持有一份有簽名和日期的同意書

Page 1 of 10