For Research Participants

OHRP’s About Research Participation initiative to provide accessible informational for potential research participants is the focus of the latest blog by the HHS Assistant Secretary for Health, ADM Brett Giroir, M.D.  You can read the blog, entitled “Empowering Research Participants with Information” here: https://www.hhs.gov/blog/2020/03/04/empowering-research-participants-with-information.html

This video explains the concept of Institutional Review Boards (IRBs), which review certain research studies involving human volunteers to ensure that the studies meet ethical standards and regulatory requirements. (6:45)

English: https://youtu.be/U8fme1boEbE 

Spanish: https://youtu.be/qXdlT9oWusc 

Health and Human Services' (HHS) Office of Human Research Protections' (OHRP) 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!

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 St., Room 2113
Baltimore, MD 21201
410-706-5037

hrpo@umaryland.edu: To email the Human Research Protections Office (HRPO).

Health care 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 to participate. These criteria are designed to protect the safety of the subjects and strengthen the research results. For example, a study may require subjects to be at least 18 years old, 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 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 health care 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 that decides 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 health care 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 health care institutions have in the research. IRB committees look for six basic things when they decide whether 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 before 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 that 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
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As a patient, you deserve the best possible medical care available. You deserve to have health care 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 treatment or compensation is 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 and 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.