Frequently Asked Questions

Yes. Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and that the objectives of the secondary analysis are in keeping with those for which consent was obtained.

Absolutely. All research that involves human subjects, exempt and non-exempt, must be reviewed by the Institutional Review Board (IRB) or by the IRB office.

Check our section on “Does My Research Require Review?” to find out if your research does not involve human subjects, or does not fit the definition of “systematic research designed to develop or contribute to generalizable knowledge.”

A person in authority must be aware of and approve your recruiting from among the clients, students, etc. of the organization you want to study. Please note if you intend to conduct research on the same premises, or with the same group, the letter should also include permission to conduct research with this population, as well as recruit subjects from it. This is especially true if you will be using class time, client appointment time, etc. to administer your survey or conduct your interviews.

The person signing the permission letter must also know what your research topic and title are. Frequently it is easier for you to write the letter for them, have their office copy it on school or agency letterhead, and then have the director or principal/assistant principal sign it.

Key informants or content experts or a panel of experts do not require consent forms, because they are not considered human subjects needing protection if you are asking them questions that relate solely to their field of expertise, and the questions are factual in nature. However, as a courtesy, you should provide them with a brief information sheet with your contact information, your advisor’s contact information and the title of your research.

A discussion of your data analysis methods indicates that you have a plan to evaluate your data in the light of your research question. If your data will not answer your research question or hypothesis, your study will be meaningless, and thus of no benefit. If there is no benefit whatsoever to conducting your research, even the slightest risk is outweighed by the lack of benefit. In this case you will need to revise your protocol, questionnaires, interview questions or survey instruments to make sure you will elicit the data that will answer your research question or fulfill the research purpose.

The data analysis section should address all sources of data you are collecting. Describe the method of analysis, any software you will use, any collection notes or data sheets you have devised to help you collect information.

If you are conducting a qualitative study, state specifically which qualitative method of analysis you will use.  For instance, if you are collecting interview data and looking for common themes throughout, please state this, and mention a potential theme or two.. If you are using the data anecdotally to support your own observations, field notes, or journals, please state this.

The IRB uses age of participants as one of the criteria used to determine whether your research is exempt or non-exempt. Participants under 18 years old are minors, and considered a vulnerable population. Research with minors would make an otherwise exempt survey or interview non-exempt, and would call for a full committee review, which can add time to the approval process.  Interviewing or surveying adults is almost always exempt.

Identifiable information is any information that can single out a participant. This includes, but is not limited to, name, job title, age, fingerprints, biometric data, gender, birth date, ethnicity or race, medical records number, and even zip code if less than 20,000 people live in that zip code. Please tell us what information on your subjects you do have or will collect, and we can then determine if it is identifiable for your research population.

“Unidentifiable” is not the same as anonymous, which only refers to not knowing someone’s name. You cannot know or use a participant’s name and still be able to identify that participant through a combination of other identifiers.

“Recruiting scripts” refer to the content of an in-class presentation or a telephone call, the text of an e-mail, letter, or newspaper advertisement, or the copy of a flyer you will post to inform prospective participants about your research. These scripts should be brief, about a paragraph long, and objective. They should be a simple invitation to participate in the research.

Recruiting scripts should briefly include: who you are, what your study is about, what will happen to the participants, when and where it will happen, and how long it will take, and your contact information. Include specific inclusion or exclusion criteria for participation on your script (must be 21, must be computer science students, must have asthma, etc.).

  • Your protocol now enters the “revision cycle.” The IRB Coordinator performs and administrative review for completeness. If incomplete the study will be returned to you.
  • Once complete and resubmitted, the protocol is assigned to a member of the IRB and to the IRB Chair for initial review. The initial review may determine that the study is Exempt, can be Expedited, or must undergo a Full Review by the IRB Committee.
  • The reviewers looks for substantive issues that need clarification, and determine the changes necessary to bring the protocol into compliance. At this point, the protocol may be returned to the PI with questions to answer, or for minor questions an email may be sent asking for clarification.
  • The IRB communicates almost exclusively by email and the Cayuse system. All requests or communication not done through Cayuse should be sent to irb@csueastbay.edu. Provide us with your University csueastbay.edu email address.
  • Please keep in mind that in the interest of protecting human subjects protocol review is carefully and thoroughly performed and is usually not completed immediately. Protocol reviews may be completed sooner than this, but allow 30 - 60 days turned around time.
  • After editing your initial protocol submittal that has been returned to you, or after accessing your original protocol in Cayuse and creating a Modification submittal, you will submit it in Cayuse and certify it in Cayuse.
  • Once your revisions are submitted, they will be reviewed to make sure all requested changes have been made, and to review any additional material you may have provided.
  • More revisions may be requested to correct any errors or omissions in the newly-submitted material, to include something that was missed the first time around, or to request again any prior changes that haven’t been made.
  • Exempt protocols will be certified as such, once any required changes are received and accepted. You will receive an e-mail notifying you of its exemption from further review.
  • Non-exempt protocols will go to the committee for a full review or to one or two IRB Members for expedited review when possible, once preliminary changes have been made. You will be notified if your proposal is scheduled for Full Review.
  • The committee may require changes after its review. You will receive an email from the IRB, notifying you of your protocol’s review status, and any final changes required by the committee.
  • Non-exempt protocols will receive an emailed official letter of approval with the date of approval and an expiration date when applicable. Date of approval will be the date of the full committee review, regardless of when your final changes were accepted and approved.
Any time you change any of your planned methodology, documents, study team, participant popluation size or type, you must submit a Modification to your protocol. 

The committee can give full approval, contingent approval (contingent on fulfilling some minor conditions before full approval is granted), or can defer your protocol for serious substantive changes. If the protocol is deferred, the revisions will have to return to the committee for approval. If given contingent approval, the revisions can be approved in the office and signed by the IRB chair. Your protocol has not been fully approved until you receive the official letter of approval from the IRB office.

All protocols have to be reviewed once a year, at a minimum. Most protocol approvals expire one year from the date of shown on the approval form.

However, the committee may approve protocols for less than a year if they feel the risks, population, consent issues, or other considerations warrant an earlier review.

The process usually takes between 2-12 weeks. This timeline is contingent upon receipt of a full protocol package, the type of review the protocol requires, and quick responses from the researcher.

For this reason, we encourage students to consider exempt research projects, because they do not require a full committee review. They can be reviewed and certified as exempt from further review by the IRB chair alone.

To submit a Modification to an approved study, log on to Cayuse Human Ethics/IRB.  Choose the study you need to modify.  Click on the "New" button on the top right and choose "Modification."  Go through each section and modify all text and sections that need modification.  Attach all revised IRB documents. For instance, if you are changing the recruiting information, submit the revised flyer, recruiting script or text. The system will automatically keep track of your changes and has a feature that allows the researchers to compare your original against the newly edited version.

The protocol changes will be reviewed. If any of the modifications are substantial changes, keep in mind the nature of your study may change from Exempt to Non-Exempt or the reverse.

We encourage all researchers to complete the CITI Human Subjects training.  If you know your study and protocol will be deemed Non-Exempt, you must make sure your CITI Human Subjects training is up to date.  If the IRB determins that your protocol/study is Exempt, you are not required to take the CITI Human Subjects training, but the IRB recommends that you do.

Do explore this web site. There are numerous job aides to guide you through each step of the process.  In addition, the Cayuse system is user friendly and takes you through the Protocol completion process step by step with each separate sections and questions.

If you do end up needing assistance, please contact the IRB Coordinator through email at irb@csueastbay.edu. We can answer any questions you may have about the protocol process. We are also available to meet with you by appointment to discuss your draft protocol.

Yes. While the Cal State East Bay IRB will review all Human Subjects Research with which the Institution engages, Reliance Agreements can be an acceptable mechanism and may be requested during the IRB Protocol submittal and review process.

The Collaborating Institution's Principal Investigator (PI) uses their Home Institution's IRB processes to request a reliance agreement.

The Cal State East Bay PI uses the Cal State East Bay IRB processes by submitting a protocol application through the CSUEB Cayuse Human Ethics (IRB) online system, and within it describes that the request is for the CSUEB IRB to enter into a Reliance Agreement to either rely on the collaborator institution's IRB for review or to be the single IRB reviewing the research from one or more collaborating institutions.

Once a Reliance Agreement is signed, one institution has relinquished review and approval of their PI's protocol to another institution and rely's on the oversight of the other institution.  Both institutions are still accountable, however, for the actions of their PIs.

 

Please see also Understanding Reliance Agreements for more information.

If you have an unexpired Protocol that was submitted and approved before the University rolled out the Cayuse system in early 2020, and you need to submit a modification, email the IRB Coordinator at irb@csueastbay.edu. The coordinator will initiate the process to have the information from your hardcopy paper or pdf protocol submittal converted and uploaded to the Cayuse system.  Once the IRB Coordinator emails you to confirm your Protocol is accessible in Cayuse, you may log onto Cayuse, choose the study, click on the "New" button, and Choose Modification.

Students use the Cayuse system to submit their protocol, but will choose their instructor or faculty advisor as the Principal Investigator (PI).  If you are a Student, but do not already have access to the Cayuse Human Ethics/IRB system at Cal State East Bay, then contact the IRB Coordinator, irb@csueastbay.edu, to request access. 

Even though you are a student, the protocol you submit is an actual human subjects research protocol that the university must review while adhering to federal regulations so your protocol must be complete and thoroughly answer the questions and describe the study.  If any questions about the content or information you do not have, please contact your instructor or faculty advisor for guidance.

 

You must submit a modification any time you make changes to your protocol, for example, you change study team members, participant population numbers, consent form or recruitment fliers, or any changes to the way in which you have said you will conduct your experiment or interventions.

If your original protocol was submitted and approved on or prior to January 20 2019, and has not been modified since, then you need to follow the Pre-2018 Common Rule.

If your protocol was submitted on or after January 21 2019, then you need to follow the Post-2018 Common Rule.

If your original protocol was submitted and approved on or prior to January 20 2019, but was modified on or after January 21, 2019 and you are unsure of which Common Rule version you are supposed to follow, then contact the IRB Coordinator at irb@csueastbay.edu for additional clarifications.