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Office of Research Compliance
Research Involving Human Subjects
Office of Research Compliance
• Three FTE and one student worker• Facilitate the IACUC• We are not the IRB or the IACUC• Best way to contact us -
Kent State Human Research Protection Program
The mission of the Human Research Protection Program (HRPP) is to protect the rights, dignity, welfare, and privacy of the human subjects in all research conducted on behalf of the University (regardless of funding) by ensuring that research is conducted in accordance with the ethical principles of the Belmont Report, and the guidance provided in the Code of Federal Regulations Title 45 part 46, and other applicable regulations and laws.
Critical components:
• The Institutional Review Board (IRB), Institutional Review Board Policy Committee (IPC)
• Office of Research Compliance• Office of Research Safety, HIPPA compliance Officer,
FERPA, Title IX, IT Security Officer, University Counsel, Technology Transfer
PURPOSE
• Review research and ensure that the rights and welfare of the human subjects involved in research are adequately protected – this means make sure risks do not outweigh benefits!
• Ensure that the research is in compliance with the Code of Federal Regulations, (Title 45 Part 46 Protection of Human Subjects) and any other applicable rules such as University Policy, Sponsor Requirements, State Law.
Purpose & Authority of the IRB
AUTHORITY• Approve the research.• Require modifications before approving the research.• Disapprove the research.• Table the research protocol for modification and further review.
What is Human Subjects Research
Per federal regulations• Research is defined as a systematic
investigations, including research development, testing and evaluation, designed to contributed to generalizable knowledge
• A human subject is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or collects identifiable private information
For a project to be considered human subjects research, both definitions must be met.
Types of Review
Initial – Level of review is determined.
Continuing/Annual Review – Level II’s and III’s.
Amendments – changes to research. Must be reviewed and approved before implemented.
Adverse events - safety Information or unanticipated problems for subjects or others.
Noncompliance – a participant calls Research Compliance office and reports that investigator is doing something he/she shouldn’t be.
Initial Review of Research
All research projects are categorized into one of three categories for the IRB review process. Each category is different in the level of scrutiny and submission procedures. The IRB is responsible for making the final decision of which category a research project falls under.
Full review by convened IRB Sensitive subjects, vulnerable subjects, sometimes children
Expedited* Can Involve children, audiotaping, research on individual or group behavior (focus groups)
Exempt from Annual Review* Surveys, evaluation of service programs, educational tests, class projects, food quality, research involving existing data
*typically do not need to attend meetings, approved through member review processes
Level II
Level I
Level III
Use of Human Subjects in Research(Level II or Level III projects)
Institutional Authorization Agreement Request
IRB Review Determination
Exempt from Annual Review(Level I projects)Types of
Application forms
Types of Application forms
IRB Review Determination
Exempt from Annual Review(Level I projects)
Use of Human Subjects in Research(Level II or Level III projects)
Institutional Authorization Agreement Request
When should you complete this form?
• if you are unsure whether or not your research needs IRB review
• when you need documentation that your project does not need IRB review
To whom should you submit it?
• Office of Research Compliance - [email protected]
Types of Application forms
IRB Review Determination
Exempt from Annual Review(Level I projects)
Use of Human Subjects in Research(Level II or Level III projects)
Institutional Authorization Agreement Request
• Federal Regulations allow 6 categories of research that can be considered exempt.
• Your research needs to only fit into one category though you can choose more than one category on the application form.
When should you complete this form?
Category 1 - Educational Settings/normal educational practices (e.g., class evaluations, comparisons of instructional techniques, effectiveness of an instructional method)
Category 2 - Educational Tests, Surveys, Interviews, Observation of Public Behavior (e.g., surveys or interviews whose subject matter would not place the subjects at risk of criminal or civil liability or would be damaging to their financial standing, reputation or employment; observation of children if researcher does not participate in activties)
Exempt from Annual ReviewLevel I
Category 3 - Educational Tests, Surveys, Interviews, Observation of public officials (e.g., research involving interviews with mayors or school board members (those that are elected) not police officers or teachers.
Exempt from Annual ReviewLevel I
Category 4 - Existing Data, documents, specimens - the information must be publicly available OR information is recorded by the Investigator in a way that subjects cannot be readily identified (e.g., limited data set record reviews, de-identified specimens purchased from a reputable commercial lab)
Category 5 – Public Benefit or Service Programs - research that is subject to approval of a federal department or agency head (e.g., financial or medical benefits provided by the Affordable Care Act or Social Security program)
Category 6 – Taste and Food Quality/Consumer Acceptance Studies- research involving foods without additives or foods in which contain food ingredients, agricultural chemicals or environmental contaminants that are at or below the level found to be safe by the Food and Drug Administration or is approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Types of Application forms
IRB Review Determination
Exempt from Annual Review(Level I projects)
Use of Human Subjects in Research(Level II or Level III projects)
Institutional Authorization Agreement Request
When should you complete this form?
If you think that there is more than minimal risk for the participants
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Vulnerable populations ( i.e., prisoners, pregnant women, children, mentally disabled)
Sensitive subject matter (i.e., suicide, sexual orientation, mental illness)
Deception
Invasive procedures, devices, drugs/supplements, group behavior, clinical trials
Types of Application forms
IRB Review Determination
Exempt from Annual Review(Level I projects)
Use of Human Subjects in Research(Level II or Level III projects)
Institutional Authorization Agreement Request
When should you complete this form?
To whom should you submit the form?
• Office of Research Compliance - [email protected]
If you want to conduct a research project at another institution that has an IRB and you :• Want the KSU IRB to serve as the IRB of record for the project, or • Want to request that another Institution's IRB serve as the IRB of record for your
project.
The process
• IRB Review Determination
• Exempt from Annual Review – Level I
• Amendment
• Annual Review
• Institutional Authorization Agreement Request
• Adverse Event
• Closeout
If completing this type of form:
Send via email from your kent.edu account Office of Research
Compliance
The process
• Use of Human Subjects in Research(Level II or Level III)
If completing this type of form:Send via email from
your kent.edu accountDiscipline-specific
Reviewer
Email Addresses available on the
website
Required Training
Online CITI training is required for ALL KSU researchers conducting human subject research. This includes:•Principal investigators and co-investigators•Students•Faculty advisors for students conducting research.•Faculty requiring students to conduct research for a course.•Visiting scholars
Valid for 3 years.
Submit a copy of the CITI completion certificate with your IRB application.
NIH training taken within 3 years can fulfill the CITI requirement. You must submit a NIH training completion certificate with the IRB application.
Instructions are available on the website.
CITI Training
SOCIAL & BEHAVIORAL BASIC/REFRESHER COURSE – Choose this course if you are a researcher that is conducting Social/Behavioral (sociology, anthropology, psychology, education) research on human subjects that involves more than minimal risk.
BIOMEDICAL BASIC/REFRESHER COURSE - Choose this course if you are a researcher that is conducting Biomedical (biology, physiology, clinical medicine) research involving human subjects that involves more than minimal risk. If you are collecting medical information from the participants and/or are gaining access to medical records, this is the training that you need to complete.
CONSENT FORMS
• Provides potential subjects with information about the research. Focus on “need to know” information, not theoretical background.
• Correctly describes the study.
• Emphasizes that participation is voluntary and that they are able to stop their participation at any time.
• Easy to read. Use short sentences and words (when possible).
• Should be written the way in which you speak to the participants (use “you” instead of “the subject”).
• Uses bulleted lists rather than paragraphs when possible.
Characteristics of a good one:
Common MistakesIndicating that data is anonymous when it is actually confidential.
Stating that there are no risks involved in the activity. Even though the risks may be low, they need to be listed in the application and consent form. Can often be described as “no greater than everyday life.”
Not completing CITI online training, or completing the wrong online training.
Appendices, Consent forms, surveys, or interview instruments are not attached for review.
Not answering all of the questions on the application or appendices.
Sending application directly to the Office of Research Compliance when it should be sent to a discipline specific reviewer first.
Not attaching translated consent forms for international research.
The application is difficult to understand.
Consent form is long and/or difficult to understand.
Common Questions
How long does it take to get approval?
Plan ahead. Do not wait until the last minute to submit your application. Approval can take 1-6 weeks. The more complete your application is…the quicker you can get approval. The total volume of submission received and the complexity/completeness of you submission will influence approval timelines
Common Questions
Is there somewhere where I can get a template to help me develop the consent form for my study?
Yes, visit the ORC website.
Do I always have to attend an IRB meeting to have my protocol approved?
No, typically only when your protocol is deemed a Level III. If you are an advisor on a student’s protocol that is reviewed as a Level III project you will have to attend the meeting.
THANK YOU!
Questions
What is the difference between anonymous and confidential?
Who has overall responsibility for an approved research protocol?
Name at least two characteristics of a good consent form?
