Informed consent is an ongoing process that must occur before any clinical trial-related procedures are started. Informed Consent Process:
- The PI discusses the trial’s risks, benefits and other aspects with the potential participant and, if required, the participant’s legal representative, before the trial begins.
- The PI gives the potential participant the time and opportunity to ask questions about the trial and discuss it with relatives and family members.
- If the potential participant decides to get involved in the trial, he or she provides voluntary consent by signing and dating the written informed consent document of which he or she also receives a copy. The participant has the right to withdraw consent at any time without penalty, repercussions or reason.
While the PI may delegate the task of administering and obtaining informed consent to a qualified individual, he or she is ultimately responsible for ensuring the process is conducted properly.
Elements of Informed Consent Document
The informed consent form, which is a legal document, must include 20 ICH-required elements. They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers’ rights.
The document must also have at least two signature and date lines: one for the participant and another for the health care professional conducting the informed consent discussions with the participant.Both documents must be easy to read and understand for both the provider and the participant.
Revisions to Informed Consent
Informed consent documents must be revised every time new safety information becomes available or there is a change in trial procedures, participant compensation or personnel noted on the consent form. Revisions to the informed consent document must be approved by an IRB/IEC prior to its use, and the informed consent process with the new information and documentation needs to be repeated with every clinical trial participant. The participant is then required to sign the revised form.
What is an IRB?
An institutional review board (IRB) is a group designated to protect the rights, safety and well-being of humans involved in clinical trials by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC will review all clinical trial protocols and the benefit vs the risk for study participants. Their main objective is to outweigh any benefit to any harm that a human may have related to the study. The review all study-related materials before and during the trial. The IRB is required to operate in accordance with national and/or local regulations as well as with ICH good clinical practices (GCPs) guidelines
Local and Central IRBs/IECs
There are two types of IRBs: local and central. Local IRBs are functions of the academic institutions that conduct research and review only their trials, while central IRBs/IECs provide review services for multiple entities.
GLMR utilizes a central IRB for all documents in relation to studies performed within our research group.
IRB Responsibilities Before, During and After a Trial
Prior to patient enrollment in a clinical trial, the IRB must review all study-related materials in an initial review. The IRB will conduct periodic reviews as well for the duration of the trial. Continuing reviews can take place once a year and include the entire trial.
Investigator Responsibilities for Compliance
The principal investigator (PI) is responsible to meet compliance with any IRB requirements. They may deviate from the study protocol without prior IRB approval only to eliminate immediate safety hazard to a study participant. In addition, the PI must notify the IRB of any deviation from the protocol as soon as possible.
A few of the Regulatory Documents that you should be familiar with prior to starting a trial are:
- 21 Code of Federal Regulation (CFR) Part 50 – Protection of Human Subjects
- 21 CFR Part 54 – Financial Disclosure by Clinical Investigators
- 21 CFR Part 56 – Institutional Review Boards (IRBs)
- 21 CFR Part 312 – Investigational New Drug Application
In addition, you must be familiar with good clinical practice (GCP), which refers to the principals and processes you are expected to follow. We supply you with the link to complete this training prior to the trial start date.
What are the documents that I have to sign?
We will provide you with the necessary documents to complete each trial. There will be forms that require your signature for each individual study. These documents are listed below.
Required documents for an investigational new drug trial in the United States include:
- Confidential disclosure agreement (CDA)
- Form FDA 1572
- Protocol, amendments and signature page
- Investigational drug brochure (IDB), also called investigator’s brochure
- Curriculum vitae for the principal investigator (PI) and subinvestigators
- Investigational review board, (IRB)/independent ethics committee (IEC) approval letter and roster
- Laboratory certifications and normal ranges
- Investigator’s financial disclosure statement
Have your site inspected. A clinical research associate (CRA) who represents the sponsor or a CRO will conduct a pre-study site visit (PSSV) at your site to evaluate your experience, expertise and interest as well as your staff, facility and potential patient population available for the clinical trial. There are also several other items the CRA will want to discuss with you during the visit, including whether or not you are doing any competing studies within the same time period.
Get IRB approval. An institutional review board (IRB) is a group designated to protect the rights, safety and well-being of patients involved in a clinical trial by reviewing all aspects of the trial and approving its startup. You will be required to obtain IRB approval for the study at your site.
Sign the contract. A contract between you and the sponsor or a CRO needs to be signed before the clinical trial starts. The document usually contains your responsibilities, including the number of subjects you are expected to enroll, timelines for enrollment and the regulatory requirements. It also includes the sponsor’s responsibilities, including financial compensation and how it will be paid. Most sponsors follow a fee-for-service model, meaning they pay for actual work performed, such as subjects enrolled and subject visits.
Prepare for a site initiation visit. A CRA will conduct a site initiation visit (SIV) after the IRB has given its approval and the contract and all essential documents have been completed. The purpose of this visit is to assure that everything is in place for you to begin enrolling patients.