Researchers

Human Subjects Research (IRB)

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.

1. Learn and refresh your training

1.1 Log into CITI (link to CITI Program)

1.2 Is Review Required? (link to details)

1.3 Revised Common Rule (CSUMB video)

1.4 Additional CITI Modules (download sheet)

1.5 OHRP's Informational Videos

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 CITI modules 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.

2. Read the Guidelines & Policy

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.

2.1 Guidelines for HSR (link to site)

2.2 HSR Policy (link to site)

3. If your research is externally (grant) funded:

3.1 Check in with the Sponsored Programs Office

3.2 Learn about NIH Data Monitoring and Sharing

4. Understand "other applicable laws, policies, regulations, and "standards of professional conduct and practice" that apply to your research

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)
- CSUMB Policies
  - Human Subjects Research
  - Research Misconduct
  - Field Trip (applies to student researcher travel)
  - Family Education Rights & Privacy Act (FERPA)
- CSU Policies
  - Research & Sponsored Programs
- 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)
- State of California, Laws & Codes
  - California Education Code
    - Specifically: Title 5, Article 2. Prohibited Instruction, §51513, pertains to surveys in K-12 public schools.
- Privacy Laws, State & Federal
- Federal Fostering Connections to Success and Increasing Adoptions Act of 2008 (P.L. 110-351) (extending foster care to 21 in CA)
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 .
Prepare a Protocol in Kuali Protocols

All supporting documentation is on Google Drive > Human Subjects Research - Public View > CPHS Applicant Materials
Post-Approval Activities

Human Subjects Research > Checklists, Forms & Policy > Post-Approval Activities
Other Protocol Types
Human Subjects Research > Checklists, Forms & Policy > Other Protocol Types
- Single IRB (sIRB) a.k.a. Collaborative/Cooperative Agreement for Engaged Human Subjects Research
  - For researchers (external and internal) with an engaged CSUMB researcher in the (pending or approved) protocol
- Transfer of a protocol, data or materials into or out of CSUMB from another institution
  - For researchers joining or separating from CSUMB who want to transfer their protocol, data or materials
- External Researcher Agreement -- NOT currently accepted
  - For external researchers without any CSUMB researcher engagement in the approved protocol
Frequently Asked Questions to the CPHS

Can't find what you're looking for? Email us at cphs@csumb.edu.

Compliance

Human Subjects Research (IRB)

Researchers

1. Learn and refresh your training

2. Read the Guidelines & Policy

3. If your research is externally (grant) funded:

4. Understand "other applicable laws, policies, regulations, and "standards of professional conduct and practice" that apply to your research

Commonly Applicable Regulations (not exhaustive)

Commonly Applicable Policies (not exhaustive)

Commonly Applicable Laws (not exhaustive)

International Research Standards

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