Contents
Part 1: What is an Institutional Review Board (IRB)?
Part 2: Purpose of an IRB
Part 3: Membership of an IRB
Part 1: What is an Institutional Review Board?
Structure
An Institutional Review Board (IRB) is an independent body established to protect the rights and welfare of human research participants. Under Title 45 Part 46 of the Code of Federal Regulations (45 CFR 46), any research that is federally funded must be reviewed and approved by an IRB.
機(jī)構(gòu)審查委員會(huì)（IRB）是為保護(hù)人類研究參與者的權(quán)利和福利而設(shè)立的獨(dú)立機(jī)構(gòu)。根據(jù)《聯(lián)邦法規(guī)》（45 CFR 46）第45篇第46部分，任何由聯(lián)邦資助的研究?必須由IRB審查和批準(zhǔn)。
Any clinical investigation involving a product regulated by the U.S. Food and Drug Administration (FDA) must also be reviewed and approved by an IRB (21 CFR 56). Individual institutions or sponsors may require that all research, no matter how it is funded, be reviewed and approved by an IRB.
涉及美國(guó)食品和藥物管理局（FDA）監(jiān)管的產(chǎn)品?的任何臨床研究也必須由IRB（21 CFR 56）審查和批準(zhǔn)。個(gè)別機(jī)構(gòu)或贊助者可能要求?所有研究，無(wú)論其資金來(lái)源如何，都必須經(jīng)過(guò)IRB的審查和批準(zhǔn)。
An IRB has specific authority over the conduct of research under its jurisdiction. No clinical study may begin enrolling participants until it has received IRB approval. The IRB has the authority to:
Ⅰ、Approve, disapprove, or terminate all research activities that fall within its local jurisdiction according torelevant federal regulations and institutional policy.
Ⅱ、Require modifications in protocols, including protocols of previously approved research.
Ⅲ、Require that participants be given any additional information that will assist them in making an informed decision to take part in research. (Requirements for informed consent are covered in the Informed Consent module.)
Ⅳ、Require documentation of informed consent or allow a waiver of documentation. (Documentation of informed consent is covered in the Informed Consent module.)
IRB對(duì)其管轄范圍內(nèi)的研究具有特定權(quán)限。在獲得IRB批準(zhǔn)之前，任何臨床研究都不得開(kāi)始招募參與者。IRB有權(quán)：
1、根據(jù)相關(guān)聯(lián)邦法規(guī)和機(jī)構(gòu)政策，批準(zhǔn)、不批準(zhǔn)或終止其地方管轄范圍內(nèi)的所有研究活動(dòng)。
2、需要修改方案，包括先前批準(zhǔn)的研究方案。
3、要求向參與者提供有助于他們做出知情決定參與研究的任何額外信息。（有關(guān)知情同意的要求，請(qǐng)參見(jiàn)知情同意模塊）
4、要求提供知情同意的文件或允許放棄文件。（知情同意模塊涵蓋知情同意的文件）
Every institution that participates in research studies must identify an IRB to review and approve those studies. The IRB must follow the requirements of 45 CFR 46 (described in this module) and of the Office for Human Research Protections. Some research sites are under the jurisdiction of two or more IRBs. In these cases, the IRBs may perform joint review, separate review or agree to abide by the review of one of the involved IRBs.
每個(gè)參與研究的機(jī)構(gòu)都必須確定一個(gè)IRB來(lái)審查和批準(zhǔn)這些研究。IRB必須遵守45 CFR 46（本模塊中描述）和人類研究保護(hù)辦公室的要求。一些研究地點(diǎn)受兩個(gè)或多個(gè)IRB管轄。在這些情況下，內(nèi)部評(píng)級(jí)機(jī)構(gòu)可進(jìn)行聯(lián)合審查、單獨(dú)審查或同意遵守其中一個(gè)相關(guān)內(nèi)部評(píng)級(jí)機(jī)構(gòu)的審查。
This module provides an overview of the regulations governing IRBs. Many of the topics covered here are also addressed in other modules of this training program. Links to those topics are provided where relevant.
該模塊概述了IRB的規(guī)定。此處涵蓋的許多主題也在此培訓(xùn)計(jì)劃的其他模塊中解決。提供與這些主題相關(guān)聯(lián)的鏈接。
Part 2: Purpose of an IRB?
The purpose of an IRB is to safeguard the rights, safety, and well–being of all human research participants. The IRB fulfills this purpose by:
IRB的目的是保護(hù)所有人類研究參與者的權(quán)利、安全和福祉。IRB通過(guò)以下方式實(shí)現(xiàn)此目的：
Ⅰ、Reviewing the full study plan (see section IRB responsibilities for the documents which comprise a full protocol) for a research study to ensure that the research meets the criteria specified in 45 CFR 46.111. (See summarized Criteria for IRB approval of research.)
1、審查完整的研究計(jì)劃（見(jiàn)IRB責(zé)任部分，包含完整方案的文件），以確保研究符合45 CFR 46.111中規(guī)定的標(biāo)準(zhǔn)。（參見(jiàn)IRB批準(zhǔn)研究的匯總標(biāo)準(zhǔn)。）
Ⅱ、Confirming that the research plans do not expose participants to unreasonable risks.
2、確認(rèn)研究計(jì)劃不會(huì)使參與者面臨不合理的風(fēng)險(xiǎn)。
Ⅲ、Reviewing and approving proposed payments or other compensation to study participants.
3、審查和批準(zhǔn)向研究參與者提出的付款或其他補(bǔ)償。
Ⅳ、Ensuring that human participant protections remain in force throughout the research by conducting continuing review of approved research. This continuing review is conducted at intervals appropriate to the degree of risk posed by each study, but not less frequently than once a year.
4、通過(guò)持續(xù)審查已批準(zhǔn)的研究，確保人類參與者保護(hù)在整個(gè)研究過(guò)程中保持有效。這一持續(xù)性審查的時(shí)間間隔與每項(xiàng)研究的風(fēng)險(xiǎn)程度相適應(yīng)，但頻率不低于每年一次。
Ⅴ、Considering adverse events, interim findings, and any recent literature that may be relevant to the research.
5、考慮不良事件，臨時(shí)發(fā)現(xiàn)和任何可能與研究相關(guān)的近期文獻(xiàn)。
Ⅵ、Assessing suspected or alleged protocol violations, complaints expressed by research participants, or violations of institutional policies.
6、評(píng)估可疑或指稱的違反協(xié)議、研究參與者提出的投訴或違反機(jī)構(gòu)政策的行為。
Ⅶ、Reviewing proposed changes to previously approved studies.
7、審查先前批準(zhǔn)研究的擬議變更。
The IRB may suspend or terminate ongoing research that:
Ⅰ、Is not being conducted in accordance with IRB requirements, or
Ⅱ、Is associated with unexpected or serious harm to participants.
IRB可暫?；蚪K止以下正在進(jìn)行的研究：
一、未按照IRB要求進(jìn)行，或
二、對(duì)參與者造成意外或嚴(yán)重傷害。
The IRB may also suspend or terminate research when additional information results in a change to the study's likely risks or benefits.
當(dāng)附加信息導(dǎo)致研究可能的風(fēng)險(xiǎn)或收益發(fā)生變化時(shí)，IRB也可以暫?；蚪K止研究。
Part 3: Membership of an IRB
An IRB must have a diverse membership that includes both scientists and non-scientists. Scientist members may include researchers, physicians, psychologists, nurses, and other mental health professionals. Non- scientist members of an IRB may have special knowledge of a certain population (pregnant women, children, or prisoners).
IRB必須擁有包括科學(xué)家和非科學(xué)家在內(nèi)的多元化成員。科學(xué)家成員可能包括研究人員、醫(yī)生、心理學(xué)家、護(hù)士和其他心理健康專業(yè)人員。IRB的非科學(xué)家成員可能對(duì)特定人群（孕婦、兒童或囚犯）具有特殊知識(shí)。
Collectively, IRB members must have the qualifications and experience to review and evaluate the scientific, medical, behavioral, social, legal, and ethical aspects of a proposed study. An IRB must have at least five members. However, it may have as many members as necessary to perform a complete and adequate review of research activities.
總之，IRB成員必須具備審查和評(píng)估擬議研究的科學(xué)、醫(yī)學(xué)、行為、社會(huì)、法律和道德方面的資格和經(jīng)驗(yàn)。IRB必須至少有五名成員。然而，它可能有盡可能多的成員來(lái)對(duì)研究活動(dòng)進(jìn)行全面和充分的審查。
ICH VS FDA
ICH:Ⅰ、Minimum 5 members；至少5名成員；
? ? ? ? Ⅱ、Minimum 1 member with scientific background；至少1名具有科學(xué)背景的成員；
? ? ? ? Ⅲ、1 member not affiliated with any institution；1名不隸屬于任何機(jī)構(gòu)的成員；
? ? ? ? Ⅳ、Independent of sponsor to provide opinion；獨(dú)立于發(fā)起人提供意見(jiàn)；
FDA:Ⅰ、Minimum 5 members；至少5名成員；
? ? ? ? Ⅱ、At least 1 scientific & 1 non-scientific；至少1名科學(xué)人員和1名非科學(xué)人員；
? ? ? ? Ⅲ、1 member not affiliated with any institution；1名不隸屬于任何機(jī)構(gòu)的成員；
? ? ? ? Ⅳ、Diverse (race, gender, culture, vulnerable population representative) ，No conflict of interest；多元化（種族、性別、文化、弱勢(shì)群體代表），無(wú)利益沖突；
Diversity of Membership
IRB membership must be diverse in terms of race, gender, and cultural heritage. Members must be sensitive to issues such as community attitudes.
Every effort must be made to ensure that no IRB consists entirely of men or entirely of women. However, no one can be appointed to an IRB solely on the basis of gender.
IRB成員必須在種族、性別和文化遺產(chǎn)方面具有多樣性。成員必須對(duì)社區(qū)態(tài)度等問(wèn)題保持敏感。
必須盡一切努力確保IRB不完全由男性或女性組成。然而，任何人都不能僅僅基于性別被任命為IRB成員。
No IRB may consist entirely of members of one profession.
任何IRB不得完全由一個(gè)專業(yè)的成員組成。
Each IRB should include at least one member whose primary concerns are in scientific areas and one member whose primary concerns are in non-scientific areas.
每個(gè)IRB應(yīng)至少包括一名主要關(guān)注科學(xué)領(lǐng)域的成員和一名主要關(guān)注非科學(xué)領(lǐng)域的成員。
Each IRB should include at least one member who is not affiliated with the institution or study site.
每個(gè)IRB應(yīng)至少包括一名與該機(jī)構(gòu)或研究現(xiàn)場(chǎng)無(wú)關(guān)的成員。
Knowledge of Vulnerable Populations
If the IRB reviews research that involves vulnerable populations — such as children, prisoners, pregnant women, or disabled or cognitively impaired persons — its membership should include one or more persons who are knowledgeable about and/or experienced in working with these populations. The individuals specializing in vulnerable populations may be fulltime voting members or alternates to fulltime voting members.
如果IRB審查涉及弱勢(shì)群體（如兒童、囚犯、孕婦、殘疾人或認(rèn)知障礙者）的研究，其成員應(yīng)包括一名或多名了解和/或有經(jīng)驗(yàn)與這些群體合作的人。專門處理弱勢(shì)群體問(wèn)題的個(gè)人可以是全職有表決權(quán)的成員或全職有表決權(quán)成員的候補(bǔ)成員。
Conflicts of Interest
No IRB member may participate in the review of any project in which he or she has a conflicting interest, except to provide information requested by the IRB.
除提供IRB要求的信息外，任何IRB成員不得參與其利益沖突項(xiàng)目的審查。
An investigator may be a member of an IRB. However, the investigator (or any other IRB member) cannot participate in the review or approval of any research in which he or she has a current or potential conflict of interest. The investigator should be absent from the meeting room while the IRB discusses and votes on the research in which he or she has an interest.
調(diào)查員可能是IRB的成員。但是，調(diào)查員（或任何其他IRB成員）不得參與審查或批準(zhǔn)其當(dāng)前或潛在利益沖突的任何研究。當(dāng)IRB就其感興趣的研究進(jìn)行討論和投票時(shí)，調(diào)查員應(yīng)缺席會(huì)議室。
Non-Voting Members
The IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that of the IRB members. These consultants are not voting members of the IRB. However, when research involves vulnerable populations, individuals specializing in these areas must be voting members of an IRB and maintained on the IRB roster accordingly.
IRB可邀請(qǐng)?jiān)谔厥忸I(lǐng)域有能力的個(gè)人協(xié)助審查需要IRB成員以外或額外專業(yè)知識(shí)的問(wèn)題。這些顧問(wèn)不是IRB的表決權(quán)成員。然而，當(dāng)研究涉及弱勢(shì)群體時(shí)，專門從事這些領(lǐng)域的個(gè)人必須是IRB的投票成員，并相應(yīng)地保留在IRB名冊(cè)上。
Interactive: Assemble Your IRB? ?交互式：組裝您的IRB
Read the following Scenario
A multisite clinical study package (including the protocol, informed consent forms, recruitment materials, and other related documentation) is being submitted for IRB approval. This US-based study is to assess the efficacy of BioMedXYZ's drug for Attention Deficit Hyperactivity Disorder in children ages 7 to 15.
多站點(diǎn)臨床研究包（包括方案、知情同意書、招募材料和其他相關(guān)文件）正在提交給IRB審批。這項(xiàng)基于美國(guó)的研究是評(píng)估Biomedxyz的藥物在7至15歲兒童中注意力缺陷多動(dòng)障礙的藥物的療效。
Users are instructed as follows:? 用戶須知如下：
From a list of eight, choose the most appropriate candidates as members of the IRB and ensure that the composition of the IRB meets the minimum criteria outlined for clinical research in the U.S. Each candidate has a bio or biography to review. After reviewing the candidates' bios to determine if they are right for this clinical study, users are to drag the most appropriate candidates to the member area in the interactive, with a total of five voting members and one non-voting expert for consultation, and analyze the feedback based on the members chosen.
從八名候選人中選擇最合適的候選人作為IRB成員，并確保IRB的組成符合美國(guó)臨床研究的最低標(biāo)準(zhǔn)。每位候選人都有一份個(gè)人簡(jiǎn)歷或傳記審查。在審查候選人的BIOS以確定他們是否適合本臨床研究后，用戶將把最合適的候選人拖到交互中的成員區(qū)域，總共有五名有投票權(quán)的成員和一名無(wú)投票權(quán)的專家進(jìn)行咨詢，并根據(jù)所選成員分析反饋。
The feedback box includes ‘must have’ criteria in three areas: (1) diversity, (2) a non-scientific member, and(3) a non-affiliated member. The ‘must have’ feedback box will include all green checks after assembling the best group of experts for the IRB.
反饋框包括三個(gè)方面的“必須具備”標(biāo)準(zhǔn)：（1）多樣性，（2）非科學(xué)成員，（3）非附屬成員?！氨仨毦邆洹狈答伩?qū)ㄔ跒镮RB組建最佳專家組后的所有綠色檢查。
Be careful to avoid any conflict of interest with the chosen candidates. The feedback box includes a notification when a member is selected that has a conflict of interest for this clinical trial.
小心避免與所選候選人發(fā)生任何利益沖突。反饋框包括一個(gè)通知，當(dāng)選擇的成員對(duì)此臨床試驗(yàn)存在利益沖突時(shí)。
Listed below are the candidates for the IRB, including names, credentials, current title, and a brief bio on the candidate’s background and expertise.? 下面列出了IRB的候選人，包括姓名、資歷、當(dāng)前職稱以及候選人背景和專業(yè)知識(shí)的簡(jiǎn)要簡(jiǎn)歷。
Candidate 1: Juan Telmo, PhD - Statistical Scientist
Juan has an MS degree in Data Analytics, with a concentration in Statistics, and PhD degree in Statistical Science. He has been a statistical scientist working for the past 5 years at BioMedXYZ firm that develops medical devices. He has expertise in statistical theory, methods, analyses, device development, and clinical research.
候選人1：Juan Telmo博士-統(tǒng)計(jì)科學(xué)家
Juan擁有數(shù)據(jù)分析碩士學(xué)位，專注于統(tǒng)計(jì)學(xué)，以及統(tǒng)計(jì)科學(xué)博士學(xué)位。在過(guò)去的5年里，他一直是一名統(tǒng)計(jì)科學(xué)家，在開(kāi)發(fā)醫(yī)療設(shè)備的BioMedXYZ公司工作。他擁有統(tǒng)計(jì)理論、方法、分析、設(shè)備開(kāi)發(fā)和臨床研究方面的專業(yè)知識(shí)。
Candidate 2: Tomer Teivel, RN - Social Worker
Tomer had a rough start in life, his mother was an alcoholic when he was a child. He found his passion helping people dealing with addiction. He earned his MS degree in social work and obtained his social worker license (LCSW). He has worked for the past 12 years in schools, hospitals, and other agencies and also in community drug treatment programs. Previously, Tome had participated in numerous research studies involving participant drug use. He has expertise in mental health treatment, research, families, and community.
候選人2：Tomer Teivel，注冊(cè)護(hù)士-社會(huì)工作者
托默的生活起步很艱難，他小時(shí)候母親是個(gè)酒鬼。他發(fā)現(xiàn)自己的熱情幫助人們戒毒。他獲得了社會(huì)工作碩士學(xué)位，并獲得了社會(huì)工作者執(zhí)照（LCSW）。在過(guò)去的12年里，他在學(xué)校、醫(yī)院和其他機(jī)構(gòu)以及社區(qū)藥物治療項(xiàng)目中工作。此前，Tome曾參與過(guò)許多涉及參與者吸毒的研究。他擁有心理健康治療、研究、家庭和社區(qū)方面的專業(yè)知識(shí)。
Candidate 3: Lilith O’Conner, BS - Teacher
For the past 3 years, Lilith has worked as a Teacher at the local Elementary School. She serves as the Youth Committee Secretary for the local Community Center and is a teacher representative for the local Board of Education. Lilith has expertise in children, education, and community. She earned her BS degree in Psychology and Early Childhood Education.
候選人3:Lilith O'Conner，理學(xué)士-教師
在過(guò)去的三年里，莉莉絲一直在當(dāng)?shù)匦W(xué)擔(dān)任教師。她是當(dāng)?shù)厣鐓^(qū)中心的青年委員會(huì)秘書，也是當(dāng)?shù)亟逃瘑T會(huì)的教師代表。Lilith在兒童、教育和社區(qū)方面擁有專業(yè)知識(shí)。她獲得心理學(xué)和幼兒教育學(xué)士學(xué)位。
Candidate 4: Carla Fox, JD, MHA - Ethicist
Carla earned her JD and MHA degrees in Health Care Law. She serves as Chairperson on the local chapter for the Board of Bioethics in Hospital Administration. She also works as a lawyer for healthcare organizations. Carla has expertise in health policy, bioethics law, and community engagement.
候選人4：卡拉·福克斯，法學(xué)博士，MHA-倫理學(xué)家
卡拉獲得了醫(yī)療保健法的法學(xué)博士和醫(yī)學(xué)碩士學(xué)位。她擔(dān)任醫(yī)院管理生物倫理委員會(huì)地方分會(huì)主席。她還擔(dān)任醫(yī)療機(jī)構(gòu)的律師?？ɡ谛l(wèi)生政策、生物倫理法和社區(qū)參與方面擁有專業(yè)知識(shí)。
Candidate 5: Brian Bradford, MD - Pediatrician
Brian attended medical school, completed residency in a children's hospital, and obtained his medical licensure. He is a partner pediatrician in general practice for 20 years. He has expertise in pediatrics and clinical care.
候選人5：Brian Bradford，醫(yī)學(xué)博士-兒科醫(yī)生
布萊恩上了醫(yī)學(xué)院，在一家兒童醫(yī)院完成了住院治療，并獲得了醫(yī)療執(zhí)照。他是20年的全科合作兒科醫(yī)生。他擁有兒科和臨床護(hù)理方面的專業(yè)知識(shí)。
Candidate 6: Dorian Picard, MD - Therapist
Dr. Picard earned a PhD in behavioral therapy and has been working in both the hospital and private sector for the last 15 years, specializing in children and adolescent behaviors with a special interest in ADHD. Due to his schedule he has limited availability.
候選人6：Dorian Picard，醫(yī)學(xué)博士-治療師
皮卡德博士獲得了行為療法博士學(xué)位，在過(guò)去15年中一直在醫(yī)院和私營(yíng)部門工作，專門研究?jī)和颓嗌倌甑男袨椋瑢?duì)多動(dòng)癥有著特殊的興趣。由于日程安排，他的可用性有限。
Candidate 7: Dung Nguyen, MPH - Policy Analyst
Ms. Nguyen obtained a Master’s degree of Public Health and Policy and now works as a management policy analyst at a firm that advises hospital and legislative administrators on health care policies. She has expertise in public health policies, epidemiology research, and biostatistics.
候選人7：Dung Nguyen，公共衛(wèi)生碩士-政策分析師
阮女士獲得了公共衛(wèi)生和政策碩士學(xué)位，目前在一家為醫(yī)院和立法行政人員提供醫(yī)療政策建議的公司擔(dān)任管理政策分析師。她擁有公共衛(wèi)生政策、流行病學(xué)研究和生物統(tǒng)計(jì)學(xué)方面的專業(yè)知識(shí)。
Candidate 8: Manfred Howard - Minister
Manfred was formerly incarcerated in the state criminal justice system. He is now a minister at the local church. He’s worked for 6 years as an advocate for adults leaving the prison system and transitioning-to- work programs. He has expertise in prisoners and community.
候選人8：曼弗雷德·霍華德-部長(zhǎng)
曼弗雷德以前被關(guān)押在州刑事司法系統(tǒng)。他現(xiàn)在是當(dāng)?shù)亟虝?huì)的牧師。他作為成年人離開(kāi)監(jiān)獄系統(tǒng)并過(guò)渡到工作項(xiàng)目的倡導(dǎo)者工作了6年。他在囚犯和社區(qū)方面有專長(zhǎng)。
Let’s consider the feedback for the Non-Voting Member.??讓我們考慮對(duì)無(wú)投票權(quán)成員的反饋。
One candidate has a conflict of interest – he works for BioMedXYZ. He would not be an appropriate choice for the IRB. That candidate is Juan Telmo, PhD. Additionally, while Manfred Howard may be an expert in his field, he is not a good choice in this case because his area of expertise is adults and prisoners.
一位候選人存在利益沖突——他為BioMedXYZ工作。他不是IRB的合適人選。那個(gè)候選人是胡安·特爾莫博士。此外，盡管曼弗雷德·霍華德可能是該領(lǐng)域的專家，但在本案中，他不是一個(gè)好的選擇，因?yàn)樗膶I(yè)領(lǐng)域是成年人和囚犯。
Several candidates would serve the IRB best as a voting member instead of a non-voting member for consultation. For example, Tomer Teivel, RN, works in environments that cater to the age group targeted for the study. He would serve the IRB better as a voting member as well as Lilith O’Conner, BS, because she has experience in early childhood education and expertise working with the target study population. Carla Brown, PhD, has legal experience and serves on a board of bioethics and Dr. Brian Bradford has a pediatric medical practice. Dung Nguyen, MPH, has expertise in epidemiology research and biostats. These candidates will be a good fit for the IRB as voting members.
若干候選人最好作為有投票權(quán)的成員而不是作為無(wú)投票權(quán)的成員進(jìn)行協(xié)商。例如，Tomer Teivel，RN在適合研究目標(biāo)年齡組的環(huán)境中工作。作為一名投票成員，他將更好地為IRB服務(wù)，Lilith O'Conner，BS，因?yàn)樗谟變航逃矫婢哂胸S富的經(jīng)驗(yàn)，并具有與目標(biāo)研究人群合作的專業(yè)知識(shí)。Carla Brown博士擁有法律經(jīng)驗(yàn)，在生物倫理學(xué)委員會(huì)任職，Brian Bradford博士從事兒科醫(yī)療實(shí)踐。Dung Nguyen，公共衛(wèi)生碩士，擁有流行病學(xué)研究和生物統(tǒng)計(jì)方面的專業(yè)知識(shí)。這些候選人非常適合IRB作為投票成員。
That leaves one candidate who is a good choice to be added to the IRB as an advisor and a non-voting member, Dorian Picard, MD. His expertise is in children and adolescents with ADHD. However, his busy schedule only allows for limited availability. So, he has agreed to be available for expert advice only.
這就留下了一位很好的候選人作為顧問(wèn)和無(wú)投票權(quán)成員加入IRB，Dorian Picard，醫(yī)學(xué)博士。他的專長(zhǎng)是研究多動(dòng)癥兒童和青少年。然而，他的繁忙日程只允許有限的可用性。因此，他同意只接受專家建議。
Now, consider the feedback for the ideal candidates to serve as voting members of the IRB for this clinical trial.? 現(xiàn)在，考慮對(duì)理想候選人的反饋，作為IRB的投票成員進(jìn)行臨床試驗(yàn)。
Several candidates have experience working directly with the age group targeted for the study - Tomer Teivel has additional experience in drug treatment and research, Lilith O’Conner has experience in early childhood education, and Dr. Brian Bradford has a pediatric medical practice. Another candidate has legal experience and serves on a board of bioethics, Carla Brown. Having regulations and ethics covered, the final ideal voting member has expertise on epidemiology research and biostatistics, Dung Nguyen. Each of these candidates would serve the IRB well as voting members.
一些候選人有直接與研究目標(biāo)年齡組工作的經(jīng)驗(yàn)——Tomer Teivel在藥物治療和研究方面有額外的經(jīng)驗(yàn)，Lilith O’conner有早期兒童教育經(jīng)驗(yàn)，Brian Bradford博士有兒科醫(yī)療實(shí)踐經(jīng)驗(yàn)。另一位候選人卡拉?布朗(Carla Brown)擁有法律經(jīng)驗(yàn)，并在生物倫理委員會(huì)任職。最終理想的投票成員阮勇(Dung Nguyen)擁有流行病學(xué)研究和生物統(tǒng)計(jì)學(xué)方面的專業(yè)知識(shí)，他的工作涉及法規(guī)和道德規(guī)范。每一位候選人都將很好地作為倫理委員會(huì)的投票成員。
Conversely, there a few candidates that are not ideal to serve on the IRB as voting members.? ?相反，也有少數(shù)候選人不適合作為投票成員在IRB中任職。
Dr. Telmo has a conflict of interest. He works for BioMedXYZ, the pharmaceutical company supplying the drug for the study. While Manfred Howard may be an expert in his field, he is not a good choice in this case because his area of expertise is adults and prisoners. Dr. Picard would be a great addition to the IRB; however, his schedule does not allow him to commit to being a voting member of the team.
Telmo博士有利益沖突。他為Biomedxyz工作，制藥公司為該研究提供了藥物。雖然曼弗雷德霍華德可能是他領(lǐng)域的專家，但在這種情況下，他不是一個(gè)不錯(cuò)的選擇，因?yàn)樗膶I(yè)領(lǐng)域是成年人和囚犯。Picard博士將是IRB的一個(gè)很好的補(bǔ)充;但是，他的時(shí)間表不允許他承諾成為團(tuán)隊(duì)的投票成員。
