Application of these principles leads to the standard expectations that investigators will include the following in all applications for IRB review and approval.
Informed Consent: Must be obtained by (a) making real efforts to see that subjects understand the project, (b) providing "a way out" for subjects if they desire one, and (c) providing a way for questions to be answered.
Risk Benefit Assessment: A thorough assessment of possible risks and benefits must be completed.
Equitable Selection of Subjects: Recruitment and selection of subjects must be done in a fair manner that does not exploit any vulnerable categories of people, affords equal sharing of risks and benefits, and goes beyond pure convenience for the researcher.
Research on human subjects, or the systematic collection of personal or private information from living human beings, can be done in virtually any discipline represented at the University. Biological, sociological, anthropological, and psychological studies all involve human subjects. Increasingly, research in the humanities such as religion, law, linguistics, cultural studies, and history, also involves human subjects.
Often research that LMU students, faculty or staff conduct is fairly benign, and the IRB will review it quickly. Sometimes there is enough risk to subjects, including the need for confidentiality, that the IRB will want to be clear that adequate protections are in place to satisfy federal and state laws. The IRB will evaluate your research plans to make sure that nothing you intend to do is unjustifiably dangerous to your participants and that their rights to participate (or not) are respected. Sometimes the IRB will recommend changes to your procedures, and will approve your research only after the changes have been made.
We urge you to browse this website to better understand how, when, and why to apply for IRB approval of your research. We answer frequently asked questions, explore the ethical and legal guidelines, direct you to the required training sites whereby you can be authorized to embark on human subjects research, provide the application forms to submit your protocol for review, display sample consent and other documents which you will need to draft prior to commencing data collection, and explain how to maintain approval of your protocol. Finally we have collected an extensive glossary of compliance terms, and many reference links to assist you in your investigation of compliance topics.
If you have any questions as you embark on this inquiry please contact Julie Paterson, Research Compliance Specialist at 310-258-5465 jpaterso@lmu.edu, or Steve Heller, Ph.D., IRB Chair at irb@lmu.edu.
In summary, the IRB’s job is to protect people who volunteer to participate in research studies conducted by and at Loyola Marymount University.