HSPP- July-August-September, 2021- Newsletter
Informed Consent- Process & Documentation
The informed consent process is one of the central components of the ethical conduct of non-exempt research with human subjects. The consent process typically includes providing a written consent document containing the required information along with an oral presentation of that information to prospective participants. The informed consent process involves the “who”, “what”, “when’, “where”, and “how” that results in a valid, and effective informed consent being obtained from a participant.
The following section presents a general overview of an effective informed consent process and its documentation. Exceptions to this process may be granted by the IRB. Those exceptions are described in IRB policy 2011-008.2.pdf – Informed Consent – Waivers and Alterations.
Who can obtain consent?
The Principal investigator or designated individuals listed on the materials approved by the IRB. Any personnel authorized to obtain consent must comply with human subjects protection training requirements. Individuals who are approved to obtain consent must be knowledgeable of the protocol and prepared to answer questions that may be posed by the potential subjects.
Study personnel who will be obtaining consent should be familiar with the following IRB policies:
- 2011-008.0.pdf– Informed Consent – Forms
- 2011-008.1.pdf – Informed Consent – Process
- 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent
Who can provide consent?
Consent is to be obtained from an individual who has authority to give consent. If the prospective participant is an adult who has capacity to consent, it is that individual who should give consent. When an individual is unable to consent on his or her own behalf, consent must be obtained from a person who has the authority to do so. Investigators should be aware of the provisions described in the IRB Policy 2011-008.5.pdf regarding the conditions and requirements to obtain consent from adults, minors, and legally authorized representatives.
The study protocol and initial study application should identify who will be providing consent (i.e., adult subjects, legally authorized representative (LAR)). If the individual to provide consent is a LAR, documentation of this status must be obtained except when the LAR is the parent of a participant who has not yet reached the age of majority, or attests to being the next of kin. One exception to the next of kin provision is that adults with intellectual disabilities who have been declared incompetent must have an appointed legal guardian provide consent to participate in research. The natural parents of the adult are not authorized to give permission unless they have been appointed legal guardian(s).
When Consent Process must occur?
An informed consent process must be conducted with a potential subject prior to any involvement of the subject in non-exempt research (e.g., prior to any procedures that are done solely for research purposes). It must happen before any interaction/interventions to collect data to ensure that the subject has an appreciation for the study in which s/he may enroll.
The process of consent should continue throughout the study, for example by explaining each visit as it occurs and ensuring the subject is still willing to participate, or by providing new information to subjects as it is learned to ensure they are still willing to participate.
Where Consent Process must occur?
The consent process must be conducted in a setting that affords sufficient privacy to the potential subject. Privacy refers to an individual’s desire to control who has access to him/herself. The setting where the potential participants will interact with the researcher team must be protected from access to the public.
What do you need to obtain Consent from a prospective participant?
The individual obtaining consent must present the subject with a written informed consent form that contains the key information that is most likely to assist a subject in understanding the research, what is expected of them, and the potential risks of harm and potential benefits, if any. The consent form must be written in a language that is understandable to the subject or subject’s LAR, and should be written in lay language using an 8th grade literacy level as a benchmark. The informed consent template and informed consent checklists available on the IRB website should be used to ensure the consent document contains the regulatory and local required elements of consent.
The individual obtaining consent should ensure that the most recently approved and stamped version of the consent form is used when obtaining consent.
How should a consent process be conducted?
The Principal investigator must describe the proposed process of consent in the material provided to the IRB.
This process should begin with allowing the potential subject time to review the consent document, and then a discussion of the key elements of a research study in the subject-preferred language.
The process must be free of any coercion (e.g. a threat of something bad happening if the subject declines participation), and free of undue influence (e.g. a sense of pressure to say yes, because the person obtaining consent is also the clinical provider). The subject must receive the following information:
- that consent is being sought for research and participation is voluntary;
- the purpose of research;
- expected duration of participation and procedures to be followed;
- the risks or discomforts and the potential for benefits to the prospective subject or to others; and
- the appropriate alternatives procedures or courses of treatment, if any, that might be advantageous to the prospective subject.
The consenter should provide ample time for questions, and may ask the subject questions about the research to assess his/her understanding of the study.
In most cases, unless the IRB has waived the requirement to document consent, at the conclusion of the consent process and after the subject has decided to participate, investigators are to obtain a signature and date of signature from the participant on an IRB approved informed consent document. The IRB also require that the person obtaining consent sign and date the form. At this time, a copy of the signed and dated consent form must be provided to the subject along with the Research Participant Feedback Form
The original signed consent form must be stored in accordance with the plans for storage described in the study application and protocol (e.g., consent form is to be filed in a research folder, or in separate secure location apart from research record, or in the medical record).
Notes in a research chart indicating on-going discussions with the subject at subsequent study visits may supplement documentation of the informed consent process.
Educational Resources for Investigators at UConn Health – Informed Consent Process and Documentation
Checklist and Weekly WebEx Sessions
Investigators may use this Self-Audit /Checklist tool along with the IRB Policies listed above to ensure the consent process and its documentation comply with UConn Health IRB Policies.
| SELF -AUDIT TOOL/CHECKLIST | |
|
INFORMED CONSENT PROCESS & DOCUMENTATION |
Consenter Initials |
| The consent process was conducted using the latest approved and stamped consent form | |
| The consent process occurred in a private setting | |
| The consent process was conducted in a language understandable to the subject | |
| The consent process started with a potential participant being given the opportunity to review the informed consent form and it was followed by a discussion about the research | |
| The process was free of coercion or undue influence | |
| The process provided the subject, sufficient time to discuss, ask questions and consider whether or not to participate | |
| Once the subject had all his/her questions answered and had ample time to consider the information s/he decided whether or not to participate. | |
| If documentation of consent was not waived by the IRB (e.g., informed consent form contains signature lines) informed consent process was documented in an IRB approved informed consent form. | |
| The consent form was signed and dated by the subject (or legally authorized representative) in the section assigned to the participant | |
| The consent form was signed and dated by the investigator in the section assigned to the investigator | |
| All names, signatures and dates were entered in the document on the same date and at the same time | |
| After the signatures were entered in the consent form the participant was provided with a copy of the complete signed informed consent document | |
| At the conclusion of the consent process, the investigator provided a Research Participant Feedback form to the subjects. | |
| The signed consent form has been stored in accordance with the plans for storage described in the study application and protocol (e.g., consent form was filed in research folder, or in separate secure location apart from research record, or in the medical record). | |
The HSPP is offering a one-hour WebEx “Informed Consent Process and Documentation” education session every Thursday and Friday at noon time for study coordinators, investigators, first time principal investigator, and students who plan to conduct Human Subjects Research at UConn Health. To register for these sessions please email Mayra Cagganello at cagganello@uchc.edu
Educational Resources for Investigators –OHRP –Simplifying Informed Consent Video
The Office of Human Research Protection (OHRP) has posted a video titled: “Simplifying Informed Consent.” In this video OHRP representatives discuss what goes into a meaningful informed consent. Practical examples are used to illustrate how to discern meaningful information for potential participants, and how to present information simply in consent documents and materials to ensure consent processes fulfill their goal of enabling potential participants to make informed decisions about whether to participate in the research.
To access this Simplifying Informed Consent video please click here
Informed Consent – Process & Documentation – Frequently Asked Questions
Why do I need to use the Main Consent Form Checklist to create my Consent Form?
UConn Health IRB created and posted the Main Consent Form Checklist .doc to assist investigators and research staff when creating consent documents. This checklist outlines the basic and additional elements of a consent form.
Although, not all elements of the informed consent form template will be required for every study, as applicable to a study, the IRB recommends inclusion of all relevant elements noted on this form and reserves the right to require additional elements.
In addition, as applicable to the study design, investigators must use additional consent checklists along with the above one when creating their Consent forms. For example, if the study involves genetic research the investigator must also complete the Consent Checklist – Genetic Research Addendum If the research involves the use of stem cells the Consent Checklist – Stem Cell Research Addendum.doc must also be used. When funding for a study comes from the National Institute of Justice, the Consent Checklist – National Institute of Justice Requirements Addendum.doc. must be used along with the main consent checklist.
Do I need to use the Consent Form Template?
UConn Health IRB created and posted the Main Consent Form Template .doc to assist investigators and research staff when creating consent documents. The IRB strongly recommends investigators to use the standard UConn Health Main Consent Form Template .doc because this template contains all the basic elements, and is tailored to multiple study designs (e.g., consent for federal funded research, consent for genetic research, consent for research subject to FDA oversight). However, this template may not cover all nuances for various studies. You may need to add, delete and/or edit sections to make them applicable to your study.
What should I do if I realized I have not documented the consent process correctly (e.g., the subject did not incorporate the date when signing the Informed Consent Form)?
In the event that an informed consent (IC) form is found to be undated, if the error is not discovered while the subject is present, the research staff should prepare a note to file attesting to the fact that they witnessed the signing of the form, and the date that it was witnessed.
Since this incident was under the control of the study team, this event should be reported to the IRB within 5 days of becoming aware of the non-compliance. The investigator should complete and submit a problem report form via iRIS system.
To avoid this type of issues, investigators obtaining consent should review the IC forms once they are signed/completed, and before the subject leaves that day to ensure that all signatures and dates are properly entered on the forms.
Who may provide consent when a subject is unable to provide consent?
When a potential subject is unable to provide consent because of impaired competency, consent must be obtained from a legally authorized representative (LAR) of the subject. Documentation of this status must be obtained except when the LAR is the parent of a participant who has not yet reached the age of majority, or attests to being the next of kin. One exception to the next of kin provision is that adults with intellectual disabilities who have been declared incompetent must have an appointed legal guardian provide consent to participate in research. The natural parents of the adult are not authorized to give permission unless they have been appointed legal guardian(s).
The investigator obtaining consent from a LAR must be knowledgeable of the IRB Policy 2011-008.5.pdf – “Informed Consent – Providing and Obtaining Informed Consent” which describe in detail who in Connecticut meet the definition of a legally authorized representative.
How far in advance of research participation, can informed consent be obtained?
The U.S. Department of Health & Human Services (HHS) do not identify how far in advance of study entry a subject can provide consent. They explain that the amount of time required by a subject to make a decision would presumably depend on the nature of the study, taking into account, among other factors, the degree of risk, potential benefits, alternatives, and desire to consult with family members or others. HHS recommends reviewing the information contained in the consent form with the subject again if a prolonged period elapses from the date of consent to the date of entry into the study.
FDA Regulated Studies -Compliance with 21 CFR Part 11
Title 21 CFR Part 11 is the portion of the Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. During the COVID-19 pandemic, an FDA enforcement discretion of Part 11 was implemented, which is still in effect. However, this enforcement discretion will eventually end.
If any FDA regulated studies at UConn Health are using work-around solutions from the FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency these systems will need to be discontinued when the Public Health Emergency is declared over.
FDA Sends Warning Letter to Individual Investigator for Clinicaltrials.gov Non-Compliance
For the first time, the FDA sent a warning letter to a principal investigator for a ClinicalTrials.gov record that was not updated in accordance with the law. Civil money penalties currently stand at $12,316 per day until the violation is corrected. Previous warning letters were sent to industry sponsors, but this is the first time the FDA has sent a letter to an individual investigator for non-compliance.
For any questions related to ClinicalTrials.gov, please contact UConn Health’s ClinicalTrials.gov Administrator, Ellen Ciesielski (eciesielski@uchc.edu) for assistance.