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. Luther Seminary accepts three historic documents, the Nuremburg Code (1949), the Helsinki Declaration (1964), and the Belmont Report (1979) as expressing the general philosophical and ethical foundation of the IRB.
The Belmont Report establishes three quintessential requirements for the ethical conduct of human subject research:
- Respect for persons (involving a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy);
- Benefice (entailing an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm); and
- Justice (requiring that the benefits and burdens of research be distributed fairly).
The decisions of the IRB are informed by these three requirements and are governed by these 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, not just federally funded research, involving human subjects must comply with the Federal Policy.
- Definition of pertinent terms
- Jurisdiction of the IRB
- Thesis projects
- IRB membership
- IRB meetings
- Records of the IRB
- Summary of the review process
- Types of reviews
- Full review
- Expedited review
- Exemptions from review
- Possible outcomes
- Informed consent
- Project completion and continuing review
Definition of terms
|Research||means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR 46.102)|
|Human subject||means a living individual about whom an investigator (whether professional or student) conducting research obtains data or private information. (45 CFR 46.102)|
|Risk||means the extent to which a human, subject to research procedures, may be exposed to physical, psychological, or other types of harm.|
|Minimal risk||means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102)|
|Informed consent||means subjects’ willingness to participate after the researcher communicates to subjects, in language they can understand, information that the subjects may reasonably be expected to desire in considering whether or not to participate, and that minimizes the possibility of coercion or undue influence.|
|Assent||means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.|
|Permission||means the agreement of parent(s) or guardian to the participation of their child or ward in research.|
|Confidentiality||pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.|
|Privacy||is the control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.|
|Protocol||is the formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.|
|Institutional Review Board||is the specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.|
|Full Review||means a review of proposals by the entire IRB. This will be conducted for research that involves greater than minimal risk, or the research is of a psychologically sensitive nature.|
|Expedited Review||means a review by the chair of the IRB and/or one other member of the IRB for research that involves no more than minimal risk, or to review minor revisions in previously approved research, or review revisions for proposals that were approved with contingencies.|
|Exempt Status||means a research proposal where the subjects are at no more than minimal risk, the subjects’ confidentiality is maintained, and the proposal meets one of the six criteria for exemption.|
Jurisdiction of the IRB
When Luther Seminary faculty, staff, or students, are involved in research conducted with human subjects at risk, the research activity must be reviewed by the IRB. The IRB has the authority to approve, require modification in, or disapprove of all such research activities. Further, the IRB has the authority to suspend or terminate approval of research that is not in compliance with the IRB’s determinations and is, or has been, associated in the execution with unexpected risk to subjects. For IRB purposes these decisions are based on the criteria set forth in these IRB Policies and Procedures and the Federal Policy.
Human subjects are involved if: 1) there is an intervention or an interaction with a living person that would not be occurring or would be occurring in some other fashion, but for this research, or 2) identifiable private data/information will be obtained for this research in a form associable with an individual. For example, secondary analysis of aggregate data does not require IRB approval.
All faculty review and approval processes applicable to Ph.D., D.Min, Th.M., or M.A. thesis proposals must be completed before the proposal will be considered by the IRB.
The IRB at Luther Seminary shall consist of at least five members with varying backgrounds from the full-time faculty in addition to the Associate Dean, Graduate Theological Education and the Associate Dean, M.A., M.S.M. The membership shall include both sexes, representation from racial and cultural backgrounds, representation from social sciences and non-science areas, at least one person who has had experience in the planning and conduct of research on humans. Appointments to the IRB are for three-year revolving terms. Temporary appointments will be made to complete a term in the instance of a vacancy. Faculty members will be appointed by the Academic Dean. The IRB may, at its discretion, invite persons with appropriate competencies to aid in its review of complex issues, but such persons will not have a vote.
To conduct the business of the IRB, a majority of its members must be present. The IRB shall approve or disapprove research only with the concurrence of a majority of those members in attendance. The IRB will convene at regularly scheduled meetings on dates published in advance. The IRB will hold extraordinary meetings at the call of the Chair.
Research proposals must be submitted to the IRB at least seven (7) days before its meeting. Any research proposals submitted to the IRB for a full review will be distributed to the members at least five (5) days prior to a meeting. Notification of the action taken by the IRB will be sent to the investigator no later than five (5) days after the meeting. Notification will be made in a standard form; notification will, if necessary, include a description of any contingencies and, in the case of disapproval, include a statement of the IRB’s reasons.
The IRB shall maintain the following records:
- Copies of all applications reviewed, scientific evaluations, if any, that accompany the applications, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
- Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
- Records of continuing review activities.
- Copies of all correspondence between the IRB and the investigators.
- A list of IRB members in the same detail as described in 45 CFR 46.103(b)(3).
- Written procedures for the IRB in the same detail as described in 45 CFR 46.103(b)(4) and 46.103(b)(5).
- Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5).
- The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.
Summary of the review process
- The investigator identifies a research project. If the investigator is a student he or she discusses the project with his or her faculty advisor.
- The required forms are completed following the guidelines available on the IRB website.
- The completed application form is signed by the investigator(s), and, where appropriate, the faculty advisor, and submitted to the IRB Administrator with any required supporting documentation, such as the 100-150 word abstract of the proposed study, copies of cover letters, informed consent forms, surveys or questionnaires, letters of agreement from cooperating institutions, etc. If the application is incomplete it may be returned to the applicant without being reviewed. Applications are normally accepted during the academic year only and must be received before May 15th to be reviewed.
- Applications claiming Exemption from IRB Review will be evaluated by the IRB Chair to determine whether the proposal qualifies for exemption as involving minimal risk, falling within one of the six criteria for exemption specified below, and meeting appropriate consent and confidentiality requirements. Applications for Expedited Review will be routed to the IRB Chair and one IRB member for evaluation and determination. Applications for Full Review will be docketed for the next regularly scheduled meeting of the IRB for which submission deadlines have been met.
- A formal letter of approval or disapproval is sent by the Chair of the IRB to the principal investigator. In the case of required or suggested modifications, the principal investigator may be asked to “Revise and resubmit” the application.
- If the application is disapproved, the investigator may appeal the decision.
- All investigators will complete and submit a Continuing Review Form at the end of each academic year and a Project Completion Form upon completion of the project.
Types of reviews
There are three types of research proposals:
- Those that require Full Review by the IRB.
- Research that meets specific criteria for an Expedited Review.
- Proposals that are Exempt from IRB review.
A description of each type of research proposal and instructions for completing the application process is presented below.
A full review by the IRB will be conducted for research that involves greater than minimal risk. A full review must be conducted at a meeting of the IRB under the procedures established below. In order to approve research under a full review, the IRB will consider the following:
- Risks are reasonable in relation to expected benefits and minimized by the use of the safest procedures consistent with standard research practices.
- Selection of subjects is equitable, taking into account the purpose of the research.
- Privacy of the subjects and confidentiality of data are protected.
- Informed consent is obtained and documented.
Proposals for full review must include an original and six copies of a fully completed Application together with associated descriptions, forms and materials called for by the Application.
An expedited review by the IRB will be conducted for research that involves no more than minimal risk, or to review minor changes in previously approved research, or review revisions for proposals that were approved with contingencies. An expedited review may be conducted by the IRB Chair and by one or more reviewers designated by the Chair from among IRB members. In order to insure that all members have involvement in the expedited review process, the Chair will designate reviewers on a rotating basis. Care will be taken in the selection of expedited reviewers to avoid a conflict of interest.
The Chair of the IRB will make the final decision regarding approval of proposals that were revised and resubmitted for expedited review. When an expedited review procedure is used, all IRB members will be advised of research proposals that have been approved under the procedure. If issues of concern arise in the process of full or expedited review, the investigator will be provided the opportunity to respond to those concerns prior to any action on that review.
Proposals for expedited review must include an original and one copy of a fully completed Application with all associated descriptions, forms, and materials.
Exemptions from IRB review
Exemptions from IRB Review pertain to research where the subjects are at no more than minimal risk, the subjects’ confidentiality is maintained, and the research meets at least one of the six criteria for exemption specified in the Federal Policy and set forth below. Research proposals that meet the criteria for exempt status must still be processed through the IRB. The Chair of the IRB will make the decision regarding exemption approval when an Application contains a Request for Exempt Status. Although a research project may meet the criteria for exempt status, it does not mean the study is exempt from meeting federal regulations regarding informed consent and storage of confidential materials. Proposals approved for Exempt Status are not required to submit a Continuing Review or Project Completion form.
In the case of minors, only research conducted in established or commonly accepted educational settings may be considered for exempt status. In this situation, the research must be conducted in the minor’s classroom or school by his/her teacher, instructor, or therapist. This does not apply to student teachers in locations outside of the Luther Seminary campus.
Proposals requesting exempt status must include one original copy of a fully completed Application with all associated descriptions, forms, and materials.
The following types of research are exempt from the required review (45 CFR 46.101b):
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. This is the only area of exemption that may apply to minors, whereby the researcher is the minor’s teacher, instructor, therapist, etc.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifies linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph 2 of this section, if (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefits or services programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (1) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use founds to be safe, or agricultural chemical or environment contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Possible review outcomes
Review of an Application may result in one or a combination of the following outcomes: (1) the proposal does or does not qualify for the level or review claimed as appropriate; (2) the proposal is approved as submitted; (3) the proposal is approved with specified required revisions; (4) the proposal must be revised and resubmitted; (5) the proposal is disapproved.
In order to involve a human subject in research, a researcher must obtain the legally effective informed consent of the subject or the subject’s legally authorized representative. Special care should be exercised when the subjects are legal minors or adults legally incapable of giving consent. Informed consent shall be documented by the use of a written consent form approved by the IRB (see the Sample Informed Consent Form and Sample Implied Consent Letter) and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form. By federal law, researchers are to keep signed informed consent forms for three years. 45 CFR 46.116
In seeking informed consent the following information should be provided to the subject:
- A statement that the study involves research, an explanation of the purposes of the research and who will be conducting the research, expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject (again, these may be emotional or psychological or social or financial in addition to physical risks);
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A description of how the confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact for answers to pertinent questions about the research (usually the investigators), research subjects’ rights (usually the IRB Administrator), and whom to contact in the event of a research-related injury to the subject (usually the IRB Administrator);
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, one or more of the following elements should also be provided to each subject:
- A statement that a particular treatment or procedure may involve risks to the subject (or the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
- Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
- Any additional costs to the subject that may result from participation in the research;
- The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject; and
- The approximate number of subjects involved in the study.
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.
In the instance of IRB disapproval of a project, or of a contingency approval, an investigator may request an appeal hearing before the IRB in full. Records and notice of action will be provided.
No other Luther Seminary approval may be provided in opposition to IRB disapproval. However, IRB approved projects may be disapproved by other offices of the Seminary.
Project completion and continuing review
All investigators will complete a Continuing Review Form at the end of each academic year and a Project Completion Form upon the completion of the project. Forms will be sent by the IRB Administrator to the principal investigator. Once a research project is determined to be complete, all associated documents on file in the office of the IRB Administrator will be retained for three years. It is the principal investigator’s responsibility to provide secure storage of the Informed Consent forms and any audio/video tapes or photographs. These items must also be maintained for three years.