1. What is an IRB?
Answer: IRB is the acronym for Institutional Review Board. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials to ensure protection of the rights and welfare of human subjects of research.
The IRB for Human Participants has the authority to review, approve, disapprove or require changes in research or related activities involving human participants. Research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at Linfield College. However, those officials may not approve research that has not been approved by the IRB for Human Participants. The IRB primary role is to ensure the protection of human participants as subjects of research at Linfield College.
2. When am I required to submit a proposal involving research with human participants to the IRB?
Answer: Studies that meet the definition of Human Subject Research must be submitted to the IRB and must receive IRB approval BEFORE any study activities take place.
3. What training am I required to do before submitting my application?
All research personnel who are responsible for the design, conduct and/or reporting of your project must complete an IRB training prior to submitting an IRB application. The course is accessible at http://phrp.nihtraining.com/users/login.php and you should attach certificates of completion for all researchers along with your IRB application.
4. Do I have to submit an application to the IRB?
Answer: If the proposed activity is “research” and it involves “human subjects” then YES you MUST obtain IRB approval
Research is defined as:
“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [DHHS 45 CFR 46.102(d)]
“testing of concepts by the scientific method of formulating a hypothesis or research question, systematically collecting and recording relevant data, and interpreting the results in terms of the hypothesis or question.” [VA 38 CFR 16; VHA Handbook 1200.5]
“A ‘human participant’ is a living individual about whom an investigator obtains either (1) data through intervention or interaction with the individual, or (2) identifiable private information”. Note that interaction includes communication or direct interpersonal contact between investigator and subject (e.g., surveys, looking at stimuli, interviews, etc.). Private information includes information about behavior that occurs in a context in which an individual can reasonably expect privacy (i.e., no observation or recording) and information which has been provided for specific purposes by an individual whereby s/he can reasonably expect that the information provided will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.
5. I am just doing a simple survey, do I still need to submit an IRB application?
Answer: Yes, if the study meets the definition for research with human participants, as explained above.
6. Do research projects conducted by Linfield students need IRB approval?
Answer: Maybe. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research . In this case, although students may be encouraged to conduct a “mock” IRB review in class they are discouraged from submitting an IRB application to the committee. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary. If the project fits the definitions of “research” and “human participants” as described above then they MUST obtain IRB approval. Addtitionally, if the project involves more than minimal risk (e.g., interacting with vulnerable populations, asking about sensitive topics, etc.) the project must be submitted to the IRB.
In cases when a classroom-based project is not submitted to the IRB it is assumed that the professor is supervising the project in accord with ethical guidelines. For example, professors may require students to complete the online tutorial. S/he may also require students to complete an IRB application, including a consent form as a means of improving students' knowledge and appreication of minimizing risk, protecting privacy and confidentiality. To further educate students about the IRB process instructors may set up “mock” IRB committees so that groups of students "review" each other's applications.
Even though some classroom initiated research is not reviewed by the IRB, it is the instructor's responsibility to work with students to review guidelines and ethics for protection of research participants and make sure they incorporate these into their methodology. Particular emphasis should be placed on:
7. I am not collecting any identifying information in my research project. Do I need to submit my proposal to the IRB for review?
Answer: Yes, if your research project involves active data collection. Federal regulations and Linfield policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study. It is likely that the project will be exempt, however, it is not up to the researcher to determine the status of review. However, if your research project is using archived data or existing information collected from human participants (e.g., secondary datasets, existing biological samples), and the data are not linked to individuals in any way, then the activity may not require IRB review. If you are unsure please email the IRB chair for clarification
8. Are there any other projects that might be exempt for review?
As discussed above, classroom-based research projects the results of which will not be disseminated and which pose no risk to participants do not need to be reviewed. Oral histories, workshop/classroom evaluations, and administrative review projects need not be reviewed by the IRB if they are not research (i.e., the purpose is to NOT generalize beyond the individual, classroom or institution).
If there is at least minimal risk to the participants (note that risk may be physical, social, psychological or legal in nature) or there are plans to disseminate the research, then IRB approval must be obtained. The IRB is unable to give post facto approval, therefore if in doubt, it is wise to have your research approved. Even if your application is categorized as “exempt” it still requires initial review but is exempted from continuing review. The IRB determines whether the claim for exemption is appropriate and whether it will be granted. Exemption from IRB continuing review continues unless the protocol is to be modified such that it no longer will meet the criteria for exemption.For more information please see Flow Chart and information regarding level of IRB reviews