All research that involves human subjects must be reviewed and approved by the Human Subjects Institutional Review Board (IRB) prior to initiation.
Q. What ethical principles guide the IRB in the protection of human subjects?
A. Three basic principles of ethics are particularly relevant to the protection of human subjects in research. They are:
- respect for persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;
- beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and
- justice: fairness in the distribution of research benefits burdens.
Q. What are the components of IRB Review?
A. In reviewing research the HSIRB gives proper consideration to the following:
- risks to the subjects
- anticipated benefits to the subjects and others
- importance of the knowledge that may be reasonably expected to result from the research
- consent process to be employed
The IRB reviews research involving human subjects if one or more of the following apply:
- the research is sponsored by UM, regardless of the location of the project
- the research is conducted by, or under the direction of, any staff, faculty, student, or other agent of UM in connection with his or her institutional responsibilities
- the research is conducted by or under the direction of any employee or agent of UM using any property or facility of UM
- the research involves the use of UM's non-public information to identify or contact human research subjects or prospective subjects
Special consideration is required for research involving fetuses, pregnant or lactating women, human ova in vitro fertilization, prisoners, children, persons with cognitive impairment, or other potentially vulnerable groups.
Q. What is the difference between the three levels of IRB review (minimal, expedited, and full board)?
A. Research in the minimal review category is exempt from applicable federal regulations, although review by the IRB is still required. Minimal review research must be anonymous and at least one of the following:
- commonly accepted educational settings involving normal education practice
- educational tests if the information is taken so that subjects cannot be identified
- (does not apply to children) surveys or interviews that do not deal with sensitive aspects of the subject's own behavior (such as drug use, sexual activity, or criminal activity), or in which the subject's responses would not place the subject at risk of liability, or threaten financial standing or employability
- (needs not be anonymous) surveys or interviews of elected or appointed public officials or candidates for office
- (does not apply to children) observation of public behavior that does not deal with sensitive aspects of the subject's own behavior or in which the subject's responses would not place the subject at risk of liability or threaten financial standing or employability
- collection or study of existing data, documents, records, or biological specimens as long as they are publicly available* research or demonstration projects of programs under the Social Security Act or other public benefit or service programs
Research in the expedited category is that which poses no more than minimal risk to the subject involving no more than:
- collection of hair, nail clippings, baby teeth or teeth in need of extraction
- collection of excreta, sweat, saliva, placenta and amniotic fluid at delivery
- non-invasive recording of data from subjects 18 years of age or older using routine clinical procedures (not including x-rays and microwaves)
- collection of blood samples of limited volume and frequency from subjects 18 years of age or older
- collection of dental plaque via routine scaling of teeth using accepted techniques voice recordings for research purposes (e.g., of speech defects)
- moderate exercise by healthy volunteers
- study of existing data, records, or specimens
- research where the researchers do not manipulate subjects' behavior and the research will not involve stress to subjects
- research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required
Research which is neither minimal nor expedited requires the full board category of review.
Q. What happens to my protocol after it is submitted to the IRB?
A. The IRB Administrator processes the submitted protocol, inputs necessary information into the database, and assigns the protocol a unique number and determines appropriate level of review. Investigators are notified as soon as possible of the decisions relating to the protocol (i.e., request for revisions or approval).
Q. What kind of timeline should I expect for being able to begin data collection?
A. Please allow up to four weeks for the IRB to process your submission.
Q. The site where I intend to conduct my research has its own IRB. Does my protocol have to be reviewed by the site IRB and the University of Memphis IRB? If so, how do I do this?
A. Some sites of research activity, such as hospitals, community mental health organizations, and other universities, have IRBs to review the research conducted at that site. Each IRB must approve your project prior to implementation.
You may submit your protocol for review to both boards simultaneously or to each board consecutively. Each board may request different revisions based on interpretations of the federal regulations. Remember that it is your responsibility as the investigator to notify each board of the decisions of the other board. You must also remember to submit any revisions to both boards and you must receive approval from both boards before implementing any aspect of the research.
Q. What about changes in the protocol once it has been approved?
A. All changes in a research protocol must be approved before the change is incorporated into the protocol. These should also be submitted to the IRB in memo form, including the protocol number to speed processing.
Q. What are the responsibilities of the Principal Investigator?
A. The principal investigator is responsible for:
- the compliance of all co-investigators, student investigators, and research associates with the IRB decisions, conditions, and requirements
- reporting to the IRB any changes to the research protocol (e.g., research design of the study, recruitment procedures)
- requesting re-approval when contact with subjects will extend beyond the approval termination date
- reporting to the IRB chair any unanticipated adverse reactions or unanticipated events associated with the conduct of this research
- seeking clarification and advice from the IRB regarding ethical aspects of the research.
Q. I am conducting research at another institution, but I am a student/faculty member at the University of Memphis. The Institutional Review Board at the institution where I am conducting my research has already approved me. Do I need Institutional Review Board approval from the University of Memphis as well?
A. : The answer most likely is yes; See the Collaboration Section on the Initial Review Request Guidelines for more information.
Q. Why do I need both approvals?
A. : Other institutions considerations when making a decision may differ based on their institutional policies than those considerations used here at the University of Memphis. Therefore, as a University of Memphis student / faculty member, your research still requires University of Memphis Institutional Review Board approval.