Speaker 1: Informed consent is by no means a one-person show. There are so many different stakeholders involved throughout the entire process. Having so many hands involved will ensure quality management of best practice when consenting, and also will create a group-oriented environment reliant on teamwork. In this module we're going to review some of the key relationships between stakeholders involved in the informed consent process. Our learning objectives for this module are to identify the different roles involved in consenting within the research team, to understand the interactions among stakeholders across the informed consent process, to apply checks and balances within team interactions related to informed consent, and to recognize quality assurance measures to ensure safe and proper consenting. Team Science is defined by the National Cancer Institute as a collaborative effort to address a scientific challenge that leverages the strengths and expertise of professionals trained in different fields. So let's take a look closer at some of these different team members. Let's identify some key stakeholders. Here we have a comprehensive list of members involved in the informed consent process. While some roles may seem more involved than others, each are equally important in ensuring quality management across the informed consent. Consider the illustration and that the persons in the colored circle are each a separate stakeholder. Let's say the yellow central figure is the participant, but who are the other players? Some of these include caregivers of the participant, interpretives, if the participant is not of English-speaking origin, the principal investigator, or abbreviated as PI, the clinical research assistants and clinical research coordinators, members of the research staff, hospital staff nurses, if the participant is inpatient, the study sponsor, the monitor, or also part of the CRO, the contract research organization. We've got the regulatory coordinator, institutional compliance and IRB reviewers, and lastly the regulatory authority or the FDA. While each have a different role in study operations, in maintaining study fidelity and in protecting human participants in research, especially throughout the informed consent process, it is important that they work together to get the job done safely and efficiently. So let's put this into a scenario-based example. Mr. James is the participant. Mr. James qualifies for the multiple sclerosis study. He is a 68-year-old man and is retired. He is in a wheelchair because he had a stroke last year and he has not yet regained his balance to stand and walk properly. Prior to his stroke, he was able to get around with a cane. What does he want to know about the study? Mrs. James is Mr. James' wife and she serves as his caregiver. She brings him to and from medical appointments and she is retired as well. Both Mr. and Mrs. James speak Portuguese fluently and speak very little English. So what does Mrs. James want to know and what are her concerns? Who can help them out here? Now let's take a look at Mr. Peterson. Mr. Peterson is a volunteer interpreter who speaks Portuguese fluently. He has been contacted to assist the informed consent process with Mr. and Mrs. James by the research institution. What is his role exactly? Well, as an interpreter, Mr. Peterson can translate the ICF document into the language in which the participant can understand. In this case, he'll be translating the document into Portuguese for the Jameses. Can he provide informed consent though? Well, a quick answer is not really, but he can perform an important role in the consent process by translating that document into Portuguese and assisting in the conversation between Mr. and Mrs. James and the research and the clinical team. And who exactly does this clinical team entail? Well, here we have Dr. Smith. What is Dr. Smith's role here as the PI? He will ensure participant eligibility by signing off on any eligibility encounters and documentation by the research staff. He obtains IRB approval for research and the informed consent form. He's responsible for informed consenting or delegating to a qualified staff member to obtain consent from the participant, such as the CRC. He'll answer any medical questions that the participants may have, as well as concerns. He oversees the safety and risks throughout the trial. He meets with the sponsors and the monitors and the clinical staff and facilitates conversations about the study between each of those members. He will also be responsible for avoiding coercion. Be aware of the patient tendency to agree or expect a cure from the physician during that conversation. As the PI, he's ultimately responsible for informed consenting, but may delegate informed consenting to trained individuals. He can supervise them and sign off on any consent documentation, but he must be looped in on any potential participant conversations. The CRC and other research staff will help to write the informed consent document using the institution's required templates. They can gain sponsor approval of the consent document before sending to the IRB for review. They will submit the consent to the IRB for approval, making necessary edits along the way. They can use official approved versions when consenting the participant if delegated by the PI. They can ensure the correct version of the ICF was used during the consent and in study enrollment files. They can identify participant needs and answer questions as applicable. They'll maintain documentation of process across visits and arrange interpreters when necessary. Throughout the process, team members include checks and balances to ensure quality processes. This can become quite complicated when the staff are managing multiple protocols at different stages of launch and follow-up. They may also be cross-covering for each other's studies in times of illness or vacation. Furthermore, many protocols undergo amendments, which may trigger additional informed consent form amendments and approvals, and sometimes resigning by the participant. It takes everyone to keep things in order. The sponsor representatives and monitors will check that all enrolled patients were consented properly. They'll make sure that correct IRB-approved consent versions were used. They'll verify signature validity, documentation of the informed consent, and that no study procedures were performed prior to the informed consent signing. So what if the monitor sees mistakes or irregularities? This is where they reach out to the site for either an explanation, correction of the error, or further action if needed. The IRB will check and approve the IRB-approved template, protocol, investigator brochure and consent, risk and benefit balance inclusion in the document, methods of recruitment and consent by the site, annual renewals of the documents, and protocol amendments and consent. An institutional compliance offer varies a little bit in that they may conduct internal audits for internal quality checks, compliance reports, patient complaints, and more IRB approvals as needed. These are two very important stakeholders in ensuring quality management across the consent process, making sure that the institution is upholding GCP requirements. Here are 12 tips to ensure quality informed consent. First, make sure that the informed consent represents the risks and benefits for the current study protocol. Second, use the correct IRB-approved version of the informed consent form at all times. Third, determine when a participant needs to sign a new version of the informed consent in the event of a protocol amendment. Fourth, assess participant comprehension through some form of teach-back or quiz feature. Fifth, use an informed consent documentation checklist to make sure that you're hitting all the steps throughout the process. Sixth, prepare study visit materials ahead and double-check the right informed consent form is included. Seventh, study information sheets can aid in the informed consent process but need IRB approval ahead of time. Eighth, will you need an interpreter for this consent? Be ready with a contact list if needed. Nine, translations needed? Those require two-way translations and IRB approval. Again, this needs to be done ahead of time. This should not be a last-minute decision. Ten, follow institutional guidelines for any reimbursements given for the study. Eleven, don't forget that participants should receive updates on the study risks and benefits at the end of the study. Twelve, get help from clinicians if there are protocol and medical questions posed in the informed consent process. Do not wing it. This should be a planned process and you should go into the visit prepared to make the participant feel that you are knowledgeable and ready to give them the consent. It's so important to remember clinical research is a team-based endeavor, including a system of checks and balances. Team science approaches will help ensure a higher quality informed consent process across the board. Here is a knowledge check question for you. Which of the following statements best describes the informed consent process as it relates to quality management? A. The study PI is solely responsible for obtaining informed consent from the research participant. B. The study coordinator is solely responsible for obtaining informed consent from the research participant. C. One benefit of the informed consent process is that it sets a collaborative tone for the research staff and promotes best clinical practice. D. It is the responsibility of the sponsor to ensure the use of the correct ICF version when consenting participants to a study. Our correct answer here is C. One benefit of the informed consent process is that it sets a collaborative tone for the research staff and promotes good clinical practice. A and B are not correct as both the PI or study coordinator can be responsible for obtaining informed consent. The PI is allowed to delegate the task to a qualified employee if applicable. But also the key term here is solely. No one person is solely responsible for consenting a participant. As discussed in this module it is a group effort. D is incorrect as it says the responsibility of the sponsor is to ensure the correct use of the ICF version. That is actually the responsibility of the site and its regulatory department. You always need to check the version and the date approved at the top of your consent before providing it to a participant.