7 Things to Know Before Becoming a Clinical Research Participant

Updated on March 22, 2020
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Kawai has been in the clinical research industry for over 10 years, with experience monitoring, auditing, and project management.


Research studies are critically important in the effort to uncover better, faster, and safer treatments and diagnostic options. The Covid-19 pandamic is a example of how research is vital to develop life saving vaccines and drugs.

Research can also help us to understand trends and patterns in our society, which can then inform changes that may need to be made to the healthcare system. With so many benefits, research has become an integral part of our lives, and we may increasingly find ourselves being approached to participate in a study.

Before researchers embark on their work, they are expected to follow very specific guidelines that ensure the protection of the participants' rights and well-being. However, there will always be opportunities for mishaps or lapses to occur during research studies.

Therefore, if you are considering becoming a participant in a research study, it is important that you understand what to expect, which guidelines are in place to protect you, and which questions you should ask to help you decide whether to participate.

I have worked in the clinical research industry for over 8 years. Based on what I've learned, here are the top 7 things you should know before you take part in a study.


1. Understand Your Rights as a Participant

Knowing your rights can protect you during the course of the study. These include:

  • Being able to make an informed decision to participate in a research without coercion, duress, deceit or undue influence. Your participation is completely voluntary and you should not feel pressured to take part.
  • Being able to withdraw from research studies at any time, even after you have provided consent previously. Your withdrawal should not have any effects on your treatment or relationship with your healthcare provider conducting the research.
  • Having access to information regarding the research. You should be informed of the study purpose, all the procedures involved, what aspects in the study is experimental and what is routine clinical practice, the drugs or devices used in the trial and the potential risks and benefits to you.
  • Being able to have to time to consider participation and ask questions if you are unsure.
  • Having access to treatment if you encounter any complications as a result of the research.


2. Know What to Expect

Different research studies will require different commitment levels from you as a research participant. Some research studies may only require you to complete one study visit while others may require you to attend multiple visits for months or even years. You may need to donate blood samples, take study medications, chart your diet using diaries, monitor your vital statuses like blood pressure, answer questionnaires, etc.—there are many possible combinations of things you may need to do in a research.

Therefore, it is important to know the study expectations to understand if you can fulfil the requirements. Researchers put in a lot of time, effort and money to start and maintain a study. So if you are unable to commit to the time required or be discipline enough to follow the instructions and do what is expected of you, don't take part in the research.


3. Understand the Risk and Benefits

All research studies carry some degree of risk. For example, for simple studies involving only the completion of questionnaires, the risk in the study include a potential breach of your personal information. For high risk studies such as drug trials, there are of course higher risks such as suffering from adverse reactions to the drug.

In addition, you need to also understand that not all research studies will directly benefit you. Some studies are only meant to increase general knowledge of particular diseases so it may eventually benefit the general public - these type of studies do not have immediate and direct benefit to you.

Before you take part in any study, you have to make sure that all the risks and benefits are clearly explained to you.

In addition, if you suffer from any injury or adverse reaction as a result from your study participation, you should request for medical attention - and all expenses to treat your injury or adverse reaction should be bore by the study, not by you.


4. Ask About Alternative Treatments

One common concern in research is the concept of therapeutic misconception. Many researchers are physicians and may ask their patients to become research participants in their study, if deemed eligible. However, some patients may think that the study is just another routine clinical treatment option and they will readily take part in the study because their treating physician had asked them to.

However, you must remember that a study is not a standard treatment option. It is to test something that has yet to be proven. As such, you should ask for alternative treatment options (not study related) as well when your physician asks for your study participation, so you can make an informed choice on whether to join the study.


5. Find out About Reimbursements and Additional Expenses

It is not ethical to offer payment or gifts to individuals just to entice or encourage them to take part in studies. However, it is acceptable to offer payment or gifts if these are considered reimbursements of an individual's time in the study and money spent travelling to and fro the research centre.

For example, some research studies require research participants to make additional trips to the research centre (more than what they would have normally done) or spend long hours at the research centre completing certain tests (which may take time away from their work). As such, research participants are compensated with small amounts of money or gifts for their study involvement.

Some paid research studies may offer high sums of money (up to thousands of dollars) to research participants. These studies, such as phase one trials, usually require a lot of time commitment from participants. Many individuals may be enticed by the high amount of money that phase one trials offer. However, it is important to understand the high risks involved in phase one trials - they are considered high risks as they are usually first in human trials whereby the investigational drug is first introduced to humans.

It is also worthy to note that reimbursements should be prorated - meaning that if a paid research study has e.g. ten visits and each visit's reimbursement for your time and transport fee is $50, you should be given $50 after each visit and not be given a lump sum (i.e. $500) only at the end of all your visits. This is to prevent research participants from feeling the need to return to the research centre simply because the researchers owe them the reimbursement fee.

Besides knowing what reimbursements each study may offer, you should also ask researchers if there is any additional cost that you may need to incur as a result of your study participation.


6. Know Where to Seek Help

Before each study involving research participants can be initiated, they must be reviewed and approved by an ethics committee. Ethics committee consist of scientific and nonscientific individuals who will review research proposals to ensure that the study designs are sound and participant's rights and safety are protected. The ethics committee will also continue to monitor the research centre to ensure that they are compliant to research policies after approving the study.

If you encounter any problems with the research centre, you have the right to report the study to the ethics committee, who will independently assess your case and conduct the necessary investigations to safeguard your rights and welfare.

7. Take a Copy of the Signed Informed Consent Form

For most research studies, especially complex trials, you will be required to sign a consent form to document your agreement to join the study. The person who obtained your signed consent should also sign the same form.

You should remember to take a copy of the signed consent form home, as this document will provide you with all the important information you need regarding the study (such as the study's purpose, procedures, your rights, reimbursement details, important contact information, etc.).

Have you ever taken part in research studies?

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To Summarize...

The things you need to know before becoming research participants include:

  1. Understand your rights as a participant
  2. Clearly know what is expected of you as research participants
  3. Understand the risk and benefits of the research
  4. Ask about alternative treatments
  5. Find out about reimbursements and additional expenses
  6. Know where to seek help
  7. Take a copy of the signed informed consent form

I hope you now have a clearer idea of the various factors you should consider before taking part in a research study.

This content is accurate and true to the best of the author’s knowledge and does not substitute for diagnosis, prognosis, treatment, prescription, and/or dietary advice from a licensed health professional. Drugs, supplements, and natural remedies may have dangerous side effects. If pregnant or nursing, consult with a qualified provider on an individual basis. Seek immediate help if you are experiencing a medical emergency.

© 2016 Kawai


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