Guidance for human research volunteers
Learning about research participation can be challenging. The Human Research Protection Program (HRPP) in the Office of Research Support (ORS) created this page to provide helpful information to people who may be interested in research participation. Education regarding research is important in order to promote a healthy relationship between investigators and research participants. So, if you have ever been approached by an investigator or you have sought out an investigator to pursue participation in research, this information is for you - the prospective subject of human research.
What Is Human Research?
+ Synonyms Used In Research
The activity known as "research" can be called many different things:
- Research Study/Study
- Experiment
- Investigation
- Inquiry
Likewise, people recruited for research are referred to by many names:
- Participant
- Study Participant
- Research Participant
- Research Subject
- Subject
- Clinical Subject
+ Investigator Responsibilities
The Principal Investigator ("PI") is the individual who assumes full responsibility for a research study. The PI is required to:
- Conduct the TNS IRB approved research protocol
- Obtain legally effective informed consent
- Maintain subject confidentiality
- Quickly respond to all participant concerns and questions
- Inform participants of changes to risks or benefits in a study
- Obtain approval from TNS IRB for any proposed changes, additions, or deletions to the study
- Promptly report all unanticipated problems or injury to the IRB
- Retain research records for 3 years after the study completion date
- Effectively train/mentor student researchers in ethical conduct of research
- Comply with all TNS procedures for the ethical conduct of human subject research
+ Other Resources
Human research is defined as an activity designed to test a hypothesis (theory). The testing of this hypothesis lets an investigator draw conclusions as to whether the hypothesis is true, false or null (neither true nor false). The results of hypothetical investigations ultimately contribute to generalizable knowledge; that is to say these investigations, although tested in relatively small numbers, may be applied to larger numbers.
Human research begins when an investigator develops a study protocol to test a hypothesis. A study protocol is a uniform set of directions the investigator follows during a research project. The study protocol defines the objective, or goal, of the research project; for example, does substance B work better than substance A? The protocol defines what sort of activities or tests will be carried out in order to answer the hypothetical question.
What is the IRB?
+ Information for Prospective Subjects
Below please find a list of questions for potential human research participants that may aid in determining whether or not to participate in a human research study:
- Is this study of interest to me?
- When does this study take place?
- Where does this study take place?
- How long does this study last?
- Does this study have TNS IRB approval?
- Is this study safe?
- Is this study confidential or totally anonymous?
- How is my privacy being protected?
- How will I be notified if risks or benefits to the study were to change?
- Do I learn anything from participating?
- Who gains from my participation in the study?
- Do I feel pressured or obligated to participate in the study?
- May I quit the study at any time?
- Whom may I contact with questions or concerns about the study?
- Whom may I contact with questions or concerns that is not involved in the study?
+ Participant Rights
If you are asked to consent to be a subject in a research study, you have the right to:
- Learn about the nature and purpose of the study, experiment, or clinical trial.
- Receive an explanation of the procedures, and any drug or device that may be used.
- Learn about any benefits you might expect from the study.
- Receive a description of any discomforts and risks that you may experience from the study.
- Learn about the risks and benefits of any other available procedures, drug, or devices that may be helpful to you.
- Learn what medical treatment will be made available to you if you should be injured as a result of the study.
- Decide to consent or not to consent to a study without feeling force, obligation, pressure, or coercion.
- Receive a copy of the signed and dated consent form.
- Quit the study at any time, you decision may not be used as an excuse to hold back necessary medical treatment.
- Ask any questions about the study or the procedures involved.
+ Human Subject Responsibilities
- Completely read the consent form and ask the Principal Investigator ("PI") any questions that you may have.
- You should understand and comprehend what procedures will occur before you agree to participate.
- Know the beginning and ending dates of your participation.
- Carefully weigh potential benefits of participation (if any) and risks of participation.
- Contact the Principal Investigator if you desire to terminate, end, or quit your involvement in any research study.
- Contact the PI and/or TNS IRB with complaints or concerns about study participation.
- Report any and all unanticipated problems to the PI immediately.
- Comply with the responsibilities of participation as described on the consent forms unless you are discontinuing participation in the study.
- Confirm receipt of extra-credit points or monetary compensation.
- Request study results if desired.
- Retain a copy of the consent form for your records.
The Institutional Review Board (IRB) is designed to protect and advocate for the research participant. Once the investigator has developed a protocol to test the hypothesis, the investigator sends this information to the IRB. The IRB makes sure the protocol follows Federal and University rules and regulations for protecting human subjects. Once the protocol has been approved, the investigator may begin the study. From that point on, the investigator will continue to give the IRB (at least) yearly updates on the study. This is a Federal Requirement to help ensure that the conduct of the study continues to protect human research subjects.
The IRB needs to have at least five members with varying backgrounds. The IRB must be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes. The IRB membership needs to include at least one member whose primary concerns are in scientific areas; at least one member whose primary concerns are in nonscientific areas; and at least one member who is unaffiliated with the institution.