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  1. What Counts as Human Research? Answer
  2. How do I know if my project meets the definition of Human Research? Answer
  3. Where are the 18 Protected Health Information components mentioned? Answer
  4. Do all researchers working with human subjects have to take Human Subjects Research training? Answer
  5. I am only conducting research appropriate for an exemption approval. It is a completely anonymous survey, no risk at all. Do I still have to take the compliance education session for certification?  Answer
  6. My thesis committee wants me to change the title of my graduate research project. No big deal; it has absolutely nothing to do with the subjects or anything like that. I'm going to go ahead and make the change and let the IRB know about it later on, OK?  Answer
  7. I am a researcher working with extremely sensitive information and feel that in the best interest of my subjects I should be able to do something more to protect them. Someone told me that I could obtain a "Certificate of Confidentiality." What is that?  Answer
  8. My Study uses MSHA Facilities and Patients.  Is there anything specific about MSHA?  Answer
  9. My brother has diabetes, how can I find a clinical trial that he may be able to participate in?  Answer
  10. Does a pilot study require IRB approval? Answer

 

What Counts as Human Research?

DHHS Definitions:

  • Research (as defined in the Federal regulations (45 CFR 46): A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  • Human Subjects (as defined in the Common Rule): Living individuals about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
  • Systematic Investigation: Typically a predetermined method for studying a specific topic, testing a specific hypothesis(es), answering a specific question or developing theory
  • Generalizable: To develop or contribute to generalizable knowledge typically means that results or conclusions of the activity are intended to be extended beyond a single person or an internal program.

 FDA Definitions:

  • Clinical Investigation: Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under Section 505(i), 507(d) or 520 (g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
  • Subject: An individual who is or becomes a participant in research, either as a recipient of the test article or control. FDA regulations also define subjects as an individual on whose specimen a device is used.

Activities must meet the definition of research and involve human subjects as defined in DHHS regulations, or be research and involve human subjects as defined in FDA regulations to be subject to the IRBs jurisdiction.

See Policy 5 for detailed information.

 


 

How do I know if my project meets the definition of Human Research?

Research is defined in the DHHS Federal regulations (45 CFR 46) as a "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

  • Systematic Investigation:  Typically a predetermined method for studying a specific topic, testing a specific hypothesis(es), answering a specific question or developing theory.
  • Generalizable Knowledge:  To develop or contribute to generalizable knowledge typically means that results or conclusions of the activity are intended to be extended beyond a single person or an internal program.

The IRB Chair makes the final determination as to whether a project meets this definition.  

Download and complete Form 129 requesting a determination of whether the proposed activity is human research. Submit it to the IRB office.  The IRB Chair will review the form 129 and determine whether the proposed activity meets the definition of human research. A written response will be returned to the submitter.  Click here for additional information.  


 

Where are the 18 Protected Health Information components mentioned?

Click here for a PDF that outlines all 18 PHI components


 

Do all researchers working with human subjects have to take Human Subjects Research training?

Yes, the requirement for human subject protection training has been mandated. Currently, everyone conducting human subjects research at ETSU, the VAMC and MSHA are required to complete ETSU's CITI mandatory IRB education program.  Click here to learn more about CITI training.


 

I am only conducting research appropriate for an exemption approval. It is a completely anonymous survey, no risk at all. Do I still have to take the compliance education session for certification? 

Yes. The mandate for compliance education makes no differentiation in the [education] requirements based on the level of risk imposed by the research.


 

My thesis committee wants me to change the title of my graduate research project. No big deal; it has absolutely nothing to do with the subjects or anything like that. I'm going to go ahead and make the change and let the IRB know about it later on, OK? 

ABSOLUTELY NOT! Once research has been approved by an IRB, no changes, modifications, or revisions can be made prior to IRB approval except where necessary to eliminate apparent immediate hazards to the subject. Any requests that are minor in nature, such as this title change, can be reviewed by expedited review procedures (reviewed and approved by the Chair or designee) with the written approval released usually within just a couple of days. Modifications submitted for approval that are determined to be "non-minor" in nature must be presented to the IRB. Non-minor modifications are changes that alter the risk. Use IRBManager to submit a modification on your study.


 

I am a researcher working with extremely sensitive information and feel that in the best interest of my subjects I should be able to do something more to protect them. Someone told me that I could obtain a "Certificate of Confidentiality." What is that? 

A Certificate of Confidentiality is a document that helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. Any person engaged in research in which sensitive information is gathered from human research participants (or any person who intends to engage in such research) may apply for a Certificate of Confidentiality. Click here to learn more.


 

My Study uses MSHA Facilities and Patients.  Is there anything specific about MSHA? 

Download this PDF file for MSHA Guidelines.  (Updated guidelines coming soon.)


 

My brother has diabetes, how can I find a clinical trial that he may be able to participate in? 

CenterWatch Clinical Trials Listing Service™, provides information and lists Industry (Pharmaceutical) and government sponsored clinical trials as well as new drug therapies recently approved by the FDA . ClinicalTrials.gov , The  U.S. National Institutes of Health , through its National Library of Medicine , has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies. CancerTrials, is a service of the National Cancer Institute , which is the Federal Government's principal agency for cancer research and training.


 

Does a pilot study require IRB approval?

Just like other studies, this depends on what kind of data you are collecting and what you intend to do with it. If you plan to use data collected from the pilot study in any publications or presentations, even just to explain the design of your study, then yes you need IRB approval.  Also, if you plan to collect data that involves an intervention/manipulation of participants, or you are obtaining private identifiable information, then you need approval.  To be on the safe side, we recommend submitting a Form 129 “Is the Proposed Activity Human Subjects Research.”  This form can be found under “Get Started” – “Does my Project Need IRB Approval”. The IRB Chair will review this short form and decide if you need to go through the IRB process or not.  


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