What is clinical research?Clinical research refers to all research carried out on humans. Clinical research is how we develop new treatments and knowledge for better health and care, building the evidence for new approaches that are safe and effective.Clinical research focuses on improving knowledge of diseases, developing diagnostic methods and new treatments or medical devices to ensure better patient care. It is carefully framed, respects a precise study protocol and is only realized under certain conditions. It must:• have the goal of increasing medical knowledge• be carried out by competent persons• take all necessary measures to protect those who lend themselves to research• obtain regulatory approvals and take all the necessary legal and ethical steps• collect the consent of those involved in researchWe work with thousands of patients and public volunteers to conduct research driving the next generation of treatment and care. These studies involve both patients and healthy volunteers.
Clinical trials and studiesClinical trials assess new treatments, technologies or methods, whilst other research studies help better understand health and specific conditions.Some trials and studies split participants into groups, for example giving one group the new treatment and the other the best current treatment or a placebo, which lacks the active ingredient (never given where your health or safety might be compromised).Comparing the results of these groups allows researchers to determine how effective the new treatment is.The main goal is improving existing imperfect and inventing nonexistent treatments to improve patients’ lives. Clinical research requires clinical testing and often randomization to make sure we are giving the best possible treatment to the patients.
Why would you participate?Clinical research is medical research that involves people like you. When you volunteer to take part in clinical research, you help doctors and researchers learn more about disease and improve health care for people in the future. Clinical research includes all research that involves people. Clinical research could include sample collection (blood draw, saliva, etc.) or administering new investigational drugs or devices.
What is clinical research protocol?Clinical research follows a document plan called protocol. The protocol is carefully designed to balance the potential benefits and risks to participants and answer specific research questions. A protocol describes the following:• The goal of the study• Who is eligible to take part in the research• Protections against risks to participants• Details about tests, procedures, and treatments• How long the research is expected to last• What information will be gatheredA clinical research is led by a principal investigator (PI). Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.Research involve larger numbers of patients who are usually randomized to receive the new treatment or the best available current treatment (or sometimes a placebo). They aim to assess and confirm how well the new treatment works, and usually take longer than Phase I or II research to run. These studies, as in the earlier phases, may involve one or more ‘treatment arms’, which allow for the safety and efficacy of the new investigational drug to be compared to other available treatments, or to be tested in combination with other therapies.
What is a clinical research sponsor?Clinical research sponsors may be people, institutions, companies, government agencies, or other organizations that are responsible for initiating, managing or financing the clinical research, but do not conduct the research.
Who takes part in clinical research?Many different types of people take part in clinical research. Some are healthy, while others may have illnesses.Healthy volunteers are needed for several reasons. When developing a new technique, such as a blood test or imaging device, healthy volunteers help define the limits of "normal." These volunteers are the baseline against which patient groups are compared and are often matched to patients on factors such as age, gender, or family relationship. They receive the same tests, procedures, or drugs the patient group receives. Researchers learn about the disease process by comparing the patient group to the healthy volunteers.Factors like how much of your time is needed, discomfort you may feel, or risk involved depends on the research. While some require minimal amounts of time and effort, other studies may require a major commitment of your time and effort and may involve some discomfort. The research procedure(s) may also carry some risk. The informed consent process for healthy volunteers includes a detailed discussion of the study's procedures and tests and their risks.A patient volunteer has a known health problem and takes part in research to better understand, diagnose, or treat that disease or condition. Research with a patient volunteer helps develop new knowledge. Depending on the stage of knowledge about the disease or condition, these procedures may or may not benefit the study participants.These studies involve drugs, devices, or treatments designed to prevent, or treat disease. Although these studies may provide direct benefit to patient volunteers, the main aim is to prove, by scientific means, the effects and limitations of the experimental treatment. Therefore, some patient groups may serve as a baseline for comparison by not taking the test drug, or by receiving test doses of the drug large enough only to show that it is present, but not at a level that can treat the condition.Researchers follow clinical research guidelines when deciding who can participate in a study. These guidelines are called Inclusion/Exclusion Criteria and are listed in the protocol. Factors that allow you to take part in a clinical research are called "inclusion criteria." Those that exclude or prevent participation are "exclusion criteria." These criteria are based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions. Before joining a clinical research, you must provide information that allows the research team to determine whether or not you can take part in the study safely. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe, and to help ensure that researchers can find new information they need.
Commitment to Protection of Human Subject Research
Sidra Medicine is committed to protecting the rights, dignity, welfare, and privacy of human subjects by adhering to the ethical principles set forth in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects. This fundamental commitment to the protection of human participants applies to all research involving humans regardless of sponsorship, funding, or the location of the research. Sidra Medicine engages in human subject research and therefore bears responsibility for protecting participants involved in the research when it intervenes or interacts with living individuals or obtains individually identifiable private information for research purposes.
Sidra Medicine’s commitment to advancing the ethical treatment of research participants, promoting responsible conduct of research, and ensuring and protecting the rights of every human research volunteer is achieved through the Belmont Report’s basic principles:
- Respect for persons – applied by obtaining informed consent, and considering privacy, confidentiality, and additional protections for vulnerable populations
- Beneficence – applied such that the potential benefits of research are maximized and possible risks are minimized to the persons involved
- Justice – evidenced in the equitable selection of research participants.
Our policies and procedures on human research comply with MOPH’s Guidelines, Regulations and Policies for Research Involving Human Subjects, International Conference on Harmonization Good Clinical Practice guidelines and other applicable regulations governing human subjects research.
The process of education, quality, compliance and monitoring as described in our policies and procedures serve to ensure the safe and ethical conduct of research that will protect human subjects in an environment of mutual trust and integrity in the pursuit of knowledge, development, innovation, and growth.
All research involving human subjects overseen and conducted at Sidra Medicine irrespective of funding must be reviewed by the IRB, unless the IRB Office determines that the research is exempt in accordance with Sidra Medicine policy and MOPH regulation. The IRB has the responsibility and authority to review, approve, disapprove, or require changes in research activities involving human subjects.