Prior to being released on the market, new medications and products must first undergo clinical trials. A clinical trial assesses the effects of new medications or products on specific medical conditions. The data produced under the study can include details about dosage levels, contra-indications, food intake and other applicable information. However, the cornerstone of successful medical studies is informed consent. If you’re considering enrolling in a clinical study, then knowing about informed consent and what it entails is key. Here is what to know about informed consent in clinical studies at Altus Research.
Informed Consent in Medical Studies
The available slots for volunteers are based on a variety of factors relevant to the study. This might include age, gender, weight, health status, and other variables. Under the principle of informed consent, researchers must disclose any risks that might affect participants.
Informed consent ensures that all participates understand the scope of the clinical trial. This includes:
- Being informed about any potential risks and benefits from the study.
- Being given information about any deviations from established medical procedures.
- Being given the opportunity to opt out of the study without consequence.
Obtaining Informed Consent
The process of obtaining informed consent by participants is done through the documentation provided by clinicians. There is no standardized formula to use for compliance, but there are specific elements that must be included.
Informed consent forms will indicate:
- The number of participants.
- A statement of findings produced by the study.
- The opportunity to discuss the informed consent documents with an advocate.
- The amount of time given before the study commences.
- An opportunity to disclose any influences, conflicts of interest, or coercion.
- Any legal disclosures, rights, and responsibilities.
- An opportunity to ask questions.
Participants must be informed in writing about the nature of the research being conducted, the amount of time required, and a general statement of why the research is being done. Additionally, all procedures must be described to each participant in writing. Confidentiality statements protect the information of the participants.
Experimental procedures and any potential risks must be disclosed, and this includes any possible side effects. If there is an unusually high level of risk involved, participants must be informed about their capacity to obtain treatment or remuneration in the event of an injury. Research participants must understand how to obtain additional information, and they must sign an agreement indicating voluntary participation.
The informed consent documentation must give the participants the right to refrain from receiving treatments without any form of retaliation or denial of benefits. They have the right to stop participating in the trial at any time. Potential risks must be disclosed to pregnant women. Participants must be made aware of any costs or potential harm that could occur if the study is ended abruptly.
Altus Research in Lake Worth, FL
Informed consent must include a full disclosure of the scope of the study, potential benefits and risks, and the volunteer’s legal rights. Study participants have the responsibility to read the informed consent documentation and ask for clarification if needed. At Altus Research, we can help you learn more about clinical studies and what to expect as a participant. Schedule an appointment at Altus Research in Lake Worth, FL by calling or filling out our online form.