Section VIII:

Review Types/Process

WPP #: VIII-1

Title 1:

Initial Review - Exempt

Effective Date:

01-15-08

Revision History:

06-20-00; 08-29-00; 06-07-04; 06-21-06; 06-30-07

 

 

 

 

OBJECTIVE:

To describe the exempt initial review process and related procedures.

 

DESCRIPTION:

All proposed projects that involve human subjects and that satisfy the definition of research must be reviewed prior to the activity beginning.  This review is called ”initial review” and is the first level of IRB review.  The types of initial review are exempt, expedited and full.  Exempt initial review is described within this WPP.

 

Exempt Research is ”exempted” from federal regulations at 45 CFR 46; which means that the research is not subject to a formal informed consent process or to continuing review by the IRB.  However, determinations of exemption must be made by a qualified member of the IRB or Exempt Review Panel.  

 

A.     Qualification for Exempt Initial Review:

Research approved under an exemption (1) must not be more than minimal risk, (2) must fit into one or more of the following categories, and (3) must comply with any additional conditions outlined within this policy. 

 

Minimal risk is defined in 45 CFR 46.102(i): ”Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

 

B.     Categories of Exemption:

In accordance with the federal regulations, the following categories of research may be exempt:

 

 

CATEGORIES OF EXEMPTION [5 CFR 46.101(b)]

 

1.        Research conducted in established or commonly accepted educational settings involving normal educational practices, such as (i) regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.  [Identifiers may be retained with appropriate protections.]

 

2.        Research involving use of educational tests (cognitive, diagnostic, aptitude, achievement), survey or interview procedures, or observation of public behavior unless: information obtained from these sources is recorded in such a manner that subjects can be identified (directly or through identifiers linked to the subjects), and disclosure of the subject’s responses outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to his or her financial standing, employability, or reputation. [Identifiers may be retained only under the conditions outlined in Section C of this policy.]

 

3.        Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Exemption category (2) (above) of this section if : (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statutes require, without exception, that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.  [Identifiers may be retained with appropriate protections.]

 

4.        Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) 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. [Identifiers may be retained for research related to (a), above.  However, identifiers MAY NOT be retained for research relevant to (b), above.  See conditions outlined in Section C of this policy.]

 

5.        Research and demonstration projects which are conducted by or subject to approval of [federal] 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 these programs; (iii) possible changes or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payments for benefits or services under those programs. [Identifiers may be retained with appropriate protections.  See conditions outlined in Section C of this policy.]

 

6.        Tests and food quality evaluation and consumer studies, (i) if wholesome food without additives is 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 (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA). [Identifiers may be retained.  See Section C of this policy.]

 

  

C.     Conditions for Exemptions:

The following conditions are placed upon the above exemptions:

1.       The exemptions at 45 CFR 46.101(b), as listed above, DO apply to pregnant women, but DO NOT apply to research involving prisoners. 

2.       The exemption for research involving survey or interview procedures or observation of public behavior [45 CFR 46.101(b)(2) noted above as the second category], does not apply to research with children, Subpart D, except for research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), and observations of public behavior when the investigator(s) do not participate in the activities being observed.  For exempt categories that permit children, see guidance under VCU IRB WPP#XV-3 for inclusion of children in Court-Appointed or State Custody and Emancipated Minors.

3.       For Category 2, two conditions must apply in order to allow for the collection of identifiable data:

§         The investigator must provide reasonable assurance of data protection/confidentiality.  AND,

§         The sensitivity of the data collected must not increase the overall risk to the research participants.

4.       For Category 4, 'existing data' means data that exists at the time of IRB submission.  Exempt category 4 does not allow for protocols designed to collect data that does not yet exist or has not yet been collected at the time the protocol is submitted to the IRB.

5.       For Category 5, the following additional criteria apply:

a)      The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).

b)      The research or demonstration project must be conducted pursuant to specific federal statutory authority.

c)      There must be no statutory requirement that an IRB review the project.

d)      The project must not involve significant physical invasions or intrusions upon the privacy of participants.

e)      OHRP (or the applicable federal agency) has authorized or concurred with this exemption determination.

6.       Studies subject to FDA regulation cannot be granted exemptions unless the exemption category identified is Category 6.

 

D.     Document Distribution and Board Actions:

Applications for exemption are completed by the principal investigator, submitted to the IRB, screened for completeness, and assigned/distributed to a single member of the VCU IRB or Exempt Review Panel on an ongoing basis.

  

Procedures for board action include the following actions pertaining to an IRB Panel or the Exempt Review Panel: 

1.       The Panel Chairperson or Senior Chairperson may conduct exempt review, and will appoint experienced reviewers from among the members of the Panel to conduct exempt review (to serve as primary reviewer).

2.       Exempt review submissions are assigned to a single primary reviewer by IRB/Exempt Review Panel Chairperson or Coordinator (who may consult with the Panel Chairperson) and distributed on an ongoing basis.

3.       If the reviewer(s) disagree with the applicability of exempt review for a given protocol, the reviewer(s) may defer to expedited review or full board review by notifying the Panel coordinator of their recommendation.  

4.       In reviewing the research, the reviewers may exercise all of the authorities of the Panel.

5.       If there is any protocol-related information requiring clarification, the exempt reviewer should contact the principal investigator directly.

6.       FINAL review by the exempt reviewer is via electronic Exempt Review and is forwarded to the IRB coordinator for processing.  The Exempt Review program requires that documentation of approval include:

a)      Exempt category(ies)

b)      Specified approval (or comments) regarding any written documents (informational or otherwise) provided to the research participants.

7.       Final documentation of approval will be generated by the ORSP staff and signed by the Panel Chairperson. (In order to ensure that the PI does not begin the research until receipt of a formal IRB approval letter, the IRB reviewer is not to communicate approval to the investigator or student investigator).

 

E.     Reporting to the IRB:

Reviewed and approved protocols, which are determined to be exempt, are reported on a monthly basis to the relevant IRB Panel (as part of the meeting agenda) or the Exempt Review Panel (as a separate mailing).

  

RESPONSIBILITY:

It is the responsibility of the VCU IRB or Exempt Review Panel to make all determinations of exemption.  Identification of research projects that qualify for exemption will be made by the Chairperson of a VCU IRB Panel, by one or more qualified persons designated by the Chairperson, or by a trained and qualified member of the Exempt Review Panel.

 

REFERENCES:

45 CFR 46.101(b)

45 CFR 46.201(b)

45 CFR 46.301(b)

45 CFR 46.401(b)

21 CFR 56.104(c)-(d)

Federal Register, Vol.48, pp.9266-9270, March 4, 1983

WPP# IV-5: Responsibilities of Primary and Secondary Reviewers and All Members

OHRP Decision Charts for Exempt Review