Frequently Asked Questions 2018-02-12T13:54:33+00:00

Frequently Asked Questions

Frequently Asked Questions About Clinical Trials and Health Research

Search the topics below to find answers to frequently asked questions about clinical trials and health research.

Do you have a general question about research participation that is not listed here?  Submit your question to info@allin4health.info

Where can I find more information on clinical trials? 2018-02-22T15:28:00+00:00

Where can I find more information on clinical trials?

www.clinicaltrials.gov

www.fda.gov

www.centerwatch.com

www.ciscrp.org

How is my information protected? 2018-02-22T15:28:00+00:00

How is my information protected?

There are guidelines put in place to protect your information.  Information is stored on protected computers. Usually researchers will remove your name and other direct identifiers (like your date of birth) from your information and replace them with a code. There will be a master list linking the codes to names, but it will be kept separate and secure. They also limit and keep track of who sees your information.  In order to work with your health information, researchers must promise not to try to find out who you are. Researchers will tell you if someone accesses your data who does not have permission to do so.

What are the drawbacks of participating in a clinical trial? 2018-02-22T15:28:00+00:00

What are the drawbacks of participating in a clinical trial?

Some clinical trials are drug trials testing how well a new drug works on the condition it is designed for, while others may be testing a new therapy method.  The medication or therapy being studied might cause side effects or might not work at all. You should talk with the study coordinator and physician about all the risks before participating in a study.

Will I be paid to participate in research? 2018-02-22T15:29:53+00:00

Will I be paid to participate in research?

Some studies will pay you for your participation while others will not. Before you agree to participate, you will be told whether or not you will be paid, how much you will be paid, how you will be paid (i.e. check, gift card), and when you will be paid (i.e at each visit/session, at completion). Payment is not meant to convince you to participate but to thank you for giving up your time and to cover any costs you may have incurred by participating (i.e. travel, taking time off work).

Does it cost anything to participate in a clinical trial? 2018-02-22T15:28:00+00:00

Does it cost anything to participate in a clinical trial?

Most clinical trials are funded by the government, pharmaceutical or device companies, or philanthropist, so there is no cost to participate.  All research related visits, medications and tests are often provided free of charge. In addition, there may be reimbursement for your travel, parking and time.  In some studies, researchers may be looking at how well the treatment compares to usual care or the care that is normally provided by your doctor.  In these cases, researchers talk with you at your regular doctor office visits and your standard office co-pay may apply. Researchers will inform you before you participate what payment you will receive and what costs, if any, there are for participating.

 

Are there benefits to being in a clinical trial or health research study? Will I benefit from the research? 2018-02-22T15:28:00+00:00

Are there benefits to being in a clinical trial or health research study? Will I benefit from the research?

In some way, all of us have benefited from the knowledge gained from clinical trials and health research. Any medication you have taken when you’ve been sick was once part of a clinical trial.  Vaccines which help prevent diseases and have even helped eliminate some disease are a result of health research.  Victims of trauma and disaster receive psychological and social support services that were also developed from health research findings.  By participating in a clinical trial or health research study you may not benefit personally, but your participation can benefit humanity by helping researchers to learn more about a certain disease or condition. However, for some studies, you may have access to experimental treatments you may not have been able to receive otherwise that may stop your disease’s progression or lessen its effects on you. 

Are there risks to being in a clinical trial or health research study? 2018-02-22T15:28:00+00:00

Are there risks to being in a clinical trial or health research study?

All clinical trials and health research studies may involve some degree of risk. For studies that just ask you to fill out a survey, the risks are minor, such as asking you questions that make you uncomfortable. For studies that ask you to take an experimental drug, the risks can be much greater; such as having a bad side effects. The research team is required to inform you of all potential risks of before you agree to take part in the study, but if you have any concerns about potential risks, make sure your ask the study team.

What are the risks/benefits of participating in a clinical trial or health research? 2018-02-22T15:28:00+00:00

What are the risks/benefits of participating in a clinical trial or health research?

It is important to note that all trials will have risks and that volunteers have the option to withdraw from a study at anytime and for any reason.  The study coordinator will go over all of the risks and benefits of a study with you before you enroll.  These will also be explained in the informed consent.  Each individual must weigh the risks and benefits in order to decide for themselves if the study is something they want to be involved in.

Why are clinical trials important? 2018-02-22T15:28:00+00:00

Why are clinical trials important?

Clinical trials are important because medicine can’t advance without testing these new treatments to see if they work and are safe.  They help physicians:

  • Find new advances in medicine,
  • Develop new ideas or approaches for treatment,
  • Identify safe and effective treatments,
  • Obtain FDA approval for use of new drugs or devices,
  • Personalize medicine by determining which existing treatments are better for specific patients, and
  • Determine which treatments are the most cost-effective.
I often hear the term”clinical trial.” What is a clinical trial? 2018-02-22T15:28:00+00:00

I often hear the term”clinical trial.” What is a clinical trial?

The term “clinical trial” can refer to a general health research study but it often refers to a specific type of study.  Usually when people use the term “clinical trial” they are referring to a drug or device study.  However, this term has been used for both drug trials and non-drug trials, so it is important to find out what type of study it is before participating.

What is health research? 2018-02-22T15:28:00+00:00

What is health research?

When people are asked about participating in a health research study, they often think of drug studies or other types of medical research, but not all research is to test new medicines or sick people. Some health research studies use questionnaires, interviews, or surveys to gather information on a wide range of subjects, including healthy people, to improve health care, change procedures, or to understand health from the patient’s perspective.

Who oversees health research to make sure it’s safe and fair? 2018-02-12T16:32:25+00:00

Who oversees health research to make sure it’s safe and fair?

All clinical trials and health research studies that involve human volunteers are reviewed by an Institutional Review Board (IRB), primarily the one at Indiana University Purdue University of Indianapolis (IUPUI) located on the IU Medical School campus. The IRB’s primary concern is to make sure that volunteers are safe and that the study is fair and ethical.  The IRB actively monitors each research study until the study is complete.

Any changes to the study must be approved by the IRB before they can take effect, and any new information about risks of the study are required to be reported to the IRB by the researchers.

Why is health research important? 2018-02-12T14:55:45+00:00

Why is health research important?

We all want to live long and healthy lives. Health research includes our physical, emotional, mental and environmental health.  Scientists and doctors who do health research are discovering new and better ways to keep us healthy all around and they are discovering new medicines and treatments for when we do get sick.
Why should I participate in a clinical trial or research study? 2018-02-12T14:49:44+00:00

Why should I participate in a clinical trial or research study?

There are many reasons why people volunteer for clinical trials and research studies.  The following are examples of some reasons people participate:

  • To help others,
  • To help advance science or knowledge about a particular health condition,
  • To possibly improve their own health,
  • To benefit from having a research team involved in their care,
  • To receive more treatment options or work with a specific physician that might not otherwise have been available to them outside the research study
Do all clinical trials involve giving blood or other samples? 2018-02-12T14:43:09+00:00

Do all clinical trials involve giving blood or other samples?

No, not all clinical trials or health research studies involved giving blood, or other biological samples (such as urine or saliva).  Any study that requests biological samples from a volunteer is required to explain this in the Informed Consent document.

Who can participate in a clinical trial or research study? 2018-02-12T13:47:07+00:00

Who can participate in a clinical trial or research study?

Anyone can participate in research studies, including people that are healthy or sick, children and dependent individuals.  Each study has requirements that must be met before a volunteer can take part.  These requirements are called “inclusion criteria” and the requirements that prevent volunteers from participating are called “exclusion criteria.”  These criteria may pertain to age, gender, the type and progression of a health condition, previous treatment history, and other medical diagnoses.

What is Informed Consent? 2018-02-12T13:44:42+00:00

What is Informed Consent?

The informed consent is a printed or web-based form that explains the purpose of the study, any risks, any potential benefits and your rights regarding the research so that you can be informed before agreeing to participate in a study.  It also lists the study procedures so you know what to expect.  You will be asked to read this form prior to participating in any study.  You should receive a copy of this consent form for your records.

What questions should I ask before consenting to participate in health research? 2018-02-12T13:19:30+00:00

What questions should I ask before consenting to participate?

It is important to be well informed before you agree to participate in a clinical trial. Every trial is going to
have different benefits and risks associated with it. The following is a brief list of some possible questions…
  1. What kind of study is this?
  2. Why are you conducting this study?
  3. Where does the study take place (ex. by phone, via mobile app, at a medical clinic)?
  4. What will I have to do (ex. fill out a survey, donate biological samples such as blood or saliva, participate in a focus group, try a new medical treatment)?
  5. Does this study involve a new medication or medical device?
    1. If so, are there any side effects?
    2. Is the treatment available outside of the study?

Normally these types of questions are already addressed in the Informed Consent but do not be afraid to ask if the answers are not immediately clear.

Even if you consent to participate in a clinical trial, you always have the right to withdraw.  By asking the right questions and talking with the research team, you can find out if a clinical trial is a good fit for you before agreeing to be part of the study.

How much time will I have to commit if I decide to be in a research study? 2018-02-12T13:09:29+00:00

How much time will I have to commit if I decide to be in a research study?

The time commitment depends on the type of study. Surveys may take 10-20 minutes. Focus groups may take 1-2 hours. Treatment studies could take months or years, but you may only be asked to come in once every few months. It all depends on what the study is looking at. The time commitment will be clearly outlined in the informed consent, but you should always be sure to ask the study team if this is a concern before agreeing to take part in the study.

“My experience in three clinical trials has been phenomenal. Although not cured, my quality of life for the nearly four years since diagnosis has been excellent. The professionalism and compassion of my [physician], the nurses, and staff have been truly exceptional.”

IU Clinicial Research participant at Indiana University School of Medicine

“Research studies not only offer the potential for improved treatment to the individual clinical trial participant, but very importantly, provide the means for development of improved and safe therapies.”

IU Clinicial Research participant at Indiana University School of Medicine