Frequently Asked Questions About Research

There are many reasons why people volunteer for research studies. Some studies test the effects of potential new drugs/treatments for a disease or condition and participation allows someone to have access to these treatments before they are available to the general public. Another reason people volunteer for research is to benefit society and help others. They want to be a part of discovering or advancing treatments for those with similar illnesses or loved ones who could become ill. General knowledge of the human body, as well as the discovery of better treatments, cures, and prevention methods would not be possible without research participants. Every medication that we take for our own health conditions is only available because other people have volunteered to participate in research.

The short answer is everyone! Patients may benefit directly from participation or from future discoveries made based on information learned as a result of a research study. In addition, medical professionals may be given access to more treatment options for patients, as well as a greater understanding of a health condition or potential treatments as a result of research done.

While many people think of research as being performed in laboratories and hospital rooms, there are a variety of settings where research studies take place. These settings include (but are not limited to) academic hospitals, private practices, research clinics, community centers, schools, churches and even in the home (e.g., online, telephone, telehealth visits, etc.).

The requirement of a hospital stay depends on the study, and every study is different. Some studies may require hospital stays, however, many studies are completely outpatient and will not require overnight hospital stays.

Depending on the study procedures, it may only be possible to conduct the study in certain places in order to have access to specific study staffand/or resources (e.g., lab facilities, MRI scanners, research pharmacies). Study sites may also be selected based on whether or not there is a large enough group of people in the area who would meet the criteria to participate.

There are many ways in which a patient may initially hear about a research study. Sometimes doctors may share a patient’s information with the study team if they think they may be a fit for the study, however, it is not usually a requirement that doctors refer you to a study. Additionally, people may learn about research studies through websites, advertisements, or flyers. Lastly, some institutions, like MUSC, are research institutions that employ an “opt-out” model of recruiting for research studies. This means that, because MUSC is an academic medical center that prioritizes research, if you are an MUSC patient, you may be contacted by a study team about research opportunities unless you have “opted-out” of receiving this contact.

Research, in general, is open to everyone; although, each study has its own unique desired participant population and eligibility criteria.

This is one of the most common questions people have about participating in research. Every study has what is called, “eligibility criteria.” This criteria consists of both a list of items necessary to include someone in a study, as well as those that would cause someone to be excluded. Criteria are based upon what question(s) the study is looking to answer, as well as protecting the safety of participants. Examples of basic criteria included in some studies are: age, gender, specific diagnoses, etc. If you are interested in the study and contact the study team, they will help you determine if you meet the study criteria. Additionally, a patient’s doctor may believe that a study could be a good fit for their patient and, therefore, suggest the study as a treatment option. Some studies with very specific eligibility criteria may require you to come in for a study visit and consent to having certain procedures performed to make sure you meet all of the eligibility criteria before being enrolled in the study.

Not all studies require an illness or health condition to participate. Although some research studies are investigating a particular illness or health condition, there are other studies that use healthy volunteers. Studies involving healthy volunteers range from surveys and questionnaires to treatment studies (those investigating a drug or device).

Depending upon the type of study, and how it’s designed, children may be eligible for participation. Although, it is very important to note that there are many special protections and rules governing research involving children. Parents or legal guardians must give consent for their children for most types of research involving children. In addition to parental consent, children of a certain age are asked to provide “assent” (or agreement) prior to participation.

Absolutely not! Participation in any research study is always voluntary, and declining to participate will not impact the level of care a patient receives. However, participating in studies can provide patients access to treatments not yet available to the public and, therefore, health care providers may discuss study participation as a possible treatment option with their patients.

Participation in research is voluntary, and one should never feel pressured or forced to enter into a study. Even after a person is enrolled in a study, they can withdraw at any time with no penalty or effect on level of care provided.

Depending on the type of study (especially for studies involving an investigational drug or device), it may be a necessary for a patient to discuss the study with their doctor and go over any important paperwork related to the study. This enables the doctor to give well-informed input to the patient. Sometimes, the provider may wish to speak with study staff before providing any guidance or recommendation to the patient regarding participation in a study.

It is quite common for investigational drug studies to use placebos. A placebo (also called “shams” when used in device studies), is something that appears to be "real" medical treatment (pill, shot, IV), but it does not contain the active substance meant to affect health. Placebos are one way in which researchers can ensure that any significant results (e.g., treatment effectiveness) are due to the intervention itself and not some other factor (eg. psychological). However, not all studies use placebos.

When a placebo is used in an investigational drug or device study, a process called randomization or “random assignment” is applied. Randomization is a process in which study participants are assigned to a group by some method that uses chance alone. Day to day examples of random assignment are flipping a coin or drawing names out of a hat.

In studies that use placebos and/or shams, many times participants will not know what treatment group they are in. This means that the participants are “blinded.” Blinding is used to eliminate the placebo effect (improvement based upon a participants’ belief and/or expectation that a treatment will help them). Sometimes, following the completion of a study, participants will be informed about what treatment they were given. Study staff will have information regarding if and when participants will receive information about their treatment group. An “open label” study is a study where participants are not blinded as to which treatment they are given; therefore, if a placebo is used in an open label study, participants know they are getting it.

Yes, it is possible participants may not receive treatment for their condition if enrolled in a study involving a placebo. If you are concerned about participating in a study involving a placebo, consult your health care provider and the study doctor for more information and to discuss your options.

No, there are many different types of research studies that would not require you to taking medication or undergo a procedure. Some examples include, but are not limited to: surveys, focus groups, or collecting specimen samples (eg. blood, saliva, urine) from you.

Every study is different; therefore, what happens during a study is unique to that study. Study activities are dependent on a study’s design, which depends on the questions the study is trying to answer. Just as study activities are unique to each study, the length of study visits (as well as the length of a study itself) can vary greatly. Some studies only require one 30 minute visit or procedure, for example, while other studies may last for years and require monthly visits that last several hours. The study team will discuss the activities, length of time, etc. with you before you agree to enroll in the study, so that you can make the most informed decision.

There are many reasons why there may not be a research study for a disease or health condition. One reason is there may not be enough patients with the condition to answer a research question. For example, research into rare conditions may not possible due to too few patients having that condition within a particular area. Another reason research studies may not be available is the treatments/therapies are very new and/or high risk (for example, stem cell therapy). In situations such as this, the possible risk could outweigh the potential benefit; therefore, research studies involving human participants may not be approved until further research (for example, using small animals such as mice and rats) showing less risk and/or more benefit is available. Another common reason for which a research study might not be found is that there are not sufficient resources (e.g., funding, personnel, equipment) to properly perform the study in that particular area.

Before deciding to participate in a research study, there are many questions to which a person may want answers. Many of these questions will be answered during the study team’s review of the Informed Consent Form (ICF) with the participant. The ICF includes important, relevant information that is needed for a volunteer to make an informed decision on study participation. Some of the most common questions are:

What are the possible risks of participating in this study?
What are the possible side effects of this treatment?
What are the potential benefits of participating in this study?
How long does this study last?
How many visits are required and how long does each visit last?
What is required of me during the visits and as part of the study in general?
What will I be required to pay for?
Is a placebo (for drug studies) or sham (for device studies) involved?
What is the chance that I will receive the placebo (or sham)?
How is the study drug supposed to work?
Is there any compensation for participation?
Why am I being asked to participate?
What is the goal of this study?
Will I find out the results of the study?
Will I receive my personal results of any kind (e.g., labs, treatment group)?
What happens after the study is over?
Who do I contact for general questions and/or in an emergency?

What a participant is required to pay for during a study varies from study to study. Many times, participants are not required to pay for anything; they may even receive compensation for their participation. However, there are studies for which a participant may have to pay for some things. For example, participants may have to pay for travel to and from the study site, meals and/or lodging. Also, with some research studies, participants may have to pay for activities (e.g., lab work, MRI) that are performed while they are enrolled in the study. This type of cost is called a “standard of care,” which means participants would be having these procedures done even if they were not on the study, and are therefore expected to pay for the procedure. Tests, procedures and medicines that are being administered specifically for research purposes, are costs the research study would typically cover. Study costs (and who pays for what) vary from study to study. Information on costs incurred while participating in a study, as well as who is responsible for covering the costs, will be fully explained by the study team when reviewing the Informed Consent Form (ICF).

Insurance is not required to participate in a study. However, if the study includes activities/procedures that would typically be billed to a participant’s insurance company, and the participant does not have insurance, then they may have to pay for those additional activities.

Availability and cost of study medication varies from study to study and participants who want to know about access to a study treatment after a study is over should discuss it with their study doctor. There are various programs that exist that can assist patients with access to their medications following a study.

Whether or not participants will be paid for taking part in a study varies from study to study. Some studies offer compensation for participation and others don’t. Compensation amounts vary based on the time and effort required for study participation. Information regarding compensation and other cost-related matters will be fully explained by the study team when reviewing the Informed Consent Form (ICF).

The possible risks and side effects people may encounter in a research study vary greatly from study to study. A study’s risks will be discussed by the study team during the review of the Informed Consent Form (ICF).

It is important to continue with your routine medical care and communicate any treatments or medications you are receiving with both your regular doctors as well as members of the study team.

Prior to research studies being implemented, and continuing throughout the duration of the research study, they are examined by review boards such as Institutional Review Boards (IRBs) that ensure that all applicable rules and regulations are in place and being followed to protect the safety and privacy of those who participate in research studies. Safety and privacy protections will be discussed by the study team during the review of the Informed Consent Form.

Research participation is voluntary. If a participant changes their mind about being in a study, they should tell the study staff that they would like to withdraw from the study. There is no penalty for withdrawing, as well as no impact on the usual care the patient receives.

A major crisis such as one of the above will likely impact the study in some way. Depending on the extent of the crisis, study visits could be delayed, canceled, or the changed (e.g., going from in-person visits to online). It is also possible that the study could be discontinued. Patient safety is always the number one priority for any research study. Should a major crisis occur, study staff will get in touch with participants to communicate information and instructions.

The members of the study team are best suited to answer any questions related to a particular study. If you have participated in a research study at MUSC and have questions about your participation some additional resources include the Office of Research Integrity Director at 843-792-4148 or the MUSC Patient and Family Care Liaison at 843-792-5555.

The best way to find out information on the outcome of a study is to contact the study staff (e.g., site research coordinator or study doctor). They may be able to share information directly with the patient or direct them to publications or other resources that discuss the results.

Regarding information on past and current studies, one of the best places to look is https://clinicaltrials.gov/. This website is a global registry that contains information [including results for past studies and enrollment information (e.g., eligibility criteria, study location and contact information) for current research studies covering a multitude of topics. You can also sign-up to be considered for research studies on Research Match. This website is a free database where interested volunteers enter some basic information about themselves, and as studies become available, those who may be a good match with the study, are sent an email with some basic information about the study as well as the study team’s contact information. It is then up to the volunteer to decide if they want to receive more information about the study.

There is also a website where people can gather information on current studies being conducted in South Carolina. SCResearch.org, is a research study registry geared towards helping prospective volunteers find studies in which to participate. Each study listed has a recruitment contact associated with the study that is available to answer study specific questions and possible eligibility. Additional sources of information include, but are not limited to: your doctor(s); radio/TV/social media/internet/print advertisements; advocacy and support groups.