Frequently Asked Questions
For Researchers
Sometimes you may think you are conducting research, but you aren’t; and sometimes you may think you aren’t conducting research, but you are (for example, a quality improvement project or an implementation project to be published for generalizable knowledge). The IRB determines whether a project is defined as research. To receive a “not human subjects research determination,” you must still follow all of the submission steps.
Sometimes you may think you are conducting research, but you aren’t; and sometimes you may think you aren’t conducting research, but you are (for example, a quality improvement project or an implementation project to be published for generalizable knowledge). The IRB determines whether a project is defined as research. To receive a “not human subjects research determination,” you must still follow all of the submission steps.
If you are seeking to launch a project at Woman’s for a graduate school assignment (e.g., DNP, CRNA, MPH), this form is your first step to gain permission/determine feasibility.
If you are a Woman’s employee or affiliate, you must have completed the CITI Human Subjects Research (HSR) certification. CITI HSR certifications last for 3 years, can be renewed as needed, and are available at no cost to you. If you are conducting a clinical trial, you must also have the CITI Good Clinical Practice certification.
If you are affiliated with an outside organization, you may provide the respective human subjects protections training certificates required by your organization.
Your affiliate organization, not the site of your research, dictates your research education. If you have different research training requirements at your institution (i.e., you are an external investigator not employed by Woman’s) Woman’s HRPP program will accept those certifications.
Documents that may be needed for submission include:
- Study Protocol
- Informed Consent Form (if needed)
- HIPAA Authorization(s) (if needed)
- Department approval forms from each department that will be involved in the conduct of the research
- If the study is funded - Financial Conflicts of Interest Disclosure form for each investigator and study coordinator
If this is the first time the investigator has submitted a study for review, a signed Investigator Agreement for each investigator will also be necessary.
Other forms, including Accounting of Disclosures and a Material Transfer Agreement, may also be needed depending on the study design.
To request an account for IRB Manager, please email research@womans.org or call 225-231-5296.
To log into IRB Manager, please visit womans.my.irbmanager.com.
Results from IRB review could be “not human subjects research,” “exempt approval,” “expedited approval,” or “full board approval.”
Research Participation and Studies
There are many ways to see if Woman’s has a research study going on that you may qualify to join:
- View our active research studies. 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 research@womans.org and can see if there is a study fit for you!
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.
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.
To sign up for a research study, you can call the Research Department at 225-231-5275 or email research@womans.org. A member of the team will be happy to discuss the study with you and help you sign up.
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.
You may call the study investigators listed on the first page of the consent document for any questions about the research study procedures. If you have questions regarding your rights as a research participant, call Human Protections Administrator Ericka Seidemann at 225-231-5296.
- Pharmaceutical companies, academic medical centers, voluntary groups, and other organizations
- Federal agencies such as the National Institutes of Health
- Doctors, other healthcare providers, and other individuals can sponsor clinical research
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.