Informed Consent
政策
UTHealth requires that informed consent must be obtained from all human subjects prior to their participation in any research unless the process, or any part thereof, has been waived by the the IRB.
关键术语
Legally Authorized Representative- 根据DHHS法规，法律授权的代表一词是指根据适用法律授权的个人或司法或其他机构，代表前瞻性的前瞻性，应受试者参与研究涉及的程序。beplay苹果手机能用吗UTHealth将遵循《德克萨斯州健康与安全法》 - 第313章。除非明显不适用，否则同意研究同意书，因为没有适用的德克萨斯州法律适用于研究同意法，如涉及认知障碍的研究和程序5所述的研究同意法。beplay苹果手机能用吗人。
程序
General Considerations -在将人类主题参与本政策所涵盖的研究之前，研究人员应获得该主题或受试者合法beplay苹果手机能用吗授权代表的法律有效知情同意。研究人员必须仅在为前瞻性主题提供足够机会讨论和考虑是否参与并最大程度地减少强制或不当影响的可能性的情况下才能寻求知情同意。
Informed consent must be conducted in a language understandable to the subject. The prospective subject must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. The informed consent may not include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
Informed Consent Document:知情同意必须从简洁而重点的关键信息开始，这些信息最有可能协助潜在的主题或合法授权的代表理解为什么或可能不想参与研究的原因。beplay苹果手机能用吗必须以促进理解的方式组织和介绍知情同意的一部分。整体知情同意必须提供与研究有关的足够详细信息，并且必须以一种不仅提供孤立事实列表的方式进行组织和介绍，还可以促进潜在的主题或合法授权的代表理解原因的理解。beplay苹果手机能用吗一个人可能会或不想参与。
The consent document should be in the second person style so the consent document conveys a dialogue with information being provided and that there is a choice to be made by the subject rather than presumption of the subject’s consent with the use of the first person style. Consent documents should be in 6Thto 8Th年级阅读水平。技术和科学术语应使用通用或外行语言充分解释。
Basic Elements of Informed Consent:In seeking informed consent the following information shall be provided to each subject:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- 描述对主题或其他可能从研究中可以合理地期望的好处的描述；beplay苹果手机能用吗
- 披露适当的替代程序或治疗方案（如果有的话）可能对受试者有利；
- 一份声明描述将维护识别该主题的记录机密性的程度（如果有的话）；
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- 一个解释，以寻求有关研究和研究对象的权利的相关问题的答案，以及在对该主题的研究相关伤害的情况下与谁联系；beplay苹果手机能用吗
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
- 一份声明，可以从可识别的私人信息或可识别的生物测量中删除标识符，并且在删除此类信息后，可以将信息或生物测量用于未来的研究或将未来研究的其他研究者分发给未来的研究者，而未经该主题或该主题的其他知情同意beplay苹果手机能用吗法律授权的代表，如果这可能是可能的；或者
- A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
Additional elements of informed consent:适当的情况下，应向每个主题或合法授权代表提供以下信息：
- 一份关于特定待遇或程序可能涉及当前无法预料的受试者（或可能怀孕的受试者）的风险（或胚胎或胎儿的风险）；
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the legally authorized representative's consent;
- 参与研究可能导致的主题的任何额外费用；beplay苹果手机能用吗
- 受试者决定退出研究和程序以有序终止受试者参与的后果；beplay苹果手机能用吗
- 一份声明，将向主题提供与主题愿意继续参与意愿有关的研究过程中产生的重大新发现；beplay苹果手机能用吗
- 研究中涉及的受试者的大约数量；
- A statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
- 关于临床相关的研究结果（包括个体研究结果）是否将在受试者中披露的声明，以及在什么条件下；beplay苹果手机能用吗和
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (e.,对人类种系或体细胞的测序，目的是产生该标本的基因组或外显子组序列）。
- For research involving test articles regulated by FDA, consent document must include a statement that the purpose of the study includes evaluation of both the safety and effectiveness of the test article; and a statement that the FDA has access to the subject’s medical records.
- 对于FDbeplay苹果手机能用吗A监督下的研究，同意文件必须包括有关临床试验注册的声明。
广泛同意的要素：Broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens (collected for either research studies other than the proposed research or non-research purposes) is permitted as an alternative to the above informed consent requirements. If the subject is asked to provide broad consent, the following information must be provided to each subject:
- The study is limited to the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens (collected for either research studies other than the proposed research, or non research purposes).
- 该研究经过了有限的IRB审查，并满足了豁免类别7或第8类的要求。
- Researchers must provide all required disclosures for broad consent to each participant or participant’s legally authorized representative:
- A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. (May be omitted if confidentiality will not be maintained.)
- A statement that participation is voluntary.
- 拒绝参与的声明将不涉及参与者应有的罚款或损失。
- A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
- 一份声明，即可能将参与者的生物测量（即使删除标识符）用于商业利润，以及参与者是否会分享这一商业利润。
- Information about future use of private identifiable information or identifiable biospecimens:
- 声明标识符可能会远离The identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future research studies without additional informed consent from the participant or legally authorized representative, if this might be possible; or
- A statement that the participant’s information or specimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
- A general description of the types of research that may be conducted with the identifiable private information or identifiable biospecimens, such that a reasonable person would expect the broad consent would permit the types of research conducted.
- 对研究中可能使用的可识别私人信息或可识别的生物测量的描述。beplay苹果手机能用吗
- Whether sharing of identifiable private information or identifiable biospecimens might occur.
- Unless the participant or legally authorized representative will be provided details about the specific research studies, a statement that they will not be informed of the details of any specific research studies that might be conducted using the participant’s identifiable private information or identifiable biospecimens, including the purposes of the research, and that they might not have chosen to consent to some of those specific research studies.
- Unless it is known that clinically relevant research results, including individual research results, will be disclosed to the participant in all circumstances, a statement that such results might not be disclosed to the participant.
- For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.
- 关于与研究参与者权利有关的有关问题的答案的解释。beplay苹果手机能用吗
- 关于与参与者可识别的信息或生物测量有关的存储和使用问题的答案的解释。
- An explanation of whom to contact in the event of a research-related injury to the participant. (May not be omitted just because the research involves no more than minimal risk.)
- Contact information for the research team for questions, concerns, or complaints.
- 与独立于研究团队的人联系信息，以解决问题，问题，问题，信息或输入。beplay苹果手机能用吗
- If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
Documentation of Informed Consent Process -Informed consent shall be documented by the use of a written consent form approved by CPHS and personally signed and dated by the subject or the subjects’ legally authorized representative. A copy of the signed consent document shall be given to the subject and the original placed in the study file unless the process, or any part thereof, has been waived by the CPHS.
放弃筛查，招募或确定资格 -An IRB may approve a recruitment plan in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject's legally authorized representative, if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
放弃或更改知情同意书- CPHS may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided that CPHS finds and documents that:
- The research involves no more than minimal risk to the participants;
- 豁免或改动不会对参与者的权利和福利产生不利影响；
- The research could not practicably be carried out without the waiver or alteration;
- Whenever appropriate, the participants will be provided with additional pertinent information after participation;
- The research is not subject to FDA regulation.
放弃知情同意的文件-CPHS可以放弃调查人员在某些参与者中找到以下任何一个或全部参与者的同意文件签名的要求：满足以下任何一个或所有参与者：
- That all of the following are true (only for non FDA research):
- 链接参与者和研究的唯一记录将是同意文件。beplay苹果手机能用吗
- The principal risk would be potential harm resulting from a breach of confidentiality.
- Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern
- That all of the following are true (for both FDA regulated and on FDA research):
- The research presents no more than minimal risk of harm to participants.
- 该研究涉beplay苹果手机能用吗及通常在研究背景外需要书面同意书的程序
- Waiver of Consent Process – Public Demonstration Project
- 这项研究beplay苹果手机能用吗是由应用程序或主题roval of state or local government officials.
- 研究或演beplay苹果手机能用吗示方案旨在研究，评估或以其他方式研究：
- Public benefit or service programs
- 根据这些计划获得福利或服务的程序
- Possible changes in or alternatives to those programs or procedures
- 这些计划下的福利或服务付款方式或付款级别可能发生变化。
- The research cannot practicably be carried out without the waiver or alteration
- The research is not regulated by the US FDA.
- Waiver of Documentation of the Consent Process: Distinct Cultural Groups
- The research presents no more than minimal risk of harm to participants.
- The participants or legally authorized representatives are members of a distinct cultural group or community in which signing consent documents is not the norm.
- There is an appropriate alternative mechanism for documenting that informed consent was obtained.
- The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
- IRB将决定研究者寿beplay苹果手机能用吗ld provide participants with a written statement regarding the research.
- The research is not regulated by the US FDA.
如果放弃了知情同意的文档要求，CPHS可能要求调查员向参与者提供有关研究或使用口头脚本的信息信。beplay苹果手机能用吗信息信或口头脚本必须提交给CPHS进行审查和批准。
CPHS审查知情同意书 -CPHS will ensure that the information in the protocol matches the information in the informed consent document regarding the purpose, risks, and benefits of the research. When the research proposal is approved, CPHS stamps the approval date on all approved informed consent documents and stipulates that copies of these dated documents must be used in obtaining consent.
Monitoring of Consent Process -在某些情况下，CPH可能需要监视知情同意程序，例如在压力很大的情况下（例如劳动力和分娩或重症监护室）的弱势群体或受试者。如果需要进行此类监控，则将涉及研究中介机构。beplay苹果手机能用吗该研究中beplay苹果手机能用吗介是一个额外的倡导者，致力于确保受试者在参与研究期间受到保护。中介在研究程序开始之前评估了对研究的理解。beplay苹果手机能用吗研究中间beplay苹果手机能用吗人在患者/主题文件中指出了有关受试者理解的结论，并向研究者报告了研究程序是否可以开始。如果与调查员有意见差异，中介还向CPHS报告。
Posting of Consent Document:For each clinical trial conducted or supported by a Federal department or agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal website that will be established as a repository for such informed consent forms. If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal Web site (e.g.confidential commercial information), such Federal department or agency may permit or require redactions to the information posted. The informed consent form must be posted on the Federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
适用的法规
- 45 CFR 46 Protection of Human Subjects
- 21 CFR 50 Protection of Human Subjects
- 21 CFR 56机构审查委员会
- FDA Informed Consent Information Sheet - Draft
- OHRP常见问题 - 知情同意
REFERENCE TO OTHER POLICIES
- 初步审查
ATTACHMENTS
如果您在本文档中发现错误，请联系cphs@uth.tmc.edu
Document Number: |
101-C07 |
Document Name: |
Informed Consent |
Reviewed by: |
研究合规执行董事beplay苹果手机能用吗 |
有效的： |
1 Aug 2008 |
修订记录： |
2009年1月1日，2011年8月1日，2016年6月1日，2018年1月19日，2021年6月1日，2021年9月1日 |
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
Committee for the Protection of Human Subjects 虹膜支持713-500-7960 |
|
|
