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IRB exempt means that some of the research regulations do not apply to your protocol. However, exempt DOES NOT mean IRB submission is not required. Exempt projects still have some research regulations that are applicable, meaning the IRB must review and approve the activities prior to beginning your research. If your protocol involves research with human subjects, the IRB must confirm your project affords the same rights and protections to subjects as any other research protocol. 

The different between exempt and non-exempt protocols is that the IRB oversite is less stringent. Only one IRB member is required to review the protocol instead of several committee members. Additionally, the protocol does not expire. 

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, thoroughly answer the questions, and describe the study. 

If you have any questions or find that you are missing information you need to answer, then please contact your instructor or faculty advisor for guidance.

TIPS

1) If you are trying to complete a research project in one semester, consider the parameters carefully so that you do not choose one bigger than that semester.  It takes time for the IRB to thoroughly review your protocol, recommend revisions if needed, and complete a final approval. The protocol review and approval times vary based on the specific details such as population, methodology, and data collection plans.

2) Read the protocol questions in Cayuse thoroughly and answer each question thoroughly.

3) Work closely with your course instructor or faculty advisor. If you do not understand a question or are not sure how to answer, then consult with your instructor or advisor.

4) If you are unfamiliar with the federal regulations, which are found in the "", take time to read them, research how they impact your research plan, and research other  about the guidelines.

5) Make sure your consent form describes everything required and does not include anything you haven't stated in your protocol.

6) Make sure your protocol describes everything required and is not missing something you have said in your consent form or recruitment document. Your protocol and forms should be in sync and not contradict each other.

7) Not everyone receives approval when first submitted. The IRB may ask you to make revisions or provide additional information.  If you receive your protocol back for revision look for the comments made by the IRB reviewers in the Comment sections and respond to those comments in the Comment Section as you also make the requested revisions. You should reply to each comment as well as provide the required revisions, attachments, and details.

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.  

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.

• Full committee review
  • Projects that meet the definition of human subjects research as defined by the federal regulations will undergo full or expedited committee review. The revision cycle includes an administrative screening, pre-review, return of necessary revisions, then assignment to part or all of the board for review. Full board review requires addition to the agenda of the next board meeting.  The committee generally requires further revisions before granting full approval in a letter to the investigator.  Training in human subjects research via the CITI course is required fo research in this category.

• Exempt review
  • Research protocols in categories defined by the federal regulations (46.104, which exhibit no or very low risks, are assigned to the Exempt research category by the IRB chair. This category of research does not undergo full committee review, but is reviewed administratively by the chair. The chair conducts the final review and signs off.

• Expedited review of non-exempt research
  • This category is assigned to research that is not exempt for some reason, according to the regulations, but is lower risk than research requiring full committee review, usually because the methods are non-invasive and the research is social/behavioral/educational.

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.”

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.

All researchers doing non-exempt research using human subjects are required to pass the online research training course offered by . This includes not only the principal investigator but also all co-investigators, research technicians, research assistants, or student assistants who have contact with the research subjects.

Researchers doing exempt research are also strongly encouraged to complete the training.

• Documents required for EVERY research protocol submission:
  • Protocol approval form (PAF)
  • Protocol statement
  • Informed consent document(s)
• Protocols for non-exempt research must include:
  • CITI training completion certificate
• Other documents may include:
  • Recruiting script/text or recruiting flyers/letters/ads
  • Final survey to be administered: Final questionnaire - Interview questions
  • Permission letter to recruit and/or conduct research
  • Photo releases (if using photographs of participants)
  • Video releases (if videotaping participants)

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.

“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.).

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.

• Attach all relevant documents:
  • CITI certificates for all researchers involved
  • Consent forms
  • Letters of permission from other agencies or schools
  • Surveys or questionnaires

• Make sure all attachments and websites are able to be opened:
  • Unlock security if passwords are needed to open documents
  • Check all links to make sure they are operational and not broken
  • PDF documents are recommended

• Check the correct boxes in each section:
  • If you are receiving funds for the protocol make sure to click YES that it will be funded. Funding includes: gift cards, cash, food and/or beverages, etc.
  • If your research population age varies, check all boxes that apply

• Enter dates of the study that reflect time for review and/or revisions of the protocol:
  • The start date should not be the date you submit your protocol
  • Make sure the year is correct (for example of an incorrect date: START: 9/1/2021 END 8/1/2022)

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.

• 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.

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. Student researchers please allow 4-6 weeks for review.

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.