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保护人类受试者委员会

Informed Consent

政策

Uthealth要求在参与任何研究之前，必须从所有人类受试者中获得知情同意，除非IRB放弃该过程（或其任何部分）。beplay苹果手机能用吗

关键术语

合法授权代表- Under DHHS regulations, the term Legally Authorized Representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. UTHealth will follow the Texas Health & Safety Code - Chapter 313. Consent to Medical Treatment Act for research consent matters unless clearly inapplicable because there is no applicable Texas law specific to research consent as described in Item 5 of policy and procedure on Research Involving Cognitively Impaired Persons.

程序

一般考虑 -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.

知情同意文件：Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.

同意文件应采用第二人称样式，因此同意文件传达了与所提供的信息的对话，并且可以选择由主题做出，而不是使用第一人称风格的对象的同意。同意文件应在6中th到8thgrade reading level. Technical and scientific terms should be adequately explained using common or lay language.

知情同意的基本要素：In seeking informed consent the following information shall be provided to each subject:

  1. 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;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. 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
  4. 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；
  5. 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）；
  6. 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;
  7. 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;
  8. 一份关于参与是自愿的声明，拒绝参加的声明将不涉及对受试者本来有权的受试者有权的罚款或损失，并且受试者可能会随时停止参与，而无需罚款或损失受试者应有的权利；和
  9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
    1. 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
    2. 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：

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
  2. 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;
  3. 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
  4. 一个主题的后果decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. 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
  6. The approximate number of subjects involved in the study;
  7. 一份声明，即受试者的生物测量（即使删除了标识符）也可以用于商业利润，以及受试者是否会在这一商业利润中共享；
  8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
  9. 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）。
  10. 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.
  11. 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。

Elements of broad consent：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:

  1. 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).
  2. 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。
  3. beplay苹果手机能用吗研究人员must provide all required disclosures for broad consent to each participant or participant’s legally authorized representative:
    1. 一份声明描述将维持识别参与者的记录机密性的程度（如果有）。（如果无法保持机密性，可能会省略。）
    2. 参与是自愿的声明。
    3. A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.
    4. A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
    5. 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。
    6. 有关私人可识别信息或可识别生物测量的未来使用的信息：
      • A statement that identifiers might be removed from 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.
    7. 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.
    8. A description of the identifiable private information or identifiable biospecimens that might be used in the research.
    9. Whether sharing of identifiable private information or identifiable biospecimens might occur.
    10. 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.
    11. 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.
    12. For research involving biospecimens, a statement specifying whether the research will (if known) or might include whole genome sequencing.
    13. 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
    14. 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。
    15. 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.)
    16. Contact information for the research team for questions, concerns, or complaints.
    17. 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
  4. 如果以研究目的进行了更改，以可识别的私人信息或可识别的生物测beplay苹果手机能用吗量的方式存储或维护，则有足够的规定来保护参与者的隐私并保持数据的机密性。

知情同意程序的文档 -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:

  1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

Waiver or Alteration of Informed Consent-CPHS可以批准同意程序，该程序不包括本节中规定的知情同意书的某些或全部内容，或者放弃获得知情同意书的要求，前提是CPHS查找和文档以下内容：

  1. The research involves no more than minimal risk to the participants;
  2. The waiver or alteration will not adversely affect the rights and welfare of the participants;
  3. 没有豁免beplay苹果手机能用吗或改变，这项研究就无法实际进行；
  4. Whenever appropriate, the participants will be provided with additional pertinent information after participation.

Waiver of Documentation of Informed Consent-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：

  1. 以下所有内容都是正确的（仅针对非FDA研究）：beplay苹果手机能用吗
    1. The only record linking the participant and the research would be the consent document.
    2. The principal risk would be potential harm resulting from a breach of confidentiality.
    3. 将询问每个参与者是否希望参与者将参与者与研究联系起来，并且参与者的愿望将管理beplay苹果手机能用吗
  2. That all of the following are true (for both FDA regulated and on FDA research):
    1. The research presents no more than minimal risk of harm to participants.
    2. 研究涉及beplay苹果手机能用吗没有令状的程序ten consent is normally required outside the research context
  3. Waiver of Consent Process – Public Demonstration Project
    1. The research is conducted by or subject to the approval of state or local government officials.
    2. The research or demonstration protocol is designed to study, evaluate, or otherwise examine:
      1. Public benefit or service programs
      2. 根据这些计划获得福利或服务的程序
      3. Possible changes in or alternatives to those programs or procedures
      4. Possible changes in methods or levels of payment for benefits or services under those programs.
    3. The research cannot practicably be carried out without the waiver or alteration
    4. 该研究不beplay苹果手机能用吗受美国FDA的监管。
  4. Waiver of Documentation of the Consent Process: Distinct Cultural Groups
    1. The research presents no more than minimal risk of harm to participants.
    2. The participants or legally authorized representatives are members of a distinct cultural group or community in which signing consent documents is not the norm.
    3. There is an appropriate alternative mechanism for documenting that informed consent was obtained.
    4. The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
    5. IRB将确定研究人员是否应为参与者提供有关研究的书面声明。beplay苹果手机能用吗
    6. 该研究不beplay苹果手机能用吗受美国FDA的监管。

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 Review of Informed Consent -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 -CPHS may require monitoring of the informed consent process under certain circumstances, such as enrollment of vulnerable subjects or subjects in stressful situations, such as labor and delivery or the intensive care unit. In the event such monitoring is required, the research intermediary will be involved. The research intermediary serves as an additional advocate dedicated to ensuring that subjects’ rights are protected during their participation in research. The intermediary evaluates the subject for understanding of the research prior to the onset of research procedures. The research intermediary notes in the patient/subject file conclusions regarding the comprehension of the subject and reports to the investigator whether research procedures may begin. The Intermediary also reports to CPHS in the event of a difference of opinion with the investigator.

发布同意文件：对于由联邦部门或机构进行或支持的每项临床试验，一份由IRB批准的知情同意书必须由获奖者或联邦部门或代理机构组成，在公开可用的联邦网站上进行审判，将是建立为此类知情同意书的存储库。如果联邦部门或支持临床试验的联邦部门或机构确定不应在联邦网站上公开提供某些信息（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

  1. 45 CFR 46保护人类受试者
  2. 21 CFR 50 Protection of Human Subjects
  3. 21 CFR 56 Institutional Review Board
  4. FDA Informed Consent Information Sheet - Draft
  5. OHRP FAQ – Informed Consent

提及其他政策

  1. 初步审查

附件

  1. Informed Consent Template

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

Effective:

1 Aug 2008

修订历史:

1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 19 Jan 2018, 1 June 2021, 1 Sept 2021, 15 February 2023

CPHS HELPLINE 713-500-7943
Iris热线索林713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

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保护人类受试者委员会
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