Health Disparities Research
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FAQ:
Frequently Asked Questions for Research Participants
- What is research?
- Who participates in research studies?
- How do I get involved in a research study?
- 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 if I want to stop participating in the research study?
What is research? "Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for the purposes of the regulations that guide and govern how research is conducted in the United States, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities. It may be important to understand the following about research:
- It is basically a study that is done to answer a question.
- Scientists do research because they don't know for sure what works best or to better understand why or how things happen.
- Some other words that describe research are clinical trial, protocol, survey, or experiment.
- Research is not the same as treatment.
Who participates in research studies? Anyone can participate in a research study. Some studies will ask that participants meet certain criteria: such as being an adult or a child, male or female; having a specific condition or experience; or, belonging to an identified group of people, such as a specific ethnic, cultural, or social group.
How do I get involved in a research study? Current research protocols.
What protection exists for research subjects? Many "checkpoints" ensure that research meets strict scientific guidelines for safety and ethical conduct and follows rules to protect the participants. Several groups who are not part of the research team examine the scientific plan and the study procedures to protect the interests of participants. This must be done before an investigator may begin the research. For example, each proposed study, including the steps to be taken for the protection of human subjects and its consent form, must be approved by the Institutional Review Board (IRB). Every organization that conducts research with human subjects, for example, a university or hospital, must have an IRB. As a research participant, you also may stop participating in a study at any time, bring concerns to the researcher and research staff, or bring to the IRB issues of safety and/or ethics.
What is an "IRB" and who are its members? An Institutional Review Board (IRB) is the group or committee that is given the responsibility by an institution to review that institution's research projects involving human participants. The primary purpose of the IRB review is to assure that the safety, rights, and welfare of the human participants are protected.
Each committee is constructed so as to comply with Federal regulations about IRBs.
What is informed consent? Federal regulations have been created to protect the well-being and rights of those who volunteer for research. Basically, the regulations state that no investigator may involve anyone in research without first obtaining the person's consent (agreement) to participate, with full information about what the research involves. This "informed consent," is obtained either directly from the potential research participant or - if the person is not competent or is younger than a certain age - from the person's legal guardian or representative. Informed consent is the participant's agreement to be in a study after being fully informed about what participating will involve. Informed consent begins with a discussion between the researchers and the prospective participants. The discussion includes important information about the research study such as:
- The purpose of the study
- The procedures involved
- The risks of participating in the study
- The benefits of participating in the study
- How long the study will last
- How the participant's confidentiality will be protected
- What will happen if the study causes harm to the participants
- That participation is voluntary
- That participants are free to withdraw from the study at any time.
Based on this discussion with the researcher, participants are asked to sign a consent form that includes this same important information in writing. Prospective study participants can take the consent form home to discuss it with family and friends before signing it. Once the form is signed, participants are given a copy of the signed consent form so that they can review it at any time. Participants should feel free to ask the researchers questions before, during, and after the study. Informed consent is an ongoing process.
Will my participation in research be kept private? Yes, researchers are required to keep all information confidential. One way of protecting participants is by assigning identification numbers so that names do not appear on any forms. Only staff directly related to the study should have access to the information. It is mandatory for researchers to ask for the participants' permission if they want to use any part of the information for other purposes, such as education or training.
There is an important exception to the confidentiality rules described above. In the case of children, the law requires researchers to report if they suspect a child has been subjected to physical or sexual abuse or neglect. This requirement applies to all settings that deal with children, such as schools, doctors, or hospitals.?
What if I want to stop participating in the study? You are free to stop participating in a research study or to "withdraw" at any time and for any reason. Your withdrawal will not affect other services you may be getting or are entitled to in the institution. If possible, you should talk with the research staff (investigators) about why you wish to stop participating - as this will help them to better understand what you have experienced and the reason/s for you decision.?
Source: University of Washington
