Before we understand the informed consent process, the question arises as to why informed consent is required. Can’t a patient visit the hospital and complete the trial process? Why consent is 1st process before initiating a trial?
The recorded history of clinical trials goes back to the biblical descriptions in 500 BC. The journey runs from dietary– legumes and lemons – to drugs. After the basic approach of the clinical trial was described in the 18th century, efforts were made to refine the design and statistical aspects. These were followed by changes in the regulatory and ethics milieu.
History of Clinical Trials;
- 562 BC – 1537: Pre-James Lind Era (World’s 1st trial reported)
- 1747: James Lind and Scurvy Trial (1st physician who conducted trial)
- 1800: Arrival of Placebo (The word placebo first appeared in medical literature)
- 1932: The “Tuskegee Study of Untreated Syphilis in the Negro Male” begins
- 1937: Sulfa craze
- From 1939 to 1945: Nazi Trial
- 1943: The First Double-blind Controlled Trial – Patulin for Common Cold
- 1947: Nuremberg Code
- 1948 First Randomized Curative Trial – The Randomized Controlled Trial of Streptomycin
- 1964: Helsinki Declaration
During the above-mentioned trials from 562 BC to 1945, no consent was taken for the trials. Due to sulphonamide, thalidomide, and Nazi trials tragedies, during world war II, the Nuremberg Code was introduced considering the ethics and voluntariness of trials.
The brush with thalidomide tragedy helped the U.S. pass the 1962 Kefauver-Harris amendments, which strengthened federal oversight of drug testing and included a requirement for informed consent.
What is Informed Consent?
Informed Consent is the process of consenting for the protection of human subjects in clinical research requires that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized Representative I.e LAR.
The main source of data for subjects considering participating in clinical trials is the Consent Form (ICF). An ICF may be a document that needs a participant’s signature upon participating in a clinical research study. The document should provide detailed information about the study the participant is participating, in and ensure that all the details are given completely, including the risks and benefits of the study.
What is an informed consent Document?
The informed consent document is a document of more than 15 pages and contains all information related to the proposed trial that the patient/subject needs to decide to take part in the clinical trials.
An informed consent document provides sufficiently detailed information on the trial so that the patient/subject can make an informed, voluntary, and rational decision to participate.
The purpose of the clinical study
Expected duration of trial
Periods of trial e.g. 2 period, 3 period
Procedures of the trial
Information on their right to decline or consent to withdraw
Potential risk, discomfort, or adverse effects
Prospective research benefits
Compensation, such as payment or rewards
Whom to contact for questions i.e. Investigator contact number and IEC member contact number
Lastly, as part of obtaining informed consent, a researcher must allow ample time for questions the participants might have. The answers should provide sufficient information without compromising the study.
Obtaining Informed Consent
All of the above-mentioned aspects must be provided to the patient/subject/participant before they are entered into the study. Informed consent must be documented by written consent in language that is reasonably understandable to participants. Most researchers use a written form that the participants sign and date and written proof is valuable in the courtroom settings, if needed.
If you are a life sciences, pharma, or medical graduate, and you want to prepare for ICF;
Let’s develop an informed consent for a study involving the interaction with others. Your informed consent must have:
- The purpose is to study a person’s interaction with others.
- The subject can choose to decline or withdraw the consent
- They will not be part of the study if they choose to decline or withdraw during the trial.
- They can’t be part of another trial.
- And, your name and contact information if they have any questions afterward.
- Purpose of Informed Consent
- Emphasis on respect for people’s rights and dignity
Key to good consent is matching the way the knowledge is relayed to the participant – as Canadian philosopher McLuhan once said, “The medium is the message.”
Clinical research may be a complex subject and touches on difficult science. it’s easy for researchers unwittingly to pepper the ICF with scientific terms and jargon – but this must be avoided at the least cost.
What information does one have to include in a consent Form?
1. What the trial is for and the way it’ll be run
The participant must appreciate the trial is for research purposes, what its aims are, the character of the treatments and therefore the probability for random assignment to everyone, the trial procedure (especially any laboratory or invasive procedures), and which aspects are experimental, they need to understand how long their participation is probably going to last, roughly what percentage other subjects are involved, and therefore the circumstances under which their participation (or the trial in its entirety) could also be terminated.
2. The risks and potential benefits
They must grasp the reasonably foreseeable risks or inconveniences and therefore the reasonably expected benefits (including any expenses or payment for taking part), plus any compensation or treatment available just in case something goes wrong.
3. Responsibilities and confidentiality
Participants must understand their responsibilities also as those of the staff running the trial. They need to appreciate that their identity will remain confidential except that the monitors, the auditors, the IRB/IEC, and therefore the regulatory authorities are going to be granted direct access to their original medical records for verification of clinical test procedures. The participants are going to be informed promptly if further information involves light which will affect them. They need to be told who to contact for further information regarding the trial and therefore the rights of trial subjects, as well as within the event of a trial-related injury.
4. The voluntary nature or participation
Participants must understand that their participation is voluntary. They have the right to refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which they’re otherwise entitled.
5. Additional information
The US FDA requires certain additional pieces of knowledge depending upon the trial. These include a handout that the particular treatment or procedure may involve currently unforeseeable risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), additional costs to the subject which can result from participation within the research, and thus the results of a subject’s decision to withdraw from the research.
The FDA also requires that the next statement be provided to each clinical trial subject: “A description of this clinical trial is getting to be available on [http://www.clinicaltrials.gov/], as required by U.S. Law. This website won’t include information that can identify you. At most, the online site will include a summary of the results. You’ll search this website at any time.”
What are the essential elements of the consent form?
The basic required elements of consent are often found within the HHS regulations at 45 CFR 46.116(a). Also, see OHRP consent Tips.
The regulations require that the subsequent information must be conveyed to every subject:
- a statement that the study involves research, evidence of the needs of the research and therefore the expected duration of the subject’s participation, an outline of the procedures to be followed during the trial, and identification of any procedures that are experimental e.g. laboratory or invasive;
- A description or detail of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the topic or to others which can reasonably be expected from the research;
- Detailed information of appropriate alternative procedures/process/courses of treatment, if any, which may be advantageous to the subject or participant;
- A statement describing the extent, if any, to which confidentiality of records identifying the topic is going to be maintained;
- for research involving quite minimal risk, an evidence on whether any compensation and an evidence on whether any medical treatments are available if injury occurs and, if so, what they contains , or where further information could also be obtained;
- Questions about the rights of research and research topics explain who to contact for answers to questions and whom to contact in the event of a research-related injury to the subject;
- statement that participation is voluntary and willingly, refusal or consent withdrawal of participate will involve no penalty or loss of advantages to which the topic is otherwise entitled, and therefore the subject may discontinue participation at any time without penalty or loss of advantages to which the topic is otherwise entitled.
Additional elements are described at 45 CFR 46.116(b).
To be continue in 2nd article……
Content : Shahenaz Karadesai