What is the procedure for getting IRB approval at CSU?
After a primary investigator completes the proposal application and submits it, along with applicable consent forms and letters of permission, the IRB staff will do an initial review to determine whether the protocol is exempt from further review. Please note that only the IRB staff have the authority to ascertain which level of review will be necessary for your particular proposal. If it is exempt, the protocol is immediately approved and the investigator is authorized to move forward with data collection. Also if it is exempt, it is not necessary to use an informed consent If the protocol is determined to qualify for an expedited review, then it will be forwarded to two of the IRB committee members, who will review the proposal and then communicate with the investigator about any necessary revisions and ultimately, authorization to go forward with data collection. If the protocol requires a regular review, that means it must be reviewed by the entire IRB committee at a regularly adjourned meeting, and then a representative of the IRB will communicate with the primary investigator following the meeting.
What are the criteria for “exempt”?
The Federal law (45 CFR 46) established specific criteria that must be met in order for review to occur at a particular level. First of all, if the research proposes data collection that falls into one of several categories, it may qualify as “exempt”. These activities are:
1. Educational research on children that focuses on regular or special educational instructional strategies, or on the effectiveness of instructional techniques, curricula, or classroom management strategies.
2. Non-controversial research with adults, meaning use of educational tests, surveys, interviews, or observations of public behavior IF there is no risk for the subjects (the term “risk” is somewhat subjective)
3. Research on elected or public officials
4. Use of existing data, e.g. accessing data that were collected for a different project or part of an agency’s regular record keeping. In order for this category to be applicable, the data must either be publicly available (e.g. court records), or completely de-identified so the researcher has no means of associating a set of data with a particular subject.
What are the criteria for “expedited” reviews to be a feasible option?
The Federal law (45 CFR 46) established specific criteria that must be met in order for review to occur at a particular level. First of all, the research must be minimal risk. Then, if the research proposes data collection that falls into one of several categories, it may qualify for “expedited” review. Following are the categories:
Category 1: Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means.
Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Category 8: Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
Category 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
When is a regular review necessary?
1. Research in which there is more than minimal risk. “Minimal risk” is usually defined as risk not exceeding that of normal daily activities.
2. Research involving prisoners.
3. Research involving mentally disabled individuals.
4. Research using pregnant women (This is almost never relevant to us; it’s in the regulation because the same regulation governs biomedical research.)
5. Most research with minors.
How does the Institutional Review Board at Cleveland State University review research proposals?
After a research proposal is received, it is processed and entered into our database of research projects. The proposal is then distributed to two members of the Board, who review it within the context of standards set forth in the Code of Federal Regulations 45 CFR 46. The reviewers can request revisions, approve or deny the proposal, or forward it on to full Board review, as described in §46.109 of the regulations
What is the process to decide whether or not research has to undergo full-board review?
Research that is described, by the reviewers, as controversial or potentially harmful to anyone involved will undergo full-board review, as likely will any research involving protected classes of human subjects.
How long will it take for my research protocol to receive approval?
If everything is submitted correctly and the research is not controversial or conducted with protected classes, a minimum of ten (10) working days is required for the initial review. This can substantially vary depending on revision requirements, etc. Plan ahead!!
What are the most common revisions that reviewers request from primary investigators and how can those common errors be avoided?
- Inadequate information about the rationale for the study question.
Often graduate students identify the purpose of the research as being a degree requirement for their Masters or Doctoral degree. While the research requirement may be a main reason for the research, there needs to be an additional, compelling reason to involve participants in a research project. Often, then IRB reviewers ask for more information about the need for the given project. By clearly stating the need and purpose for the research on Item IIIa of the proposal form, it alleviates the extra turnaround time needed when reviewers must ask researchers to further clarify the research purpose.
- Inappropriate use of the terms "anonymous" and "confidential".
These two terms are often confused and improperly used interchangeably. Such inaccurate uses occur on both the proposal forms as well as on the Informed Consents. If the researcher will have any means of tracing a set of responses back to a specific individual, then the data is confidential. If data is being collected without any identifying information associated with the recording of the data, then the data is anonymous. NOTE: Data CANNOT be both anonymous and confidential; it is one or the other.
Do I have to keep my data confidential or anonymous?
No, researchers are permitted to credit participant responses with the people who generated those responses, as long as participants have been clearly notified, in the Informed Consent, that their responses are NOT confidential.
Who do I contact if I have any questions about submitting research?
Questions about anything related to institutional review can be directed to Mary Jane Karpinski, the Institutional Review Board Coordinator, at the Sponsored Programs and Research Services (216) 687-3630. Board members can answer questions as well.
Where is the Institutional Review Board located?
The IRB is administered through the Sponsored Programs and Research Services located in Parker Hannifin Hall, 2258 Euclid Avenue. The Board members are spread throughout the campus and beyond.
What are some general requirements for consent forms?
In every consent form, there should be some form of personal introduction and a description of the research. A statement needs to specifically state that the participant can withdraw at any time without penalty.
For those conducting research during class time, consent forms MUST present an option for the student should they choose not to participate OTHER THAN missing class.
The requirements for the consent forms are confusing. Is there a sample consent form that can be used as a guide?
Yes, sample consent forms are available to be used as guides when assembling your own forms.
How will CSU IRB know that I have registered and taken the CITI certification tests?
CSU has a server that enables us to store, and track, all individuals who have taken and passed the CITI modules that are required. Also, you will be assigned a completion number that you will be asked to record when you complete your IRB Proposal Form.
How often do I need to update my Researcher Certification?
The IRB requires continuing education and updating of the certification every three years.