On the University of Maryland Baltimore campus, the School of Medicine serves as the foundation for a large academic health center that combines medical education, biomedical research, patient care, and community service. With the support of our patient care partners, including University of Maryland Medical System and the Baltimore VA Medical Center, the School of Medicine offers clinical trials addressing a wide range of health problems, such as cancer, HIV/AIDS, neurologic diseases, heart diseases, kidney diseases, high blood pressure, trauma, and psychiatric problems. The School of Medicine also has active research and development programs in vaccines, complementary medicine, and in medical devices and technology.
Research Subject Advocate
1. Review and Consultation regarding Reportable Events
2. Participant advocacy
3. Liaison between participants and research investigators
4. Available to the research community to discuss problems, concerns, and questions
What if I have a question about my participation in a research study?
University of Maryland Baltimore
Human Research Protections Office
800 W. Baltimore Street, Suite 100
Baltimore, MD 21201
Send a comment to the Human Research Protections Office (HRPO)
Frequently Asked Questions
What is a research study?
Patients who receive standard care are sometimes asked to be a research study volunteer (also called a subject or participant). Most research studies have certain criteria you have to meet in order to participate. These criteria are designed to protect the safety of the subjects and to strengthen the research results. For example, a study may require subjects to be at least 18 years of age, to have a certain kind of disease, to be taking a specific type of medicine, or to have a certain set of symptoms.
Research studies usually involve some procedures or tests that are not a part of standard care and are done in addition to the normal course of treatment to gather scientific information. Some studies are designed to simply gather scientific information without providing standard care to the subjects at all. Once a person agrees to be a research subject, they agree to participate in all of the study activities. Study activities could last only a few minutes or a few years depending on the kind of research. Some studies involve answering questions or filling out surveys while other studies require taking experimental medicines or using experimental devices. Depending on the type of research, study subjects may receive payment for their participation or reimbursement for expenses related to the research activities.
Participation in research is voluntary. This means that subjects have the right to refuse participation or to withdraw from a study, at any time, if they change their mind about their initial agreement to participate.
What is an Institutional Review Board (IRB)?
An IRB is a committee of scientists, nonscientists, and community members who decide whether research proposals meet specific standards, regulations, and policies. IRB members have different kinds of knowledge, experience, and backgrounds to ensure that their decisions are well informed and objective. IRB committees review, approve, and monitor human research activities in hospitals, medical institutions, and other healthcare environments.
What does an IRB do?
1. the risks to the research subjects are minimized and justified
2. the risks to the research subjects are reasonable in relation to the possible benefits of the study results
3. the selection of the research subjects is equitable
4. enrollment of the research subjects includes a process of informed consent and documentation
5. that adequate preparation is taken to protect the privacy and confidentiality of the research subjects
6. that adequate resources are available to evaluate and monitor the welfare of the research subjects
throughout the research study
What is informed consent?
As a patient, you deserve the best possible medical care available. You deserve to have healthcare workers treat you with respect, see you as an individual, give you opportunities to talk about treatment options, respect your ability to make decisions about your medical care, realize your right to refuse medical recommendations for your medical care, and give you the same quality of services they give to other patients.
Simply put, informed consent means that a person is given enough information and enough time to make a knowledgeable and clear decision.
Before a person can make an informed decision to become a research study participant they must be:
1. given clear, relevant, and honest information about the nature of the study
2. told that the study involves research and the purposes for the research
3. told about the possible risks, benefits, and alternatives to study participation
4. told whether any treatments or compensation are available if complications occur during the study
5. aware of the amount of time and level of involvement or commitment required for study participation
6. given details about the possible side effects or discomforts involved in the study activities
7. told what patient health information is used in the study and how this is kept private and confidential
8. invited to ask questions before giving consent and at any time during the course of the study
9. allowed enough time, without pressure, to reach a decision about study participation
10. given a written copy of the consent agreement
11. told that they have the right to withdraw their consent and to stop participation in the study at any time
12. given IRB contact information for questions, concerns, or complaints about the research study
13. advised of the expiration date for the signed consent form and the reasons for this
14. told of changes to the consent form & provided the opportunity to sign or not sign the revised form