What counts as human research?

DHHS definitions

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

 Human Subjects are defined in the Common Rule  as 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- means 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 means 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.

FDA regulations define subjects as 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. 

How do I know if my project meets the definition of human research?

A form 129 (available at  the IRB website) requesting a determination  of whether the proposed activity is human research  must be completed and submitted  to the IRB office prior to beginning the project. 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. 

What are the 18 protected health information components mentioned?
     The identifiers are listed in the Code of Federal Regulations as: (1) Names; (2) All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census:(a) the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and (b) the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000; (3) All elements of dates including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; (4) Telephone numbers; (5) Fax numbers; (6) Electronic mail addresses; (7) Social Security numbers; (8) Medical record numbers; (9) Health plan beneficiary numbers; (10) Account numbers; (11) Certificate/license numbers; (12) Vehicle identifiers and serial numbers, including license plate numbers; (13) Device identifiers and serial numbers; (14) Web Universal Resource Locators (URLs); (15) Internal Protocol (IP) address numbers; (16) Biometric identifiers, including finger and voice prints; (17) Full face photographic images and any comparable images; and (18) Any other unique identifying number, characteristic, or code. You can check out the Reference Library to learn more about HIPAA.

Do all researchers working with human subjects have to take a responsible conduct in research compliance 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.

I am only conducting research appropriate for a exemption approval. It is a completely anonymous survey - no blood and guts involved - 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 - 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 tweak the risk (increase or decrease risk) or would serve to cause a potential subject to reconsider whether or not they would want to remain in the study (e.g., adding on 10 more needle sticks). Go to the Submission Guidelines to view the guidelines and form for submitting a modification (revision or change).

I see the chair for the IRB at least once a week. May I give the chair my research proposal or modification?
     No. The chairs graciously welcome your discussion and questions, as do the IRB and VA R&D staff.  When it comes to actually submitting proposals, addendums and modifications, however, these must never be given to a chair. All information (e.g., initial submissions, AEs, requests for modification approvals, etc.) intended for IRB review and approval should always be submitted directly to the IRB Administrative Office where the staff will prepare it for the review of the chair, designee or convened board - whichever is appropriate. Accountability and process for submission and reviews is under federal mandate or guidance statements. Refer to the bottom of the IRB homepage for the IRB office address.

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 brother has diabetes, how can I find a clinical trial that he may be able to participate in?
     CenterWatch Clinical Trials Listing ServiceTM, 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.

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Last updated on March 1, 2011
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