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 IRB gives proper consideration to the following:
The IRB reviews research involving human subjects if one or more of the following apply:
- 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
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.
- the research is sponsored by Union University 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 Union University in connection with his or her institutional responsibilities
- the research is conducted by or under the direction of any employee or agent of Union University using any property or facility of Union University
- the research involves the use of Union University's non-public information to identify or contact human research subjects or prospective subjects
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:
Research in the expedited category is that which poses no more than minimal risk to the subject involving no more than:
- 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 which is neither minimal nor expedited requires the full board category of review.
- 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
Q. What happens to my protocol after it is submitted to the IRB?
A. The IRB Compliance Officer 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. Remember, no research may begin until IRB has given your research protocol full approval with no revisions. The review process for protocols submitted for minimal or expedited review takes at least two weeks. The review process for protocols submitted for full board review can take up to a month or longer to complete. You should expect at least a few minor revisions. Many of these can be considered by the chair alone. To speed the review process when revisions are required, please highlight the changes.
A sizable number of protocols at the full board level of review must come back to the full board the next month. Why? Typically these protocols were not prepared with care, and they require substantial revisions and additions. It is safe to say that the less conscientious the initial preparation, the longer it takes to receive final approval. The IRB cannot approve applications in which critical information is missing or poorly articulated.
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 Union University 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, whichever you prefer. 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
Glossary of Terms
* Anonymous data collection means that even the researcher does not know the identity of the subjects.
* Confidential data collection means that the researcher knows the identity of the subjects either directly or through the use of a master list used for coding but will not release identifying information when sharing the data with others.
* A human subject under 45 CFR 46 is defined as "a living individual about whom an investigator conducting research obtains:
- data through intervention or interaction with the individual, or
- identifiable private information."
* "Interaction includes communication or interpersonal contact between investigator and subject." (45 CFR 46)
* "Intervention includes both physical procedures ... and manipulations of the subject or the subject's environment that are performed for research purposes." (45 CFR 46)
* Principal investigator is an employee, faculty member, or student of Union University who accepts responsibility for the research.
* Research is defined in 45 CFR 46 as a systematic empirical investigation designed to develop or contribute to generalized knowledge.