Institutional Review Board
Institutional Review Board (IRB)
The US government provides extensive guidelines under the heading “Public Welfare” to protect the information and the right to confidentiality of research participants (sometimes called human research subjects or human subjects). In addition to confidentiality protection is the issue of consent to participation and outlining risks involved in participation.
At a seminary, these ethical issues are assumed to be part of our ethical practice of ministry (e.g., church-based, leadership, community engagement and counseling, etc.). However, so that we are all accountable to one another, the IRB is a group assigned to ensure the safety of all people affected by research conducted by the seminary, both internally and externally.
- All research conducted using the Calvin Theological Seminary Community is subject to review by the IRB. Research participants cannot be recruited, and data may not be collected until IRB approval or exemption is given. This includes, but is not limited to, the following examples:
- Any student research conducted as part of their academic program in which data is collected by whatever means from people within or outside the seminary community, such as counseling programs in which a thesis or dissertation requires empirical research. However, many other academic programs collect data from people to report the information to a professor, class, or even a group outside the seminary. Students in the DMin program are likely to conduct research requiring IRB review. Occasionally, other academic programs will collect data subject to IRB review.
- Even research collected for various uses by students or administration for anything other than internal educational purposes is subject to review. There are exemptions for some usages of collected data, but the safest way to determine this is to contact the chair of the IRB committee.
- All research involving vulnerable populations (e.g., children, disabled, elderly, economically disadvantaged, incarcerated, substance abusers, immigrants) must be reviewed by the IRB.
- The gathering of data by Calvin Theological Seminary personnel for internal educational purposes only (e.g., student statistics such as census reporting, Institutional Assessment) is exempt research and does not need IRB approval.
Principles undergirding the IRB process
- Respect: Out of respect for persons, researchers must seek voluntary and written informed consent from potential participants.
- Beneficence: The principle of beneficence requires that researchers maximize the potential benefits to the research respondents and minimize the potential risks of harm.
- Justice: The principle of justice means that the participants are selected fairly and that the risks and benefits of research are distributed equitably.
Research to be reviewed by the IRB: Gathering data from humans regarding their opinions, experiences, and personal data for dissemination within and outside the seminary community. This can be done through surveys, interviews, student assignments and records, and retrospective data, using either quantitative or qualitative methodologies.
Examples of Research to be brought to the Committee for Approval:
- Research involving research participants conducted by students as part of their academic program, whether they are using participants from within or outside the Seminary community.
- Research conducted by faculty/staff as part of their seminary responsibilities, whether they are using participants from within or outside the Seminary community.
- Any research that utilizes data from current or past Seminary community members.
- Researchers from outside the Seminary community who want to collect data from people affiliated with the seminary must be approved by the IRB at Calvin Theological Seminary or another institution’s IRB.
- Research conducted with clients or ministry participants by anyone affiliated with the seminary, whether or not those participants are connected to the seminary.
The process for applying for IRB review is relatively simple.
- If you are unsure whether you are required to apply, contact the IRB committee chair. If you know you will need IRB approval, skip to step 1 without a letter of inquiry.
- If your planned research involves no more than minimal risk, complete the online application.
- If your planned research includes more than minimal risk, complete the online application with as much information as you can, including related narrative documents and appendixes (more detail is better than less, but do not submit a whole research proposal).
- Wait for IRB acknowledgment of the application. Please include an IRB review period in your research timeline. Generally, once an application is submitted, the IRB process will be three weeks or less unless more information is required.
- Once approved, you will be sent a document with an approval number that should appear on all documentation (consent forms, reports, thesis/dissertation, etc. (E.g., This study was approved by the Calvin Theological Seminary Institutional Review Board #xxxxx).
- Until final approval is received, recruitment of participants and data collection may not begin.
- If a need arises during the study to change IRB-approved research, you must contact the IRB committee with all changes. Depending on the significance of the changes, you may be asked to submit a revised application. All changes in research must be approved by the IRB before implementation “unless the change is designed to eliminate an apparent immediate hazard to subjects” (45 CFR 46.103(b)(4)). “Immediate apparent hazards to subjects” are generally considered a situation in which action must be quickly taken during the study to prevent or to treat a significant possible adverse event in a way that may not be consistent with the protocol (for example, it may require the use of a protocol-prohibited medication). When actions are taken to prevent immediate apparent hazards, they should be promptly reported to the IRB, with any documentation of resulting changes in protocol or consent, such as new safety assessments.
- An appeal review for denied applications can be submitted to the Calvin Theological Seminary Academic Dean.
What issues are addressed in the IRB application?
Included in the IRB application are specific questions addressing the following issues:
- Nature and Purpose: A brief description of the research goals and the significance of the study and defined plans for disseminating the research results (i.e., academic credit, publication, presentation, etc.)
- Methods and Procedures: Methods and procedures to be used in the research project.
- Descriptions of the questionnaires to be administered and debriefing procedures (include a copy of the questionnaires and debriefing materials in the appendix).
- The order and activities that the participants will be involved in with approximate times required for completion.
- Participant Population: Description of the participant population.
- How many participants will be involved in the research activity?
- How will they be recruited?
- Probable participant characteristics, including age, gender, race, ethnicity, etc.
- Description of the recruitment methods (include copies of any recruitment materials—posters, flyers, newspaper ads, etc., if available).
- Selection process, including how participants are assigned to research groups.
- Risks/Benefits/Compensation: Risks, benefits, and compensation for participants. If the risks to the participant are higher than minimal risk (i.e., the probability and magnitude of harm or discomfort are greater in and of themselves than those typically encountered in daily life or during the performance of a routine physical or psychological test), describe the nature of the risks and how they will be minimized. Please indicate if there are no foreseeable risks to the participant. The IRB assumes that your research is an attempt to further knowledge and will benefit humanity. Please describe your research study’s potential to benefit individual participants or classes of participants, if any. If there are no risks associated with a project, it is acceptable for there to be no direct benefit to the individual participants; however, participants must be told what the researcher hopes to learn from the project and why. Will participants receive compensation for their involvement in the project? If participant compensation is anticipated, please include details concerning the form and amount of payment, as well as the conditions under which participants would receive partial or no payment at all (i.e., early withdrawal from the study).
- Informed Consent: Methods and the process by which informed consent will be obtained and documented.
- Studies with multiple phases may need additional consent for a second phase.
- Include a copy of the Informed Consent document(s) that will be used. This document must state that the project has Calvin Theological Seminary IRB approval. It must also give basic contact information for the primary researcher and research advisor (e.g., faculty member, if applicable).
- Anonymity and Confidentiality: How will the anonymity and confidentiality of the participants be maintained?
- Where and how will identifying information be stored, who will have access to this information, and how will the results of the research be reported (i.e., group data, individual cases, etc.)
- Who will have access to the data, such as research assistants? How will the research assistants be trained regarding maintaining confidentiality?
The following documentation must be submitted with the application:
- Informed consent script/form (required)
- Permission script (required if participants are under the age of 18)
- Scripts/Questionnaires for data collection (required if you are utilizing these tools in your research)
- Subject recruitment materials (required if you are utilizing these in your research)
- Documents providing additional information on funding if received.
- Off-site letter of support (required if you are carrying out your research outside of Calvin Theological Seminary)
- Off-site IRB approval (required if the location you are doing research requires its own IRB approval).
Please ensure all the application materials below are submitted to email@example.com. Please include your Project Title as the subject header. Application review will not begin until all required documents are submitted.
Additional Considerations When Submitting an IRB Application
- Ensure informed consent documents for all participants in all study phases are included.
- Include risks and benefits related to participation, including emotional/relational impact, and resources for participants if they experience negative effects (e.g., sources of additional information about the topic, referral for counseling services).
- How will research assistants be selected, trained, and monitored?
- Is the researcher’s and advisor’s contact information included in the information given to participants?
- Describe the secure storage of research records.
- Include special additional considerations for vulnerable populations (e.g., minors requiring parental consent).
- Research participants cannot be recruited and data may not be collected until IRB approval or exemption is given.
- An IRB review application is not a research proposal; therefore, the rational literature review, method, and data analysis need not be addressed. In the case of student research, those issues are typically the purview of the thesis/dissertation committee.
- The IRB application is not assessed based on grammar, writing style, and referencing, but we ask that care be taken since it is a graduate school document. If there is a lack of clarity on essential aspects, the application will be returned with guidance regarding resubmission. This will delay the beginning of participant recruitment and data collection.
- Once an application is submitted, the IRB process will be three weeks or less unless more information is required.