Understanding Denver Seminary’s Institutional Review Board (IRB)

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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 members of the Seminary community.
• Requests from outside researchers wanting to collect data from people affiliated with the seminary that has not been approved by another institutions IRB.
• Research conducted with clients or ministry participants by anyone affiliated with the seminary, whether or not those participants are connected to the seminary.

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Procedure

The process for applying for IRB review is relatively simple.

1. 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.
2. If your planned research is one that entails no more than minimal risk, complete the online application.
3. If your planned research includes more than minimal risk, complete the online application with as much information you can including related narrative documents and appendixes (more detail is better than less, but do not submit a whole research proposal).
4. Wait for IRB acknowledgment of the application. Note: include an IRB review time period in your research timeline. Generally, the IRB process, once an application is submitted, will be 3 weeks or less, unless more information is required.
5. Once approved, you will be sent a document with an approval number that should appear on all documentation (consent forms, reports, thesis/dissertation, etc. For example: This study was approved by the Denver Seminary Institutional Review Board #xxxxx).
6. Until final approval is received, recruitment of participants and data collection may not begin.
7. If in the course of the study, a need to make any change to the IRB approved research you must contact the IRB committee with all changes. Depending on significance of the changes, you may be asked to submit a revised application. Prior to implanting any change all changes in research must be approved by the IRB, “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 the documentation of resulting changes in the protocol or consent such as new safety assessments.
8. An appeal review for denied applications can be made to the Denver Seminary Vice President of Academic Affairs.

What issues are addressed in the IRB application?

Included in the IRB application are specific questions addressing the following issues:

1. Nature and Purpose: A brief description of the goals of the research and/or the significance of the study. Describe the intended plans for disseminating the results of the research (i.e., academic credit, publication, presentation, etc.).
2. 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.
3. 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.
4. Risks/Benefits/Compensation: Risks and benefits for a participant, as well as any compensation that will be given to participants.
   • if the risks to the participant are greater than minimal risk (i.e., the probability and magnitude of harm or discomfort are greater in and of themselves than those normally 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 be of benefit to humanity. Please describe your research study’s potential, if any, to benefit individual participants or classes of participants. If there are no risks associated with a project, it is acceptable for there to be no direct benefit to the individual participants. In this case, participants must be told what you hope to learn from the project and why.
   • will participants receive compensation for their involvement in the project. If participants will be compensated, please include details concerning 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).
5. Informed Consent: Methods and 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 include a statement that the project has been approved by the Denver Seminary IRB, and must give basic contact information for the primary researcher and research advisor (e.g., faculty member, if applicable).
6. Anonymity and Confidentiality: How will anonymity and confidentiality of the participants will be maintained?
   • where and how will identifying information be stored, who will have access to this information, and how the results of the research will be reported (i.e., group data, individual cases, etc.).
   • who will have access to the data such as research assistants? How the research assistants will be trained regarding maintaining confidentiality?

Additional Documentation

In addition to the form, in some cases additional documentation is required. Such as:

• 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 Denver Seminary)
• Off-site IRB approval (required if the location at which you are doing research requires their own IRB approval).

Please ensure that all of the applicable materials below are submitted to irb@densem.edu. Make sure to include your Project Title as the subject header. Review of your application is dependent upon their submission

Additional Considerations When Submitting an IRB Application

• Ensure informed consent for all phases of the study and all participants is included.
• Include risks and benefits related to participation including emotional/relational impact, as well as resources that will be given to 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 how to resubmit. This will delay the beginning of participant recruitment and data collection.
• Generally, the IRB process, once an application is submitted, will be 3 weeks or less, unless more information is required. Remember that research participants cannot be recruited, and data may not be collected, until IRB approval or exemption is given.

[i] Research is defined as: “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities” (Code of Federal Regulations, 45 CFR 46.102d).

[ii] A Human Subject means: “A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (Code of Federal Regulations, 45 CFR 46.102f).