Email:
http://www.choa.org/Pediatric-Research/For-Professionals/Research-Administration/Institutional-Review-Board/
NON-HUMAN SUBJECTS RESEARCH DETERMINATION FORM
Children’s Healthcare of Atlanta does not require review of studies that do not meet the definition of human subject research. Often there is a "grey area" between Quality/Process Improvement, Case Studies, EBP and Research. This Guidance is to help you define your project at the onset, and to insure proper review and regulatory requirements are met.GENERAL INFORMATION
1. STUDY TITLE2. LEAD RESEARCHER
3. AFFILIATION or DEPARTMENT
4. PHONE / 5. EMAIL ADDRESS
6. CO-RESEARCHER
7. FUNDING / Will these activities be supported by a DHHS award (e.g., NIH, NSF, DoE and DoD) through a grant, contract, or cooperative agreement?
*If Children’s is the prime recipient of a DHHS award, but another institution will carry out the non-exempt human subjects research activities, Children’s IRB approval is required. / Yes No
A. HUMAN SUBJECTS RESEARCH DETERMINATION - FDA
FDA 21 CFR 56.102 (23c&e)
Human Subject- an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.
Clinical Investigation- any experiment that involves a test article and one or more human subjects…
2. Will an investigational medical device (including FDA-regulated software) be used on any individual’s specimens? / Yes No
If no to both, continue to section B. If you answered yes to EITHER questions 1 or 2 STOP HERE, the study requires review by the IRB. Please submit the appropriate initial submission form to the IRB. All IRB forms can be found at: http://www.choa.org/Pediatric-Research/For-Professionals/Research-Administration/Institutional-Review-Board/IRB-Forms-Instructions
B. RESEARCH DETERMINATION
Research- a systematic investigation designed to develop or contribute to generalizable knowledge.
45 CFR 46.102(d)
Guidance-
1. What is your INTENT for the project? A systematic investigation usually involves answering a question regarding a new or innovative practice, but research can also involve reporting your new/innovative practice without a specific question. Is your project simply to report a series of interesting cases? If so, you would likely say “No” to the project being a systematic investigation. Are you trying to show that what you are doing is superior or has specific outcomes? If yes, consider question #2.
2. What do you plan to do with the results of this project? The intent to publish does not mean the information is necessarily "generalizable". You can publish or present your practices, but just not as research unless you have IRB approval. However if your intent is to show others outside of Children's that what you are doing can be applied elsewhere, the data is "generalizable".
WHEN IN DOUBT- Contact the IRB at X: 57477 or X: 59376
1. Is the proposed study a systematic investigation (i.e., does this study involve data collection and analysis to answer a question)? / Yes No2. Is the intent of the study to develop or contribute to generalizable knowledge (i.e., results from the study may be applied to populations beyond the specific study population)? / Yes No
If you answered yes to both questions 1 and 2, the study requires review by the IRB. Please submit the appropriate initial submission form to the IRB. All IRB forms can be found at: http://tinyurl.com/choa-pedsresearch
If you answer no to either question 1 or 2, please skip section C, submission is not required.
C. HUMAN SUBJECTS DETERMINATION
45 CFR 46.102(f):
Human Subject- a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
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- communication or interpersonal contact between researcher and subject
Private Information- includes information about behavior that occurs in a context in which an individual can reasonably expect privacy (i.e., medical records. Private information must be individually identifiable (the identity of the subject is or may be ascertained or associated with the information.
Guidance- If you feel your project is indeed RESEARCH, you then need to determine if the study involves Human Subjects. A study that accesses previously de-identified information that cannot be linked back to the subject through direct or indirect identifiers may be Research but not with Human Subjects and does not require IRB review. This requires that study staff not only does not record PHI, but does not access or view PHI at any point in the project.
However, if you or your study team are accessing the medical record (viewing/accessing PHI) , the answer to #2 would be “Yes” and the study would require IRB review. If that identifiable information is not being recorded (Example: Looking at the medical record, then only recording age, vs. DOB), the study would need to be submitted as Human Subjects Research, but would be considered Exempt and would not require Continuing Renewal.
1. Does this study involve obtaining information about living individuals? / Yes Noa. If Yes to #1, does the study involve intervention or interaction with the individuals (i.e., prospective collection of specimens, surveys, etc.)? / Yes No
If you answered yes to both questions 1 and 1a STOP HERE, the study requires review by the IRB. Please submit the appropriate initial submission form to the IRB. All IRB forms can be found at: http://tinyurl.com/choa-pedsresearch
2. Do the activities involve accessing individually identifiable and private information about living individuals (i.e., extracting data directly from medical record)? / Yes No
If you answered yes to both questions 1 and 2 STOP HERE, the study requires review by the IRB. Please submit the appropriate initial submission form to the IRB. All IRB forms can be found at: http://tinyurl.com/choa-pedsresearch
3. Does the study involve analysis of existing data/specimens (all data and/or specimens must have been collected prior to the start of the study)? / Yes No
a. If Yes to #3, will the data/specimens be coded in a way that a link exists that could allow the data/specimens to be re-identified? / Yes No
b. If Yes to #3a, do you have a written agreement that prohibits the study team from having access to the link? / Yes No
If Yes to 3 and 3a and No to 3b, STOP HERE, the study requires review by the IRB. Please submit the appropriate initial submission form to the IRB. All IRB forms can be found at: http://tinyurl.com/choa-pedsresearch
IF SUBMISSION IS NOT REQUIRED: You must read and agree to the statement of assurance on this form. Print a copy of this checklist, sign, date and save for your records. If you prefer an official letter of determination from the IRB, please submit this form to the IRB along with a brief description of the study.
IF SUBMISSION IS REQUIRED: Submit a new study application to the IRB.
Statement of Assurance
I agree to the following:
· I will take specific measures to protect the confidentiality of information obtained retrospectively about existing data studied in this review
· I will record the data in such a way that individuals will not be identifiable in any public communication unless specific permission, documented in writing, to do so is granted by the individual(s) or parent(s)/guardian(s) of those individuals involved.
· I will submit a separate new study application, as required by the IRB, if further studies involving humans are desired in this project.
I accept and agree to the terms set forth as it pertains to this checklist.
______
Lead Researcher’s Signature Date
Printed Name
Human Subject Decision Chart
The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR 46.
Version 3-16-2016 Page 1 of 4