Frequently Asked Questions
Find out what to expect before joining a clinical research study at NHG Health, including your rights, responsibilities, and how your safety is protected.
Choosing to participate in a research activity is a very important decision.
The following information is written with the aim to help you understand the issues surrounding research and perhaps address some concerns relating to participating in research.
It is often helpful to talk to a doctor, family members, or friends about deciding to join a research study.
About Clinical Research
What is Clinical Research?
Clinical Research is research conducted in human volunteers to answer scientific health questions. Clinical Research helps to determine the safety and effectiveness of experimental drugs or devices. Clinical research is commonly described as a “Clinical Trial”, “Clinical Study” or an “Experiment”. Clinical Research is not the same as Clinical Treatment.
Why is Research important?
Research is an essential process in the search for better, faster and cheaper alternatives to existing treatment and diagnostic options. Research has the potential to uncover important knowledge that can improve our quality of life.
What are the various types of Research?
There are many unanswered questions in healthcare. Research studies are designed to answer some of these questions. The research design varies with the research question being asked. Some of the more common types of research are:
Interventional research is designed to determine whether a new treatment, new combination of drugs, a new device, a new surgical intervention, or new radiation therapy is safe and effective.
Prevention research is designed to look for better ways to prevent disease. These include research on drugs, vitamins, vaccines, minerals, and lifestyle changes.
Diagnostic research studies are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening research studies test the best way to detect certain diseases or health conditions.
Epidemiological research tries to answer health issues in large groups of people or populations in natural settings.
Quality of Life research explores ways to improve comfort and the quality of life for individuals with a chronic illness.
What happens during a Research Study?
The Research Team, which may include Doctors, Nurses and other healthcare professionals, will check the health of the Participant at the beginning of the Research Study and screen the Participant using specific inclusion / exclusion criteria.
A Participant who is found to be eligible will be enrolled into the research study, should he or she consent to participate in the research, and the research team will perform the research related activities according to the research protocol. Research Participants might have more tests and doctor visits than patients who are not participating in the research.
What are phases of Clinical Trials?
The process of development of a new drug involves various phases. Before a drug is study in humans it undergoes extensive pre-clinical testing. Here is a simple description of the four phases of a clinical trial:
Phase I: This first phase is carried out to assess the safety of the new drug. Only small groups of volunteers (20-80) are recruited for this phase.
Phase II: Once a drug is shown to be safe in Phase I testing, it goes on to phase II trials to test the efficacy. In Phase II, a larger group (100-300) of patients with the disease is involved.
Phase III: During this phase, the drug efficacy is determined, and larger group of population (1,000-3,000) is recruited. Results from phase III helps pharmaceutical drugs gain further knowledge on the drug's effectiveness, benefits and range of possible adverse reactions.
Phase IV: This phase is also known as the post marketing phase. Phase IV clinical aim to determine how a particular drug compares to other currently available drugs especially with regards to long term safety, efficacy and cost effectiveness.
What is Randomization?
In some Research Studies, Participants are randomized (equivalent to "tossing of coin") into treatment groups. In some of these studies, neither the Participant nor the Researchers may know what treatment the Participants would receive during the Research Study.
Who sponsors Research
Research is sponsored or funded by various bodies such as hospitals, foundations, voluntary groups, and pharmaceutical companies, in addition to government agencies such as the A* STAR and National Medical Research Council.
Participating in Research
Why do people participate in a Research Study?
There are various reasons why people volunteer to be a research participant. The usual reasons why people participate in a research study are that they feel they are able to play a more active role in their own health care, gain access to new research treatments before they are widely available. Many people also participate in research for an altruistic reason - to help increase medical knowledge that will help future patients.
Who can participate in a Research Study?
Each research study has a specific set of criteria to determine who can participate in the research, known as the eligibility criteria. The factors that allow someone to participate in a research are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on factors such as age, gender, the disease under study, previous treatment history, and other medical conditions.
The inclusion and exclusion criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the research questions they plan to study. Before joining a research, a participant is screened using these criteria to determine whether he or she qualifies for participation in the study.
Is it safe to participate in Research Study?
Many people fear that participating in medical research will result in them taking drugs of unknown dosage or undergo some unproven dangerous treatments. Some may have concerns where and how the research results may be used or who will gain access to the results.
The ethical and legal codes that govern medical practice also apply to research. In addition, there are numerous regulations and guidelines that have in place safeguards to protect the participants.
NHG Health has a robust Human Subjects Protection Program to protect the safety and well being of research participants. All research studies conducted in NHG Health are reviewed by an independent ethics committee called the Domain Specific Review Board (DSRB). Only research that is approved by the DSRB can be conducted in NHG Health. The DSRB is composed of medical doctors, paramedical staff, statisticians, and lay people who collectively review all research proposals to ensure that the research is ethical and the rights, safety and welfare of research participants are protected.
What is Informed Consent?
Informed consent is the process in which the researcher provides adequate information to a potential participant to assist him or her in making an informed decision on whether or not to participate in the study. This information includes details about the study, such as its purpose, duration, required procedures, potential risks and potential benefits. The participant is provided with an Informed Consent Form with all these details. The participant is given the time to think carefully about the study and the opportunity to ask questions before making a decision. Informed consent is not a binding contract, and the participant may withdraw from participating in the research at any time.
What should you consider before participating in a Research Study?
If you are interested in participating in a research study, you must find out as much as possible about the study prior to making a decision whether or not to participate in the research.
Most of this information can be found in the Informed Consent Form for the study. For example, you may ask about the following:
Study Details:
What is the purpose of the research study?
What procedures will be followed in this study?
What are your responsibilities in this study?
Medical care:
What is not standard care or experimental in this study?
Who will be in charge of your care?
Would you be able to continue to see your own doctor?
Who to contact if you experience adverse events?
Possible Risks and Benefits:
What are the possible risks and side effects?
What are the possible benefits from participating in the study?
Would it be necessary to practice contraception during the study period?
What are the alternatives to participation?
Costs and Compensation:
What are the costs & extra payments if you participate in the study?
Could you stop participating if you change your mind?
Would there be compensation for research related injury?
Other issues:
What are the measures in place to protect confidentiality of your medical information?
Would you have access to the study treatment after the completion of the study?
Who is conducting the research study?
What are your responsibilities as a Volunteer Research Participant?
As a volunteer research participant, your responsibilities are:
To understand the information given and clarify any doubts you may have before agreeing and giving consent to participate in a research study.
To attend the scheduled medical appointments and take the medication (if any) as scheduled by the research study.
To inform the research study investigator of any side effects or changes that you may experience.
To answer any research questionnaire or survey truthfully.
To abide by the rules and regulations stated in the research study procedure.
What are your rights as a Volunteer Research Participant?
As a volunteer research participant, you have the right to:
Be informed regarding the nature, purpose, potential risks and benefits of the study.
Be informed of alternative medical treatments.
Ask questions regarding the research.
Withdraw from the research without penalty or loss of benefits to which you are otherwise entitled to.
Make an informed decision regarding your participation without undue influence, duress or coercion.
What are the possible benefits of participating in a Research Study?
A research study that is well-designed and well-executed enables the participant to play an active role in their own health care, gain access to new research treatments or research drugs before they are approved for use, and help others by contributing to medical research.
What are the possible risks of participating in a Research Study?
New drugs or procedures may have side effects that are unknown. New drugs or procedures may also be less effective than current available treatment. Even if a new drug has benefits, it might not work for you.
What happens if I suffer an Adverse Event or an Emergency while participating in a Research Study?
Should you experience any adverse reaction or has an emergency during a study; you should inform the treating doctor and contact the researchers immediately.