FAQ

What are the common errors in applications?
Common mistakes on applications include: not having the consent and/or assent forms printed on your department letterhead; not having all signatures on the application (cover, page 1), checking "Yes" to all protected population participants when the research is using general population (#7, page 5).

How long will review take?
Applications are date stamped on the day they are received by Grants & Contracts and the intake review takes place within 24 hours. If your application is complete (all signatures, forms and consent provided appropriately), it will be assigned a CPHS log tracking number and forwarded to a CPHS reviewer. CPHS reviewers each have 10 working days to complete their review. Level I/Exempt protocols require a single reviewer. Level II/Expedited protocols require two reviewers. Level III/Full Board Review protocols are reviewed at monthly CPHS meetings typically on the third Friday of each month. Contact the CPHS Coordinator, Jennifer Bliss, at (831) 582-5130, or CPHS@csumb.edu to confirm CPHS meeting dates. It is the researcher's obligation to submit your application with enough time for CPHS review prior to anticipated start date.

How do I know the status of my application review?
All correspondence regarding your application is conducted in writing by e-mail using your CSUMB e-mail address per campus policy http://policy.csumb.edu/student-email-notification. Applicants receive their first correspondence from the CPHS Coordinator, Jennifer Bliss with the CPHS log tracking number and confirmation of review processing. The next correspondence might come from a CPHS reviewer if they have any questions or issues about your proposed protocol. Your application review is PENDING while the CPHS reviewer awaits your response. A final correspondence will come from the CPHS Administrator, Cindy Lopez, Director of Grants & Contracts. This message will contain information about the protocol assessment (Level I/Exempt, Level II/Expedited, Level III/Full Board Review) and your official start date. You may not begin your research in advance of receiving this message and approved start date.

Whom do I contact for additional information?
You have several resources available to you. Members of the CPHS are available to answer your questions. The CPHS Coordinator is Jennifer Bliss, at (831) 582-5130. The current CPHS Chair is Chip Lenno, at (831) 582-4799. The CPHS Administrator is Cindy Lopez, Director of Grants & Contracts, and can be reached at (831) 582-3089.

Who has to apply for human subjects clearance?
All faculty, staff and students who plan to conduct research which meets the Federal definition of human subject research (CFR 45 Part 46) must submit an application. This includes externally funded and non-funded research.

How is "research" defined in this context?
Federal regulations say, "Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." "Research" does not include (a) Instruction; (b) Surveys for evaluating performance of faculty, staff and students, or other studies for institutional use only; or (c) Student practica or course work assigned for the purpose of learning or repeating previously documented research methods.

Why do I have to apply for human subjects clearance?
Researchers over the last fifty years have come to recognize an obligation to minimize the risk to which human subjects of their research are subjected. The human subjects clearance process is customary at all universities and research institutions and ensures adherence to minimum standards of protection. The process exists to help the researcher meet his or her ethical obligations. Any proposal for external funding that contains human subjects issues must be reviewed prior to submission to the funding agency.

Who reviews my application?
CSUMB has an Institutional Review Board (IRB) for this purpose, the Committee for the Protection of Human Subjects (CPHS). The committee structure is available on-line. Federal Regulations also require that one or more members of the public also sit on the Committee. The CPHS has the authority to request additional assistance from others with expertise that is particularly germane to any given application.

Not all applications (protocols) must be reviewed by the entire CPHS ("Full Board Review"). Most protocols require only a single reviewer to assess a protocol as "Exempt".* Other protocols may need only two reviewers to assess the protocol as "Expedited".  *Note that the word "Exempt" applies only to the full board review, not to the researcher's responsibilities to comply with Human Subjects Policy.

What kinds of things will the CPHS be looking for?
Please note: Applications cannot be accepted without all required attachments and signatures. Please use the Application Checklist (cover, page 1) to ensure a complete submittal.

The essential task of the CPHS is to weigh the potential risks of the proposed research to the benefits anticipated from this research being undertaken. The anticipated benefits to the subjects or to society must outweigh the risks to the participants in order for an application to be approved. It is imperative, therefore, that the Principle Investigator's application make very clear statements about both potential risk and anticipated benefits related to the study.

In addition, the CPHS will be looking to ensure that standards will be met in the areas of informed consent, inclusion and exclusion, and confidentiality and privacy.

What exactly is a benefit and what is a risk?
A benefit is a valued or desired outcome, or an advantage. A risk is the probability of harm or injure occurring as a result of participation in the research study. Federal regulations define a minimal risk as one wherein "the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."

Traditionally, IRBs look for risk of three kinds of harm: physical harm, psychological harm, and social/economic harm. What steps are being taken to mitigate the risks? What steps have you taken so if any harm occurs to the subject, s/he has access to help during and/or after the project.
Additional protections are afforded fetuses and pregnant women, prisoners and others living in involuntary settings, and children. If the subjects of your study involve members of any of these groups, be sure to address your specific concerns.

What is meant by "informed consent"?
Informed consent takes place when a subject voluntarily agrees to participate in the planned research, based upon adequate knowledge and understanding of such relevant information as process, risk and outcomes. Studies based on deceiving subjects are generally not approved. The CPHS will be looking for the PI's description of how informed consent will be obtained.

What is meant by "inclusion" and "exclusion"?
Federal policy guidelines seek to "ensure that women and minorities and their sub-populations are included in all human subject research." Historically, many researchers, especially in the biomedical field, used primarily white males as subjects and then attempted to generalize their findings across the rest of the population.

The CPHS is charged with assuring that any bias in the selection of subjects for the study is justified and wholly necessary to address the research question. Thus, investigators are now required to demonstrate that their sampling methods do not exclude a given population or sub-population, UNLESS doing so is essential to the study itself. So, for example, if one were interested in studying the effects of a certain pedagogical approach on bilingual (English-Spanish) students, one could certainly put forth a proposal to study just those students to the exclusion of others. However, if one wanted to study the effects of the reduction of funding of certain school-based programs, one's sample should be inclusive or the application should contain a justification for why it is not. Cost is not an acceptable reason for excluding these groups from study populations.

Where can I find the application form and policies?
Forms and instructions are available online.

What should be considered when addressing privacy and confidentiality issues?
Generally speaking, confidentiality refers to protecting the identity of the subject. Without prior written informed consent of the subject, the PI or her or his staff may in no way allow any information about the study to be released that might in some way identify any of the subjects. This includes descriptive information as well as the subject's responses. Anonymity usually refers to the identity of the subject not being known to the PI or his or her staff at all. It is not the same as confidentiality. Privacy sometimes refers to the protection that the PI will give to the storage of the raw data provided by the subject, to insure that only the PI and her or his staff will have access to it. Privacy also includes matters of confidentiality.

Is there additional guidance for international research?
Yes. OHRP maintains resources of internationally agreed policy statements, regulations, guidelines, etc. at: http://www.hhs.gov/ohrp/international/index.html. Provide details in your application about the human subjects protections regulatory requirements for the country in which you intend to conduct research.

How often does the CPHS meet?
The CPHS typically meets on the third Friday of each month. Grants & Contracts maintains the current meeting schedule. Contact the CPHS Recorder for meeting dates: (831) 582-5130.

Can I start my research before the application is reviewed?
No! Under no circumstances may the research proceed until it has been approved by the Committee. Failure to adhere to this could result not only in unforeseen risks to the human subjects, but could also jeopardize all federal funding of research at this university.