Q: If I have IRB approval at another university, do I need to get approval with the Simpson University IRB?
A: If your research has been found to be exempt from review from another university then you do not need approval from the Simpson University IRB. However, prior to participant recruitment you do need to provide documentation to the IRB that your study was found to be exempt (e.g., certification of exemption). If your research has not been approved by another university then the Simpson University IRB must review the research proposal prior to the researcher initiating recruitment or data collection on the Simpson University campus or with its associated faculty, students and/or staff.
Q: Does my project need to be submitted to the IRB?
A: All faculty, staff and students at Simpson University conducting research with human participants (defined in chapter 2.2 of the IRB policy and procedure manual) must submit their research protocol to the IRB for review and approval prior to commencing the project.
If the primary purpose of an activity is for instructional purposes, then it is not considered research and an application for research does not need to be submitted for IRB approval. However, if the data (e.g., tests, papers, portfolios, etc.) are to be publicly broadcast or shared beyond the scope of the classroom (e.g., conference presentations, publications, etc.) then the use of data is considered to be for the purposes of research and an application for research must be submitted to the IRB and approved prior to any data collection.
Q: What kind of research requires full versus partial review?
A: Expedited review is required for research which presents minimal risk, presenting a probability and magnitude of harm equivalent to that found in daily life.
Full review is required for research involving more than minimal risk. Full review is also required if the research involves children, pregnant women, prisoners or the cognitively disabled, and if the research involves deception (incomplete disclosure) of participants.
Q: What is the difference between confidentiality and anonymity?
A: Confidentiality - Maintaining confidentiality of information collected from research participants means that only the investigator(s) or individuals of the research team can identify the responses of individual subjects; however, the researchers must make every effort to prevent anyone outside of the project from connecting individual participants with their responses. A confidential study means that while the participant’s identity potentially could be determined by the information they give, steps will be taken to insure that they will not be identified.
Anonymity - Providing anonymity of information collected from research participants means that either the project does not collect identifying information of individual subjects (e.g., name, birth date, address, Email address, etc.), or the project cannot link individual responses with participants’ identities. In other words, an anonymous study means that there is no way anyone can tell if a person was a participant in the study and cannot be identified by any information they give (even by the investigator). Anonymity may or may not extend to participant descriptors, such as sex or age. A study should not collect identifying information of research participants unless it is essential to the study protocol.
Q: How do I know whether I need an assent or consent form?
A: Informed consent is more of a process, rather than a means for obtaining a signature. Informed consent is required from each participant for all research studies; however documentation of the consent process (i.e., signed consent form) may not always be required. Federal regulations require written informed consent for all competent participants; however, there are reasons for which consent may be gathered through assent rather than a signed consent form. Assent is an active affirmation of a desire to participate. Assent may be used with young children or those with limited cognitive ability. In these cases, the assent procedure should be appropriate to the age of the participant. For example, participants over the mental age of 12 typically could be asked to read, discuss and sign adult consent form whereas children of the mental age of 7-12 can be given a verbal explanation of the study aims and procedures and asked if they are willing to participate. In either case, when investigating participants under the age of 18, assent from the minor and informed consent from the parent or guardian is required for participation.
Q: Do I always need to obtain informed consent?
A: Yes. In accordance with Federal regulations, informed consent must be sought and documented from each prospective participant or the participant’s legal guardian/representative. For any kind of confidential research, informed consent can be obtained by asking participants to read and sign an informed consent letter. (See Appendix C of the IRB Policy and Procedure Manual for a informed consent template.) For anonymous survey research, informed consent can be obtained without a signature, as long as the participant is informed in writing of their rights as a participant and that by completing the survey they are indicating their consent to participate. The elements investigators must include in their consent form can be found in Appendix C.1 of the IRB Policy and Procedure Manual.
In rare circumstances, the IRB may grant an informed consent waiver when the research project: 1) involves no more than minimal risk, 2) cannot practicably be carried out without a waiver, 3) where the waiver will not adversely affect the rights and welfare of participants, and 4) whenever appropriate, the subjects will be provided with additional pertinent information after participation. If you feel that your research poses only minimal risk to the participants, then you may wish to seek IRB permission to obtain verbal consent only.
Q: How will I know when I can begin my research?
A: The IRB Chair will contact you via email as soon as a decision about your proposal has been reached. You should be contacted approximately 1-2 weeks after your proposal was submitted (if seeking exempt or expedited review) or 1-2 weeks after your proposal was reviewed by the IRB if seeking full review (See meeting dates posted on the IRB webpage).
Upon reviewing a research application, the board shall make one of three determinations: (1) approval; (2) approval only if specified modifications are made; and (3) disapproval. If you receive approval then you may begin your research activities immediately. If you receive approval only if specified modifications are made, you must respond to the modifications within 90 days and await final approval from the IRB before beginning any research activities with participants (i.e., recruitment, testing, etc.)
Q: How can I get assistance in preparing the forms and understanding the submission process?
A: Please contact Dr. Danielle Beck, IRB Chair, at firstname.lastname@example.org or (530) 226-4639.