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 EDUCATIONAL RESEARCH RULES OF OPERATION GUIDE THE IRB AND THE RESEARCHER/INVESTIGATOR IN HUMAN SUBJECTS RESEARCH?

A. Five educational research rules of operations are relevant to human subjects research. They are:

• protection: the National Research Act of 1974 protects individuals invited to participate in research studies and protects participants from physical, mental, or emotional harm.  Notification must be given to the participants and the IRB regarding any potential harm associated with the research project.
• confidentiality: the Family Educational Rights and Privacy Act of 1974 states that the anonymity of research study participants be maintained unless with the express permission of the participants.  An example of keeping this principle is by using code numbers rather than names on data.
• beneficence: educational research is intended to contribute to the knowledge of the field and to shed light on the human condition. Simply stated, the researcher/investigator must document that some measurable good will come from their study.
• honesty: the research process, at times, involves decisions regarding maintaining the integrity of the data or analysis. The researcher/investigator is always expected to make choices consistent with personal and research integrity.
• accurate disclosure: research participants must be informed accurately about the general topic of research and any unusual procedures or tasks in which they will be involved. Accurate disclosure does not necessarily involve full disclosure since detailed knowledge of the purpose of the project could introduce participant-generated bias into the research.

Q. WHAT ARE THE COMPONENTS OF IRB REVIEW?

A. In reviewing research the IRB 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 Mission 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 Mission University in connection with his or her institutional responsibilities
• the research is conducted by or under the direction of any employee or agent of Mission University using any property or facility of Mission University
• the research involves the use of Mission University’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, or records 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 review category is that which poses no more than minimal risk to the subject involving no more than:

• non-invasive recording of data from subjects 18 years of age or older
• study of existing data or records
• research where the researchers do not manipulate subjects’ behavior and the research will not involve stress to subjects

Research in the full board review category is research that is neither minimal nor expedited and requires full board review. The IRB Chair refers all full board review research requests/proposals to the IRB for review and recommendation.

Q. WHAT HAPPENS TO MY PROTOCOL AFTER IT IS SUBMITTED TO THE IRB?

A. The IRB Compliance Officer processes the submitted protocol, records necessary information, assigns the protocol a unique number, and verifies the 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 the 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. Many of these can be considered by the IRB Chair alone. To speed the review process when revisions are required, please highlight the changes.

Protocols at the full board level of review may be returned for revisions. 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 MISSION 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