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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 chair determines its status, and screens the complete protocol package to ensure that all necessary documents are included.
- Next, the IRB chair looks for substantive issues that need clarification, and determines the changes necessary to bring the protocol into compliance. At this point, an email will be sent to the researcher, requesting changes.
- We communicate almost exclusively by e-mail, so all requests should be sent to email@example.com. Provide us with your University csueastbay.edu e-mail address.
- Please check with the office if you haven’t heard that your protocol or revisions have been received. We usually send the e-mail confirmation within a couple days of a protocol’s arrival.
- We request that you e-mail your revisions to the office, so any minor changes can be made electronically by staff.
- 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 in the office, 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 or expedited review, once preliminary changes have been made.
- 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 e-mailed official letter of approval with the date of approval and an expiration date. Date of approval will be the date of the full committee review, regardless of when your final changes were accepted and approved.
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.
Submit a Modification Request form. Explain the changes you want to make and your reasons for making them. Attach all revised IRB documents. For instance, if you are changing the recruiting information, submit the revised flyer, recruiting script or text. Highlight changes so we can compare the old and new documents. If the changes are substantive, or involve higher risk to the participants, you would also have to incorporate the changes in a revised protocol, which may have to go to the full committee.
Within a few days after you submit your protocol, you will be notified by the ORSP whether your protocol has been classified as exempt or non-exempt. If non-exempt, you must complete the CITI training program before your protocol can be approved. If your protocol is considered exempt, you are strongly encouraged to complete the training.
Do explore this web site. All the information, forms and templates are here. If you still need help, please contact our office via email at firstname.lastname@example.org. 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, draft consent or draft culminating experience description.
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.