Procedure for Determination of Exemption from Human Subjects - IRB PRO105

Procedure for Determination of Exemption from Human Subjects - IRB PRO105

Abstract:
This procedure documents the requirements for determining an exemption from Human Subjects research regulations, including the responsibilities of the Investigator, OIRB and IRB. An attachment that details federal criteria for determining exemption is also included in the document.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:
UAB Human Research Protection Program

HRPP Document: PRO105

Effective Date: 3/30/07

Revision Date: 5/12/11

Subject: Procedure for Determination of Exemption from Human Subjects Regulations; Ethical Review

PURPOSE

This procedure describes how UAB reviews human subjects research to determine if it qualifies for exemption from the human subjects regulations in accordance with 45 CFR 46.101 and 21 CFR 56.104. This procedure also describes how research exempt from human subjects protection regulations may undergo ethical review. This procedure is not to be used to grant exemptions under the FDA category 21 CFR 56.104(c) for emergency use of a test article in a life-threatening situation (see Attachment A, FDA exemptions applicable to research, Category (c)).

PROCEDURE

Investigator Responsibilities

An investigator submits one copy of the following materials to the OIRB:

  • Completed FOR203 IRB Exemption Review Application, including the Faculty Advisor/Course Instructor signature if the Principal Investigator is a student;
  • Completed FOR205 Protocol Oversight Review Form (PORF) and any other departmental approval materials;
  • Any questionnaire, survey, or test instrument to be given to participants;
  • Any application for extramural funding (e.g., grant or contract) including the Office of Grants and Contracts Administration (OGCA) Tracking number;
  • A release form or letter for obtaining existing data, documents, records, or pathological or diagnostic specimens from the head of the department responsible for providing the material.

This information must be included with the application.

OIRB Responsibilities

Clerical staff:

  • Documents receipt of application;
  • Logs application into the database;
  • Checks investigator training status;
  • Prepares approval letters for signature;
  • Sends correspondence to the Principal Investigator.

Senior/Administrative staff:

  • Prepares application materials for Chair or designee review;
  • Checks to ensure the following materials are in the packet:
    • Exemption Review Application;
    • Any correspondence related to the application;
    • Department approval (PORF);
    • Other supporting documents;
    • Application for extramural funding, if applicable.
  • Prepares communications to the Principal Investigator regarding the review including, as appropriate:
    • Request for further information;
    • Notification that the protocol is not eligible for exemption, the reason, and recommended future course of action;
    • Notification of approval accompanied by an approval date and IRB protocol number;
    • Notification that although a research project satisfies exempt criteria, it is potentially ethically problematic and will need to undergo IRB convened review;
    • Notification that any modifications to the protocol require review to assure the modifications do not change the exempt status of the protocol;
  • Enters final action in database;
  • Issues approval form;
  • Schedules exempt protocol for presentation to the IRB.

IRB Responsibilities

Chair or designee:

  • Prepares a memorandum for the IRB staff with a list of IRB members who are designated to conduct review using the exempt procedure;
  • Reviews application and determines if research qualifies for exemption using the criteria in Attachment A (below), OHRP Decision Trees, and the GUI330 IRB Reviewer—Exemption Approval Tool;
  • Requests additional information for review if information is insufficient;
  • Documents the final action of the review, referring to the exempt category satisfied by the research, or denies approval if no exempt category applies;
  • Examines proposed research for any problematic issues on the basis of the Belmont Principles or UAB-adopted guidelines, and if identified, refers to IRB for further review;
  • Returns packet, determination of review, and documentation to senior OIRB staff;
  • Reviews the list of exemptions granted on a monthly basis.

Approved on May 12, 2011, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director  

 

ATTACHMENT A TO PRO105:

CRITERIA TO DETERMINE EXEMPTION FROM 45 CFR PART 46 AND 21 CFR PART 56 FOR HUMAN SUBJECTS RESEARCH

Exclusions from exemption
: Exemptions at 45 CFR 46.101(b) do not apply to research
involving prisoners
Exemptions applicable to research: Unless otherwise required by Department or Agency Heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review:
  1. Research (non-FDA regulated) 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.
  2. Research (non-FDA regulated) 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. If the research involves children as subjects, the procedures are limited to educational tests and observation of public behavior where the investigators do not participate in the activities being observed.
  3. Research (non-FDA regulated) 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.
  4. Research (non-FDA regulated) 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. The data, documents, and specimens exist at the time the research is proposed.
  5. Research and demonstration projects (non-FDA regulated) 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. The protocol (a) will be conducted pursuant to specific federal statutory authority; (b) has no statutory requirement for IRB review; (c) does not involve significant physical invasions or intrusions upon the privacy interests of participant; and (d) has authorization or concurrence by the funding agency.
  6. 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 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.
FDA exemptions applicable to research:
The following categories of clinical investigators are exempt from the requirement for IRB review in accordance with 21 CFR 56.104:
  1. Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981; and the research is not “research” involving “human subjects” as defined by DHHS regulations.
  2. Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date; the research is not “research” involving “human subjects” as defined by DHHS regulations.
  3. Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use the test article at the institution is subject to IRB review; and the use is not “research” involving “human subjects” as defined by DHHS regulations. See PRO151 Procedure for Emergency Use of FDA Regulated Test Articles,
  4. Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or 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.

OHRP Decision Trees for Determination of Exemption:

www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm