General Questions for Participants
- What is research?
- Who participates in research studies?
- How do I get involved in a research study?
- What are some good questions to ask before deciding to participate?
- If I am a student, do I have to participate if it is a class or program requirement?
- Does research involve special risks?
- What protection exists for research subjects?
- What is an IRB, and who are its members?
- What is informed consent?
- Will my participation in research be kept private?
- What happens if I have an emergency?
- What if I want to stop participating in the research study?
- Will I be told the results of the research?
*Research is a systematic investigation, including research development, testing, and
evaluation designed to develop or contribute to generalizable knowledge. Activities which
meet this definition constitute research for purposes of this policy, whether or not they are
conducted or supported under a program which is considered research for other purposes.
For example, some demonstration and service programs may include research activities.
Anyone may seek to participate in a research study. In some cases, participants may be required to meet certain qualifications. Remember that if you agree to be in a research study, your participation is strictly voluntary, and you may withdraw at any time.
There are lots of ways to get involved in research studies:
- If you have a particular interest in a specific topic, an internet search may be helpful.
- On a local level, some departments may have websites on which there is contact information regarding ongoing or new studies.
If you decide to participate in a study, be sure to ask lots of questions so that you are fully informed about what you will be expected to do and how much time it will take for you to participate.
- What will happen to me when I participate in the research?
- What are the potential risks that may happen when I am in the study? What are the chances that I will encounter those risks?
- Will I gain any benefit from being in the study?
- How long will the study last? How long will it take me to complete the study?
- How will my privacy be protected?
- Will I be paid to participate in the study? If so, how much?
- What happens if there is a problem while I am in the study?
- Who should I contact if I have questions or concerns about the study?
This question is hard to answer without specifics of the study. Please contact the IRB Chair or IRB Administrator if you have concerns.
The researchers and the IRB have worked hard to reduce any risk or harm that may occur during the research. However, for there to be a risk-free study, the researcher would need to know every possible outcome. If that is the case, then there would be no need to do the study.
The risk varies from study to study, so it is important to talk to the investigator of each study to help you think about what the level of risk means to you. This information is important for you to be able to decide if you are comfortable with the level of risk.
In order to protect persons who volunteer for research studies, a number of safeguards are in place to be sure that research meets strict guidelines for safety and ethical conduct of the work. All proposed research that involves human participants must be reviewed and approved by an impartial body, the Institutional Review Board (IRB). In addition, as a volunteer in a study, you are free to withdraw your participation at any time and bring any concerns that you may have to the attention of the investigator, the IRB Administrator, or the IRB Chair.
The IRB is a group of faculty, staff, and at least one member of the community who is given a charge to review all proposed research projects that involve human participants. The committee is constructed to function in compliance with established policies and procedures specified by Federal regulations regarding IRBs. The primary purpose of the IRB process is to assure that the safety, welfare, and the rights of participants are protected.
The informed consent process is an essential part of the protection of research participants. The Federal government has established guidelines by which all investigators must abide. In fact, no investigator should enroll a participant in a research study until there is assurance, to the fullest extent possible, that the participant understands the expectations, risks, benefits (if any), and willingly agrees to participate in the study.
Informed consent is a process by which potential participants are informed about the purpose of the study, the procedures that are involved, the risks and benefits (if any) that participants are likely to experience while in the study, the expected time commitment, how confidentiality of personal information and any data that are collected are protected, what to do if a problem is encountered during the study, an assurance that participation is voluntary, and that participation can be withdrawn at any time.
Documentation of informed consent is obtained by using an IRB approved form that will be signed by the participant and the investigator. If a participant is too young or cannot read and sign an informed consent document, then the investigator can document that the informed consent process was undertaken by using a simplified form (assent form) or a verbal assent. For any child who has not reached independent status to participate in a study, the child's parent(s)/guardian(s) must also participate in the informed consent process, and documentation of such participation must also be obtained.
A copy of any documents that are signed or to which verbal assent has been given must be provided to the appropriate parties.
Informed consent is a process, and the investigator and the participants are encouraged to engage in an ongoing dialog regarding the study.
Absolutely. Researchers are required to keep all information confidential. The primary way by which this is done is to assign numbers to all participants so that names or other identifying information does not appear on any forms. Further, access to the data is limited to only those staff who are directly related to the study. If a researcher wants to use any information they obtain in the course of the study for education or training, they must obtain permission.
The exception to the rule regarding confidentiality is that researchers are required to report to state officials if they suspect that a child has been physically or sexually abused or if a child has been neglected.
If an emergency occurs during the experiment, the health and safety of the participant is paramount, and appropriate medical treatment (if needed) should be sought by the investigator.
If there is an emergency that occurs while you are not in the study and will prevent you from participating, please advise the investigator at your earliest convenience.
Remember you are a volunteer, so you can stop participating at any time and for any reason. You will not be penalized for withdrawing from the study.
You are not required to tell the research team why you wish to stop participating; however, it may help them understand any concerns that you have, so they can correct or address your concerns if possible. They cannot force you to participate.
You can always ask to be told about the results of the study in which you participated. The information that you will be given will be in aggregate so that no individual data will be divulged unless you want to know about your own data. Remember, that it may take many years for the investigator to get enough information from which to draw meaningful conclusions.
* Source: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf Accessed 9/20/08