Human Research Protection Program

Research conducted in established or commonly accepted educational settings that specifically involves (1) normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content, or (2) the assessment of educators who provide instruction.

Note: This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (including visual or auditory recording) at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.

2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination.

Note: This category may only be applied to research with children when educational tests or the nonparticipant observation of public behavior are involved, and either Criterion 1 or Criterion 2 are met.

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation.
3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination.

Notes

• For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

• If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purpose of the research.

• This category may not be applied to research involving children.

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

1. The identifiable private information or identifiable biospecimens are publicly available.

2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects and the investigator will not re-identify subjects.

3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research," as those terms are defined at 45 CFR 164.501, or for "public health activities and purposes," as described under 45 CFR 164.512(b).

4. The research is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 USC 3501 note, if all of the identifiable private information collected, used or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 USC 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 USC 3501 et seq.

Research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.

Such projects include, but are not limited to, internal studies by federal employees, and studies under contracts or consulting arrangements, cooperative agreements or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

Taste and food quality evaluation and consumer acceptance studies:

1. If wholesome foods without additives are consumed.

2. 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 and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level fund 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.

Note: This category may be applied to research involving children.

Clinical studies of drugs and medical devices only when:

• Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required.

OR

• Research on medical devices for which (i) an investigational device exemption application (21 CR Part 812) is not required, or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Collection of blood samples by finger stick, heel stick, ear stick or venipuncture from:

• Healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 milliliters in an eight-week period and collection may not occur more frequently than two times per week.

OR

• Other adults considering the age, weight and health of the subjects, the collection procedures, the amount of blood to be collected and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 milliliters or 3 milliliters per kilogram in an eight-week period and collection may not occur more frequently than two times per week.

Prospective collection of biological specimens for research purposes by noninvasive means.

Collection of data on subjects 18 years of age or older through noninvasive procedures routinely employed in clinical practice, excluding procedures involving X-rays or microwaves as well as procedures involving general anesthesia or sedation. Where medical devices are employed, they must be cleared/approved for marketing.

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.

Collection of data from voice, video, digital or image recordings made for research purposes.

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.

Continuing review of research previously approved by the entire Institutional Review Board as follows:

• Where the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects.

OR

• Where no subjects have been enrolled and no additional risks have been identified.

OR

• Where the remaining research activities are limited to data analysis.

Continuing review of research in which the Institutional Review Board has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Full Committee Review

Projects that involve more than minimal risk or prisoners, or those that do not fit into one or more of the categories for expedited review or exempt status, must be reviewed by the full board at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary interests are nonscientific.

In the event the IRB lacks the appropriate expertise to assess scientific merit and the research is judged by the IRB to have greater than minimal risk, the IRB may seek outside expertise to assist its evaluation of the proposed research.

Approximately one week prior to the next scheduled board meeting, all protocol materials scheduled to be reviewed are distributed to the full board. It is the expectation that all members of the committee review the protocol materials prior to the meeting and be prepared to participate in the discussion of the significant concerns, raise additional concerns, provide necessary clarifications and/or propose resolutions.

The meeting is called to order by the board chair once a quorum of committee members is reached. If a quorum of members is not reached or is lost once the meeting has begun, all proposals not reviewed are tabled and reviewed at the next scheduled meeting or the meeting is rescheduled for such a time that a quorum of members are present.

Once the protocol has been sufficiently discussed by a quorum of committee members, the members present vote on the review determination. In order for a given project to be approved, it must receive the approval of a majority of the members present at the meeting.

Possible outcomes of a full committee review are:

• Approval: The protocol is approved and no changes are required or recommended. Research may proceed.

• Conditional Approval: The protocol is approved contingent on minor revisions being made. (At this point, revisions may be reviewed by the IRB administrator.)

• Requires Revision: The protocol cannot be approved without revisions, clarifications or additional documents. Once these are submitted, the review process is repeated. (At this point a subset of the committee may be designated by the chair to review the revised protocol on a rolling basis.)

• Disapproval: The protocol cannot be approved due to issues the committee believes are non-revisable and inherent in the research.

Note: For a protocol to be approved, a majority of the committee members present must vote to approve the protocol.

In addition to determination of approval/disapproval of the research protocol, the reviewer(s) of nonexempt research will assess the level of risk to subjects involved in the research and determine a continuing review schedule that will be no less than annual.

Note: Any protocol approved by the IRB may be subject to further review by officials of the institution. The institution may not, however, override the IRB's decision to disapprove a protocol.

Once the review process is complete, the IRB administrator notifies the investigator electronically of the determination and next steps. A signed hard copy is available upon request by the principal investigator.