I want to Talk to Someone
- If you want to talk with someone about the study procedures or have questions about the research project itself, contact the researchers or faculty member listed on the Informed Consent form.
- If you want to talk with someone about your experiences being a research participant, an issue or problem with the research or a researcher, if you have a complaint, and/or if you have questions about your rights, please contact the NC State IRB office at firstname.lastname@example.org or via phone at 1.919.515.8754.
- If you would like to voice a complaint or concern, you may submit this form to the IRB office.
Frequently Asked Questions
A research study is a very careful way of looking at something and collecting data in order to answer a specific question aiming to inform or solve a problem. It can include things like asking questions, giving a survey, or looking at a particular behavior or physical response. Many different kinds of studies are conducted. Some of these studies may test if a product is safe and effective, some may look at phenomenons or experiences, some may seek to find out what practices work best for a specific issue, and some others may be done to determine the best way to treat or prevent an illness.
All research studies follow a protocol. A protocol is like a recipe that sets expectations and provide guidance while the research is being done. It tells the researcher what can and cannot be done when they are conducting the study. All of this is done to protect the you – the research participant. Before this protocol is implemented, it is reviewed by the Institutional Review Board for ethical treatment of people.
The Principal Investigator (PI), is the person who conducts the research study. The PI is also the person who is responsible for making sure everything is done properly and that you and other research participants are treated in accordance with their approved protocol. Along with the PI, there may be other people who help with the study. These people are called research team members or collaborators. There may be people who look at all the data that is collected in the study and other individuals involved in operating the study. You have the right to know who is on the research team and who is collaborating.
o As a participant you work with the researcher to help them answer their research questions. The information that you share with them becomes data that they analyze and use to provide recommendations to the general population. As a participant you will experience activities or interactions that are approved to be done with humans. These interactions and activities generate information that researchers use and make meaning from.
o You volunteer to be in research and share this information about yourself. The information could be about your thoughts and feelings, your experiences, your body’s response, or your environment. It is your choice to participate or not and continue to participate in research or stop participation at any time.
o It is with your permission that researchers are able to gather information about you. If you choose to participate, it is your role to ask questions and to be forthright and collaborative with your researchers.
o The Institutional Review Board (IRB) has two parts. An IRB Office and an IRB Full Board. The IRB Full Board is made up of a group of people such as scientists, non-scientists, and community members. The IRB Office is made up of employees that help facilitate the review of research done at NC State. Overall, the IRB is a group of people who review research to make sure it will be done ethically and safely and that the benefits of the research are balanced with the risks to the participants.
o The IRB Office and sometimes the IRB Full Board closely looks at every research study before it is conducted with any humans.
▪ When we review research we are looking to make sure the research is designed and performed ethically. Because some research studies involve risk, the IRB assesses the study protocol to make sure the risks are justified and minimized. In addition, the IRB wants to make sure the Principal Investigator (PI) follows all the rules the federal government has set up to protect human subjects who volunteer to participate in research.
o The IRB serves to protect your rights and your welfare before and during the research study and ensures that any risks you are exposed to are reasonable and justified. The IRB does not make a decision for you. The IRB decides, when approving research studies, that it is reasonable to ask people whether they want to be involved in it.
o The NC State University IRB’s primary function is to protect human subjects by ensuring safeguards are in place for each study that NC State researchers perform. The IRB does this by reviewing all research activities affiliated with NC State (even international). Research activities with human subjects including recruitment, consent, data collection, and data analysis cannot begin until the IRB reviewed the research protocol and has given full approval.
o The IRB also serves as a place for participants, along with research staff and employees, to report any complaints or suspicious activities related to the research study.
o If you decide to volunteer in a research study, information about the study will be given to you in a consent form. This form is to help you understand exactly what will happen while you are participating in the research study. It is designed to help you make up your mind about participating, or not participating, in the study.
o The informed consent document will outline all the rights you have as a volunteer in a research study.
o During the consent process and in the Informed Consent form, you will be told about the study procedures, the risks associated with the study, any benefits that may exist. You will be told about your rights, who to contact, compensation (if applicable), and any alternative options to participating in research that may be available to you.
o After reading the consent form, you can make your final decision about participating in the proposed study.
o Sometimes the consent process involves a form you sign or it can instead be a verbal consent process.
o Before you decide to volunteer to take part in a research study, you need to know as much as possible about the research study. If there are any issues that concern you, be sure to ask questions. You might want to write your questions down.
o Remember, if you do not understand the answer to one of your questions, ask the question again and ask the person to explain the answer in a way you can understand it. If you forget the answer to the questions during the study, just ask them again.
o The following are a list of sample questions you may have for a research. Not every question will apply to every study:
▪ Who is doing the study and what questions might it answer?
▪ Who reviewed or approved this study to be done?
▪ What could happen to my body, emotional health, reputation, or environment, if I take part in this study?
▪ What tests or procedures will I experience during the study?
▪ How long will this study last and how much time will I spend as a participant in the study?
▪ If I decide to participate, how will my participation affect my daily life?
▪ Will I be charged anything or paid anything to be in this study?
▪ Can I get the same information, education, or treatment without being in the study?
▪ Who will be told that I am taking part in this study and what information will they receive about me?
▪ What happens to any specimens (e.g., blood, body tissues, urine) or information (e.g., thoughts feelings, opinions, apritude) that I give as a part of this study?
▪ Will my information or specimens be given to any other researchers and will my name be associated with it?
▪ What happens after the study ends?
▪ Will I be told the results of the study?
▪ How do I stop participating in the study if I change my mind?
▪ What other options do I have if I decide not to take part in this study?
▪ Whom do I contact for questions and information about the study?
▪ Whom do I contact for questions about my rights as a participant?
o Participating in research is a useful and interesting way to give back to your community.
o Studies and research are about discovering things that can make our lives better. By participating in a study, you may help improve experiences, care, learning, environments, products, or devices that affect you and those around you.
o The results from these studies often help professionals provide better care, education, services, products, or support for those they interact with. It is important to remember that not all studies lead to better treatments.
o Some studies show that professionals are already doing what is best. Even when a research study does not find better treatments or systems or outcomes, the results can still help researchers come up with new ideas.
o There are many reasons to participate in research. You may want to:
▪ help improve education, processes, systems, environments, devices, services, and more.
▪ help find a treatment or cure for an illness or help other people who are sick
▪ help scientists find out more about how the human body and mind
o If you decide to take part in a research study, you do so as a VOLUNTEER. That means YOU decide whether or not you will take part. If you choose to do so, you have many important rights.
o There may or may not be a direct benefit to you if you take part in a research study. For example, if you are involved in an educational study, sometimes you will receive new educational techniques that improve your learning.
o No one can completely predict the outcome of a research study or how it might affect you. The study may not help you personally, but your participation in the study may result in information that will help others in the future.
o Sometimes research procedures may cause discomfort and/or side effects. The questions being asked could make you uncomfortable. The risks and side effects of the research may not be known completely when you start the study.
o The research staff will discuss with you known possible risks so you can decide if you want to volunteer. If you do volunteer, the research staff will tell you about any new risks that they learn about during the study for as long as you participate in the study.
o Participation can take a lot of time and commitment.
o If anyone asks you to take part in a research study, you have the right to say “no.” Remember:
▪ Your decision will not affect your access to resources or benefits that you would normally have.
▪ You need to weigh both the risks of the study and the benefits so that you make an informed decision about how the study will affect you.
▪ It may be helpful to talk with family members, friends, advisors, or health care providers
▪ If you decide to volunteer for a research study, you can change your mind and stop or leave the study at any time.
o Think about the goals of the research and what it is trying to accomplish. Do they align with your goals? Your values?
o Think about the eligibility criteria for the study, do you meet them?
o Are you comfortable with the study procedures outlined in the Informed Consent process?
o Would participating in this research provide you a direct benefit?
o Would being a part of this research make you feel good?
o You can tell the researcher you want to stop.
o You can close out the internet browser you may be using.
o You can leave the room or facility you may be in.
o You can tell the researcher you do not want your information used as data (in most cases).
o You can choose not to show up (though it is helpful to notify the researcher beforehand).
o The Consent Form should outline any information regarding stopping participation.
o Sometimes you will find out about the results and sometimes you will not.
o Some researchers send you reports back so that you can see the findings.
o Some researchers ask you to directly provide feedback on the information they found.
o You can always ask the researcher to share their findings with you.
o The Informed Consent form will often tell you if you are able to receive updates and information about the results and findings of the study.
Education and Resources
Informational Videos about being in Research
Ethical Principles and Regulations Governing Research
- Regulations and Why We Have Them
- The Common Rule (Regulations Governing IRB’s until January 2019)
- The Final Rule (Regulations Governing IRB’s After January 2019)
- The Belmont Report (Guiding Ethical Principals for IRBs