Q. What is a Human Subject?
A. Human subject is defined by the Code of Federal Regulations (CFR) as "a living individual about whom an investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects.
Q. What is the definition of research?
A. Research is defined in the CFR as "a systematic investigation designed to develop and contribute to generalizable knowledge." Some examples of activities that constitute research include:
- Any study intended to result in publication or public presentation
- Any activity resulting in publication or public presentation, even though it involves only review of existing data that was collected with no intent to publish
- Any use of an investigational drug or device
Thus, research with human subjects includes survey and interview research, as well as evaluation studies.
Q. Why is informed consent needed?
A. Informed Consent is intended to allow all human subjects, prior to their participation, the opportunity to understand the nature and scope of the research, issues related to confidentiality and risks associated with their voluntary decision to participate in the research.
Q. Who is considered a vulnerable population?
A.Vulnerable populations includes children, pregnant women, ethnic minorities or those who are unable to speak English, people with mental impairment and prisoners.
Q. What is minimal risk?
A. Minimal risk involves no more than what is normally encountered in the daily lives of healthy individuals.
Q. What is voluntary participation in research?
A. Voluntary participation means that all subjects freely choose to participate in the research (without any coercion or undue influence), and understand that it is their right to withdraw from the study at any point without any consequences to themselves.
Q. When is the institutional permission letter required as part of the application?
A. For a study to be carried out at another institution, the Principal Investigator must seek a written permission letter from a person from the institution with authority to approve the recruitment of human subjects and to conduct research at the institution.
Q. Can I designate my research exempt if it qualifies for it?
A. Exempt research designation may not be determined by the Principal Investigator, but the IRB upon review of the application must grant the exempt designation for a protocol.
Q. What are the requirements for class-based exemption?
A. A Classroom project that will be used for teaching and learning the research tools in the classroom or for pedagogy and will not be published, or presented beyond the classroom are exempt. These projects must not include minors or vulnerable populations, entail no more than minimal risk, must not use deception, and will not use audio and video taping.
Q. What is identifiable information?
A. Identifiable information is any type of information that can reveal the identity of a participant. This includes, but is not limited to, name, job title, age, fingerprints, biometric data, gender, birth date, ethnicity or race, medical records, and the zip code for a location with small population. Confidentiality of the participants’ identity must always be maintained.
Q. What is considered a complete IRB application?
A. Complete IRB application includes, a completed application form, informed consent forms that will be used for the study, interview questions and/or the survey copy, the institutional permission letter, and the Principal Investigator training certificate.
Q. Who needs to complete the online PI Certification training?
A. PI Certification training is required of all those project personnel who will be interacting with human subjects or will have access to the data and/or are involved in the analysis.
Q. What constitutes complete disclosure?
A. Disclosure of the scope of the project must be clearly and in plain language spelled out in the informed consent forms. It must also communicate that participation is voluntary with no consequences for the participant who may not want to participate or may stop participating at any time they decide to.
Q. What if the disclosure of the real objectives is not desired?
A. Deception of the scope or nature of the project must not be used for the project. However, in some instances, it may be necessary for objective research. In those cases the IRB will carefully evaluate the need and extent of deception and the risks and rewards associated with it in approving the application.
Q. What if I want to continue my project beyond the one year IRB approval?
A. Continuation of research on a project that extends beyond the IRB approved period requires IRB approval. IRB approvals are for one year, and any extension of the research beyond this period requires filing a Research Continuation Form for IRB’s review and approval.
Q. What do they mean by “Respect” in the context of my research?
A. Respect refers to the principle that all individuals should be treated as autonomous agents (i.e. having ultimate control over their lives), and that persons with diminished autonomy (unable to exercise complete control) are entitled to protection.
Q. What is the definition of “Beneficence” in light of the human subject research?
A. Beneficence is the principle that the investigators are obligated to protect; the well being of human subjects involved in the research by maximizing the benefits and minimizing the harm.
Q. What does “Justice” mean in the context of my research?
A. Justice obligates the need that all groups are entitled to share equally in the benefits of any research, and likewise no group should be expected to bear more than their share of the burdens of research.