The UTHSC-H 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 CPHS.
Legally Authorized Representative - 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. UTHSC-H 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.
Informed Consent Document:
1. Basic Elements of Informed Consent: In seeking informed consent, the following information shall be provided to each participant.
a. A statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
b. A description of any reasonably foreseeable risks or discomforts to the subject.
c. A description of any benefits to the subject or to others that may reasonably be expected from the research.
d. A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
e. A statement describing the extent to which, if any, confidentiality of records identifying the subject will be maintained and that notes the possibility that the regulatory authorities, IRB, and sponsor’s monitors may inspect the records.
f. For research involving more than minimal risk, an explanation as to whether any compensation is provided 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.
g. 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, and whom to contact in the event of complaints about research.
h. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
2. Additional Elements of Informed Consent – When appropriate, one or more of the following elements of information shall also be provided to each subject:
a. A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable.
b. Anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent.
c. Any additional costs to the participant that may result from participation in the research.
d. The consequences of a participant’s decision to withdraw from the research and procedures for orderly termination of participation by the participant.
e. A statement that significant new findings developed during the course of the research which may relate to the participant’s willingness to continue participation will be provided to the participant.
f. The approximate number of participants involved in the study.
g. A statement that CPHS has reviewed and approved the protocol, including the protocol tracking number.
h. A statement regarding the possibility of sharing study results with participants.
3. CPHS will ensure that the language of the consent document is 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.
4. CPHS will ensure that the information provided in the consent document is in a language understandable to the subject at 6th to 8th grade reading level. CPHS will ensure that technical and scientific terms are adequately explained using common or lay language.
5. CPHS will ensure that the consent documents do not contain any exculpatory language through which the subject is made to waive or appear to waive legal rights, or releases or appears to release the Investigator, the Sponsor, or the institution from liability for negligence.
6. For all research involving test articles regulated by FDA, CPHS will ensure that the consent document includes 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.
Informed Consent Process - The informed consent process is necessary to ensure that subjects or subjects’ legally authorized representatives are fully informed about the research before deciding to volunteer as research subjects. When reviewing a consenting process proposed by the investigator, CPHS shall consider the following:
a. The consent discussion will be conducted by the Principal Investigator, collaborator or a member of the study staff who is authorized by CPHS as a designated person for conducting the Informed Consent discussion.
b. The consent discussion will take place in person. CPHS may approve of an alternate method of obtaining informed consent such as phone, fax, email or mail.
c. The consent will be obtained before performing any study procedures, including screening participants for study inclusion, unless waived by CPHS.
d. Subjects will be approached in a conducive environment. CPHS may determine that it would not be appropriate to approach a subject immediately before a procedure or surgery, while in labor, while under sedation and any other situation where a subject might feel compromised.
e. Subjects will be given adequate time to make a decision about study participation prior to signing the informed consent document.
f. The investigator has provided an adequate plan that minimizes the possibility of coercion or undue influence when consenting potential subjects.
g. The consent process is not a one time event, but an ongoing process throughout the subject’s participation in the research.
h. The information to be communicated to the subject or the legally authorized representative does not include exculpatory language through which the subject or legally authorized representative is made to waive or appear to waive any of the subject’s legal rights.
i. The information to be communicated to the subject or the legally authorized representative does not include exculpatory language through which the subject or legally authorized representative releases or appears to release the investigator, the sponsor, the organization, or its agents from liability for negligence.
The CPHS requires that informed consent must be obtained from the research subject. However, when the subject population may not be able to give an effective consent, CPHS may approve for the legally acceptable representative to provide consent on behalf of the subject.
CPHS will ensure that the investigator provides a written informed consent document in a language that is understandable to the potential subjects based on the study population.
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.
Waiver of Informed Consent - 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:
a. The research involves no more than minimal risk to the participants;
b. The waiver or alteration will not adversely affect the rights and welfare of the participants;
c. The research could not practicably be carried out without the waiver or alteration;
d. Whenever appropriate, the participants will be provided with additional pertinent information after participation;
e. The research is not subject to FDA regulation.
Waiver of Documentation of Informed Consent - CPHS may waive the requirement for the investigator to obtain a signature on the consent document for some or all of the participants if it finds either section a or b below is met:
a. That all of the following are true (only for non FDA research):
i. The only record linking the participant and the research would be the consent document.
ii. The principal risk would be potential harm resulting from a breach of confidentiality.
iii. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
b. That all of the following are true (for both FDA regulated and on FDA research):
i. The research presents no more than minimal risk of harm to participants.
ii. The research involves no procedures for which written consent is normally required outside the research context.
In cases where the documentation requirement for informed consent is waived, CPHS may require the investigator to provide participants with a letter of information regarding the research or utilize a verbal script. The letter of information or the verbal script must be submitted to the CPHS for review and approval.
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 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.
1. 45 CFR 46.116
2. 45 CFR 46.117
3. 21 CFR 50.20
4. 21 CFR 50.25
5. 21 CFR 50.27
6. FDA Information Sheets: A Guide to Informed Consent
7. OHRP Guidance – Informed Consent
REFERENCE TO OTHER POLICIES
1. Initial Review
1. Informed Consent Template
2. Informed Consent Checklist
3. Waiver of Documentation Form
4. Waiver of Consent Form
5. IRB Waiver or Alteration – Retrospective Chart Review Form
6. IRB Waiver or Alteration – Decedent Data Form
7. IRB Waiver Screening and Recruitment Form
8. Genetic Consent Template
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1 Aug 2008
1 Jan 2009
1 Aug 2011