How Will You Be Protected?
JCI-Human Subjects Research Programs Standards
Sidra Medicine adheres to the highest standards for the protection of research participants, as set by the Joint Commission International (JCI).
Sidra Medicine leadership is fully committed to maintain and continuously improve our compliance with JCI standards for the sole interest of patients’ safety.
Is it safe to participate?
Most clinical research in Qatar is approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are reduced and are outweighed by potential benefits. IRBs are committees that are responsible for reviewing research in order to protect the rights and safety of people who take part in research, both before the research starts and as it proceeds. You can ask the sponsor or research coordinator whether the research you are thinking about joining was reviewed by an IRB. If the study involves drugs or devices or treatments the Minister of Public Health (MOPH) authorization is required.
What are the rights of clinical research participants?Participants are entitled to a clinical research that adheres to all legal and ethical standards. In addition, participants have a right to:
• A clear, transparent Informed Consent process before they agree to join the research
• Withdraw from the research at any point in time
The Informed Consent process aims at answering any and all questions that might be relevant to a participant’s decision to agree or decline to join a research.
What is informed consent?Informed consent is the process of providing you with key information about a research study before you decide whether to accept the offer to take part. Only participants who, after having all their questions answered, sign an Informed Consent form can enter the research.
The process of informed consent continues throughout the study. The research team provides an informed consent document that includes details about the study, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The informed consent document also explains risks and potential benefits. If you do not understand English, a translator or interpreter may be provided. Taking part in a clinical research is voluntary. An Informed Consent document is not a contract.
Therefore, a participant may change his or her decision – any participant has the right to withdraw at any point of the research. A withdrawal will not affect the participant’s relationship with their doctor nor will it result in a loss of benefits to which the participant is otherwise entitled. Potential medical risks of a sudden withdrawal from the research should be detailed in the Informed Consent document.
What are the risks and potential benefits of participating?Clinical research may involve risk, as can routine medical care and the activities of daily living. When weighing the risks of research, you can think about these important factors:
• The possible harms that could result from taking part in the study
• The level of harm
• The chance of any harm occurring.
Most clinical research pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in research of experimental treatments. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to consider and sign before participating in research. Also, a member of the research team will explain the study and answer any questions about the study. Before deciding to participate, carefully consider risks and possible benefits.
Well-designed and well-executed clinical research provide the best approach for you to:
• Help others by contributing to knowledge about new treatments or procedures
• Gain access to new research treatments before they are widely available
• Receive regular and careful medical attention from a research team that includes doctors and other health professionals.
Risks to taking part in clinical research include the following:
• There may be unpleasant, serious, or even life-threatening effects of experimental treatment.
• The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more procedures, hospital stays, or complex dosage schedules.
How is the privacy of participants protected?If a patient agrees to participate, the following are required to be informed:
• The primary physician responsible for the patient's healthcare on a day-to-day basis
• The doctor and research team looking after the patient in the research.
The fact that someone is taking part in a research will be written in that patient’s medical notes. Investigators cannot tell anyone else about a participation in a research unless the patient gives his or her permission.
During the research, all of the information collected about the participants will be kept confidential, as with any other medical records. When investigators publish the results of a research, they are not allowed to include any information that would identify people – a patient’s name will not be used in any reports or publications.
The clinical research protocol will define what is to be done with samples and information of participants. Specific sections within this document will detail for how long samples and information must be kept before they are destroyed.
If samples and/or information are to be used further, then this will be either:
• included in the original research protocol
• be part of the informed consent that a patient signs prior to his participation in the research
• be written up in a specific informed consent which the patient will also be asked to sign