Compliance

Researchers

  • The CPHS requires all members of a research team who are "interacting or intervening with subjects", OR will have "access to personally identifiable private information" of subjects OR who could "reasonably ascertain the identity of a subject" be informed about human subjects protections prior to submitting a protocol.

    Complete Training Certification

    Before you take CITI training, watch this!

    Certification in the protection of Human Subjects must be valid prior to, and during, research involving Human Subjects. Complete basic training prior to submitting your protocol and be aware that (evidence of) additional training may be required by the CPHS in order for your protocol to be approved. Additional training typically involves FERPA and Data Security & Privacy training (assigned by the institution to every CSUMB employee). Additional modules in CITI are typically required commensurate with the subject population or risks subjects or researchers, such as: Consent with Subjects Who Do Not Speak English, Illegal Activities or Undocumented Status in Human Research, and Research in Public Elementary and Secondary Schools.

    Is your research grant funded?

    The Sponsored Programs Office (SPO) will assist you to develop and submit a proposal for externally funded research that involves Human Subjects.

    Learn the basics about externally funded Human Subjects Research and Data Monitoring and Sharing Plans through a podcast series developed by the NIH.

    NIH Extramural Nexus logo

    Watch OHRP's Informational Videos

    The Office of Human Research Protections (OHRP) has created a series of short videos with basic information about research. These videos are intended to help potential participants understand how research works, what questions they should consider asking, and things to think about when deciding whether to participate in a study.

    As a researcher, watching these videos gives you the understanding of what your subjects should know, and may ask you during the course of the research.

    If you're a Social & Behavioral Science researcher be sure to check out the one called "Participating in Social & Behavioral Health Research" (video on left) for a heads up on what subjects know (or should know) about your research.

    Is Review Required?

    Some research designs do not require CPHS review so you must first determine if your project is or is not "research involving human subjects" per the Code of Federal Regulations Title 45, Part 46 — Protection of Human Subjects.

    The CPHS reviews all "research involving human subjects" including: Exempt, Expedited, and Convened Meeting protocols. The CPHS will also verify "Not HSR" when a researcher is unsure, or requires evidence of IRB review (for publisher or other).

    The CPHS acknowledges this is a grey zone, but it is imperative for researchers to understand when and if to submit a protocol (application) for Human Subjects Research to the CPHS, and to what extent your protocol should be "trimmed down" for a Not HSR verification review vs. a Regular Protocol review.

    Quality Improvement Activities

    Many activities are not designed with the objective of "generalizability". They're designed to measure and report on performance data for clinical, practical, or administrative uses. To learn more about Quality Improvement Activities, check out OHRP's FAQs and CPHS' guidance Teacher Efficacy, Program Evaluation and Service Assessments.

    Excluded Activities (per Revised Common Rule)

    As of 1/21/19, the Revised Common Rule identifies the following disciplines rarely conduct activities meeting the definition of Human Subjects Research: Oral History, Journalism, Public Health Surveillance, Criminal Justice, and investigative activities in support of intelligence, homeland security, defense, or national security missions.

    That said, if a researcher seeks to aggregate data from multiple sources (archives or repositories), and draw conclusions which apply to general/similar/other populations, that project may constitute Human Subjects Research. The CPHS recommends submitting a "trimmed down" protocol for Not HSR verification review in these cases.

    Read the Guidelines & Policy

    CPHS Revised Common Rule Guidelines for Human Subjects Research

    The regulatory maze that researchers are required to complete in order to conduct Human Subjects Research is complex, no question. The first step to understanding how to conduct Human Subjects Research at CSUMB is to read the Committee for Protection of Human Subjects (CPHS) Guidelines and CSUMB's policy Human Subjects in Research.

    New Regulations!

    On January 21, 2019, changes to the regulations for Human Subjects Research will take effect. The Revised Common Rule changes several things our researchers should be aware of. Comprehensive information is at Final Rule Resources provided by CITI Program. Below are highlights selected by the CPHS as "high interest" (to our researchers).

    Refined Definition of Human Subject

    As of 1/21/19, the regulatory definition of human subject includes "identifiable biospecimens": Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

    Increased Emphasis on "Vulnerability"

    The revised Common Rule elaborates on the concept of "vulnerability" as a function of the possibility of coercion or undue influence on subjects' ability to make an informed decision about participating in research. In addition to traditional indicators of "vulnerability" (i.e.: societal marginalization or discrimination, etc.), the circumstances under which a subject is informed and consents to participate (initially and continuously throughout the research) are entirely relevant to their "vulnerability".

    Expanded Definition of Clinical Trial

    In an effort to harmonize regulations with the FDA, as of 1/21/19 the definition of "clinical trial" is: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. NOTE this applies to biomedical and behavioral health-related research not all experimentally designed research.

    Federally funded studies which meet this definition must post their consent forms publically. The Office for Human Research Protections (OHRP) has two publicly available federal websites that will satisfy the consent form posting requirement at: http://ClinicalTrials.gov or a docket folder on http://Regulations.gov. More may be identified in the future.

    Continuing Review No Longer Annual

    As of 1/21/19, Continuing Review is no longer required annually and the final, close-out report may be submitted when all interaction or interventions with living individuals are complete. In other words: The final, close-out report may now be submitted even if data analysis, including analysis of identifiable private information or identifiable biospecimens is occurring and/or follow-up access to clinical data from procedures that subjects undergo as part of clinical care is occurring.

    That said, as of 1/21/19, the CPHS has the authority to designate any periodic frequency of status report applicable to the research. Exempt, Expedited, and Full Board Review protocols will be assessed individually and periodic status reporting will be commensurate with the proposed research. Most protocols submitted by CSUMB researchers will only require one final, close-out report.

    Informed Consent Emphasis

    As of 1/21/19: Consent procedures must now be focused on the subjects' comprehension to the extent that it is preferable to exclude all non-applicable elements of Basic Informed Consent IF it will improve subjects' understanding of the research. In other words: Consent procedures should only include applicable elements of Basic Informed Consent AND exclude all elements which will confuse or mislead subjects about the proposed research.

    Highlighted changes to basic informed informed consent elements:

    • Begins with a concise and focused presentation of key information.
    • 4 new elements pertaining to biospecimens.
    • Electronic "signature" now considered signed (vs. waived).
    • Federally funded biomedical and behavioral health-related research which meets the new definition of "clinical trial" must post a version of the consent form on a publically available federal website (see Expanded Definition of Clinical Trial above).

    Revisions to Exempt Categories

    Exempt Category 1: As of 1/21/19, this category includes a statement that the research cannot "adversely impact students' opportunity to learn required educational contentor the assessment of educators who provide instruction".

    Exempt Category 2: As of 1/21/19, this category includes a clarification that the data may involve visual or audio recording. Not currently available at CSUMB is an additional provision which will, in the future, permit collection of sensitive, identifiable data IF a highly itemized consent procedure is approved and each individual's custom consent is tracked/complied with by the researcher.

    Exempt Category 3: As of 1/21/19, this category is new and permits "benign interventions" with adults that involves deception or incomplete disclosure under certain conditions. Not currently available at CSUMB is an additional provision which will, in the future, permit collection of sensitive, identifiable data IF a highly itemized consent procedure is approved and each individual's custom consent is tracked/complied with by the researcher.

    Exempt Category 4: As of 1/21/19, this category includes biospecimens, as well as special carve-outs for HIPAA-covered data, federally conducted research, and federally generated data.

    Exempt Category 5: As of 1/21/19, this category clarifies what are "research and demonstration projects that are conducted or supported by a Federal department or agency".

    Exempt Category 6 is not changed.

    Exempt Category 7 & 8: These categories pertaining to biospecimen repositories, are not currently available at CSUMB. The provision will, in the future, permit collection of sensitive, identifiable data IF a highly itemized consent procedure is approved and each individual's custom consent is tracked/complied with by the researcher.

    Not Currently Available at CSUMB

    NOT being implemented by the CPHS are two new provisions: Broad Consent and Limited Review. These provisions require highly itemized consent procedure and researcher tracking compliance with each individual's custom consent. OHRP's guidance on these provisions is very vague and as it currently stands, in practice the regulatory burden on researchers would be excessive.

    Other Applicable Laws, Policies, Regulations, and "Standards of Professional Conduct and Practice"

    Research is inevitably subject to a variety of other applicable laws, policies, regulations, and "standards of professional conduct and practice". It is the responsibility of the researcher to understand all laws, policies, regulations, and "standards of professional conduct and practice" applicable to their research.

    Commonly Applicable Regulations (not exhaustive)

    View the complete list of federal agencies who have "signed onto" the Common Rule. Note that the FDA has not ("signed onto" the Common Rule) and FDA regulations (TITLE 21—Food and Drugs) contain some discrepancies with 45 CFR 46.

    Commonly Applicable Policies (not exhaustive)

    • Site & Data-related Policies
      • Site Authorization: To conduct research at another institution, on private property, at K-12 school(s), or another location requiring site authorization.
      • Population Access Authorization: To conduct research with subjects protected by institutional policy, or on a platform where the vendor's terms of service or user agreement requires pre-authorization (i.e.: social media websites).
      • PII Data Access Authorization: To conduct research with PII data protected by institutional policy (i.e.: school district policy on surveys that ask students questions of a personal nature).

    Commonly Applicable Laws (not exhaustive)

    International Research Standards

    When HSR is to take place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in CSUMB's policy. It is the researcher’s responsibility to understand and comply with all applicable foreign policies and procedures. See OHRP's guidelines on International Compilation of Human Research Standards. The CPHS may refer CSUMB researchers to consultation services provided by OHRP’s International Activities program before approving a protocol.

    Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the 2020 edition of the International Compilation of Human Research Standards is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 133 countries and from many international organizations. These laws, regulations, and guidelines are classified into nine categories:

    1. General, i.e., applicable to most or all types of human subjects research
    2. Drugs and Devices
    3. Clinical Trial Registries
    4. Research Injury
    5. Social-Behavioral Research
    6. Privacy/Data Protection
    7. Human Biological Materials
    8. Genetic
    9. Embryos, Stem Cells, and Cloning

    If the CPHS determines that the human subjects research norms of the foreign country afford protections which are at least equivalent to those in CSUMB's policy, the CPHS may approve the substitution of foreign procedures in lieu of the procedural requirements referenced in .

  • Human Subjects Research > Checklists, Forms & Policy > Prepare a Protocol

    Google Drive > Human Subjects Research - Public View > CPHS Applicant Materials

  • Human Subjects Research > Checklists, Forms & Policy > Post-Approval Activities

  • Human Subjects Research > Checklists, Forms & Policy > Other Protocol Types

  • Human Subjects Research > Questions & Answers