Listen to 3 Quick Takes from experts in the community on the following questions (Time: 20 mins)
- What are five tips for a patient or caregiver to be prepared for informed consent?
- What challenges do participants face while going through the consent process, and what actions can researchers take to improve the process?
- How do we facilitate informed consent for approved therapies?
Key Takeaways:
- Read the consent form fully and allow enough time to ask questions to better understand things like the procedure, risks, and time commitment involved prior to consenting.
- Investigators should explain the processes and procedures in simple, plain language that the participant and family can understand.
- Investigators are obligated to be open about what they know and do not know about the risks, and benefits of the investigational treatment when going through the informed consent process.
- Consent goes beyond the written form. Having an open dialogue with the research team before, during and after you sign the form is important to achieve full participant understanding.
- The decision-making and ICP must evolve as gene and cell therapies get approved. Managing the expectations and outcomes of receiving this type of treatment are very important to making a fully informed choice. See more below on these Special Considerations for CGT.
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What is Informed Consent?
Informed means you are made aware of and understand possible risks and benefits of a treatment, and consent means you have then given permission to proceed with the treatment. It is important to understand that informed consent is a process that begins with the recruitment and screening of a potential participant, the signing of the consent document and continues throughout the individual's involvement in the research or clinical trial and after it concludes.
Clinical trials determine how safe and effective a treatment is, or its potential to slow or stop a condition. However, it is possible the participant will not receive any benefits and be exposed to unknown risks. This is why informed consent is so important and is a process rather than a one-time event. If individuals are unable to provide consent themselves, they should be granted a legally authorized representative (LAR). This is an individual or governing body authorized under applicable law to consent on behalf of the potential participant who would receive the procedures involved in the research.
Researchers must perform 3 steps to properly obtain consent from a potential participant or LAR:
- Educate on the research study: Participants should be given accurate and clear information throughout the entire process in an organized, easy to understand manner, and in a language they understand. This includes understanding their rights as research participants. Investigators should help to ensure the participants' rights are protected.
- Assess and ensure participant understanding: Participants should be given many opportunities to ask questions, and investigators should assess their understanding by asking questions in return. If there is a lack of understanding, the topic should be revisited or further explained.
- Obtain voluntary consent: Participants will decide whether to participate, and there should be no coercive tactics (including force, threats, incentives and bribes) to convince them of a decision.
Many organizations have created guides to assist with the informed consent process, what the forms may include, and questions to ask while deciding whether to participate:
Special Considerations for CGT Clinical Trials
Informed consent is of special importance for the gene and cell therapy field due to the complex nature of investigational trials. A few key pieces to note about these trials are as follows:
- Therapies being investigated in clinical trials are not guaranteed to provide benefit—they’re a series of steps to progress research toward treating diseases.
- Participating in a clinical trial for a new investigational treatment may prevent future participation in other trials.
- There are numerous known and unknown risks associated with gene and cell therapy products. When weighing risks and benefits during the informed consent process, remember that an experimental therapy provided in a clinical trial is not an approved treatment.
Before the ICP takes place, a thorough readiness and resilience assessment should occur. This assessment helps the researcher to better understand the participant and their needs when moving through the ICP. Best practices for assessing patient readiness and resilience prior to consenting to a cell and gene therapy treatment can be found here.
Vulnerable Populations
Gene and cell therapy trials typically involve more vulnerable populations, such as children and adults with impaired cognitive abilities, who are being guided by caregivers. The caregivers are often in a heightened emotional and mental state as well. Vulnerable refers to people in research studies that are more susceptible to the possibility of coercion or undue influence. Children and adults with cognitive impairments cannot typically provide consent to participation, but they should be evaluated for their capacity to provide assent, or willingness, to participate.
The ICP for vulnerable populations should be handled with extra care due to the complexities that may affect their decision-making process.
ASGCT has submitted comments on a draft guidance for the ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’. Some of the key points of the societies position on informed consent are as follows:
- Cell and gene therapy products may have a range of considerations not typical for small molecule drugs which must be adequately and compassionately explained to potential trial participants
- Children cannot provide consent for participation in a clinical trial themselves
- ASGCT agrees additional safeguards are necessary for consenting children
Pros and Cons to Different Informed Consent Processes
Traditional Consent
The traditional and standard way to consent to research involved in a clinical trial involves the potential participant and the investigator meeting face to face, in the same location. It can also occur via mail, telephone, or fax which often refers to processes within e-consent. The standard process is associated with travel costs and time, which is particularly hard to navigate for multi-site clinical trials or individuals and families who live far from trial sites. Over the phone, or e-consent options present barriers for some due to lack of a controlled environment free of distraction, to truly focus on the information being presented.
Teleconsent
One option for improving this process for complex trials, and other research-based programs, is Teleconsent. Teleconsent differs from traditional informed consent by ridding of the in-person and pen-to-paper signature, and instead utilizes video interaction between the participant and the provider followed by a photo-based or handwritten e-signature. The convenience is an advantage, but a larger benefit lies in the improvement of patient-centered care. Teleconsent allows providers to not only explain what is to be consented to, but also allows for follow-up questions and further explanation. It does not require any transportation costs as compared to the in-person method and helps diminish the burden of commute and wait times. Previous solutions to ease these burdens, such as e-consent, require the participant to email or fax the form back, and lacks the ability for the provider to interact with patients to answer questions or concerns while going through the forms. This can prolong the already lengthy process and may contribute to lack of continued follow up in the study.
Call to Action
Many stakeholders play a role in the ICP for potential research participants. There should be less burden on the participant, thorough assessments to gauge participant understanding of procedures, and ways to reduce challenges experienced by patients, sponsors, and clinicians during consent. It will be important to continue discussion on how informed consent may change as the trial moves from investigational therapy to an approved treatment and how this process can be improved for future participants in gene and cell therapy trials.
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