Activities that contstitute “human subject research” are regualted by U.S. federal law by both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (DHHS). Each agency's rules apply to different kinds of research. Below is information about research regulated by the FDA. If, after reading the information below, you believe that you are conducting "human subject research" that is covered by the FDA, you may want to contact the CU Denver Clinical Research Support Center at 303-724-1111 or ClinicalResearchSupportCenter@ucdenver.edu for further guidance.
If, after the reading the information below, you believe that you are not conducting research regulated by the FDA, please scroll down and click the next accordion folder to see if you may be conducting "human subject research" regulated by the U.S. Department of Health and Human Services.
Definition of "human subject research" activities that are regulated by the FDA
“Human subject research” that is regulated by the U.S. Food and Drug Administration is defined as an activity that (1) meets the definition of “research” and (2) involves “human subjects” as defined either by the FDA regulations. Please review the definitions below:
(1) "Research" as defined by FDA regulations means any experiment that involves a test article and one or more
human subjects, and that either must meet the requirements for prior submission to the Food and Drug
Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not
meet the requirements for prior submission to the Food and Drug Administration under these sections of
the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted
to, or held for inspection by, the Food and Drug Administration as part of an application for a research
or marketing permit. The terms research, clinical research, clinical study, study, and clinical
investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
• Experiments subject to Food and Drug Administration regulations, including any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 3 12.3(b)]
• Experiments subject to Food and Drug Administration regulations, including any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]
• Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3
(c), 21 CFR 56.102(c)].
(2) A "human subject" as defined by FDA regulations includes any individual who is or becomes a subject in research; either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. In the case of a medical device, a human subject/participant is also means a human on whose specimen an investigational device is used.
If, after reviewing the accordion folder above, you determine that you do not plan to conduct "human subject research" that is regulated by the FDA, please review the information below to see if your study is regualted by the U.S. Department of Health and Human Services (DHHS).
“Human subject research” that is regulated by the United States Department of Health and Human Services (DHHS) is defined as an activity that both:
(1) meets the definition of “research”, and
(2) involves “human subjects”.
If your study meets both conditions, as defined below, you are conducting “human subject research” that
needs to be submitted to COMIRB.
However, if you are planning activities that do involve “human subjects” as defined below, but do not
meet the definition of “research”, you may be conducting a program evaluation or a quality
assessment/improvement project that does not need to be submitted to COMIRB.
If you read through the definition
of research below, and feel that this is the case for your study: please close this
accordion folder, then click to open the accordion folder below entitled “I may be conducting a program
evaluation or quality assessment project”.
Definitions of "human subject" and "research":
1. "Research" as defined by DHHS regulations:
“Research” is a systematic investigation, including development, testing and evaluation, designed to
develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or
unfunded, or may be conducted as a component of another program not usually considered research. For
example, demonstration and service programs may include evaluation components, and may constitute
research activities under this definition.
For the purposes of this policy, a “systematic investigation” is an activity that involves a prospective
study plan which incorporates data collection, both quantitative and qualitative, and data analysis to
answer a study question.
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw
general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the
specific study population), inform policy, or generalize findings.
2. A "Human Subject" as defined by the U.S. Department of Health and Human Services:
A living individual about whom an investigator (whether professional or student) conducting research
obtains:
1. data through intervention or interaction with the individual, or
2. individually identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture)
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.
Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place, and information which has been
provided for specific purposes by an individual and which the individual can reasonably expect will not
be made public (for example, a medical record).
Private information 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) in order for obtaining
the information to constitute research involving human subjects.
Addition resources and next steps:
If your study does meet the definition of “research” and involves “human subjects” as defined by the
Department of Health and Human Services or the FDA, then you must submit your study for COMIRB review.
If you are unsure, COMIRB offers several tools to help you make a determination:
Determination of Human Subject Research
COMIRB Human
Subject Research Decision Tree
Please contact the COMIRB Help Line at 303-724-1055 with any questions.
If your study does meet the definition of "human subject research," please check the rest of the accordion folders on this page to see if your study falls into
any special
Categories, then proceed to "Step 2" by scrolling to the top of this page and clicking the link in the grey column to the left.
If you have reviewed the definition of "human subject research" in the accordion folders above and feel that you may be conducting an activity that involves "human subjects" as
defined in the federal regulations, but does not meet the federal definition of "research", you may be conducting program evaluation or quality assessment/improvement
project.
These projects do not need to be submitted for COMIRB review; however, we do ask that you complete our QA/Program Evaluation Research
Tool.
If you feel your project may be a quality improvement/assurance project or program evaluation, please review and complete the QA/Program
Evaluation Tool.
This tool provides guidance and asks a series of questions meant to determine if your project is a quality improvement/assessment project or "human subject research". We suggest that you use this tool as guidance, and we strongly suggest that you contact COMIRB for assistance to decide if you need to submit your project for review.
This tool is for your records and does not need to be submitted to COMIRB. Please click the following link to access the QA/Program Evaluation Tool.
NOTE: If you make the determination that you are not conducting "human subject research" that needs to be reviewed by COMIRB, and this determination is incorrect, you will be held accountable. Please contact the COMIRB Help Line at 303-724-1055 with any questions. If you are uncertain, you can always submit your project for COMIRB review to determine that your project is not "human subject research".
Please click here to review guidance on using banked data or specimens (please note this document includes 2 pages), then please review the information below.
If your study involves identifiable banked specimens or banked data, you must submit your study for COMIRB review.
If your study involves identifiable banked data, please proceed to Step 2 in the grey column to the left to see if your study qualifies for Exempt review; however, if your study involves banked specimens, please click on either Step 3 or Step 4 in the grey column on the left of the screen for information how to submit for Expedited or Full Board review (depending on where the decision tree led you) because reseaerch involving banked specimens is not eligible for Exempt review at this time.
If, after viewing the guidance you believe that your study is not "human subject research", you are not required to submit it to COMIRB; however, this can be very difficult to determine. If you would like to submit your study for an official determination by COMIRB that your study is not "human subject research", click the accordion folder below entitled 'Submitting to COMIRB for project review' for instructions on how to submit your study for COMIRB review.
(For more information see the Office of Human Research Protection guidance on research involving coded private information or biological specimens by clicking here, or call COMIRB at 303-724-1055)
If you plan to conduct a multi-site study, special considerations have to be made. If you plan to conduct research at CU Denver, or one of our affiliate organizations, you may
need authorization from them, in addition to COMIRB review.
Please see the links at the top of this page for research staffs' contact information at each of the
institutions under COMIRB's purview.
If you plan to conduct a multi-site study that involves research at non-affiliated institutions (institutions other than those included in the links above), each site must gain approval from a local IRB, or the local IRBs must cede oversite to one of the other IRBs. It is important to also note that the activities going on at a particular site may not "engage" them in research (i.e. the activities do not require oversite by an IRB). Below is information on ceding and research engagement. Due to the complexity of these issues, we ask that you please contact the COMIRB Help Line at 303-724-1055 for guidance.
Ceding instructions
If you want COMIRB to cede oversight to another IRB, or would like COMIRB to oversee research at another site related to your study, please click the "Submissions for Special
Cases" link in the grey column on the left side of the screen for information on IRB ceding.
Is a site engaged in research?
Institutions may be involved in studies that meet the definition of "human subject research", but activities at the institution may not require oversight by an IRB (either
COMIRB or a local IRB) if the site is not considered to be "engaged" in research activities. Please be aware that local institutional policies for oversight may still exist.
Please click the following link to refer to Office of Human
Research Protection engagement guidance for complete information and assistance in determining whether a site is "engaged" in research.
You must submit your study for COMIRB review if you meet either of the two categories below:
1. If you are engaging in "human subject research" as defined in the accordion folders above, you must submit your study for COMIRB review. If this is the case, please proceed to Step 2 by clicking the link in the grey column on the left of the screen to determine what level of review is appropriate.
2. If you are not engaging in "human subject research" as defined in the accordion folders above, but would like COMIRB to issue an official determination that your study is not "human subject research". If this is is the case, please click the accordion folder below entitled 'Submitting to COMIRB for project review' which includes instructions on submitting a project to COMIRB for a determination that your project does not meet the definition of "human subject research".
A reminder that each of our affiliate organizations may require that you submit proposed research studies to them for authorization, before submitting them to COMIRB. Links to
contact information for research services at COMIRB's affiliated institutions can be found at the top of this web page.
See the accordion folder below for specific submission instructions
NOTE: If you are currently a student, fellow, or resident, you will need a faculty advisor for your research study. In addition, you will need to complete both of the following
forms:
Responsibilities for Faculty Mentors for Student Form
Responsibilities of Students Conducting Human Subject Research Form
Select the appropriate instructions below for information on how to proceed:
I plan to conduct "human subject research" as defined in the accordion folders above:
If you plan to engage in "human subject research" please proceed to Step 2 to determine what type of COMIRB review is appropriate by scrolling to the top of the page and clicking
the link in the grey column on the left hand side of the page.
I plan to conduct a project that does not meet the definition of "human subject research", but I would like an official determination that my project does not meet the definition of "human subject research":
Complete the following 4 steps to submit your study to COMIRB for an official determination that your study does not qualify as "human subject research":
1. Before you may submit to COMIRB, you must gain access to our electronic research administration website, the eRA(InfoEd) system. Click here for information on how to gain access to the eRA(InfoEd) system. When you have access, you will be ready to continue with the submission process.
2. Complete the Application Form, which can be downloaded by clicking here. Make sure to select "Non Human Subject Research" in Section D. *To prevent problems, make sure to use Adobe Reader to open and edit the "Smart PDF" Application Form. Click here to download a free copy of the newest version of Adobe Reader.
3. Compile supporting documents printed with the PI's name and page numbers:
- A. A cover letter listing what documents are included in the submission.
- B. Grant application (if funded by a federal grant)
- C. Data collection tools.
- D. Recruitment materials, advertisements, invitations to participate, informational materials subjects (if applicable).
- E. VA or Denver Health clearance letter (if research is conducted at or involves employees of these sites).
4. Submit the materials to COMIRB. -
A. If submitting electronically via the eRA(InfoEd) system, click here for instructions.
- B. If submitting a paper application, submit one copy of all documents to COMIRB (please submit to the Anschutz Campus unless you are located on the Downtown Campus):
Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045
Downtown Campus
1380 Lawrence Street Building [LSC], Room 300
Campus Box 120
Phone: 303-315-2732
There is currently no fee for non-"human subject research" review determinations.
Applications are reviewed on a continual basis, in the order they are received. The investigator will be notified of the review findings by email. Research may not begin
until the investigator has received notification from COMIRB that the research qualifies for exemption. If the research involves the VA, the project may not begin until it is
approved by COMIRB and then the VA R&D Committee.
|
|