Human Research Participant FAQs
Frequently Asked Questions About Human Research
- What is research?
- What is a research study?
- What is a research participant?
- What is a protocol?
- What is an Institutional Review Board?
- Can anyone be in a research study?
- What is a Principal Investigator?
- Will I benefit from the research?
- Are there risks to participating in research?
- What is informed consent?
- How do I decide whether or not to participate?
- Is my participation voluntary?
- Do I have rights as a research participant?
- Are there questions that I should ask before agreeing to participate in a research study?
- Are there questions that I might ask myself after the study is over?
- What should parents consider before allowing their child to participate in research?
- How can I get more information?
When people are asked about participating in a research study, they may think of clinical trials (drug studies) or other types of medical research, but not all research is medically oriented. Some research studies use questionnaires, interviews, or surveys to gather information on a wide range of subjects, including information about habits, opinions, and beliefs. Other studies observe the way people interact with one another or react to certain situations, providing new insights into human behavior in social or business-related interactions.
A research study is a pre-designed and structured way of analyzing behavioral or bio-medical questions, collecting data, and analyzing the data. It can be something as simple as asking questions, giving a survey, or looking at a particular behavior. On the other hand, it can be more complicated and may look at a specific disease or condition.
A research participant (also referred to as a research subject) is an individual who decides to participate in a research study. Participation is completely voluntary. You can decide not to participate or, if you start participating in a study, you can stop participating any time you want.
All research studies follow a protocol or plan of how the research will be done. A protocol tells the researcher what can and cannot be done when he/she is conducting the study. All of this is done to make the study scientifically valid and to help protect the research participant. An Institutional Review Board must review research studies and protocols.
The Institutional Review Board (IRB) is made up of a group of people including scientists, non-scientists, ethicists, and some people from the local community. The IRB looks closely at every protocol or research study before it is allowed to begin. Because research studies involve risk, the IRB looks at the study to make sure the risks are justified and minimized as much as possible.
The protocol or plan for every research study defines, for scientific and safety reasons, who can and cannot be a participant. In order to protect research subjects, only people who meet the criteria defined in the research protocol are allowed to be in the study.
The Principal Investigator (PI) is the person who is responsible for the conduct of the research study. He/she is responsible for making sure everything is done properly and according to the research protocol. In addition to the PI, there may be other researchers or staff who help with the study.
In one way or another, all of us have indirectly benefited from the knowledge gained from research. The vaccines that help prevent diseases and the medications that we take are just a few examples of scientific discoveries that resulted from research. Many of the psychological and social support services that we routinely provide to victims of trauma and disaster also were developed in response to research findings. Whether there is a possibility that you will directly benefit from the research that you participate in depends on the type and intent of the research. You may or may not directly benefit from participation but there almost always is a benefit to society.
It is important to note that research is experimental and that means it involves risk, sometimes more than you would experience in a normal day. Federal regulations require researchers to inform participants about the risks involved – and to do everything possible to minimize those risks. However, risk can never be completely avoided.
When you are deciding whether or not to volunteer in a research study, the facts of the study may be given to you in a consent form and/or described to you verbally by the researcher. This process is intended to help you understand exactly what you will be required to do or what will happen to you in the research study. It is intended to help you make up your mind about whether or not to participate in the study.
The informed consent process and/or document will outline all the rights you have as a volunteer in a research study. You will also be told about the known or expected risks and any potential benefits that may exist. After reading the consent form and having the research answer your questions, you can make your final decision about participating in the proposed study. It is important that you be given enough time to ask as many questions as you want to about your voluntary participation in the study.
You should not sign the form agreeing to the research until all of your questions have been answered to your satisfaction. Signing this form does not waive any of your legal rights or alter your ability to stop participating at a later time. You should be given a copy of the form to take with you in case you have questions later.
The decision to participate in a research study is a personal one. It may be helpful to discuss your options with researchers and your family but ultimately the choice is yours. There are a number of reasons why people choose to participate in research, but no matter what the reason might be, it is important that your decision not be made lightly.
Yes, participation in a research study is completely voluntary. You are free to decline to participate for any reason or, if you are participating, you may stop at any time. If the research involves a survey or interview, you may refuse to answer any individual questions. Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services or benefits to which you are otherwise entitled.
Yes, you have the following rights as a research participant:
- To be treated with respect, including respect for your decision whether or not you wish to enroll in, continue in, or stop being in a study.
- To choose to stop being in a study at any time.
- To be given time to read the consent form and have the research study explained to you.
- To be given time to ask questions and to be told whom you can contact if you have any more questions.
- To be given a copy of the consent form after you have signed it.
Yes, you may want to ask some or all of the following questions when deciding to participate:
- Why is the research being done?
- Does anyone review the research before it begins?
- When will this research take place?
- Where will the research take place?
- What will be done to me or what will I have to do as part of the research?
- How long will my participation last?
- How will I benefit from the research?
- If not me, who will benefit from the research?
- Could the research hurt me?
- What will the researcher do with my personal information or other data obtained through my participation in the study?
- How long will the study last?
- Will the results of the research be disseminated and/or published?
- Can I contact the researcher after the research begins if I have questions?
- Is there anyone, other than the researcher, that I can contact if I have questions or concerns?
Yes, you might want to consider:
- Would I be willing to participate in other research studies if asked?
- Would I recommend research participation to others?
Research Involving Children
Many types of research studies ask to include children as participants. Some examples are studies about learning styles, early language development, and social development. Children are considered a vulnerable population because their psychological, physical, social, and cognitive capacities are not fully developed and, because they are vulnerable, special ethical and regulatory considerations are required to protect their rights.
The risk levels considered during review of research studies may be minimal risk (classroom observation, curriculum evaluation, or standardized testing evaluation, for example) or greater than minimal risk (i.e. sensitive data collection or therapeutic interventions). Benefits to the children are also considered during the review. For minimal risk studies, the direct benefits do not have to be that high. However, for greater than minimal risk studies, the research results should present a reasonable opportunity to further our understanding of our ability to prevent or alleviate a serious problem affecting the health or well-being of children.
You may be asked for permission to allow your child to participate in a research study. If your child is able to comprehend the procedures and risks of participation, s/he will have to assent to participation. It is the researcher’s responsibility to provide you and your child with information about the research study. It is your responsibility to weight the risks and benefits of the research study and ask questions about the study and your child’s involvement. The parental permission form that you will be asked to sign should list the things that will be done in the research and the risks and potential benefits of the study, but you can ask additional questions.
Questions that must be answered before you provide permission for your child to participate are:
- What will your child be asked to do?
- How much time will it take?
- What are the risks of participation?
- What are the potential benefits of participation?
- How will my child’s identity and the data collected be protected?
- Does my child want to participate?
There are general research brochures that you can get from Federal Regulatory Agencies by visiting the following links:
Office of Human Research Protections (English version): http://www.hhs.gov/ohrp/sites/default/files/ohrp/education/brochures/3panelfinal.pdf
Office of Human Research Protections (Spanish version): http://www.hhs.gov/ohrp/sites/default/files/ohrp/education/brochures/ohrp3panelspanish.pdf
Food and Drug Administration (English): http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM390869.pdf