What is a research study?
Researchers are people who ask questions about particular topics. A research study is a way of collecting and analyzing data to answer those questions. Research studies can take many different forms. Some research studies involve interviewing people, making observations of a person, people, or place, investigating diseases or conditions, or giving a survey.
What is a research subject?
A research subject is a person who voluntarily decides to participate in a research study. Research subjects are vital to helping researchers answer the questions they are investigating. However, it is important to know your rights and remember that you can quit a research study at any time for any reason without fear of negative repercussions.
What is a protocol?
A protocol is the instructions that must be followed to conduct a research study safely. The protocol tells researchers and participants what can and cannot be done during the study. Research must submit protocols for review and approval by the Institutional Review Board to protect research subjects.
Who can be in a research study?
Research studies typically have a list of who can and cannot be included in a study. In order to protect research subjects, only people who qualify can be in a study.
What is a PI?
The PI, or Principal Investigator, is the person who in charge and conducts a research study. The PI can be a faculty or staff member or even an undergraduate or graduate student associated with UHD. The PI is responsible for making sure all procedures for the study are done properly. The PI is also in charge of other persons who help with the study.
What is an IRB?
IRB stands for Institutional Review Board (IRB), but is also known as the Committee for the Protection of Human Subjects (CPHS) at UHD. The primary role and responsibility of CPHS is protect individuals who volunteer to participate in research studies and to ensure that all the federal rules and guidelines that are set up to protect human subjects are followed by the Principle Investigator and any other individuals who are conducting the research study. This special committee is made up of a group of faculty and staff from UHD representing all the departments on campus and some community members who represent special groups of people such as prisoners and people with disabilities. When someone associated with UHD wants to conduct a research study with human subjects, they must submit an application to CPHS for review and approval. CPHS reviews every research application before a study is conducted on or with any people. Some research studies involve risk. Members of CPHS read through research applications to make sure the potential risks to subjects are justified and minimized.
What in an informed consent?
If you decided to volunteer to participate in a research study, an individual coordinating the project will give you an informed consent form. This form is very important, and we strongly encourage you to read it carefully. This form should present key information about the research study in clear, easy to read and understand language. This includes having the form available to you in your home language, if that language is other than English. The informed consent form should clearly describe the purpose of the research study, the how long your will be participating, describe all the procedures, describe any foreseeable risks or discomforts, and describe any potential benefits to you. Most importantly, this form should make it clear that your participation in the research study is voluntary and that you should not feel pressured to participate by anyone. Additionally, the informed consent form should remind you that you have the right to quit the project at any time without negative repercussions. Finally, individuals conducting research studies associated with UHD must have the name and contact information for the current chair of UHD’s IRB Committee who you can reach via email at email@example.com. Still have questions about informed consent? Take a look at the Health and Human Services Informed Consent FAQs.
What are my rights as a Research Subject?
Please visit the UHD Participant Bill of Rights page.
What are my responsibilities as a Research Subject?
Please visit the UHD Research Subject Responsibilities page.