Research Study Participants

As you review the information on this site, you will be referred to as a participant and sometimes a subject. Both are correct and are used interchangeably. The federal regulations refer to participants in research studies as subjects.

Medical City Plano Institutional Review Board (MCP IRB) is a federally mandated organization of scientists and doctors, as well as lay people from the local community. The IRB acts as an advocate for people who are participants in research studies by doing the following:

• Making sure that any risks are as small as possible
• Making sure that all risks and potential benefits of the study are presented fully and openly
• Deciding whether it is right to ask people whether they want to take part in a research study
• Reviewing each research study while it is going on to make sure participants are protected
• Acting as a liaison between the research team and the participant, if there is any issue that needs to be resolved

We will provide useful information if you are considering participating in research, are currently involved in research, or want to find out more about research from the viewpoint of a participant.

Medical City Plano Institutional Review Board recognizes the importance of your decision to take part in a research study. Therefore, we want you to be educated in all aspects of research before you decide to participate. If you are considering involvement in a research study, you should know that you have certain rights as a research participant. For more valuable information about participation, please review a brochure designed by The Office for Human Research Protections (OHRP) "Becoming a Research Volunteer: It's Your Decision".

The New England Research Subject Advocacy Group (NE RSA) has published a series of brochures and videos to support the communication between researchers and subjects. These resources provide useful information and helpful questions to think about before deciding to participate in a research study.

These brochures and videos have been approved by MCP IRB for use and, Investigators can provide these brochures or links to these brochures/videos without additional IRB approval.

The OHRP website includes resources designed to help potential subjects better understand research and find the information they need to decide whether to participate in research. The website includes short videos, a printable list of questions that potential subjects can ask researchers, and links to additional resources.

If you are considering involvement in a research study, you should know that you have certain rights as a research participant.

You can discuss any questions about your rights as a research subject, in private, with a member of the IRB. You may contact the IRB Office at (972) 396-4044 or via email.

If you have concerns or complaints about the research or research staff and you do not wish to give your name, you may call the Ethics and Compliance Hotline at (800) 455-1996 . This is a 24 hour telephone answered by people who do not work at Medical City Plano IRB.

The consent form you receive when you are invited to be a research subject includes some contact information for any questions or concerns about the study. You are encouraged to contact the researcher if you have questions.

Clinical research can look a lot like regular, or standard, medical care. Sometimes it is hard to tell the difference.

Here are some of the ways they may be similar:

• The researcher and your health caregiver can be the same person
• The setting may be your regular clinic
• The treatments may seem the same

Research is done to help find out if a treatment or procedure is good for a large group of people with a certain disease or condition. Research helps to answer questions for the future health of those populations. Standard medical care focuses on individual needs in the present.

You are likely to be presented with an informed consent form indicating approval by the IRB. This document is intended to provide you with relevant information necessary to decide whether or not you want to participate. This form itself should be coupled with a discussion of the research.

Generally, informed consent will involve a description of the following:

• An explanation of the purpose of the research
• A description of what you will be asked to do, how long it will take if you participate and whether or not you will be compensated for your time
• A description of any risks involved in participating; these risks could be physical, psychological, social or criminal—the steps taken to minimize these risks should also be described
• A description of any benefits to you or to society as a whole
• The degree to which the information will be kept confidential
• Who to contact if you have questions about the research or about your rights as a participant
• A statement that you are free not to participate and can stop participating at any time

Any participation in a research study is completely voluntary. You are free to decline participation for any reason. You may also stop participating at any time or refuse to answer any individual questions. Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services to which you are otherwise entitled. For example, if you are a patient, your doctor or the hospital cannot hold this against you when determining your medical care. If you are receiving treatment, that treatment cannot be withheld if you do not agree to participate. Whether or not you participate is entirely up to you.

You should not sign the consent form agreeing to participate in the research until all of your questions have been answered to your satisfaction. Signing this form does not waive any of your legal rights or alter your ability to stop participating at a later time. You should be given a copy of the form to take with you in case you have questions later.

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

As described in the brochure "Becoming a Research Volunteer: It's Your Decision" here are some questions you should ask before volunteering to participate in a research study:

• Why is the research being done?
• What will be done to me as part of the research?
• How will I benefit from the research?
• Could the research hurt me?
• What will the researcher do with my information?
• Will the research cost me anything?
• Who pays if I'm unexpectedly injured in the study?
• How long will the study last?
• What happens if I decide to leave the study early?
• Who should I call if I have a question about the research?

• A research study may or may not help you personally
• In the future, the research results could help others
• Taking part in research in voluntary