University of Pennsylvania Institutional Review Board
Human Research/Exempt Determination Form
Protocol # / PI: Title:Reviewed by
Form Version 1 January 2007
University of Pennsylvania Institutional Review Board
Human Research/Exempt Determination Form
Human Research is defined as any activity that:- Meets the DHHS definition of “Research” and involves one or more “Human Subjects” as defined by DHHS regulations.
- Meets the FDA definition of “Research” and involves one or more “Human Subjects” as defined by FDA regulations.
- Is this activity Research?
- Does this activity involve human subjects?
If no, does the activity involve use of cadavers or identifiable body parts? / Y / N / Refer to Dwayne Hallman, Director, SOM Morgue
215-898-8054;
If no, is the activity limited touse of limited data sets? / Y / N / SOM Policy RA-CMP-001 requires IRB submission.
- Convened Board?
- Expedited?
- Exempt?
Note:
The exempt categories do not apply to research involving:
- Exemptions do not apply to research involving prisoners.
- Category 2 does not apply to research with children involving survey or interview procedures or observations of public behavior when except for research involving observations of public behavior where the investigator does not participate in the activities being observed.
45 CFR 46.101(b)(1): Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Practices.
45 CFR 46.101(b)(2): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
Note: For research involving children, where the investigator was manipulating the participant’s environment before or after a survey, the research is not eligible for exemption.
45 CFR 46.101(b)(3): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
45 CFR 46.101(b)(4): Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
NOTE: 1) To qualify for this exemption category, the materials existed at the time the research was proposed.
2) Protocols involving retrospective chart reviews where the protocol need to indicate what information would be recorded by the investigator.
45 CFR 46.101(b)(5): Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
NOTE: In order to qualify for this category, the , the protocol has to:
- Be conducted pursuant to specific federal statutory authority.
- Have no statutory requirements for IRB review.
- Not involve significant physical invasions or intrusions upon the privacy interests of participant.
- Have authorization or concurrence by the funding agency.
- .
45 CFR 46.101(b)(6):
21 CFR 56.104(d):
Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
If
- Consultant Needed?
Form Version 1 January 2007
University of Pennsylvania Institutional Review Board
Human Research/Exempt Determination Form
- Ethical Considerations For Exempt Research:When approving exempt research, the IRB will determine that the following criteria are met where applicable:
Met N/A The research presents no more than minimal risk to participants
Met N/A Selection of participants is equitable.
Met N/A If the research involves interactions with participants, the circumstances of consent minimize coercion and undue influence.
Met N/A Participants will be informed that the study involves research, will be provided with information about the study procedures that the research is voluntary, and will be provided with information about whom to contact with questions.
Met N/A Provisions for protecting the privacy interests of participants are adequate.
Met N/A If private identifying data are recorded, provisions for maintaining the confidentiality of data are adequate.
Recommendations/AdditionalComments:
Reviewed by:
Date:
Form Version 1 January 2007