Human Subjects Research (IRB)

All research projects that involve human subjects research conducted by or under the direction of any employee or agent of CSUMB or auxiliaries 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. IRB review and approval must occur in advance of study initiation.

Definitions

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

A systematic investigation is 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. For example, exploring a cause and effect relationship or correlation.

Generalizable knowledge is when the project seeks to disseminate the research findings beyond the boundaries of the institution (e.g., conference presentation or poster, publication, and including graduate thesis or dissertation) or use external to the institution's instructional setting (such as pursuing external funding). This includes pilot studies and those with small sample sizes; it isn't the number of subjects that determines if review is needed. For example, a project initiated with hopes of seeking external funding in future or sharing the aggregate results with local agencies to improve local laws..

A human subject is a living individual about whom an investigator (whether professional or student) conducting research:

1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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  includes communication or interpersonal contact between investigator and subject. This also includes interactions conducted remotely such as online surveys or phone interviews.

Identifiable is information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the 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).

“About whom” refers to the fact that in research involving human subjects the information gathered pertains directly to them as a person, not just about a general concept or group they might be part of; it's about their personal experiences, characteristics, or responses. For example, surveying public health professionals about where they perceive gaps in medical care is about their profession and gaps in medical care not about the individual completing the survey or people to allow an air monitor to be placed near or inside their home.

“Readily ascertained” means data or biospecimens where the identity of the individual could be determined from the data collected. This often occurs with a small sample size, large volumes of data about individuals, or working with a convenience sample with which the researcher may have a direct relationship. For example, by linking datasets such as demographics, educational records, and extracurricular activities for a group of students, individuals may be readily identifiable.

A party is “engaged in research” if it (or its employees, staff, or agents) has a key role in designing the research, conducting the research, analyzing and interpreting the results, or gaining informed consent from human subjects. For example, if a CSUMB faculty member designs a study and has surveys deployed by a survey firm, the faculty member is engaged in research but the survey firm is not.  For more information, review this updated guidance. 

Examples of applying the above definitions

IRB review is required when a researcher is engaged in human subjects research (HSR). This occurs when an agent or employee:

• Intervenes with a living individual for research purposes even if the data is recorded without identifiers (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 even if the data is recorded without identifiers (e.g.: controls environmental light, sound, temperature, social interactions).
• Interacts with an individual for research purposes, including screening potential participants for eligibility through analysis of identifiable private information or biospecimens.

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 for research purposes. (This includes with or without a coding system and even if the data is recorded without direct identifiers it may be readily ascertainable depending on the volume of data and sample size))
• Obtains, receives or possesses tissue from a living individual that possesses or is linked to any kind of identifiable private information.
• Receives a direct HHS award to conduct human subjects research that will be carried out by a subcontractor or collaborator.

Some examples of when IRB review is NOT required include:

• Quality improvement projects, including program evaluation. NOTE: Except 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.
• Single patient case studies
• Research with deceased individuals
• Research accessing only a limited data set or deidentified data set
• Research on coded tissues or samples for which the investigator does not hold (or have access to) the code linking samples to identifiable information
• Performing commercial services (meriting neither professional recognition nor publication privileges), and adheres to commonly recognized professional standards for maintaining privacy and confidentiality (e.g., paid transcription services, a qualified laboratory performs analyses of blood samples on a commercial basis)
• Releasing anonymous (no codes, links or identifiers) individual information or biospecimens
• Releasing identifiable private information to a State or Local Health Department for public health reporting purposes or requirements (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.

If your research falls into the categories listed above, you do not need to submit an application to the IRB. However, if documentation of a non-human subjects research (NHSR) determination has been requested or is anticipated, you should submit to the IRB for a formal determination.

Frequently Asked Questions

I have read the above information and definitions and I am still confused. Where can I get more information?

You can take the Human Subjects training through CITI Program, you can review this information available from OHRP, or you can submit your project to the CSUMB IRB and request a determination.

What are the requirements for classroom-based projects?

A classroom project that will be used for teaching and learning the research tools in the classroom or for pedagogy and will not be published, or presented beyond the classroom does not require IRB review and approval.

Does a pilot study need IRB review?

Yes. It isn't the number of subjects that determines if review is needed; the determining factor is whether or not human subjects are involved and it is research.

What is identifiable information?

Identifiable information is any type of information that can reveal the identity of a participant. This includes, but is not limited to, name, job title, age, fingerprints, biometric data, gender, birth date, ethnicity or race, medical records, and the zip code for a location with small population.

I'm analyzing de-identified data in collaboration with researchers at another institution and they already have IRB approval. Do I need to submit to CSUMB’s IRB too?

It likely is not required. However, if you anticipate professional recognition or publication privileges for your work or the collaborators are asking for you to provide an IRB determination, you should submit to the CSUMB IRB.

Does genetic testing or stem cell research need review if the specimens are de-identified?

Yes. Genetic testing and stem cell research increases.