The following regulatory definitions (see 45CFR46) are used to guide the Human Research Protection Program:
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Will my research project require IRB review?
Your project will require IRB review if…
- You are a faculty/staff member/student at Loma Linda University or its affiliated entities; or
- You are using LLU facilities, subjects, or their identifiable information;
and your research involves…
- living human subjects about whom you collect (1) data through intervention or interaction or (2) identifiable information via medical records or specimens; or
- collecting identifiable information about deceased persons via medical records, specimens or autopsy materials.
Note: Federal regulations do not consider research on deceased persons as human subject research. However, Privacy Rules apply to deceased as well as living persons, so the IRB (as the institution’s Privacy Board) must review how decedent information will be used. See section on Privacy.
To obtain an IRB Determination of human subject research:
If any question arises whether IRB review is required or if documentation of not-human-subject determination is required by a sponsor or publisher, complete and submit the IRB Request for Determination. Investigators may also contact the IRB administrator for guidance and clarification. Studies that are human subject research but may qualify for one of the EXEMPT categories must be submitted to the IRB.
Investigators may use also use either one of the following forms, as applicable:
- IRB Application for Retrospective/Archival Data
- IRB Application for Research Use of Biospecimen
- OHRP Decision Charts (see Chart 1)
- Institutional policy (H-23): Determination of Human Subject Research
- Institutional policy (H-26): Review Level – Initial Submission of Human Subject Research
- IRB Request for Determination
- Any officer;
- Faculty with an appointment at the level of Assistant Professor or above and classified as Full-time (FT), Administrative full-time (AFT), Geographic full-time (GFT), or Part-time (PT).
A faculty member may not serve as PI if:
- the proposed research is a partial fulfillment of a degree program in which the faculty member is enrolled, or
- his/her appointment is at the rank of Instructor, or
- he/she is classified as a Voluntary faculty member.
If a person does not meet the criteria outlined in policy H-11 to be designated a PI, but has equivalent research training, he/she may submit an application packet meeting the criteria in procedure H-11A to the Vice President for Research Affairs. If approved, he/she may submit research requests as PI.
- Institutional Policy (H-11) Principal Investigator Eligibility.
The PI is responsible for the scientific design and conduct of the study in accord with the Ethical Principles & Guidelines for Research Involving Human Subjects (the "Belmont Report") including the following:
- The ethical performance of the project.
- The protection of the rights and welfare of human subjects.
- Strict adherence to any stipulations imposed by the IRB.
- Appropriate oversight of the research protocols and research staff
Co-Investigators & Student Investigators
All members of the research team accept their responsibilities to comply with Loma Linda University policies and procedures for protection of human subjects including the following:
- Assist the PI in performing their responsibilities described above
- Maintain qualifications and training for their research roles
- Understand the requirements for protecting the rights and welfare of human subjects and seek guidance when appropriate
- Carry out research procedures in accord with IRB-approved protocol.
Clinical Research Coordinators
Personnel providing administrative support under the guidance of the Principal Investigator play a key role in implementing human research protection at the study site, including the following:
- Assist in preparing documents required for IRB review and approval
- Assist research study personnel in adhering to applicable institutional policies and procedures for human subject protection.
- Maintain current and complete study records documenting subject’s participation in the study and IRB approval.
- Regularly participate in training on regulatory and ethical requirements for human subject protection.
University Administration (See Human Research Protection Program)
Loma Linda University (LLU) and its affiliated entities are responsible for the rights and welfare of human research participants as described in the policies and procedures of its Human Research Protection Program and its assurance to the federal government. The institution delegates the necessary authority to the Vice President for Research Affairs to accomplish the following:
- Provide adequate resources to implement its Human Research Protection Program in accord with federal regulations and applicable ethical standards
- Grant the LLU Institutional Review Board the authority to function independently of other organizational entities in its role in protecting research participants.
- Assure that the IRB is free from undue influence and investigates all reports to the contrary.
- Implement safeguards to assure that no research involving human subjects is conducted without prior IRB review and approval.
Sponsors supporting research activities at LLU and its affiliated entities agree to comply with the ethical standards of human research as defined in applicable federal and state regulations including the following:
- Acknowledge the institution’s role in protecting rights and welfare of human subjects.
- Reimburse the institution for those study costs related to human subject safety and welfare, including applicable fees for Institutional Review Board fees.
- Report promptly to the University results of safety monitoring, including findings that could affect the safety of participants or their willingness to continue participation, influence the conduct of the study, or alter the IRB’s approval to continue the study.
- For Federal, State, or Private Grants: Find Funding opportunities in the LLU Grants Guide
- For Industry-sponsored Grants (for investigator-initiated clinical research): Read CTC’s Industry Grant Guide here
- For Industry-Sponsored Clinical Trials: Work with CTC to put the appropriate Clinical Trial Agreement in place.
- For Federally-funded Clinical Trials: Contact the Contracts Analyst in Research Affairs - Financial Management
For guidance on the conduct of human research at the VA facility, contact the VA Office of Research Administration, (909) 825-7084 (extension 2264). In addition to complying with that institution’s IRB requirements, review by the LLU IRB is also required if one or more of the following circumstances apply:
- The conduct or recruitment of the research involves LLUAHSC resources (property, facility or funding, including extramural funds administered by the institution)
- The research is conducted by or under the direction of any employee, student or agent of LLUAHSC in connection with his or her institutional responsibilities.
- The research is conducted by or under the direction of any employee, student or agent of this LLUAHSC using any property or facility of this institution
- The research involves the use of LLUAHSC non-public information to identify or contact human research subjects or prospective subjects.
The process for someone coming from another institution to transfer an IRB-approved study will vary depending on the status of the study.
Study involves analysis of already collected data or human tissues. If the study was started at an institution holding a Federal Wide Assurance, the LLU IRB will accept evidence of IRB approval at the originating institution. Documentation of IRB approval should be submitted to the LLU IRB along with a copy of all materials submitted to and approved by the original IRB. The LLU IRB will open a file and begin a new approval period. From this point forward the principal investigator will be responsible for maintaining IRB approval at LLU. PI must ensure that the covered entity of the originating records has approved the transfer of the research records, that the HIPAA authorization allows the data to be used for the research or that the research data is sufficiently de-identified (not coded) so that the records may not be re-identified to the research subject. PI is responsible for any disclosure tracking requirements to be fulfilled.
If subjects are still being recruited. The principal investigator must complete the appropriate LLU IRB application, modify all recruiting and consent documents to follow the LLU templates for the consent and HIPAA authorization and submit these items along with all materials submitted to and approved by the former IRB. The study may not start recruiting at LLU until IRB has approved this submission. From this point forward the principal investigator will be responsible for maintaining IRB approval at LLU. All HIPAA concerns listed in number 1 above must also be met for any records transferred to LLU.
Any research records containing subject identifiers. Unless the original consent (and HIPAA authorization, if applicable), specifically allows transfer of identifiable records or specimens with personal identifiers, the research material must be de-identified (not coded) so that the research subjects may not be re-identified. This means that many items normally included in research records must be removed prior to transferring to LLU.
Prior to transfer of research data to another institution, if the data are subject to HIPAA compliance, approval must be obtained from the Privacy Officer of LLUMC, ensuring that the records have been properly de-identified. HIPAA disclosure tracking must be completed for any records that contain PHI. The HIPAA authorization must allow for the use of the data for the research and must name the researcher as being authorized to use the data.