Is CPHS Review Required?
CPHS review is required when a study meets the definition of "Research Involving Humans as Subjects".
In determining whether or not a project requires review by the CPHS, the first step is to determine if the project meets the regulatory definition of "research" and to then determine whether the people involved meet the regulatory definition of "human subjects" (per §46.102 Definitions for purposes of this policy). The CPHS only reviews activities that meet BOTH these regulatory definitions. Research not meeting these regulatory definitions does not require CPHS review although other authorizations may be required to commence the research/project. It's the researchers responsibility to understand and follow all laws, policies, regulations, and "standards of professional conduct and practice" applicable to their research/project.
Is it "Research" (per §46.102)?
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic Investigation
The CPHS considers a project to be a "systematic investigation" if it is designed to explore cause-and-effect relationships among a set of factors (e.g.: independent variables) and a topic (dependent variable), or at a minimum when the design includes precise definitions, clear measures for observation, and is organized in such a way that the researcher can test the hypothesis or research question.
Generalizable Knowledge
The CPHS considers "generalizable knowledge" to include the dissemination of research findings beyond the boundaries of the institution (e.g., publication, including graduate thesis or dissertation), presentation or use external to the institution's instructional setting.
Are the participants "Human Subjects" (per §46.102)?
Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction
Interaction includes communication or interpersonal contact between investigator and subject.
Private Information
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,a medical record).
Identifiable Private Information
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Identifiable Biospecimen
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Regulatory Exceptions
Deceased Individuals
OHRP does not consider use of private information or specimens from deceased individuals to be human subjects research. The subjects are not "living individuals".
De-identified 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. The subjects are not "identifiable".
Demonstration and Service Programs
Some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
More on when review IS necessary
CPHS review is required when a researcher is engaged in human subjects research. This occurs when an agent or employee:
Intervenes with a living individual for research purposes (e.g.: to draw/collect blood or other biological samples, dispense drugs, administer treatments, use physical sensors, test sensory acuity, collect information by survey, interview for data collection).
Manipulates an individual’s environment for research purposes (e.g.: controls environmental light, sound, temperature, social interactions).
Interacts with an individual for research purposes including informing subjects about the research for the purpose of obtaining consent through analysis of identifiable private information or biospecimens obtained from subjects.
Note: Employees who make information available about a study and/or obtain permission from an individual to release contact information to a researcher but do not obtain consent from individuals nor act on behalf of the researcher are not engaged in research.
Obtains, receives or possesses individually identifiable private information (with or without a coding system) for research purposes.
Obtains, receives or possesses individually identifiable private information for use in maintaining a statistical center for a multi-site research program.
Receives a direct HHS award to conduct human subjects research that will be carried out by a subcontractor or collaborator.
CSUMB Involvement
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.
Collaborative Research
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 as the lead researcher.
When the lead researcher is NOT from CSUMB, but an agent or employee of CSUMB is engaged, the protocol must be submitted to the CPHS as a request to collaborate in human subjects research, otherwise referred to as Single IRB or sIRB.
Studies in which the duties of the lead researcher are formally contracted by CSUMB to a non-CSUMB performance site must either obtain review and approval by the CPHS, or authorization to collaborate in human subjects research, otherwise referred to as Single IRB or sIRB, whichever is most appropriate to the study.
Students Enrolled in Joint Doctoral Program
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 in Foreign Countries
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.
Pilot Studies
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.
Existing Data Analysis of Private Information or Biological Specimens
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.
External (Nonaffiliated) Researchers
When NO agent or employee of CSUMB is engaged in the research, lead researchers not affiliated with CSUMB (e.g., external researchers) who intend to conduct human subject research on CSUMB premises, with CSUMB subjects, or by requesting access to personally identifiable information or data not publically available, must submit an External Researcher or External Researcher Access Request form as appropriate.
After reviewing the external researcher’s request, the CPHS will convey the external researcher’s request for access authorization (to site, subjects, or data). However, access requests are subject to the discretion of the agent or employee providing it as well as any applicable regulatory restrictions. CPHS approval of an external researcher’s protocol does not equate to access permission granted.
More on when review is NOT required.
Performing Commercial Services
When an agent or employee of CSUMB performs commercial services for the researchers (or performs other genuinely non-collaborative services meriting neither professional recognition nor publication privileges), and 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).
Releasing Information or Biospecimens under specific conditions:
Releasing anonymous (no codes, links or identifiers) individual information or biospecimens to a researcher.
Releasing identifiable private information to a State or Local Health Department for public health purposes (no research component to the activity).
Releasing private identifiable information to a researcher when written permission of the subject has been obtained and is documented.
Program Evaluation, Needs Assessment and Quality Control
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 typically 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".
Exception: 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".
Practica: Undergraduate Research Methods (training)
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:
If the course instructor intends to utilize the data collected for Human Subjects Research purposes, the protocol must be reviewed by the CPHS prior to conducting the activity.
If the project results in findings that the instructor subsequently wishes to use for professional research purposes (e.g., to develop or contribute to “generalizable knowledge”), the study must be replicated and conducted under an IRB-approved protocol.
All graduate student research is not eligible for the practica research exclusion.
Practica research projects which involve the use of community-members as participants should seek assessment by CSUMB’s Risk Management Office prior to conducting the study.
Consultation
When an agent or 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 lead researcher’s responsibility to ensure all data accessed by the consultant is properly coded or de-identified so there is no way the consultant can associate it with a subject. Should any identity discovery occur during the course of the research, the lead researcher is required to immediately halt all research activities and submit a CPHS Adverse Event Report for review.
Per Guidance on Research Involving Coded Private Information or Biological Specimens (2008), OHRP does not consider research involving only coded or de-identified private information or specimens to involve human subjects as defined under 45 CFR 46.102(f) if the following conditions are both met:
The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; AND
The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;
Note that the HHS regulations do not require the IRB to review and approve this agreement.
There are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
There are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
The CPHS has extrapolated OHRP's Guidance on Research Involving Coded Private Information or Biological Specimens (2008), to also apply to research protocols designed with the following criteria:
Subjects self-mask (i.e.: for safety or security reasons they will not reveal) their real identities; and
The lead researcher documents in writing that they will make NO attempt to identify the individuals involved.
Note that CPHS strongly recommends review and of these research designed via a Not HSR Verification review of the protocol.
Oral History, Case Study and Market Research
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.
Field Expertise
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.
Participant as Mechanism
A 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.