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Things to Do and Know Before Preparing your IRB Application


1. Determine whether your project requires IRB review

The federal regulations offer a specific definition and guidance on what is “human subject research” and what is not. However, it's not always easy to determine whether a given project fits that definition. This is especially difficult when conducting social, behavioral, and educational research (SBER).

For example: program evaluations, journalism projects, or the study of marketing campaigns are not human subjects research and therefore do not require IRB review. Similarly, classroom research projects that are not shared outside of the classroom do not meet the definition either.

Please consult Human Subject Regulations Decision Charts found on the Office for Human Research Protections (OHRP) website. Also, please read the expander section below: “Does My Project Need IRB Review?” If you are still not sure, please contact the IRB Administrator, Carole Moran Krus, (216) 397-1527, ckrus@jcu.edu.

 

2. Familiarize yourself with the IRB review process

Even if you’ve successfully submitted an application before, please review this Investigators’ Guide to make sure you understand the process and your responsibilities as an Investigator. Also review the Special Guidance topics and Informed Consent sections of this website. Reviewing these sections should help you avoid common problems and delays in your application process.

It is imperative that you download a new application form and templates each time you complete a new IRB application because these documents are updated on a regular basis. The IRB Office reserves the right to reject an application submitted on an outdated form. All our forms and templates are found on the IRB Forms & Templates page.

All human subjects research projects will be classified into one of three types of review categories: Exempt, Expedited, or Full Board. The type of review required is determined by the level of risk that the research poses to the participants. Please review the expander section below, Types of IRB Review & Review Categories. In each case, no research activity can begin until the IRB has issued a Notice of Exemption or Notice of Approval for your application.

 

3. Complete CITI Training

All investigators, co-investigators, faculty sponsors, and research assistants must complete the Research with Human Subjects Training Course offered by the Collaborative Institutional Training Initiative (CITI Program). The IRB will not review any application where any of the investigators (anyone engaged in the research activity) or sponsors have not completed the course within the last three years. Please see the CITI Training pages found in the expander section below for instruction on creating a user profile and registering for the correct online course.

Sometimes it's difficult to tell if a project needs to be reviewed by the IRB. Your research project must be submitted to the IRB if it involves the collection of data from human subjects and fits the following definition of “human subject research”:

What is HUMAN SUBJECT RESEARCH?

human subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about a human subject, which includes a subject’s opinion on a given topic. Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

In order to be considered human subject research, the Private information that is collected must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information through coding).

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Research can include a wide variety of activities, including experiments, observational studies, surveys, tests, and recordings designed to advance the knowledge of a particular field.

It generally DOES NOT INCLUDE such operational activities such as quality assurance, quality improvement, certain aspects of public health practice, program evaluations, marketing studies, fiscal or program audits, journalism, history, biography, philosophy, “fact-finding” inquiries (such as criminal investigations, intelligence gathering), and simple data collection for other purposes.

What you do with your results matters…

If you plan to publish, present, or archive your research, or otherwise share the results of the study, including the uploading of your results to an online or cloud-based platform (such as an e-portfolio, resume, or LinkedIn profile), IRB review will likely be required. Please be aware that you must submit your research project application to the IRB for approval prior to initiating the research.

Human subject research that is not disseminated (e.g., it is conducted as part of coursework and is not shared outside of the classroom; university or departmental assessments that are not shared beyond the university; etc.) is NOT subject to review by the IRB. Instructors: keep in mind that students who conduct research as part of a class activity may want to share their resulting paper independently beyond your course. When in doubt, contact the IRB Office before assigning a human subject research project to your students.

Project review is generally required for: 

  • Survey, Interview, Focus Group, & Observational Research
  • Evaluation Research: such as those which collect data on a new course, technique, or pilot study to assess the effectiveness of the method or material, especially if the results are likely to be presented or published. The IRB will not review standard course evaluations.
  • Oral History: The IRB will review some oral history projects for risk of harm or loss of privacy to the subject. Projects must be considered as research resulting in generalizable knowledge. Items of consideration during a review of oral history projects would include:
    • Who is being interviewed (any members of a vulnerable population group?)
    • The topic of the interview (anything likely to cause distress during the interview or in the event of a breach of privacy?)
    • What will be done with any recordings from the interview (destroyed? made publicly available?)
    • Is the subject fully informed of the content and intent of the project and the disposition of the recordings?
  • Research on Existing Data: the study of already existing non-public data, documents, or records, must be reviewed by the IRB. If the secondary data is taken from a publicly available source (e.g., published census data or test scores; newspaper articles), you do NOT need to file with the IRB.
  • Graduate Thesis, Master’s Essay, Capstone Project, Honors Project, etc., any paper that is archived in the JCU academic department or Grasselli Library searchable archives.

 

Project review may not be required for:

Journalism projects:
Journalistic investigation, such as a project conducted with the intent to publish a newspaper article, is not reviewed by the IRB. However, if the data collected during the project will be used in a thesis or essay or later published in a scholarly article, the project must be reviewed by the IRB prior to the start of the project.

Classroom Projects:
In many academic programs, a course in research methods/methodology is part of the curriculum. Instructors may encourage their students to design small projects simply to teach them how to properly conduct research. In many cases, the data will not be used to contribute to generalizeable knowledge and may not require IRB review. However, IRB approval should be obtained for class research projects if (1) data will be collected from a human subject (e.g., opinions, behaviors, feelings, personal information), regardless of the sensitivity of the data, AND (2) the results of the classroom research project will be disseminated — including master’s theses; presenting outside the classroom; citing in another paper; poster presentations; or including in a resume, online portfolio, graduate school application, etc.

Program Evaluations:
Investigators may gather data from human subjects through direct or indirect interaction to evaluate a program, a specific policy, or marketing campaign. The information they collect will not be used to contribute to generalizeable knowledge, rather the results will be used to improve or develop an internal program.

Non-Human Studies:
Projects in which the focus is a business, event, or topic do not normally need IRB review. For example, if you are interviewing bookstore managers to determine how many copies of the new Betsy Ross biography are displayed in the store window, IRB review is not required since data on human subjects is not collected. However, if you ask the managers how they feel about the American flag or what their salary or social security number is, the IRB will need to review the project since opinions or private data are being collected.

If you are researching the history of tree planting in the eastern suburbs of Cleveland and want to talk to landscapers on species, methods, and soil quality, IRB review is not necessary. If, however, you want respondents to describe any traumatizing accidents they have witnessed while planting trees, IRB review will be necessary since data on personal experiences will be collected.

If the project collects private data in a manner which may cause harm or loss of privacy to the subject, the IRB should be consulted to minimize the risk to the individual.

Departmental or University-Wide Studies:
If you are conducting research for use by your department which will not be disseminated publicly, the project may not need IRB review. Focus group, interview, or survey research, for example, which will be used to collect information on campus for NCA accreditation, does not need to be reviewed by the IRB. However, if data collected for accreditation will be published or shared with other universities, the IRB would review the project.

Projects which collect data to evaluate and improve services are not normally reviewed by the IRB. However, the data cannot be presented at a conference or referenced in a published article.

If the project collects private data in a manner which may cause harm or loss of privacy to the subject, the IRB should be consulted to minimize the risk to the individual.

Biographies and Case Studies:
Single subject studies will not result in generalizable knowledge are therefore do not fall under IRB jurisdiction.

RETROSPECTIVE IRB APPROVAL IS NOT PERMITTED:
Investigators are strongly cautioned to consider whether or not the information collected will be used to contribute to generalizeable knowledge; the investigator must decide in advance, as it is not possible to retrospectively review and approve a project once data collection has begun. If an investigator is unsure about how the data will be used, it is better to err on the side of caution and submit an application for review.

Final Note:

Even when projects do not qualify as “human subjects research,” as defined by federal regulations, they must be conducted with the utmost regard for University policies, Jesuit values, ethical standards, and the welfare of human participants.

The federal regulations, Title 45 CFR Part 46 (2018), define three levels of IRB review as described below. The IRB Office will make the final determination whether your application is appropriate for full, expedited, or exempt review. Human subject research is reviewed by the IRB according to The Criteria for IRB Review as found in the federal regulations at 45CFR46.111. These criteria are used for both expedited and full board reviews; not all of the §46.111 criteria are applied to exempt research.

In order of increasing level of risk, the types of review are:

EXEMPT:

Only minimal risk research may be classified as exempt. The federal regulations identify EIGHT categories of research (new categories for 2018) that are exempt from the full application of The Criteria for IRB Review. The first four exempt categories are, by far, the most common at JCU.

The 8 Exempt Categories can be summarized as:

Exempt 1: Educational Research
Exempt 2: Minimal-Risk Tests, Surveys, Interviews, or Observations
Exempt 3: Benign Behavioral Interventions
Exempt 4: Secondary Research of Identifiable Private Information or Biospecimens
Exempt 5: Federally Supported Research for Public Benefit or Service Programs
Exempt 6: Taste and Food Quality Evaluations
Exempt 7: Creation of Data/Biospecimens Repositories for which Broad Consent is Required
Exempt 8: Secondary Research using Data Repositories for which Broad Consent is Required

See Exempt Research Categories document for the detailed specifications.

The IRB does not formally “approve” research that is classified as exempt; rather it makes a determination that the research meets the criteria for at least one of the eight exempt categories. After the exempt determination, the IRB office will then evaluate the protocol for general confidentiality and data security issues, informed consent format, experimental design methodology, and ethical considerations. The IRB does not conduct continuing reviews of exempt research, but any changes to the exempt project should be reviewed by the IRB to ensure the exemption still applies.

Note: if the IRB Office determines that a research project is exempt, that research activity cannot begin until the IRB Office completes their evaluation and issues an Exemption Notice to the Principal Investigator. Minor revisions to a protocol may be required before an Exemption Notice can be issued.

Beware of The Exemption Misconception!

Exempt research does NOT mean that the investigator is exempt from being required to submit an application! “Exempt” is the name given in the regulations for certain categories of minimal risk research that are “exempt” from formal IRB review. Submission of an IRB Application for Human Participant Research is required for all human subjects research.

EXPEDITED:

Expedited review is a process by which certain types of minimal risk research may be reviewed and approved without convening a meeting of the full IRB. Expedited reviews are not necessarily “quicker” or conducted with less rigor, but fewer reviewers are required for approval. Expedited projects are reviewed by the IRB according to The Criteria for IRB Review.

There are nine categories of minimal risk research that may receive expedited review. Typical expedited reviews are completed in 2-3 weeks from the time the application is first received. However, applications that require heavy revision may take longer to be approved by an expedited review.

FULL BOARD:

Research that poses greater than minimal risk to research participants will be reviewed at a convened meeting of the IRB according to The Criteria for IRB Review. IRB meetings are scheduled approximately once per month in the fall and spring semesters; note that the IRB does not meet during the summer. The IRB meeting schedule is posted on the IRB Members & Meetings page.

EXAMPLES of Full Board Reviews: Non-minimal risk projects that may investigate, for example, sexual orientation, substance abuse, eating disorders, religious identity, illegal activities, veteran or wartime experiences, or which reveal social security numbers, salary, or criminal history or which employ deception; research with children, the homeless, the handicapped, or prisoners. Note that risk often may be managed by altering the method of data collection or storage.

What is CITI Training?

The Human Subjects Research courses provide basic training in the conduct of ethical human subjects research and includes the historical development of human subject protections, confidentiality & privacy, informed consent, and current regulatory and guidance information. This course is targeted to the type of research generally conducted at John Carroll: social and behavioral research studies such as those often conducted in the areas of psychology, communications, education, sociology, counseling, and business. The CITI Program website requires both JavaScript and cookies to be enabled in order to function.

Who needs CITI Training?

Students, faculty, and staff researchers (and faculty sponsors) who file IRB applications will need to complete online training offered by the Collaborative Institutional Training Initiative (CITI Program). All the researchers who are engaged in the research efforts should be listed on the application and are required to complete a CITI course in Human Subjects Research before the application can be considered complete for submission.

"Engaged" researchers include: all co-researchers, graduate assistants, research interns, data analysts, statisticians, and audio or videotape transcribers. Please contact the IRB Office if you have any questions about the CITI training requirement. 

If you received CITI training while working or studying at a different institution: login to your CITI profile and open the “Main Menu/My Courses” tab. Select the last tab at the bottom of the page, “Affiliate With Another Institution,” then choose “John Carroll University.” Your CITI training records will then be accessible to the JCU IRB. If you have questions about verifying your CITI training, contact the IRB Administrator.

If you received OTHER Human Subjects Research Training (such as NIH training or institution-specific training), please contact the IRB Administrator to validate this training.

How to I start?

Access CITI here to login. In order to become a CITI learner, you must create a CITI profile. Click here for detailed information on how to do this.

Which course do I take?

All the courses available to John Carroll University CITI learners are listed below. The Human Subjects Research courses are those required by the IRB.

  • All non-student IRB researchers and sponsors should complete the “IRB Researchers and Sponsors” course.
  • All student researchers, both undergraduate and graduate students, should complete the “IRB Student Researchers” course.
  • Any of the other courses listed on the CITI webpage are optional and available to anyone in the JCU community.

 

Courses now available include:

Human Subjects Research

  • IRB Researchers and Sponsors
  • IRB Student Researchers
  • IRB Members

Animal Care and Use

  • ACU courses cover the general principles of the ethical care and use of animals in research, training, and testing. There are numerous choices to select if interested.

Conflicts of Interest

  • For PHS-funded researchers

Health Information Privacy & Security (HIPS)

  • IPS covers the principles of data protection, focusing on the healthcare-related privacy and information security requirements of the Health Insurance Portability and Accountability Act (HIPAA) and the educational records and data-related requirements of the Family Educational Rights and Privacy Act (FERPA).

Responsible Conduct of Research: RCR Course for Grant Workers

  • For federally funded researchers and their workers.

Institutional/Signatory Official

  • This training is for the Institutional Official (IO) of the IRB and the IACUC. At JCU, the Institutional Official is the Provost and Academic Vice President.

Good Clinical Practice (GCP) Certification: Often required for researchers receiving federal funding

  • GCP – Social and Behavioral Research Best Practices for Clinical Research
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • GCP for Clinical Investigations of Devices

 

For additional information, including a list of required and optional modules found in each course, see the flyers listed below or visit the CITI FAQ page.

FLYER: CITI Training For Students
FLYER: CITI Training for Researchers and Sponsors