# Presentation: 047938

## PRIM&R 2005Session E23: What’s New in Compliance? An Update from the Office of Research Oversight, Department of Veteran’s AffairsCase Study IIKaren M. Smith, PhDRegional Office DirectorMidwestern RegionOffice of Research Oversight

**PRIM&R 2005****Session E23: ****What’s New in Compliance? ****An Update from the Office of Research Oversight, ****Department of Veteran’s Affairs****Case Study II****Karen M. Smith, PhD****Regional Office Director****Midwestern Region****Office of Research Oversight**

## The research entails:

- An educational intervention
- Pre- and post-intervention survey of providers

## Possible criteria for an exemption:

- “...research activities in which the only involvement of human subjects will be in one or more of the following categories...”
- (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.
-  (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.
*(38 CFR 16.101(b))*

**Possible criteria for an exemption:**
- “...research activities in which the only involvement of human subjects will be in one or more of the following categories...”
- (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.
-  (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.
*                                                                         **(38 CFR 16.101(b))*

## An additional category of exempted research to consider:

- 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.
*                                                                        **38 CFR 16.101 (b)(4)*
**To qualify for an exemption, the information to be used in the research:**
-   Must exist at the inception of the study
-   Must be recorded without identifiers

## Waiver or alteration of consent:

- An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
- (1)The research involves no more than minimal risk to the subjects;
- (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- (3) The research could not practicably be carried out without the waiver or alteration; and
- (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
*                                                                                    **38 CFR 16.116(d)*

## Research that may be reviewed by an expedited process must:

- (1) present no more than minimal risk to human subjects, and
- involve only procedures listed in one or more of the following categories...
**Some possibly relevant categories for this case:**
- (5) Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
- (7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
-                  *Federal Register: November 9, 1998 (Volume 63, Number 216)*

## Consider also,

- The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
*         **Federal Register: November 9, 1998 (Volume 63, Number 216)*

## Look again at the wording of the Common Rule for allowing a waiver of consent:

- An IRB may approve a consent procedure which **does not include,** **or which alters**, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent...
*                                                                    **(38 CFR 16.116(d))*