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Informed Consent

In accordance with the Belmont Report Principle "Respect for Persons", the informed consent is one of the most important aspects of conducting a research study. Without the subjects that volunteer to participate, research would only exist in a very limited capacity. The goal of informed consent is to ensure that these volunteers are adequately informed about what the research is about, why it's important, what is expected of the research subject both procedurally and economically, any risks that they may incur because of the research, and ongoing and continuous discussions pertaining to the study and the research subject's participation.

Considering that informed consent is one of the most important aspects of conducting a research study please take a minute to review these slides to acquaint yourself with the informed consent process and the informed consent document requirements:

Consent Process and Consent Document Requirements

THE CONSENT PROCESS

Obtaining informed consent is a process, much more than obtaining a signature on a form. It is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, (IRB approved of course!), verbal instructions, question/answer sessions and measures of subject understanding. IRBs, clinical investigators and research sponsors all share responsibility for ensuring that the informed consent process is adequate. Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator, (Principal Investigator or Co-Principal Investigator) and the subject.

The IRB may conduct investigator file review audits to ensure compliance with FDA regulations, as well as NHRMC IRB's policies and procedures.

Please refer to the following guidelines in regards to obtaining Informed Consent and Informed Consent documentation.

  • The informed consent template located on the IRB website under "Submission Forms" is to be used for all consents in research conducted at NHRMC. The template contains all of the elements of consent as defined by the FDA and HIPAA regulation requirements. The template also includes an instruction page indicating required text versus text that may be modified and sample text. Please use the tracked change feature of Word when making any edits to the document during the review process.

  • The IRB approved copy of the consent form will be stamped "Approved" with the handwritten date of approval, scanned and will be sent to the PI and Study Coordinator electronically for you to use to obtain consent from subjects.

  • Please save the most recently approved version of the informed consent form on a computer drive accessible to all persons approved to obtain consent. Segregate or delete all previous versions of the informed consent form. Mass printing of multiple consent forms is not advised. The consent form should be printed at the time it's needed to obtain consent from a subject in order to avoid the use of an outdated consent form.

  • The subject will need to initial each page. The subject will need to sign, date and initial the last page in the indicated sections.

  • For clinical treatment studies a clinically credentialed person is required to obtain verbal consent for participation in the study, and they must be documented in the research records as PI or Co-PI. This conversation is to be documented in the medical record. A detailed page-by-page review and acquisition of the written consent may be conducted by the study staff. It is the discretion of the IRB, based on the study, as to the credentials required to conduct the presentation and acquisition of the written consent. The written consent is then signed by the PI or Co-PI, the facilitator that presented the written consent and the study subject. If you wish to add or change a PI or Co-PI please do so by submitting an update/submission form to the IRB.

  • The original fully executed informed consent form will be maintained in a secure manner by the PI or study staff in their designated research office. A copy of the fully executed informed consent will be given to the subject. If applicable, a copy of the fully executed informed consent will be included in the patient medical record. The conversation and presentation regarding informed consent with the patient should also be documented in the medical record.

  • If an amendment to the protocol is required that alters the informed consent, or changes are made to the informed consent, the version date of the amended protocol that supports those changes must be indicated in the footer of the revised informed consent.

4. Ensure appropriate signatures and initials are obtained and dated correctly. This is not the end of the consent process! As the study progresses the researcher will continue to inform the subject pertaining to study progression and developments.
1. Present the study to the patient in a relaxed environment with limited distractions. Provide the information on a level the patient can understand. Allow adequate time for the patient to consider the options and thoroughly review the information.
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3. Reinforce the discussion by reviewing the consent form page by page. Allow the patient to ask questions, take the consent form home, and discuss options with friends, family, etc.
2. Patients should comprehend important elements of the information provided. Researchers can assess this understanding by asking the patient questions or asking the patients to explain the information back to the researcher.

 

Waivers of Informed Consent

In certain situations the federal regulations permit the IRB to grant a waiver and/or alter a change in the informed consent process for research studies. For a better understanding of when these waivers are appropriate please review these slides:

Consent Waivers

Additional Training Materials:
OHRP Informed Consent Training Video

 
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