The Lutheran Medical Center Institutional Review Board
The Lutheran Medical Center Institutional Review Board (IRB) is the IRB for all of Lutheran HealthCare. Lutheran HealthCare (LHC) is committed to the ethical principles for the protection of human participants in research that are set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. LHC recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving human participants fulfills these ethical principles. The basic ethical principles outlined in the Belmont Report guide deliberations and decision-making of the Institutional Review Board (IRB) and include respect for persons, beneficence, and justice.
The Lutheran Medical Center IRB meets on the 4th Thursday of every other month, starting in January. In November, the IRB usually meets on the 3rd Thursday. All new proposals to be reviewed at each bimonthly meeting should be submitted by the 7th of that month to be eligible for review at the next scheduled meeting.
What is an Institutional Review Board (IRB)?
An IRB is the committee that determines whether research may be done at an institution and monitors the research while it is being carried out. Because of serious ethical violations at other organizations in the past, IRB became part of standard health care review practices. At Lutheran HealthCare, the IRB is composed of representatives of many clinical departments as well as non-scientists and a community member.
What is research?
According to the U.S. government, research involves the collection of information from research participants that results in knowledge or conclusions that can applied generally (i.e., that is generalizable). Case reports are not considered research, but retrospective chart reviews are. Quality improvement projects are not considered research because they are not presented outside of an institution and thus are not generalizable.
When does a researcher need to fill out an IRB application?
A researcher needs to apply for permission to conduct any research at Lutheran HealthCare. This includes retrospective chart reviews, surveys and searches of electronic patient databases, as well as research that involves new medical interventions with patients. It also includes research where the research participants are physicians, nurses or any other employees or health professionals, as well as research where the research participants are inpatients or outpatients.
What signatures do I need on an IRB application?
In addition to the principal investigator, the following parties must sign the IRB application: the department head (if the research involves Lutheran Medical Center patients or employees); or the Lutheran Family Health Centers’ medical director (if the research involves patients or employees of the Lutheran Family Health Centers); or both (if the research involves both).
Does all research need informed consent documents?
According to HIPAA, all researchers must obtain informed consent from their research participants. Under special circumstances, researchers can ask the IRB to waive the requirement for informed consent, such as for most retrospective chart reviews. (A template to help researchers request such a waiver is available on the Lutheran HealthCare website.) When research participants fill out a survey, this is considered equivalent to giving informed consent – so no separate consent form is needed for surveys (as long as the survey is clearly voluntary).
Do I need special training to conduct research at Lutheran HealthCare?
Yes, you need to have taken a course in research ethics. A free online course, which usually takes approximately thirty minutes to complete, will meet this requirement. The instructions for accessing this course are on the IRB application and the Lutheran HealthCare website. Lutheran Medical Center residents are required to take this course during their orientation.
How do I know when my research is approved?
The IRB will send you written notification of approval. You must receive this notification before starting your research project.
What is continuing review?
The IRB will let you know how often it will review your research. During the continuing review process, the IRB will ask you questions about your research or even audit your files. This must be done at least once a year and sometimes more frequently. If you do not respond to the IRB’s request for information (continuing review form) in the time frame stated, your project will be closed. If the continuing review form is not submitted within 30 days, no other application from you will be considered by the IRB until the form is received. If the continuing review form is not received within 60 days, all of your other projects will be suspended.
Is there a financial review of research projects?
All research projects are subject to review and approval by the Lutheran HealthCare finance office to ensure that any expenses incurred are appropriately reimbursed. Any research project financed by a for-profit sponsor will be subject to a one-time $1,500 IRB application fee. In addition, all funded research projects will be assessed a 10% administrative overhead fee by Lutheran HealthCare.