Information for Research Participants
Salus IRB’s purpose is to ensure 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 their rights and welfare, allowing them to make informed decisions about whether or not to participate in research.
Three Ethical Principles
In addition to following 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.
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 decisions 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 Consider Before Signing the Informed Consent Document (ICD)
Before you agree or disagree to participate in a research study, you should understand all of the potential risks, benefits and 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 an individual choice; you may choose not to participate in a study. Before making your decision, you should ensure all your questions have been answered completely and that you understand 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
- Any terms you do not 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
- What happens to any blood samples, tissue samples or data collected during the study, and 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 all of your questions have been answered and you have acknowledged that you are informed about the information above, you are able to decide whether or not to participate and give consent. If you decide to participate in the research study and sign the informed consent document, please keep it in a safe place for reference. If you have questions about the research‑related procedures, contact the study doctor or a member of the research team.
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 all your questions have been answered, you may then decide whether or not you choose to participate. You may take your time making this decision and discuss it with a friend, family member or your family doctor and the research team, should you choose. 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.
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
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.
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.
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 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.
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.
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.
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.