Research Participants
Salus IRB’s Purpose
Salus IRB’s purpose is to assure the protection of the rights and welfare of research participants in evaluating research. Additionally, we provide prospective, current, and former research participants with the information and support necessary to assist in protecting your rights and welfare allowing you to make an informed decision about whether or not to participate in research.
Three Ethical Principles
In addition to following the federal regulations, industry standards, and internal policies, Salus IRB employs three basic ethical principles of “The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects in Research,” when evaluating research; respect for persons, beneficence, and justice.
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.
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 requires that the benefits and burdens of research be distributed fairly. Participants should be treated fairly. Selection of participants should be equitable so that benefits and burdens are shared at both the individual and societal level.
These three principles are at the forefront of every decision made by Salus IRB.
What is an IRB?
An Institutional Review Board, also called an Independent Review Board (IRB) is a group of people (or a “board”) who review research to assure that it will be done in a way that protects the rights, safety, and welfare of the research participants. IRBs review the informed consent document to ensure it provides enough information about the research in terms you can understand, so that you can decide whether or not you want to participate. If the board feels the research meets the criteria set forth by the FDA or 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 United States Department of Health and Human Services (DHHS) and the Food and Drug Administration (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 in the study;
- The methods the study doctor will use to ensure that research participants are fully informed of their rights.
What is Informed Consent?
The study doctor or a member of the research team will discuss the study with you and explain the information in the informed consent document. When you believe you have enough information to make a decision about your participation, this is considered “informed consent.” Even if you decide to participate now, you may change your mind at any time and decide not to continue in the study.
Things to Know Before You Sign the Informed Consent Document (ICD)
Before you agree or disagree to be in a research study, you should understand all of the potential risks and potential benefits and 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 and the study doctor and/or the research team. Taking part in a study is your choice; you do not have to take part in a study. Before you make your decision, you should have all of your questions answered so that you know the following:
- The purpose of the research and what is being tested
- The procedures to be followed and any drug or device that will be used
- Any risks or discomforts that are known and can be expected
- Any potential benefits that can reasonably be expected
- For treatment studies, any alternative treatment options that are available and their relative risks and benefits
- How to seek medical care if there are complications
- Anything you do not understand in terms that you do understand
- That you have the right to withdraw your consent to participate at any time without prejudice
- That the study doctor or study sponsor may withdraw your consent at any time without your permission
- If you withdraw or are withdrawn from the research, what will happen to your study records
- If blood or tissue samples or data were collected during the study, what happens to these after the study
- That you will be given a copy of the signed and dated informed consent document to take home
- That you will be given the opportunity to decide to consent or not to consent to a research study without fraud, deceit, duress, coercion, or undue influence
The informed consent document should be in a language you understand.
Once you have had all of your questions answered and are ‘informed’ about all the information above, you are then able to decide if you want to be in the study and give ‘consent’ to take part. If you decide to participate in the research study and sign the informed consent document, you should keep it in a safe place for reference. If you have questions about the research‑related procedures you can read about them in this document, or contact the study doctor at the phone number in this document.
You are encouraged to ask as many questions as necessary before, during, and after taking part in any research study. You should not agree to take part in a research study until your questions have been answered to your satisfaction. After you have had all your questions answered, you can then decide whether or not you want to participate. You may take your time to make this decision and discuss it with a friend, family member, or your family doctor and the research team if you want to. 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.
You may contact Salus IRB at any time before, during, or after your participation, with questions, comments, or concerns.
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