The Institutional Review Board (IRB) oversees all research projects involving human participants. Please use the decision tree to determine the documentation you need to submit to the IRB. All investigators must complete training for human subject protection through the NIH. Certificate of completion should be saved and submitted to the IRB with your application. Certificates should be dated less than five years prior to the application.

Announcement: A new online training program is being developed and will be available soon.

Application and Review

Applications are accepted on a rolling basis throughout the year.

All applications should be submitted online HERE with the appropriate documentation attached to your application. Do not attach thesis or dissertation proposals, or grant applications, in lieu of the CLU application and requested documents.

IRB Reviewers may request revisions to the application or supporting documents. Revised documents should be submitted for review via email to irb@callutheran.edu.

IRB approval will be provided via email notification to the address provided on the application for the principal investigator. Revisions to an approved application must be submitted to the IRB via email at irb@callutheran.edu.  Please provide a description of the original procedure(s) followed by the revisions to that procedure(s).  Describe how the revision(s) will influence risk, benefits and confidentiality.  Describe your intent with data already collected/subjects tested, if applicable.  Finally, attach a revised informed consent/assent document with revisions highlighted.

ONLINE TRAINING

Prior to application preparation

Do I Need to Submit? What Category?

DO I NEED TO SUBMIT AN APPLICATION?

Only projects that qualify as human subject’s research need IRB review and oversight.  Please read below to determine the status of your project.

 

Not human subject’s research

Some projects do not qualify as human subject’s research.  In order to determine this, two criteria are considered.  First, are human subjects involved, are data obtained through intervention/interaction with the individual, or is identifiable private information obtained?  Second, is the data obtained part of an investigation to develop or contribute to generalizable knowledge?  Both criteria need to be met in order for a project to qualify as human subject’s research.

 

Studies that are not human subject’s research, as defined by the categories below, do not need IRB review, so no application need be submitted.  If the investigator is unsure, or if the work involves a vulnerable population, the IRB should be consulted to determine if an application should be submitted.

 

  • Data collection for internal departmental, school or other administrative purpose.
  • Service surveys administered to improve services or programs, as long as privacy is protected, confidentiality is maintained, and participation is voluntary.
  • Interviews where questions focus on things, products, or policies rather than on people or their thoughts regarding themselves.
  • Course-related activities designed specifically for educational or teaching purposes, where data collected is not intended for use outside the classroom.
  • Biography or oral history of an individual
  • Independent contract for procedures carried out for an external agency
  • Quality improvement projects
  • Case histories
  • Publicly available data to analyze public figures
  • Secondary data analysis that is not identifiable

Human subject’s research

If your project is human subject’s research, an IRB application is required.  Applicants are asked to recommend a category of review in Section A of the application.  Use the following information to make this recommendation.  While the IRB will consider your recommendation, the category of review used for your project will be based upon the information provided in your application.

Federal Categories of Review

Full Review  - Any project not covered in the categories below will go for Full IRB Board Review – this will involve 3 or more reviewers and will be completed within 2 weeks.

Expedited Review – review is completed by the IRB chair or one experienced member, typically within one week.  The project must meet both criteria below.

  • No more than minimal risk – “The probability of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”.
  • The entire project must be consistent with one or more of the following federally defined categories:
    1. Clinical studies on drugs or medical devices for which an IND or/and IDE application is not required. Similarly, a study with a cleared/approved medical device that is being used in accordance with its cleared/approved labeling.
    2. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture.
    3. Prospective collection of biological specimens for research purposes by noninvasive means.
    4. Collection of data through noninvasive procedures routinely employed in clinical practice. Includes physical sensors, weighing, testing sensory acuity, MRI, ECG, EEG, EMG, ultrasound, and echocardiography.  Excludes any procedure involving anesthesia or sedation, x-rays or microwaves, or use of unapproved medical devices.
    5. Research involving data, documents, records, or specimens that have been collected or will be collected solely for non-research purposes. Some research in this category may be exempt.
    6. Collection of data from voice, video, digital, or image recordings made for research purposes.
    7. Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Some research in this category may be exempt.
    8. Continuing review of research previously approved by the IRB where no new subjects are being enrolled, all enrolled subjects have completed study activities, and research only remains active for long term follow up of subjects.

Exempt Review – this status does not mean the study isn’t human subject’s research; the researcher is still obligated to follow human subject’s protection guidelines.  This status means the research is not monitored by the IRB.  Research identified as exempt does not have to file final reports or continuing review.

  • The following six categories are exempt from IRB regulations, as described in the Code of Federal Regulations.
    1. Research conducted in established or commonly accepted educational settings, involving normal educational practices. Most action research projects in education fall in this category.
    2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. Some observation studies do not qualify for exemption, determined by level of risk and interaction with subjects.
    3. Research not exempt under b above, may qualify if subjects are elected or appointed public officials or candidates for public office. Civil servants are not included in this exemption.
    4. Research involving the collection or study of freely available de-identified existing data, documents, records, pathological specimens, or diagnostic specimens.
    5. Research and demonstration projects conducted by heads of government departments or agencies which are designed to evaluate public programs.
    6. Taste and food quality evaluation and consumer acceptance studies.

 

An Overview of the IRB Process

CALIFORNIA LUTHERAN UNIVERSITY

PROCEDURES FOR OBTAINING INSTITUTIONAL APPROVAL

FOR RESEARCH

The IRB will review all research projects involving human participants. Projects may be approved, disapproved, approved with modifications, or identified for pending action that will require the submission of additional information. The IRB will inform investigators of its decision in writing via email.

Applications for research with animals are no longer accepted by the IRB.  These applications should be made to the CLU IACUC at iacuc@callutheran.edu.

1.     Criteria for Approval

Projects must conform to the Institutional Guidelines for Treatment of Human Participants in Research.

2.     Categories of Review

There are three categories for review: Exempt Status, Expedited Review, and Full Board Review. Please see the document titled “Federal Categories of Review” on the IRB website.

Course-related activities designed specifically for educational or teaching purposes, where data collected is not intended for use outside the classroom, are not considered human subjects research and IRB application is not required.  The Class-Project application has been discontinued.

3.     Review Procedure

Applications are online, with the link available at: http://www.callutheran.edu/irb/

The IRB Committee consists of California Lutheran University faculty and one (1) community member. A Full Board Review involves 3-5 IRB Committee members and requires a majority vote. An Expedited Review typically involves the IRB Committee Chair and one other member--where both members do not agree, the proposal goes to the entire committee for a Full Board Review.  If a proposal is submitted by one of the committee members or for students of one of the committee members, that member abstains from the voting process.

The application form must be completed in its entirety.  All sections must be complete or the application will be returned.  Attach copies of proposed informed consent forms and proposed instruments (e.g., questionnaires, interview questions, etc.), as applicable, to the electronic submission.  Permission letters must also be attached for projects that intend to recruit subjects from an agency or school.

The applicant for a Full Board Review will be informed of the committee’s decision (including modifications needed) within approximately 2 weeks from receipt during a normal semester session (excluding holidays). Applicants for an Expedited Review will be informed within approximately 1 week.

 4.     Special Requirements for Research With Minors

Signed consent is to be obtained by the participant’s parent(s) or legal guardian(s). Assent (i.e., affirmative agreement) is to be obtained from the participant.

5.     Definitions

Minimal risk

“…the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons” (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm, p. 27 of 35, retrieved 12/1/2006).

Vulnerable Populations

As defined by the Code of Federal Regulations (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), this category includes (but is not limited to) children, persons at risk for suicidality, persons with impaired decisional capacity, and prisoners.

 6.     Additional Resources

 Complete information about ethical standards and IRB requirements by the U.S. Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) can be found at: http://www.hhs.gov/ohrp

 The Federal Policy for the Protection of Human Subjects (45 CFR 46) can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

 The Belmont Report, an important basis for the development of ethical research standards in the U.S., can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/Belmont.htm

A tutorial on ethical requirements for research, designed for employees of the NIH but available to anyone, can be found at: http://www.nihtraining.com/ohsrsite/guidelines/graybook.html

______________________________

 

                                                                                                                     Revised 12_17

Institutional Guidelines for Treatment of Human Participants

INSTITUTIONAL GUIDELINES FOR TREATMENT OF HUMAN PARTICIPANTS IN RESEARCH[1]

[1] Adapted and paraphrased.  Source: American Psychological Association (1990). Ethical principles of psychologists (Amended June 2, 1989). American Psychologist, 45, 390-395.

1.     It is the investigator’s responsibility to ensure that the participants’ dignity and welfare are protected and that federal, state, and professional standards governing the conduct of research are met. Approval by the IRB does not preclude the necessity of obtaining approval from other governing agencies related to the study.  For example, researchers studying patients in a hospital may also be required to obtain approval from the person or committee overseeing such practices at that hospital.

2.     Participation in any research project must be voluntary. Participants have the right to decline to participate in any study and may terminate their participation in a study at any time.  The investigator has the responsibility to ensure that participants understand these rights.

3.     Studies are to be evaluated to ascertain the degree to which participants are at risk, and any potential risk to participants must be offset by potential benefits of the research to participants or its potential contribution to knowledge. If the risk/benefit ratio is unacceptable, alternative designs must be considered or the study will not be approved and must not be conducted.

4.     For any human subjects research, the investigator must obtain informed consent prior to subject’s participation. Informed consent requires the obligations and responsibilities of both the investigator and participants to be stated in language that is easily understandable by each.  The investigator must honor all obligations detailed in the informed consent procedure.  Participants must be informed of any aspects of the research that might influence their choice to participate; any inquiries about any aspects of the study must be answered to the satisfaction of the participants.  Anything other than full disclosure requires additional steps to ensure that the participants’ welfare and dignity are protected.  Research involving children or people with impairments will require special informed consent procedures to be approved in advance by the IRB.          

5.     If the methodological requirements of a study require the use of deception, the risk/benefit ratio must be assessed (as in 3 above). Before such a study is conducted, the investigator must (a) determine whether deception is, in fact, a methodological necessity, (b) investigate the feasibility of using alternative procedures that do not involve deception, and (c) ensure that  participants receive a full and sufficient explanation for the use of deception as soon as deception is no longer necessary.

6.     During the conduct of a study, the investigator is responsible for the ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom must maintain ethical standards of treatment.

7.     It is the responsibility of the investigator to protect the participants from physical and mental discomfort, harm and danger during the course of research. Procedures for contacting the investigator for a reasonable period of time following the conclusion of a study should be established and communicated to the participant in the event that questions or concerns about his or her role in the study arise.

8.     At the conclusion of the study, the investigator will, in a timely fashion, provide all participants with a complete disclosure of the nature of the study; any misconceptions and questions will be settled at this time. Procedures for contacting the investigator for a reasonable period of time following the conclusion of a study should be established and communicated to the participant in the event that questions or concerns about his or her role in the study arise.

9.     The investigator has the responsibility of ensuring and maintaining participants’ confidentiality and/or anonymity. Participants must be assured that the information they provide to an investigator during the course of a study is confidential or anonymous unless otherwise agreed upon in advance.  All informed consent forms must be retained in a locked storage compartment separate from the study’s data in order to ensure confidentiality and anonymity.  If others may have access to consent forms and data, participants must be informed that others indeed may gain access to this information.  Moreover, in this case every effort must be exerted to maintain confidentiality, and these steps must be explained to participants as part of the informed consent procedure.

10.    The University shall respect the right of students of conscientious refusal to participate in human experimentation. When a student expresses conscientious objections to engaging in a study or exercise that uses human participants, the student and the instructor will attempt to negotiate an alternative that is in the instructor’s judgment an effective substitute.

11.    Instructors shall make known in the syllabi any uses of human participants in a course, and students shall make known any reservations about participating in the use of such participants by the second class after receiving the syllabus in order to facilitate planning for alternatives.

12.    Students and faculty unable to reach agreement on accommodation of conscientious refusal may file an appeal for mediation with the appropriate Academic Dean.

                                                                                                                    Revised 08-010

Application Preparation

Application to Use Human Participants in Class Projects

Class project applications are no longer required. Faculty are asked to oversee human subjects concerns for class-based projects that serve an academic purpose and are not intented for use outside the classroom. If in doubt, please inquire with the IRB (irb@callutheran.edu).

Study Continuation or Conclusion

Contact the IRB Chair with questions at irb@callutheran.edu

To access your forms in Dynamic Forms:

If you have already completed your form: Forms History

If your forms was saved, but not submitted: Pending Forms

 

©