Application Process
Getting Started With the IRB |
What is the Institutional Review Board (IRB) and what purpose does it serve on Southern Adventist University’s campus?
The IRB facilitates the conduct of ethical academic research done by faculty, staff, and students across Southern's campus. All research projects involving human subjects or personal identifiers must be approved by the IRB to ensure compliance with federal regulations and institutional policies designed to protect the rights, welfare, and privacy of human subject participants.
| 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.” (Code of Federal Regulations, 45 CFR 46.102d). |
| 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). |
Common types of research done at Southern include graduate student theses and dissertations,
undergraduate course assignment research, and faculty research projects. To determine
whether a given research activity or project needs IRB approval, further guidance can be found in the IRB policy manual. Most research projects will require a Form A application to be submitted and approved
by Southern's IRB before project initiation.
How do I receive IRB approval?
Once you have developed your research project proposal, you'll need to submit a completed application form to irb@southern.edu. The IRB committee will review your proposal and determine whether it meets standards for approval. More information on this process can be found on the Application Process page.
Note: All student research must be approved by the student's faculty supervisor prior
to IRB submission.
Do I need Academic Research Committee (ARC) approval in addition to IRB approval?
The ARC assesses and awards funding to academic research conducted by Southern faculty.
Faculty requesting research funding through the ARC must submit a separate research grant application to the ARC in addition to the research project application submitted to the IRB. Research projects must be approved by the IRB regardless of whether or not the research
is funded.
IRB Application Process |
Jump to section:
The IRB uses three types of review mechanisms: Exempt, Expedited, and Full. It is up to you as the researcher to understand and decide what type of review your research requires. Descriptions and requirements of each review type are provided below.
Exempt Review:
An Exempt Review status does not mean the study is exempt from IRB review; it means the proposed research activities fall within a lower level of risk and any human subject involvement falls within one or more of the exemption categories listed in full here. Exempt studies are exempt from a full committee hearing but still require IRB approval.
Qualifying studies usually include research that is conducted in established or commonly accepted educational settings and involves normal education practices. Other studies that may fall under an Exempt Review include research involving the use of educational tests, survey and interview procedures, or observation of public behavior, as well as research that involves the collection or study of existing data if publicly available or recorded in a way that maintains confidentiality of personal identifiers.
Confidentiality of all personally identifiable information must be managed throughout the research and thereafter. The information collected must be recorded in such a manner that the human subjects cannot be identified directly or indirectly. If any disclosure of information outside the research could reasonably place the subject at risk of criminal liability or civil liability or be damaging to the subject’s financial standing, employability or reputation then it no longer qualifies for an Exempt Review.
Expedited Review:
Studies qualifying for an Expedited Review are those with minimal risk to the participants. Minimal risk is defined as research that does not exceed the average probability and degree of psychological or physical harm normally encountered in the everyday life of a human being or during a routine clinical intervention. Investigators may apply to the IRB for Expedited Review if their proposed research activities fall into one or more of the categories listed in full here.
Qualifying research activities include limited studies of drugs and medical devices, collection of blood samples, biological specimens collected through noninvasive means, and data collected through noninvasive clinical procedures. Other studies that may fall under Expedited Review involve the use of data collected for non-research purposes, data collected from videotaping or audiotaping, and low-risk behavioral research that does not meet requirements for an Exempt Review.
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The expedited review procedure may not be used for classified research involving human subjects.
Full Review:
Research activities that present more than minimal risk to participants, and/or does not meet the classifications for an Exempt Review or Expedited Review as defined above, will require a Full Review from the IRB committee.
Qualifying studies include research that puts participants at risk of physical harm or significant psychological/emotional distress. Research activities involving vulnerable populations or highly sensitive topics may also qualify for a Full Review.
Once you have determined what type of review your research requires, complete a Form A - Application Form. All sections of the application must be completed. The application itself will include specific details on what information needs to be included. Please read each section carefully to ensure that you have provided all of the required information, including all supporting documentation.
Below is a brief overview of what the application requires.
| Research Request Type | Exempt, Expedited, Full Review, or Animal/Plant - see the above section on determining review category. |
| Researchers | Please list the name of the Principal Investigator and Other Investigators on the project. Contact information for all researchers should be included in the application. If the project is a student research project, the student(s) will be listed as investigator(s) and a Faculty Advisor must be listed. |
| Research Starting Date | The anticipated start date entered on the application must be a date in the future (not a calendar date that has already passed by the time the application is submitted); you must obtain IRB approval prior to the initiation of any phase of the research project. |
| Research Purpose | The purpose of the research must be adequately and comprehensively explained. Give precise details on why you are conducting the research including information on your hypotheses and/or research questions. Describe the objectives of your research. This should be written so that the reviewers will have a clear understanding of exactly what you plan to do. |
| Background/Rationale | Clearly and comprehensively define the reason why you are conducting the research and explain your rationale for doing so. You must also include citations/references from previous research that has been done on the same or similar research topic. |
| Methods | Clearly and comprehensively describe the research methodology that will be used, including specific information on the data collection procedures and how the procedures will allow you to address the hypotheses/research questions for your project. |
| Sample Population | Describe the sample population and the number of participants that you anticipate recruiting for the study. Describe the recruitment methods that will be used. If the research involves those considered as vulnerable populations, please be sure to check the appropriate box on the application form. |
| Informed Consent | Full details about the consent format and process should be included in the application as an attachment. Informed consent can be in an oral or written format, and in rare circumstances a waiver to consent can be requested. A waiver of consent can be requested when the consent itself would be the only identifiable information about the participant. When oral consent will be used, the same elements that would be included in a written consent should be verbally communicated to the subject before he or she agrees to participate. If the research involves children it may require both a parental consent form and an assent form (which the child signs). As a general rule, children age 7 and up can understand the basic information of the study if it is provided to them at their comprehension level. |
| Risks/Benefits | Describe in detail any risks (if any) associated with participation in the research project. Risks can range from physical harm and side effects to psychological and emotional harm and side effects. In some cases, inconvenience, travel, or boredom may also be considered risks of participation. Include information in the application about what precautions will be taken to minimize risks and/or what resources will be available to assist participants should some unforeseen instance occur. Describe the anticipated benefits to the participants or benefits that could contribute to generalizable knowledge. |
| Privacy/Confidentiality | Note that research cannot be both anonymous and confidential. Anonymous research is research that does not contain any identifiable information about the participants. Confidential research is research that does include some identifiers (i.e., not anonymous) but the research data will be maintained in a confidential manner (only the researchers will know the identity of the participants). Within the application please clearly define if the research is anonymous or confidential. If the research is confidential please define how the records will be coded, how the data will be stored, how long the data will be maintained, and what will be done with the data once the information will no longer be maintained. If video or video tapes will be used you will need to include details about how these instruments will be secured/stored and how/when they will be disposed of. If video or videotapes are used please add a sentence in the consent form stating that the participant can request that the videoing be stopped at any time. |
| Questionnaires/Other Instruments | Any questionnaires, tests, survey instruments, or data collection sheets which are not standard and well-known must be submitted in full as part of the application; usage permissions, if required by the author(s) of a research tool, must also be sought and included in the application. Structured interview questions and/or outlines for unstructured interviews also must be included. |
| Additional Attachments | Any media (e.g., flyers, social media post, video message) or material used to recruit subjects (e.g., sample email or text message) must be included. Site permissions from any physical location where research is being conducted must be included. CITI training certificates must be included. Regarding any other supporting materials: if in doubt, include it! |
All student applications must be signed by the faculty supervisor then scanned and submitted as a PDF file, OR submitted directly by the faculty advisor on behalf of the student researcher. CITI training certificates must also be completed and submitted where appropriate.
All research applications should be submitted by email to irb@southern.edu. Only Word or PDF files are acceptable submissions.
Prior to initiating an IRB application, new researchers are required to complete the Collaborative Institutional Training Initiative (CITI) training, an introductory online course in human research ethics.
Click here to be taken to the CITI training webpage. Create an account using a Southern email address and locate Southern Adventist University as the institution name, then continue the registration process.
CITI Modules have been grouped for (1) Biomedical Research, (2) Social and Behavioral Research, and (3) Research Involving Data and Specimens Only. Select the group that best describes your area of research and complete the online course module. After completion, download your CITI Training Certificate and ensure it is provided as part of your IRB application.
An instruction guide to completing the CITI Training modules can be downloaded here.
Upon submission of your Form A research application to the IRB, you will receive an email notifying you that your application is being processed. At this point, your application and all supporting documents will be screened for completeness. Any missing information (i.e., application sections left blank, research instruments not included, etc.) will need to be received before the application can be reviewed by the IRB committee.
Applications will be appropriately reviewed by the IRB committee. If the research application is approved, you will receive an official letter of approval from the IRB and may proceed with your research activities.
If the information provided on the application seems incomplete or raises any concerns, the IRB may require that revisions are made prior to considering approval. You will be notified of the IRB’s concerns and asked to revise your application or otherwise respond to the IRB feedback. Additional review by the IRB may continue until an approval decision is made.
You may not move forward with any phase of your research project until receiving official
approval from the IRB. Projects that are found to be continuing without IRB approval are in non-compliance
with SAU IRB policy and federal regulations. In these circumstances a non-compliance
report will be sent to the Academic VP for further action.
If minor or major changes are planned to an active study, you must notify the IRB. The IRB must approve any proposed changes to the original application before continuing research and the investigator must receive an email confirming this decision. There is no such thing as an “emergency” exemption and no university official other than the IRB Chair may grant approval to study modifications.
The initial evaluation as to whether an addendum/modification is major or minor starts with the principal investigator, who should assess the degree of change in procedures and risks. The IRB Chair or committee reviewers may change the status of that designation if they deem the designation inappropriate.
Minor changes have no impact upon the original goals and protocols outlined in the original application. Minor changes include those that do not adversely alter the overall harm-benefit profile of the study or would not potentially affect the willingness of current subjects to remain or enroll in the study. Examples include: change of project title, minimal changes in wording of a survey instrument, minor grammatical changes to an informed consent and/or child's assent form, addition or deletion of collaborators and/or co- principal investigators, change in student advisor, additional sites for the performance of the research (include a letter from the authorized individual for a new location).
Minor changes may be approved by submission of a Form B – Modification Form application. The investigator must fill out a Form B application outlining the modifications prior to making any changes that will affect the information given on a previously approved application. The Form B application must be submitted to the IRB by emailing irb@southern.edu. Updated versions of any supporting documents must also be included.
Once the IRB approves the proposed minor modifications, you will receive notification of approval. Further review may be required if the IRB has questions or concerns about the changes outlined in the Form B.
Major changes involve substantial changes to the research protocol, including changes in the purpose or process of the research project. Examples might include a change in sampling population, survey instruments, interview protocols, administration of a treatment of any kind, and/or the informed consent process. Any research that increases the level of risk to the participant above what was described in the initial application MUST be assumed a major change.
If major changes are planned, the investigator should submit a new Form A application
to irb@southern.edu. A new application will be treated in accordance with any other
IRB application and reviewed according to IRB policy.
In some instances, students participate in research projects in order to learn about the process of conducting research, rather than contributing to the broader body of knowledge in the field. These projects do not usually meet the definition of research as outlined in the IRB policy, but must still comply with IRB principles.
Student class project research may be exempt from IRB committee review and instead follow the Form C - Certification for Student Class Projects procedure when all of the below criteria can be met:
-
The purpose of the student research is for students to learn about the process of engaging in research or applying a pedagogical technique. If publications, formal reports, or presentations at professional conferences are planned, the student(s) must submit a Form A application directly to the IRB for approval.
-
The assignment is part of a class, course credit is earned for completing the CITI training and the research project, and the student research is conducted under faculty supervision.
-
The project is eligible for an exempt or expedited review (i.e., no project requiring Full Review may be dealt with under this procedure).
-
The instructor has completed CITI training and is qualified to approve student research. When appropriate, students must complete the CITI training and submit completion certificates to the instructor.
-
The project is not an honors project, thesis, dissertation, or independent study; these types of research require normal IRB application and review according to the IRB policy.
If all the above criteria are met, faculty members may submit a Form C - Certification of Student Class Projects using the steps below:
-
Submit a Form C to the IRB once the research project(s) have been identified. On this form you will indicate the name of the course, the assignment, and the name of researcher(s) along with the Title of the Research Project. This Form C must be approved by the IRB prior to proceeding with the research project(s). All projects for this course may be submitted on the same Form C.
-
Students are required to submit the appropriate Form A application form to the instructor for approval, rather than submitting to the IRB for committee review. Where necessary, a certificate of CITI training completion must also be submitted.
-
The professor will review and approve the Form A application forms submitted by the student to them as instructor of record and keep these forms in a locked file in their office.
-
At the end of the semester, submit a Form D - Certification of Completion of Student Class Projects to the IRB designating completion of the research project(s).
For further guidance on when to use the Form C procedure for class project research, please refer to the IRB manual.