What words come to mind when you hear the word research? Some people think “guinea pig”. Why? Because of abuses of research volunteers in some past studies. One of the most talked about is the Tuskegee syphilis trial. As a result of the poor and unethical treatment of research volunteers, the Belmont Report was formed to ensure the safety of research volunteers. The Belmont Report states that all people taking part must be treated with respect, justice and beneficence. These three words are the guide of how research is carried out today.

Research Leads to Better Health

We take many things about our health for granted:

• Quick pain relief from a pill
• Living a normal life with cancer, diabetes, heart disease or AIDS

All of these things were made possible by medical breakthroughs. 

We are living longer, healthier and happier lives because people volunteer for and take part in research studies. That’s why research volunteers are medical heroes! Because behind every medical breakthrough and new treatment are thousands of people who take part in research studies.

Thank You for Taking Part

If you or someone you know have ever taken part in a research study, THANK YOU! Around the world, people benefit because individuals they have never met volunteer every year to take part in medical research.

If You’re Thinking about Taking Part

If you are thinking about joining a research study, and have questions about what it means to be a research volunteer, this online research center may help you decide to take part. Research volunteers and their safety are the most important part of the research study. There are many ways you are kept safe during a research study.

Safety first – There are research safety rules and regulations at the national and local levels, as well as at the institutions where research is being done. Researchers must know and follow the rules. But you should also know the rules and make sure they’re being followed. 

Know your rights – During the informed consent process, you will learn about the study, why it is being done, how long it will last, what you are being asked to do, any risks or benefits, any costs to you and what will happen if you become injured as a result of taking part in the study. The bottom line is you decide if you want to take part or not. If you decide to take part, you will sign the informed consent document, which is like a bill of rights. It is important to know your taking part is voluntary and you can decide to not take part at any time with no penalty to yourself. At every step of the way it is your choice.

Volunteering is not a permanent job. You have a right to be treated safely and fairly. If you no longer feel safe or confident as a volunteer, you can withdraw at any time. You should tell the research staff that you have decided not to participate anymore, and you can withdraw safely from the study. Or if the study staff or a regulatory group decides that you are no longer protected enough from potential harm or bias, they can withdraw you from the study. There are times when they could also end the study altogether for safety or other reasons.

Know yourself – Not every trial is right for every person. If you don’t meet eligibility criteria or can’t do your part, you might put your health or the study at risk. Eligibility Criteria is a way of determining whether a volunteer is a good fit for a study. For example, think of joining a sports team. A football team might look for someone who is strong or has a good tackle, while a soccer team might look for someone quick who can pass a soccer ball well.

Know the study – Learn what you will be asked to do during the trial, learn about the research plan and what procedures you will have to go through. Be aware of the risks and benefits associated with volunteering for the study. Because this is a research study, you might not get direct benefits. However you are helping others by learning about why the study is being done.

Learn more – Your first source of information about any personal health concerns should be your primary doctor, but you can also get information from top medical journals. These are usually written for scientists and healthcare professionals, so to get information that is easier to understand, try attending medical conferences, information days at your local hospital and look for internet sites that publish summaries of medical information. Your local research center will also be an invaluable resource for you.

Advocacy groups for different diseases and conditions are good resources for people interested in learning more about disease. These groups often provide easy-to-understand information and updates in scientific advances for a particular disease.

The NetWellness section  provides information that will help you connect to the studies that are right for you.

 

Helpful Research Terms

Clinical research: a type of research that involves a particular person or group of people

Clinical trial: a particular type of clinical research that tests whether a new medicine or device is safe and effective

Consent form: One part of the informed consent process (see “informed consent”). A consent form is a document that describes and explains the parts of the study. Each form has at least 8 parts. The parts will cover what the study is about, who can join, what you will be asked to do, any risks or benefits, any costs, any inconvenience, what your information will be used for, and that your taking part is voluntary. After all questions have been answered and the volunteer agrees, it is signed by the volunteer. By choosing to sign the consent form, a person shows that s/he understands the study and is willing to take part.

• Purpose- why the research is being done

• Procedures- what the study involves, including how long the study will take

• Risks- what could happen if you join a study

• Benefits- what you might get out of joining

• Alternatives- what your other options are

• Confidentiality- data you provide is not shared with anyone that you have not agreed can see it

• Cost or compensation- any money you might have to pay or you might be paid

• Questions- names and numbers of the people you can call if you have questions or problems.

• Voluntary- it’s up to you – it’s your choice

Data: the information that researchers get and look at

Device: A piece of equipment made for a particular purpose; especially a mechanical or electrical one. An example would be a pacemaker.

Eligibility: A process of finding out whether a volunteer is a good fit or match for a study.

FDA (Food and Drug Administration): A government agency that monitors and approves drugs and devices before they can be used in the general public; one of the “referees.”

Informed consent: A process that involves talking with a study team about why they’re doing the study, what you will have to do while taking part in a research study, how much time it will take, whether you will be paid , whom to contact if you have questions – everything you need to know about volunteering. Part of the informed consent process includes a consent form (see “consent form”).

Investigator: A professional, usually a doctor, but may also be a nurse, pharmacist or other health care professional; one of the “coaches.”

IRB (Institutional Review Board): A special group of professionals who look over research studies to protect the safety of study participants; one of the “referees.”

Observations: Looking at and learning why things are the way they are.

Participant: A person taking part in a study. Also called a research volunteer or research subject; one of the “players.”

Protocol: The study plan; the “play book.”

Recruitment: Finding and getting people to join a study.

Research Subject: A person taking part in a study. Also called a participant or research volunteer; one of the “players.”

Research Volunteer: A person taking part in a study. Also called a participant or research subject; one of the “players.”

Retention: Refers to the completion of follow-up visits and procedures involved in the study; staying in the study until it is completed.

Sample: A small set of a larger group.

Standard Treatment: The treatment we know works for most people and that usually happens at the doctor’s office or hospital; part of usual care (see “usual care”).

Surveys: The use of written or verbal questions to gather information about people’s thoughts and behaviors.

Usual Care: What you normally get at the doctor’s office; includes preventative health care, routine screenings, and standard treatment (see “standard treatment”).

For more information:

Go to the Research Center health topic.