IRB Approval Instructions
Understand the IRB approval process
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What is the function of the IRB?
The Luther Seminary Institutional Review Board (IRB) exists as a safeguard to promote and ensure ethical and responsible treatment of human subjects involved in research conducted at Luther Seminary.
Who sits on the IRB?
The IRB is an independent voluntary committee, appointed by the Academic Dean, made up of faculty members and members of the community who have no direct ties to the Seminary. Some of the IRB members are experienced and directly involved in human subject research; others are not and are recruited to bring other types of knowledge and experience to IRB deliberations.
What is the jurisdiction of the IRB?
All research that involves human subjects and that is conducted under the auspices of Luther Seminary by its faculty, staff, or students is required to be reviewed and approved by the IRB. "Research" is defined under applicable federal regulations as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. "Human Subject" means a living individual about whom an Investigator (whether professional or student) conducting research obtains data or private information.
What standards and principles guide IRB decisions?
The decisions of the IRB are governed by Luther Seminary's IRB Policies and Procedures, and by the Federal Policy (also sometimes called the "Common Rule") codified at Title 45 Part 46 of the Code of Federal Regulations. Where the IRB Policies and Procedures and the Federal Policy come into conflict, the Federal Policy is to govern. The Federal Policy requires that all federally funded research must comply with the Federal Policy. It is Luther Seminary's policy that all research involving human subjects must comply with the Federal Policy.
Based on these authorities, the IRB will apply the following general criteria in evaluating research proposals:
- Are the risks and discomforts to subjects minimized?
- Are the risks and discomforts to subjects reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result?
- Will voluntary and informed consent to participate in research be obtained from each subject or the subject's legally authorized representative and will it be appropriately documented?
- Will the privacy of subjects and confidentiality or anonymity of data be protected?
How do I apply for IRB approval of my proposal?
Application for approval of a research proposal involving human subjects is made by downloading and submitting the Application for the Approval of Use of Human Subjects in Research form provided on this website. You must use this application form or your application will not be considered. When and how you should submit the application is prescribed below.
Which of the three possible levels of review is appropriate for my proposal?
Three possible levels of review, Full Review, Expedited Review, and Exempt Review, are established in the Federal Policy and the IRB Policies and Procedures for evaluation of research proposals, depending upon the level of risk involved and other factors. The same application form is required for all three levels of review, and the same consent requirements apply. You are asked to declare in the application which level of review you deem is appropriate. Descriptions of the three levels of review and the criteria to be used for determining which level is appropriated to a given project is set forth in the IRB Policies and Procedures. You should consult with your advisor/instructor, and if necessary the IRB Chair, to determine which level is appropriate.
What if my research consists solely of surveys or interviews?
In general, surveys, interviews, and secondary use of data qualify for Exempt Review so long as no sensitive questions or use of children or other vulnerable populations are not involved. Use of sensitive questions or vulnerable populations will require Full Review.
What are sensitive questions?
Questions or items on the following topics will require additional protection of subjects' privacy. Parents or guardians and subjects must be informed of the sensitive questions before they give permission or consent to participate. Generally information on these topics will be gathered anonymously.
- Information pertaining to illegal, anti-social, self-incriminating, and demeaning behavior;
- Information relating to the use of alcohol, drugs, or other addictive products;
- Information relating to sexual attitudes, preferences, or practices;
- Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
- Information that would normally be recorded in a patient's medical record and the disclosure of which could reasonably lead to social stigmatization or discrimination;
- Information pertaining to an individual's psychological well-being or mental health;
- Information relating to a subjects political affiliations;
- Critical appraisals of other individuals with whom the subject has close family relationships;
- Income, other than that required by law to determine eligibility for participation in a program or for receiving assistance under a program.
Who is considered vulnerable population?
Vulnerable populations include those subjects who, as outlined in state and federal regulations, must be provided extra protection. This includes, but is not limited to minors, prisoners, fetuses/pregnant women, elderly and cognitively impaired, patients with incurable diseases, persons in nursing homes, unemployed or otherwise economically disadvantaged persons, patients in emergency rooms, ethnic or racial minority groups (except those included in a general population), homeless persons, refugees, children, and those incapable of giving consent.
Whenever potential subjects are persons of diminished capacity and capable of giving assent, the researcher must obtain their assent in addition to obtaining permission to participate in research from their guardian before involving the individual in a study. Thus, in the case of children or minors aged 7-18, permission must be obtained from a parent or guardian as well as assent from the subjects. This will require explaining what their participation means and their rights in age appropriate language.
What if I plan to audiotape, videotape or photograph my subjects?
In research projects involving audio or video taping or photographing of subjects, the following guidelines apply:
- Subjects must be advised that their participation includes the use of audio/video taping or photographing.;
- Before consenting to being taped (audio or video) or photographed, subjects should be informed of the current and planned use of the materials including storage and access by persons other than the researcher. Subjects must be advised when tapes or photographs will be erased or destroyed;
- This permission will normally be included in the consent form. If consent forms are not used, the elements of informed consent must be explained to the subjects and an appropriate release must be obtained. This release statement may be included as a preamble to the taped procedure;
- The researcher must make proper arrangements for secure storage of all audio and video tapes and assure that their use complies with the guidelines outlined in the informed consent/release form. Plans may include storage, erasing, or destroying after a given time period.
How do I obtain consent from my human research subjects?
An essential element of any proposal is the way in which voluntary and informed consent will be obtained from human research subjects. The requirement of obtaining of effective consent is a process, not simply a form, by which communication is made to the prospective subject of the purpose, risks, benefits, and voluntary nature of the research. The consent form ultimately obtained from the subject documents that the communication process has taken place. The consent form must contain all of the essential "elements" of informed consent set forth in the Federal Policy and the IRB Policies and Procedures. In cases where consent is to be assumed by the return of a survey instrument, researchers should follow the Sample of Implied Consent Letter. In all other cases, the Sample of Informed Consent Form should be used. The consent form should be written in lay terms, using simple declarative sentences. Technical terms or terms of art unavoidably used should be defined parenthetically. Copies of signed consent forms must be retained for three years after completion of the research and must be available for IRB review if necessary.
When and how should I submit my application?
All applications should be submitted to the IRB Administrator, Room 220B, Northwestern Hall. Applicants for Exempt Review should submit one paper copy of the application together with associated materials, applicants of Expedited Review two paper copies, and applicants for Full Review seven copies. Applicants for Full and Expedited Review may submit their applications at any time during the academic year (September-May 15th). Applicants for Full Review must submit their applications at least seven days in advance of a regularly scheduled meeting of the IRB. (At the time of application submission, the IRB administrator will indicate the timeline for approval. It is recommended to allow at least 60 days prior to the time you plan to begin research).
How are applications at each level evaluated and what outcomes are possible?
Applications for Exempt Review are evaluated by the IRB Administrator to verify that Exempt Review is appropriate and that applicable confidentiality, consent, and other requirements are met. The Chair will approve the proposal, approve the proposal with stipulations, or elevate it to Expedited or Full Review. Applications for Expedited Review are evaluated by the Chair of the IRB and one other board member. They will approve the proposal, approve the proposal with stipulations, or elevate it to Full Review. Applications for Full Review are read by all board members and passed upon at a full IRB meeting. If possible, the IRB prefers that the investigator and advisor/instructor attend this meeting. The IRB may approve the proposal, approve the proposal with stipulations, or disapprove it. Notification of the outcome of the review will be by letter issued normally within two weeks of submission of the application in the case of Exempt and Expedited Reviews, and within one week of the IRB meeting in the case of Full Review.
What if I need to change my research design or protocol after IRB approval?
If you wish to change a research procedure after IRB approval, you must submit a written request, sufficiently documented, describing and justifying the proposed change. Such changes may include enrollment criteria of subjects, method of data collection, or changes prompted by an adverse event, defined as any undesirable and unintended, although not necessarily anticipated impact on a subject as a result of the research. The IRB will then reassess the research project and may require its modification or termination.
All investigators must complete a Continuing Review Form at the end of each academic year.
All investigators must complete a Project Completion Form upon completion of the project.