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This section is designed to assist former, current, or prospective Human Research Participants in obtaining information or offering input regarding research and clinical trials. It provides contact information for the Research Subjects Advocate and answers frequently asked questions.
The University of Maryland School of Medicine was established in 1807. It is the first public and fifth oldest medical school in the United States and the first to institute a residency training program. The School of Medicine is the founding school of the University of Maryland, and today it is an integral part of the 11-campus University System of Maryland.
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.
OHRP’s Division of Education and Development:
New resources are available on OHRP’s About Research Participation website, www.hhs.gov/about-research-participation. A video about randomization that helps participants understand randomization in the context of research is now available in Spanish. This video explains what researchers mean when they say a study is “randomized,” and how randomization might affect participants’ experiences in a study. This video is the fourth in a series that’s available in English and Spanish.
Also new is a set of infographics created to explain the how and why of the HHS regulations to the general public. Users can learn about the history of the regulations and how OHRP and other federal entities help protect human subjects. All of the pages are available as PDFs that can be easily printed for sharing and use as educational tools.
We continue to hear about new and creative ways these resources can be used to educate prospective volunteers and improve the informed consent process. Please consider sharing this information with other human research protection professionals and programs!
RESEARCH SUBJECT ADVOCATE
Research Subject Advocate and Safety (RSAAS): The Research Subject Advocate is a confidential channel for former, current, or prospective participants, designated representatives or community members to discuss problems, express concerns, ask questions, obtain information or offer input regarding research. The Research Subject Advocate is unaffiliated with any individual protocol.
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
If you have questions, concerns, complaints, or believe you have been harmed through participation in a research study as a result of researcher negligence, you can contact members of the IRB or the staff of the Human Research Protections Office (HRPO) to ask questions, discuss problems or concerns, obtain information, or offer input about your rights as a research participant. The contact information for the IRB and the HRPO is:
University of Maryland Baltimore
Human Research Protections Office
620 W. Lexington Street, Room 2113
Baltimore, MD 21201
firstname.lastname@example.org - to email the Human Research Protections Office(HRPO)
FREQUENTLY ASKED QUESTIONS and RESOURCES
Healthcare professionals who are committed to finding better ways of doing things and more effective forms of treatment collect information through research studies (also called clinical trials, research projects, or experiments) to find answers to specific questions that could improve the current standard of medical care. Research contributes to the development of new medicines, new techniques, new procedures, and new ways of identifying and treating medical conditions. These discoveries often change educational programs, social policies, professional standards, and technologies.
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.
An Institutional Review Board (IRB) has the job of making sure healthcare providers in the United States live up to these expectations for quality care whenever patients or other individuals are involved in research studies.
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.
Federal law says that any human research, even research that is not funded by the federal government, has to be approved by an IRB before it can take place. The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are responsible for setting the guidelines and regulations that govern human research. They define what human research is, what kinds of research studies can take place, and what roles the IRB and healthcare institutions have in the research. IRB committees look for six basic things when they decide whether or not a research study can take place:
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
Informed consent must be obtained from individuals or their legally authorized representatives prior to participation in a research study. An informed consent form provides individuals with enough information about the research to make an informed decision as to whether they wish to take part in a study. Informed consent is more than a paper form to sign. Informed consent is an ongoing process which is active through the course of the study. It is an open line of dialogue between participants and the investigator about the research. If new information becomes available during the course of a study, the investigator communicates this to participants. This is especially important if the information could affect a person’s willingness to continue to participate in the study. Sometimes this information is conveyed verbally, through a modified consent form or even a letter. An example of such a letter is provided here: Participant Notification Letter Sample
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
Vulnerable subjects, such as children, prisoners, pregnant women, the elderly, or individuals with intellectual limitations may need special safeguards when it comes to research. There are specific governmental and professional regulations in place to help protect individuals in these categories from being forced or coerced into research study participation.
INFORMATION ON CLINICAL TRIALS
For more information on Clinical Trials, please review the following:
- Should I Take Part In Research - A brochure for potential research participants
- Center for Clinical Trials
- NIH FAQ on Clinical Trials
- Research Participants and Volunteers
THE CENTER FOR INFORMATION & STUDY ON CLINICAL RESEARCH PARTICIPATION (CISCRP)
Founded in 2003, The Center for Information and Study on Clinical Research Participation (CISCRP) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research participation and the role that each party plays as a participant in the process. CISCRP’s staff and board of advisors have highly diverse backgrounds - from the clinical research, healthcare and advocacy communities. CISCRP’s funding comes from a wide variety of sources including individual donors, government and research institutions, foundations and corporations.