Categories of Protocols
Three categories of research protocols reviewed are:
Exempt Research Proposals
1. The chair of the RERB in consultation with the RERB members is responsible for reviewing the preliminary determination of research investigations and for making final institutional determination whether research protocols qualify for exemption.
2. The researcher must submit to the RERB a proposal so that a determination for exemption can be made.
3. The following categories of research are normally exempt from full board RERB review but must be reported to the RERB for determination of exempt status:
(Please note that studies using children (i.e., minors) or special populations are ineligible for exempted review.)
a. Research conducted in established or commonly accepted educational settings, involving normal educational practices.
b. Research involving educational tests (i.e., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior.
c. Research involving existing data or documents that are publicly available or if the investigator records the information in a manner that human subjects cannot be directly or indirectly identified.
4. Research will NOT BE EXEMPTED IF:
a. The information obtained is recorded in a way that the subject can be identified, or in a way that identifiers can be linked to the subject;
b. Any disclosure of the human subject’s responses outside of research could reasonably place the subject at risk of criminal liability, civil liability, or damage financial standing, employability, or reputation.
c. The research involves elected or appointed public officials or candidates for public office (federal statutes require confidentiality, without exception, of the personally identifiable information which must be maintained throughout the research and thereafter).
5. Exempt research protocols will be forwarded to the appropriate sponsoring agency if deemed exempt by the RERB. All non-exempt research proposals will be forwarded to the RERB for review.
Expedited Research Proposals
1. The status of the research protocol as “expedited” is determined by the chair of the RERB in consultation with appropriate RERB members; other members are called upon as necessary to ensure sound judgement of the expedited review.
2. The eligibility of some research for review through the expedited procedure is in no way intended to negate or modify the federal guidelines or procedures.
3. The expedited review process is used by the RERB to:
a. review minor changes in previously approved research during the period for which approval is authorized;
b. review research that involves no more than minimal risk to subjects as demonstrated by the research protocol and indicated by the RERB chair and board memeber.
4. Expedited review is conducted by the RERB chair and by one or more of the experienced RERB members designated by the chair to conduct the review.
The RERB members conducting the expedited review exercise have all of the authorities of the RERB except that the reviewers may not disapprove a research protocol.
The reviewers shall refer any research protocols about which they have concerns or which they are inclined to disapprove to the full board for review.
5. The RERB chair and members conducting the expedited review shall inform the full board in writing of research protocols that have been approved.
6. At a convened RERB meeting, any member may request that any research protocol that has been approved under the expedited procedure be reviewed by the RERB in accordance with full board review procedures. A vote of committee members will be taken for review with a simple majority required for full board review.
7. Research that qualifies for expedited review includes recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practive. For example:
a. The use of physical sensors that are applied either to the surface of the body or at a distance, and do not involve input of matter, or a significant amount of energy into the subject, or an invasion of the subject’s privacy
b. Such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography
Expedited review does not include:
a. exposure to electromagnetic radiation outside the visible (for example, x-rays, microwaves)
b. collection of hair and nail clippings in a non-disfiguring manner, deciduous teeth and permanent teeth if patient care indicated a need for extraction
c. collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to labor
d. voice recordings made for research purposes such as investigations of speech defects
e. moderate exercise in healthy volunteers
f. the study of existing data, documents, records, pathological specimens, or diagnostic specimens
g. research on individual or group behavior of characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not mainpulate subject’s behavior and the research will not involve stress to subjects
h. research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required
Full Board Review Research Proposals
1. Research proposals scheduled for full board review are distributed to all members of the RERB prior to the meeting.
2. When consultants or experts are used to provide special expertise to the RERB in its review of a protocol, the research protocol is distributed to the consultants or experts prior to the meeting.
3. For a research proposal to be approved, it must receive the approval of a majority of those members present at the convened meeting.
4. Where research is deemed to be of particular sensitivity, a unanimous decision is viewed as essential.
5. No RERB may have a member participating in the RERB’s initial or continuing review of any project is which the member has a conflicting interest, except to provide information requested by the RERB.
6. Where research activities were initially approved under expedited review, procedures are subsequently reviewed by the full board, the decisions reached at the convened meeting will supersede any decisions made through the expedited review.
7. In order to facilitate protocol review, the RERB requests that the protocols, consent forms, and attachments be prepared carefully and completely according to these guidelines.
8. The protocols become part of the permanent records maintained by the RERB, and therefore, are subject to inspection and review by various government and granting agencies.