Information for Research Participants

Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. The principle of beneficence underlies the need to engage in a risk/benefit analysis and to minimize risks.

Justice demands that the benefits and burdens of research be distributed fairly. Participants should be treated justly. Selection of participants should ensure that benefits and burdens are shared at both the individual and societal level.

Respect for persons involves recognition of the personal dignity and autonomy of individuals, and special protections for those persons with diminished autonomy. The principle of respect for persons underlies the need to obtain informed consent. Potential research participants should be treated as individuals capable of deliberate judgment; they must be given the opportunity to be fully informed about, and to choose voluntarily and without coercion, what will or will not happen to them. At the same time, appropriate protection must be offered to persons with diminished capacity for self-determination.

• CenterWatch
• ClinicalTrials.gov
• National Cancer Institute
• Type I Diabetes TrialNet

• Frequently Asked Questions on Popular Topics
• Clinical Trials Guidance Documents
• FDA Patient Engagement Regulations: Good Clinical Practice and Clinical Trials
• Clinical Trials: What Patients Need to Know

• Glossary of Common Terms
• NIH Clinical Research Trials and You

• ClinicalTrials.gov: Learn About Clinical Studies
• HHS: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• The Center for Information & Study on Clinical Research Participation

Before you agree to participate in a research study, you should understand all of the information presented in the informed consent document. However, the informed consent document is not meant to replace the discussion that should occur between you, a friend, family member, or your family doctor and the research team. If your family doctor is part of the research study, you may discuss your care with another doctor who is not part of the research study.

Any time you have questions during the study, you may call the study doctor at the number provided in the informed consent document. If you cannot get in touch with the study doctor or if they do not respond to your inquiry in a timely manner, contact Salus IRB.

Please contact Salus IRB any time before, during or after your participation with questions, comments, concerns, to offer input, or to obtain information.

An institutional review board, also called an independent review board (IRB), is a group of people (or a “board”) who review research to ensure that it will be conducted in a way that protects the rights, safety and welfare of research participants. IRBs review the informed consent document to ensure it provides adequate information about the research in terms participants can understand, so that you can decide whether or not you choose to participate. If the board feels the research meets the criteria set forth by the FDA or the Department of Health and Human Services (DHHS) for IRB approval, they will approve the research. Sometimes, they require changes to the research and/or the informed consent document.

The IRB continues to provide oversight of the research until its completion.

IRBs follow the regulations of the DHHS FDA. When a study is proposed to the IRB, the IRB considers the following points, among other things, prior to granting approval of the research:

• The possible risks versus possible benefits of the study
• The methods the study doctor (investigator) will use to protect the privacy of participants
• The methods the study doctor will use to ensure that research participants are fully informed of their rights

In case of an emergency, please call 911. If it is not an emergency, please contact the study doctor or research team as soon as possible according to the instructions in the informed consent document. If you believe something happened because of negligence on the part of the study doctor or research team, the informed consent document does not prevent you from seeking legal aid.

If you agree to participate in the study and sign the informed consent document, you may still change your mind for any reason, at any time. It is important that you contact the study doctor or research team to inform them that you changed your mind. Depending on what kind of study you are in, they may need to perform some tests or ask you some questions to make sure that you withdraw from the study safely.

You should consult your informed consent document concerning if, when and how much you will be compensated for your participation in the study. If you believe there is an issue as to how much you are going to be paid, or when, please first contact the study doctor or research team with your concerns. If you do not believe your concerns were appropriately addressed, please contact Salus IRB.

The study doctor can end your participation at any time if they believe it is in your best interest not to continue. Your participation in a research study can be stopped if you do not follow the procedures listed in the informed consent document or the study doctor’s instructions. Salus IRB, the study sponsor, and/or the FDA or DHHS may also stop the entire study if they believe it is in the best interest of the participants.

Reference your informed consent document for information regarding if, when and how much you will be paid for your participation in the study. You may contact the study doctor or research team at the phone number listed in the informed consent document. Sometimes, it takes a few weeks after a study is complete for all of the participants to be paid. The study doctor or research team can tell you when you should expect to receive payment.

All studies are different. In some studies, participants are paid, and in other studies they are not. You will be told whether or not you will be paid, how you will be paid, and how much you will be paid before you decide whether or not to participate.

The informed consent document should tell you if it is possible for you to view the results of the research study. Some studies do not allow participants to view their results until the entire study is complete and all data is analyzed. Please note that in some cases, this may take a very long time. In some cases, you may contact the study doctor or research team to get results concerning your participation in the study.