1. What is “Human Subjects Research?"
A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
2. What is “Human Subjects Research Training?"
This is instruction in the responsible conduct of research as per federal and state codes. See training section of this website for instructions on how to enroll in a program.
3. What pre-application advice would you give to ensure the approval of my study?
Submit each of the items requested in the Application section of this website. For funded projects, submit IRB Application when it would appear that you will be funded. Consult Julie Paterson, Research Compliance Specialist, 310-258-5465 email@example.com with questions.
4. Under what circumstances am I excluded from IRB review?
- Researchers do NOT need to apply for Human Subjects Research Approval for the following kinds of activities:
a. Accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client.
b. Research using only historical documents, archaeological materials, or other historical or pre-historical artifacts.
c. Quality improvement and quality assurance activities conducted solely for the intent of maintain or improving quality of services provided by an institution where the data collected is not generalizable and will not be shared outside of the institution through discussion, presentation, or publication.
d. Class assignments primarily intended for educational purposes that involve interaction with human subjects that do not place human subjects at more than minimal risk and do not utilize systematic data gathering procedures with vulnerable populations. Results must be presented for the class only; if students or their professors think they may want to present the data in a more public context (e.g., conference or journal publication) in the future, then they should apply for Human Subjects Approval.
- Students do NOT need to apply for Human Subjects Research Approval when:
a. Class assignments primarily intended for educational purposes that involve interaction with human subjects that do not place human subjects at more than minimal risk and do not utilize systematic data gathering procedures with vulnerable populations. Results must be presented for the class only; if students or their professors think they may want to present the data in a more public context (e.g., conference or journal publication) in the future, then they should apply for Human Subjects Approval.
b. Class assignments conducted within research methods classes with the intention of demonstrating how research is conducted that involve interaction with human subjects that do not place human subjects at more than minimal risk and do not utilize systematic data gathering procedures with vulnerable populations.
c. When a student working on a project that already has Human Subjects approval, will use some of the data to fulfill a course or degree requirement, such as a senior thesis or master’s degree. The original principal investigator must submit an amendment to the IRB requesting the student be added as a researcher on his/her project for the stated purpose.
5. What is the difference between being excluded from IRB review and being approved Exempt?
A protocol which involves Human Subjects Research is approved in one of (3) categories:
Exempt from Full Review: cleared by the Chair
Expedited Review: reviewed by the Chair and one other member
Full Review: must be considered by the Committee
A protocol which is excluded from IRB review does not involve Human Subjects Research.
6. What is Informed Consent?
Volunteers are given the opportunity to decide whether or not they wish to participate in a study. They are told the nature and duration of the study, their possible involvement in it, the risks and benefits inherent of their participation, and provisions made to maintain confidentiality and anonymity. They are reminded of their option to withdraw at any time without prejudice.
7. How do I apply to the IRB?
See application section of this website. An application should be completed with questions that do not apply followed by N/A. The Cover sheet should be executed by the PI and his/her department chair. An Informed Consent Form should be drafted from the template provided, and a Human Subjects Bill of Rights attached.
8. What are the filing deadlines?
IRB applications should be filed by the first of the month to be considered that month.
9. What are the possible outcomes of review?
For proposals reviewed by the IRB, a letter will be sent to the investigator by the IRB Chair, indicating one of four possible outcomes:
b. Approval Pending (approved if designated changes are made): A protocol may be approved by the IRB on the provision that changes be effected prior to initiation of data collection.
c. Revise and Resubmit: A protocol can be deferred by the IRB. Additional information will be requested before a decision can be made. In this type of scenario an application will be reviewed by the IRB as its next meeting.
d. Denial: A protocol that has been denied approval by the IRB cannot be initiated by the investigator. The reasons for the denial are provided in writing. The investigator will be given the opportunity to respond either in writing or in person at the next IRB meeting.
10. How long does the review process take? Do some types of studies take longer than others?
Applications submitted by the first of the month will be pre-reviewed within the first two weeks of the month. Applications sent to full review will require an additional two weeks.
11. Who is on the IRB Committee?
The Committee is made up of (8) members, of whom (7) are professors or leadership at the University, and (1) is a professional from within the community. For names of individual professors consult the IRB Committee section of this website.
12. Does classroom research require IRB approval?
For classes where there may be a high likelihood that data from course-related activities could be published or presented outside of the classroom, collection of the data requires prior approval from the IRB.
Instructors in qualitative method file a general protocol before the instructional term, listing themselves as principal investigator, and enrolled students as "other project personnel." Other project personnel (i.e., the students) complete the on-line tutorial before collecting any data. The instructor in the course provides the IRB with updates on the sub-projects being pursued by their students in the form of amendments when there are changes in the subjects being used, the methods employed, or the research questions pursued. The instructor informs the student researchers that they need to prepare and file a separate protocol with the IRB if, and as soon as, it becomes apparent that the work begun for instructional purposes may ultimately be used for research purposes, i.e., be presented in any public forum, written or oral. Students who wish to use data collected in the course for subsequent research file with the IRB as independent researchers by the end of the course.
In summary, if the data from course-related activities are not to be published or presented outside of the class for which it was assigned, there is no need for IRB review. However, if the data are to be publicly presented or published, IRB approval must be obtained, either via an instructor’s general protocol or by individual student protocols, prior to the collection of the data.
The following are the procedures to follow if you are having students conduct research projects in your courses. This information is approved by LMU’s Institutional Review Board (IRB).
Research done as part of a class assignment/project or coursework does not fall under the umbrella of formal research nor does it necessitate IRB approval. However, the one exception to this policy is for course-related activities with the intent of being published or presented outside of the class for which it was assigned.
b. Instructional Process
Research activities done for a course/instructional purposes only should be highly structured and supported by faculty member assigning the project, and the following requirements should be implemented in the class:
o Good research must be done in good taste and ensure the protection of all involved in the process;
o Faculty must review all procedures and research questions;
o Any research conducted must be anonymous in nature;
o Sensitive questions are discouraged unless complete support and advisement from the faculty member in designing the most comfortable method of delivery for participants;
o All Research done at a school site – especially involving students (minors) – should receive principal or classroom teacher approval first and faculty members should again be involved and oversee all procedures and questions to protect participants.
o Any report written from such coursework should be in aggregate form and anonymous.
c. Research Process
Research (including activities from a course) that will be publically disseminated (at a conference/publication) should go through the IRB process:
o Any research with the intent to develop or contribute to generalizable knowledge must go through the IRB prior to data collection.
o During the course of study, the instructor must inform student researchers that they need to prepare and file an application protocol with the IRB if, and as soon as, it becomes apparent that the work begun for instructional purposes may ultimately be used for research purposes (i.e., be presented in any public forum, written or oral).
o Students who wish to use data collected in the course for subsequent research must file with the IRB as independent researchers by the end of the course.
o Faculty members should assist students in the IRB application process and serve as the faculty sponsor for the application.
In summary, if the data from course-related activities are not to be published or presented outside of the class for which it was assigned, there is no need for IRB review. However, if the data are to be publicly presented or published, prior IRB approval must be obtained by individual student protocols – with faculty sponsorship – prior to data collection.
13. Can I work with minors?
Assent: Children (those under 18) should be given an explanation - at a level appropriate to the child's age, maturity, experience, and condition - of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. Children should be asked if they wish to participate in the research or not. Mere failure to object on the part of the child should not, in the absence of affirmative agreement, be construed as assent. In the proposal, the investigator should indicate: 1) how assent will be obtained (what the investigator will say to the child and whether or not the child's parent(s) or guardian(s) will be present); 2) how assent will be documented. The child may either sign a very brief assent form or verbally indicate a willingness to participate. See Assent section under Forms in this website.
14. How do non-LMU PI’s access our facilities or personnel?
All human subjects research conducted at LMU facilities or involving LMU personnel, including students, faculty, staff and/or patients, must identify an LMU faculty member to serve as the Principal Investigator for the project and submit their research proposal to the LMU IRB) for approval. This policy applies to the recruitment or direct involvement of students, faculty, staff and/or patients, as well as the use or collection of human biological specimens, or the review of any records for research purposes.
Important Exception to the Policy: An exception to the requirement for administrative review for research being conducted by outside faculty or groups is a survey of faculty by their professional organizations. These do not require administrative approval.
15. How does one access databases concerning LMU personnel?
All LMU affiliated researchers using data collected from individual human participants in research must have their research protocols approved by the (IRB). This includes the use of data collected from individual human participants, archives, databases, and library collections.
Issues examined closely by the Committee are: use of identifiable data, safeguards to ensure that subject confidentiality is protected, who will have access to the information, and where the data will be stored.
16. May I videotape my subjects?
Recording information about subjects using videotape can be useful in a wide range of studies, both experimental and non-experimental. Because video recordings of subjects do not protect privacy and confidentiality to the same degree as, for example, anonymous surveys, researchers may need to pay particular attention to some issues when designing research that uses video recording.
Video is often used to record data from individual interviews, group interviews, and on-going social interaction. Not all such uses are considered "research" as defined by regulations on human subjects protection. Uses of video for non-research purposes does not need to be reviewed by the IRB, but may raise legal and ethical issues.
Collecting video for use in training generally does not constitute "research." Video is often used to give people feedback about their own performance (i.e., teaching) or to create teaching materials. However use of video for these purposes does raise questions about the privacy rights of individuals, ownership of images as a form of property, and other issues.
Collecting data on individual subjects using video may be done as a form of evaluation. Unless the results of such evaluations are to be used to make contributions to "generalized knowledge" they do not constitute "research" under the guidelines under which the IRB operates.
Often data are collected without the intent of being used for research, but the materials later become relevant as a possible source of data. Uses of data of these types must be reviewed by IRB. Since the materials were not collected with human subjects concerns in mind, there may be difficulties in approving their use for these purposes post hoc. If video materials might be used for research purposes later, have your procedures reviewed and approved by IRB.
Research participants should be made aware of what their participation involves (and any possible risks), the uses to which the data they provide will be put, who will have access to their data in what form, and then provide prior consent. Participation should always be voluntary. Since it is not always possible to achieve this standard of human subjects protection, the IRB evaluates the possible risks to subjects against the possible benefits in general knowledge that arise in "real world" research.
Studies that video record individual or group interviews must solicit individual informed consent prior beforehand. If a video recording occurs in a "public" setting where a reasonable person would expect that they might be observed by strangers, the expectation of privacy and confidentiality of the data are usually less.
If the video recording occurs in a private setting, the consent of the authority controlling that setting should be obtained - if at all possible. For example, school authorities should generally know of and consent to collecting video data at their school.
If the data being recorded place subjects at minimal risk, and if the behavior occurs where there is no reasonable expectation of privacy, then use of the data without assuring voluntary participation may be allowable. These are judgment calls, and the burden of evidence falls on the investigator to convince the IRB.
In video recorded data are that subjects are generally easy to identify. In experiments, we can use random numbers to identify subjects, in surveys, arbitrary identifiers can be connected to the data - but images on video do not provide for anonymity. Because of this, extraordinary precautions may need to be taken to assure confidentiality.
If the access to the video recording does not place a research subject at more than a minimal risk, concern about confidentiality is less. However, most people may regard their image itself - regardless of the behavior or setting - as sensitive material in itself. The subject's sensibilities about this, not the researcher's views, are what matters.
Video data should be kept secure (as should all research data). No one without a need to know should be given access. Ideally, subjects will know who will have access for what purposes, and have consented to allowing access to their images.
The investigator may wish to consider applying for a "certificate of confidentiality" to provide some degree of protection of the raw research data from subpoena and other non-research access.
17. How do I renew approval for an existing study?
Submit a fresh cover page with the proper signatures. Summarize your research activities during the previous granting period specifically: number of subjects studied and any adverse reactions encountered; benefits which have been derived; any difficulty in obtaining subjects or in obtaining informed consent; and approximate number of subjects required to complete the study.
18. What if I want to make changes, or request an addendum to my protocol?
Submit a fresh cover page with the proper signatures and a description of the proposed changes. Upon approval by the Committee renewal will retain the original approval number.