For all new research projects, at a minimum, please complete the IRB Application/Basic Study Information Form HRP-211 (forms), the Study Protocol Template (templates), and the Informed Consent Template (templates). In addition, you will need to submit the following, as applicable:
- Child Assent Form (all studies involving children)
- Interview/survey questions
- Recruitment Materials (letter, email/telephone scripts, flyers, etc.) Please see information below for guidelines.
- Signed Site/School/District Approval Letters if a researcher is conducting research at or through an organization or institution, an authorized person must formally allow access to the population the researcher hopes to collect data from. (Please see below for further required elements)
- All study personnel are required to have Human Subjects Research Training. Documentation of training MUST be submitted along with the Study Application in order to be reviewed and a determination made. Applications without training documentation will be "on hold" until the IRB receives the necessary training documentation.
- Anyone listed as a FacultyAdvisor on the IRB Application MUST provide documentation of Human Subjects Research Training. Please also refer to the "Role of the Faculty Advisor" below:
Please email all required documents to the CLU IRB Committee at the following email address, firstname.lastname@example.org, to initiate the review process. Make sure to submit all documents as Word or pdf Files. DO NOT SEND DOCUMENTS AS LINKS.
If you are a Graduate Student and serving as a Principal Investigator, you must have a Faculty Advisor in order to submit an application to the IRB. The Faculty Advisor should be listed on the Study Protocol and in Form HRP-211 - Appendix A. We will not accept any IRB Applications without a Faculty Advisor.
*For research studies involving minors, the Faculty Advisor's contact information must be on the main Informed Consent Form, along with the Prinicpal Investigator's contact information.
Who can serve as a Principal Investigator (PI) for a research study?
At Cal Lutheran, a person appointed as either regular or research faculty, in good standing, may be designated as Principal Investigator (PI). Students pursuing a graduate or terminal degree may also be designated as PI so long as their faculty advisor is listed on the IRB application.
At Cal Lutheran, a person appointed as regular faculty (assistant professor, associate professor, or professor) may be designated as Principal Investigator (PI).
Persons appointed as special faculty (lecturer, senior lecturer, instructor, adjunct, visiting professor, senior mentor, or professor emeritus) and staff are not eligible for PI status, unless a formal request is made in writing and PI exception is granted by the Director, Research Protections Office (see Procedure to Request PI status below). Persons holding these titles may be granted Co-investigator status, which requires a regular faculty member to serve as PI and to assume responsibility for the project. If research continues at Cal Lutheran beyond the special faculty’s employment, then an amendment must be filed to transfer the project responsibilities to a new Principal Investigator (PI), who must be a current Cal Lutheran employee. If the special faculty leaves California Lutheran University and wishes to continue the research at another institution, then a Study Closure Form (HRP 212) must be filed with the Cal Lutheran IRB, and notification must be given to the IRB at the new institution and their procedures followed.
Students pursuing a graduate or terminal degree may be designated as PI so long as they receive authorization from their faculty advisor to submit to the IRB and list them on the IRB application. Authorization from the faculty sponsor must be included in the submission to the IRB.
Undergraduate students at Cal Lutheran are ineligible to assume the role of PI. For undergraduate human subjects research projects, students should send their application to their professor or faculty advisor for submission to the IRB. This faculty member should be listed as the PI on all study documents.
Procedure to request a PI Exception:
The candidate requesting the exception must complete the PI Exception Form (dynamic form, see link below). Once all required fields and applicable documents have been uploaded, this form will get sent to the candidate's Department Chair/Dean for approval. Final approval will be given by the Director, Research Protections Office.
What criteria do reviewers apply when looking at my project?
Reviewers look at purpose, methodology, adequate handling of informed consent, whether the research deals with high risk or sensitive issues and, if so, whether the benefits outweigh the risks, and the degree to which confidentiality is both assured and protected.
What delays approval of my IRB application?
Some things that may delay approval of your IRB application include submitting an incomplete application by failing to: complete compliance training, cross-checking information on the informed consent form against information in the study protocol and other pertinent documents, so that the information is consistent, and proofreading the application and relevant documents. It is important that all sections of the template documents be addressed or enter N/A if not applicable.
What is Multi-Site Research?
“Multi-site” research means that the same research procedures (i.e., study protocol) are being conducted at two or more U.S. research sites and each site is under the control of a local participating investigator. Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.”
What is Collaborative Research?
Collaborative Research is research conducted in cooperation with an institution or individual not affiliated with Cal Lutheran. It involves two or more US research sites where each site is conducting a different part of a research protocol under the direction/control of the lead PI. Outside institutions or individuals involved in such research activities are external collaborators.
What does it mean to be Engaged in Research?
Please refer to the following HHS website:
Under NIH and Common Rule guidelines, both collaborative and multi-site research may require the use of a single IRB. An authorization or “reliance” agreement may be established to cede regulatory oversight to one of the IRBs as the IRB-of-Record. If you have questions about your collaborative or multi-site research project or wish to discuss a reliance agreement, please contact the CLU IRB.
Please use the following guidance when putting together Recruitment Materials:
- Does NOT state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol
- Does NOT promise “free treatment,” when the intent is only to say subjects will not be charged for taking part in the research
- Does NOT include exculpatory language
- Does NOT emphasize the payment or the amount to be paid, by such means as larger or bold type
- The advertisement is limited to the information prospective subjects need to determine
their eligibility and interest, such as:
- The name and address of the investigator or research facility
- The condition under study or the purpose of the research
- In summary form, the criteria that will be used to determine eligibility for the study
- A brief list of participation benefits, if any
- The time or other commitment required of the subjects
- The location of the research and the person or office to contact for further information
- Please see the attached document for more information on required and recommended elements along with elements that are not allowed.
Payment to Subjects
Payment to research subjects for participation in studies is not considered a benefit. Rather, it should be considered compensation for time and inconvenience or a recruitment incentive. If applicable, please discuss any payment in the Recruitment Section of the Study Protocol. It should also be noted in the Informed Consent Form, but not as a benefit.
Research Using Surveys
All proposed survey research that includes a sample population from CLU requires scheduling and a sample draw (contact list) from the Educational Effectiveness and Institutional Research office (EE&IR) even if the research project has IRB approval. Please refer to the EE&IR Website for further guidance on research using surveys.
The use of ZOOM for Data Collection
Please refer to the guidance document below:
If it is a large group, they would also say to require registration that is manually approved as an additional measure of security. The following is an ITS video on the new features and security guidance with the latest version of Zoom.
If you are going to be recording interviews as part of your study procedure, please be very clear/specific as to whether it is audio only or both audio and video. In addition, please make sure to provide this information throughout all the application documents to maintain consistency.
Identifiable Information - Anonymity vs. Confidentiality
Always keep in mind how you will maintain the privacy/confidentiality of the subjects in your study. The data collected is identifiable and not anonymous when (1) it can be linked to specific individuals, or (2) a combination of the information/characteristics could allow others to ascertain the identities of individuals. Examples of directly identifiable information may include (but are not limited to) the following:
- Contact information (e.g., home address, work address, fax number, email address, phone number, license plate number, driver’s license number)
- ID numbers (e.g., student ID, employee ID, social security number, IP address, IMEI number [unique number associated with a cell phone], user name, account number)
- Voice (e.g., audio recording)
- Facial features (e.g., photograph and video recording)
- GPS tracking data and location data
In some cases, elements of information/characteristics that are not regularly identifiable alone can be considered “identifiable” when combined. For example, a combination of age, gender, ethnicity, and place of employment might allow identification of certain individuals in some situations.
It is recommended that you add “potential loss of confidentiality” as a Risk within the Protocol and Informed Consent Form.
Please note that California prohibits the use of lotteries/raffles. Per California State Law, it is "illegal to give out a prize by chance in exchange for payment or 'valuable consideration', and participation in Research has been interpreted as a type of valuable consideration". Therefore, it is University Policy that they will not be allowed as compensation in Human Subjects Research.
There is a Basic Study Information Form with Comments to assist in completing the form. If you use this, please "resolve" the comments as you complete the form.
NOTE: Any studies that were Full Board Approval or determined Expedited, MUST submit a Study Closure Form to close out your study. Exempt Studies DO NOT need to submit a Study Closure Form.
Please do not delete any main sections within the templates. If "Not Applicable", please put "N/A".
If a researcher is conducting research at or through an organization or institution, an authorized person must formally allow access to the population the researcher hopes to collect data from. Site/School/District Permission Letter must have the following:
The letter must be on the site’s letterhead
The letter should be dated
The letter must be provided by an Administrator-level employee of the site
The letter must include the title of the Research Protocol
The letter must indicate that the organization understands the topic of the research and the research procedures ( you can specify specific procedures to be used, ie. Survey)
The letter must include a statement permitting the research to be conducted at the site
If the study involves accessing private records (including medical records) a statement of permission to do so must be included (this may not be applicable)
You must have the signature, printed name and title of the person providing the permission
Any students or faculty conducting human subjects research are required to complete the initial CITI Training most appropriate for their research area. Individuals conducting Social Behavioral research should complete the Social Behavioral Sciences CITI Training and those conducting biomedical research (ie. Exercise Sciences) should complete the Biomedical Sciences CITI Training (Basic Biomedical Course).
In order to maintain CITI certification, a refresher course must be completed every three years. Training certificates must be current, within the last 3 years, to be accepted.
You can reach the CITI website through the MyCLU Homepage, and click on the CITI Logo in the "Tools & Support" section. Then follow the remaining instructions.
"How to complete CITI Training":
- Choose California Lutheran University as your institution.
- On the Main Page, choose Group 3 to begin the course.
- Complete the required modules and associated quizzes. You may re-review the modules and repeat and quizzes to attain the overall passing score of 80%.
- Upon successful completion of the modules and quizzes, print a copy of your completion report/certificate for your records.
Non-CLU Students, Faculty or Staff conducting Human Subjects Research at CLU need to provide the CLU IRB the following documents:
- IRB Approval Letter or Exemption Letter
- Study Protocol
- Informed Consent Form
- Recruitment Materials
- Survey/Interview Questions
In addition, please complete the following form:
Please email the form and other requested documents to the CLU IRB at email@example.com.
For any questions, please contact the IRB Committee at the above noted email address.