CPHS review is required when a study meets the criteria as defined by the federal regulations for human subjects research.
In determining whether or not a project requires review by the CPHS, the first step is to determine if the project is research and to then identify whether the people involved are also human subjects. The CPHS only reviews activities that involve the participation of human subjects in research. The definitions used by the CPHS in determining the need for review follow:
The Department of Health and Human Services (DHHS) Code of Federal Regulations (45 CFR 46.102d) has defined research as, "A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." As described in the Belmont Report, "...the term 'research' designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).
A human subject is defined as "a living individual about whom an researcher conducting research obtains (1) data through intervention or interaction, or (2) identifiable private information (45 CFR 46.102f)."
The CPHS considers generalizable knowledge to include the dissemination of research findings beyond the boundaries of the institution (e.g., publication (including thesis or dissertation) or presentation or use outside the specific instructional setting. The exception to the parameters defined occurs when a report of findings is issued to an agency that has contracted with the university to acquire programmatic information (e.g., needs assessment, program evaluation, quality control).
For more human subjects research-related definitions, please visit the Office for Human Research Protections (OHRP) website: http://www.hhs.gov/ohrp/archive/irb/irb_glossary.htm. Additional definitions (not comprehensive but frequently asked) are at: CPHS Definitions (https://docs.google.com/document/d/1wedofpKgvbUGnrvDAzHZuwuWpLVy3eBh7rDEXLGREd4/edit?usp=sharing).
CPHS review is required when a researcher is engaged in human subjects research. This occurs when an agent or employee:
Regardless of where the research activity will occur, the CPHS is required to review all research involving human subjects that is sponsored by CSUMB, the University Corporation at Monterey Bay or its ancillaries.
All research projects that involve human subjects conducted by or under the direction of any employee or agent of CSUMB or University Corporation at Monterey Bay in connection with his or her institutional responsibilities or that utilizes any property or facility of this institution, whether funded or not funded, are subject to the federal regulations governing such research (see 45 CFR 46 and The Belmont Report), and to the policies and procedures outlined in the University's Assurance of Compliance. CPHS review and approval must occur in advance of study initiation.
Research conducted in collaboration with other universities, research institutions, or hospitals must be reviewed and approved by the CPHS when the research is conducted by or under the direction of a CSUMB employee or agent.
When the lead researcher is from CSUMB, the protocol should be submitted to the CPHS before submittal to the collaborative partner IRBs to ensure home-IRB approval is secured. See 4.13.4 Study Location & Access for additional relevant information pertaining to collaborative research.
Studies in which the duties of the researcher are formally contracted to a non-CSUMB performance site must obtain approval from a CPHS designated for that institution in addition to review requirements imposed by the CPHS.
The CPHS is required to review all research conducted by or under the direction of an agent of CSUMB unless the researcher is hired on his/her own time, does not utilize CSUMB resources, and will not reference CSUMB in documents or publications associated with any reported outcomes.
The CPHS is required to review all research conducted by or under the direction of an CSUMB employee or agent performing research related activities as part of their responsibilities at this institution.
The requirement to obtain approval from the CPHS is in addition to review requirements imposed by the other institution with which the researcher is affiliated. This applies to doctoral students who are fulfilling requirements for a degree and who are enrolled in two academic institutions.
Research conducted in a foreign country by or under the direction of a CSUMB-affiliated researcher must be approved by the CPHS and adhere to the current laws, regulations and guidelines specified in the edition of OHRP’s International Compilation of Human Research Standards for the research location and/or population land of origin.
Any proposed variations to ethical practices endorsed by CSUMB and federal regulations (recruitment procedures, consent process, confidentiality practices) that result from cultural, political or social issues unique to the country in which the research will occur must be supported by the researcher within the protocol submitted for review.
Studies that meet the definition of research that involve human subjects must receive CPHS review and approval prior to initiation. Pilot or feasibility studies may include as few as one person, however, the same federal, state and institutional requirements to protect human subjects in research apply regardless of the number of subjects involved.
Per OHRP’s Guidance on Research Involving Coded Private Information or Biological Specimens (2008), human subjects research is occurring under either of the following circumstances: The research involves the use of identifiable private information or specimens where the identity of the subject(s) is or may readily be ascertained by the researcher (or anyone on the researcher’s research team); or, the identity of the subject(s) may be associated with the information either directly or indirectly through a code/key system accessible by the researcher (or anyone on the researcher’s research team).
All data included in this type of protocol must be: Existing at the time the research is proposed; originally collected under a previously approved human subject research protocol or an equally rigorous informed consent process; and, provided to researchers from a legitimate source or may already be in the possession of the researcher.
At the discretion of the CPHS, researchers may be required to collect informed consent for the use of existing identifiable private information or specimens for research purposes.
Persons not affiliated with CSUMB (e.g., external researchers) who intend to conduct human subject research on CSUMB premises (including collaborative recruitment techniques, such as: CSUMB faculty or staff assisting with recruitment on behalf of an external researcher), or by requesting access to personally identifiable information or data not publically available, must submit to IRB review using the CPHS External Researcher form and/or the External Researcher Access Request form as appropriate.
After reviewing the external researcher’s request, the CPHS may convey the external researcher’s request for access internally; however, all such access requests are subject to the discretion of the source providing it and any applicable regulatory restrictions. CPHS approval of an external researcher’s protocol does not necessarily ensure access provision. External researcher activities that involve only the use of CSUMB facilities must obtain clearance from CSUMB’s Risk Management Office prior to conducting the study.
Human subject research that involves the use of personally identifiable information or data not publically available must be approved by the CPHS in advance of initiating the research using the appropriate submission forms. After reviewing the researcher’s protocol, the CPHS may convey the researcher’s request for access internally; however, all such access requests are subject to the discretion of the source providing it and any applicable regulatory restrictions. CPHS approval of an researcher’s protocol does not necessarily ensure access provision.
CSUMB is not engaged in research when an employee or agent of the university:
Consults on research but at no time obtains, receives, or possesses identifiable private information (e.g., a consultant analyzes data that cannot be linked to individual subjects, either directly or indirectly through coding systems, by any member of the research team).
Performs commercial services for the researchers (or performs other genuinely non-collaborative services meriting neither professional recognition nor publication privileges), and (ii) adheres to commonly recognized professional standards for maintaining privacy and confidentiality (e.g., an appropriately qualified laboratory performs analyses of blood samples for researchers solely on a commercial basis).
Releases anonymous (no codes, links or identifiers) individual information or specimens to a researcher.
Releases identifiable private information to a State or Local Health Department for public health purposes (no research component to the activity).
Releases private identifiable information to a researcher when written permission of the subject has been obtained and is documented.
Although an activity may be considered research (…systematic investigation designed to contribute to generalizable knowledge…), it may not involve human subjects (…a living individual about whom information is obtained through intervention or interaction). Human subjects protections under 45 CFR 46 and 21 CFR 50 and 56 do not apply when:
Field expertise is sought: The information collected is not about the individual. That is, the person interviewed/surveyed is asked to provide information specific to his/her expertise or profession as opposed to personal information about him/herself (opinions, thoughts, or perceptions). For example, a welder asked to describe the composite of shielding gas, shielding gas flow rate, and formation of the weld bead is not disclosing information about him/herself and, as such, is not a research subject. Likewise, an entomologist who describes the varieties of pesticide used to control a specific pest and to identify the types of pesticides that are used most frequently is contributing his/her expertise rather than information about him/herself.
Participants are acting as a mechanism: The person is asked to wear a device to measure something external to the person (air quality, environmental toxins). No data about the person are collected.
Deceased individuals: A human subject is a living individual about whom an researcher conducting research obtains: Data through intervention or interaction with the individual; or, identifiable private information. Research involving only records from deceased individuals does not involve human subjects.
Studies conducted for the purpose of program evaluation, needs assessment, or quality control in which findings are solely intended for use in internal program planning and development and are not designed to contribute to generalizable knowledge (publication or presentation) are not subject to CPHS review. OHRP refers to these projects as "Quality Improvement Activities".
Most Quality Improvement Activities are not designed to satisfy the definition of “research” under 45 CFR 46.102(d), “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…” Therefore there is no requirement for such activities to undergo review by the CPHS.
However, when the project involves introducing an untested intervention for purposes which include both: (a) improving the quality of service delivery, and (b) collecting information about participant outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, such activities typically do satisfy the definition of “research”. Projects such as these must undergo review by the CPHS prior to the introduction of the untested intervention, otherwise the information collected about participant outcomes cannot be used for establishing scientific evidence in determining how well the intervention achieved its intended results. For additional CPHS guidance, see "Teacher Efficacy, Program Evaluation, and Service Assessments".
An employee of CSUMB consults on human subject research but does not receive or possess identifiable private information or data about subjects participating in the study. It is the researcher’s responsibility to ensure any data accessed by the consultant is properly de-identified so there is no way the consultant can associate it with a subject. Should any identity discovery occur during the course of this research, researchers are required to immediately halt all research activities and submit a CPHS Adverse Event Report for review.
An employee of CSUMB is a consultant through a non-institutional contract. Research activities will occur outside of his/her CSUMB employment and he/she will not reference CSUMB in documents or publications associated with any reported outcomes.
The primary purpose of providing training in research methods is for students to become more knowledgeable about the research process in the structured setting of course or class assignment. Instructors may assign a project, in conjunction with the course, in which students design a study, recruit participants, collect and analyze data and report their findings in the form of a final paper. Since the intent of the project/assignment is to train students, the assignment is not considered to be research as defined within the federal regulations and is therefore not subject to CPHS review.
The course instructor is responsible for informing students about ethical research practices and providing direct supervision of each project. Eligible projects cannot involve subjects from a protected population, or collect personally identifiable information or data which may cause the participant harm (psychological, physical, legal, social and/or economic) during research or if it’s ever revealed.
Conditions:
Irrevocably de-identified existing private information or specimens: OHRP does not consider the use of private information or specimens which have been irrevocably de-identified (i.e., stripped of identifying information so that there is no way it may be associated with a living individual) to be human subject research. Should any identity discovery occur during the course of this research, researchers are required to immediately halt all research activities and submit a complete protocol for review at the discretion of the CPHS.
Coded existing private information or specimens: OHRP does not consider the use of existing coded private information to be human subject research if both of the following conditions are met: (1) the data is not collected specifically for the currently proposed research project (e.g., it’s existing); AND (2) the researcher (or anyone on the researcher’s research team) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example: The researchers and the holder of the key enter into a binding agreement prohibiting the release of the key to the researchers under any circumstances, until the individuals are deceased. Should any identity discovery occur during the course of this research, researchers are required to immediately halt all research activities and submit a complete protocol for review at the discretion of the CPHS.
It is primarily on the grounds that oral history interviews, case studies and market research, in general, are not designed to contribute to “generalizable knowledge” that they are typically not subject to IRB review.
In some instances, these projects may be designed to lead to more general knowledge and therefore will require CPHS approval. Research projects with protected populations, life history interviews for medical research, and projects that are designed to support sociological, political science or policy research are examples of such activities.
Scholars or others who wish to use archived materials as secondary sources in research or dissemination projects of their own must present an IRB approval to the archivist either from the CPHS or their home institutions.