Researchers use a list of rules called eligibility criteria to decide who can be involved in the study. This makes sure you are who the study is looking for and it is safe for you to participate. The factors that allow someone to participate in a research study are called inclusion criteria, and the factors that disqualify someone are called exclusion criteria.
- Pharmaceutical companies, academic medical centers, voluntary groups, and other organizations
- Federal agencies such as the National Institutes of Health
- Doctors, other health care providers, and other individuals can sponsor clinical research
There are many ways to see if Woman’s has a research study going on that you may qualify to join:
- View our Research Study Directory. If a study interests you, call the number provided or complete the online form to see if you qualify.
- Call 225-231-5275 or email email@example.com and can see if there is a study fit for you!
There are two options for signing up for a research study:
- Call Woman’s Hospital Research Center team at 225-231-5275 or email firstname.lastname@example.org to ask about joining a study. A member of the team will be happy to discuss the study with you and help you sign up.
From start to finish, here’s an example of how your experience in a research study could go:
- Contact us: Find a study that you are interested in on the Woman’s Research Study Directory and call the phone number provided.
- Phone screening: A team member will explain the study to you in detail, answer your questions, and then collect your information to see if you might be a good fit for the study. Information may include your age, race, weight, and health history. Depending on the study, sometimes we can determine over the phone if you qualify. Other times, you may have to come to Woman’s for a “screening visit” to collect additional information, such as measuring your blood pressure or your height.
- In-person Screening Visit: At your screening visit, you will be asked to read an informed consent form. This document details everything about the study - its purpose, what procedures are involved, your risks, etc. You will be asked to read this document very carefully and ask any questions. If you agree, you would sign the consent form along with the research team member. You will then be asked additional questions to see if you qualify fully for the study. If you meet all of the eligibility criteria, you will be enrolled in the study.
- Participating in the study: The research team member will explain and schedule the visits and procedures needed for the study. You will be given their email and phone number to reach them at any time during the study for questions, concerns, re-scheduling, etc.
- My results and the study results: At the end of the study, you can ask if there are individual test results that can be shared with you. Also, if the study team can share the results of the whole study with you once it is over.
Most of the time, participating in a research study is paid for, fully or in part, by the study sponsor. A “study sponsor” could be a non-profit organization, the federal government, or a pharmaceutical company. Some costs may be your or your insurance company’s responsibility.
Any financial obligations to taking part in a study will be discussed in the study consent form before you sign up. Additionally, some studies offer money to offset your time and travel you spent participating in the study.
Risks and benefits of participating in a clinical trial can be found in the study consent form or by speaking with the study staff. In addition, the major risks of participating in a study will be explained to you by a member of the research team before you sign up, who will answer your questions about the study.
Before deciding to participate, you should carefully weigh the risks against possible benefits. You may or may not receive direct benefit for yourself and your condition as a result of participating in research, but in either case, what researchers may learn could help others.
Researchers are required to keep your information and medical data confidential. How your data and privacy are being protected is outlined in the consent document. All research studies done at Woman’s are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are reasonable when compared with potential benefits.
An IRB is an independent committee that consists of physicians, nurses, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected.
Your participation in a research study is completely voluntary, and you can withdraw at any time without any penalty. You will be giving consent, not signing a contract. You should discuss with your physician or study staff your intent to withdraw from the study so that you can do so safely.
Your care after you complete a research study may be discussed with your physician or the study staff.
You may call the study investigators listed on the first page of the consent document for any questions about the research study procedures, or Ericka Seidemann, Human Protections Administrator, 225-231-5296
, about any questions you may have regarding your rights as a research participant.