Expedited Review Certification Form

IRB REVIEWER FORM

Expedited Review Certification Form

New Studies and Continuing Review – revised August 2012

[with consent form]

SECTION 1: STUDY TITLE & IRB FILE

xxxx

Reviewer: xxxx /

Date: xxxx

SECTION 2: PRINCIPAL INVESTIGATOR AND PRIMARY CONTACT INFORMATION

Principal Investigator: xxxx

Coordinator: xxxx

SECTION 3: ITEM(S) TO BE REVIEWED -- xxxx

Please use this checklist for reference when reviewing this protocol

SECTION 4: EXPEDITED REVIEW DETERMINATION

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.

The expedited review procedure may not be used for classified research involving human subjects.

Research activities present no more than minimal risk to human subjects. Yes No

SECTION 5: APPLICABILITY

(A) Involves only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.

The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) IRB reviewers are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

SECTION 6: CATEGORIES FOR INITIAL AND CONTINUING REVIEW

Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR 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.

(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml (about 1 pint) in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b) from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, 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 ml (about 3 Tablespoons) or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

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

Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

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

(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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

(8) Continuing review of research previously approved by the convened IRB as follows. All determinations marked with a * need to be documented in the minutes or records as to whether these have been met.

(a) Where the research is permanently closed to the enrollment of new subjects and all subjects

have completed all research-related interventions and the research remains active only for

long-term follow-up of subjects; *

OR:

(b) Where no subjects have been enrolled and no additional risks have been identified;*

OR:

(9) Continuing review of research not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

THINKING POINTS

· Are any specific populations excluded from the research?

· Does any population receive unfair benefits or risks from the trial?

· Does the application and protocol clearly identify the expected recruitment population?

· Does the protocol contain procedures for protecting privacy and confidentiality?

· Does this study require the use of PHI?

· If yes, has HIPAA information been included in the informed consent?

· If consent is not required, has a complete Waiver of Research Authorization been submitted?

· Is a Partial Waiver of Research Authorization for screening purposes being submitted?

· Is there any provision to provide for payment of research-related illness/injury?

· Did the investigator discuss measures for ensuring voluntary participation throughout the consent?

· Adequate time for the investigators to conduct and complete the research?

· Adequate number of qualified staff?

· Adequate facilities?

· Access to population that will allow recruitment of the necessary number of subjects?

· Availability of medical or psychosocial resources that subjects may need as a consequence of the research?

· Consent documents contain a statement that the results of the research will be posted on clinicaltrials.gov

Additional considerations for initial review

· Should review be obtained more often than annually? Yes No

· If this a multi-site research study, is the management of information that might be relevant

to the protection of participants adequate? Yes No

Additional considerations for review of modifications to previously approved research

· If information has arisen that might affect the willingness of participants to continue to take part in the research, will it be provided to those participants?

· The IRB evaluated whether the management of information that is relevant to the protection of participants is adequate?

Additional Considerations for Continuing Review:

Yes No

§ The regulatory criteria for approval are met.

§ The protocol needs verification from sources other than the investigators that no material

changes have occurred since previous IRB review.

§ The current consent document is still accurate and complete.

§ Any significant new findings

The following section is N/A; all participant follow-up is complete and the study is open only for final data collection/analysis.

SECTION 7: Informed Consent Process

Basic Elements of Consent Disclosure: All of the following should be true.

The consent process discloses that the study involves research

The consent process discloses the purpose of the research

The consent process discloses the expected duration of the participant’s participation

The consent process discloses the procedures to be followed

The consent process identifies any procedures that are experimental

The consent process identifies the procedures required by the prevailing standard of care

The consent process discloses any reasonably foreseeable risks or discomforts to the participant

The consent clarifies that risks to the participant are reasonable in relation to anticipated benefits, if any,

and the importance of the knowledge that may reasonably be expected to result.

The consent process will disclose any benefits to the participant or to others, which may reasonably be

expected from the research.

In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies participants would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. [45 CFR 46.111(a)(2)]

The consent process will disclose appropriate alternative procedures or courses of treatment, if any, that

might be advantageous to the participant.

The consent process discloses the extent, if any, to which confidentiality of record identifying the

participant will be maintained.

The consent process explains whom to contact for answers to pertinent questions about the research

The consent process explains whom to contact in the event of a research-related injury to the participant

or to give comments, express concerns, or complaints or offer input.

The consent process will disclose that participation is voluntary and refusal to participate will involve no

penalty or loss of benefits to which the participant is otherwise entitled; and that the participant may

discontinue participation at any time without penalty or loss of benefits to which participant is otherwise

entitled.

The circumstances of the consent process provide the prospective participant or the legally authorized

representative sufficient opportunity to consider whether to participate.

The consent process explains circumstances under which the participant’s participation will be terminated

by the investigator without regard to the participant’s consent.

The costs to the participant resulting from the research are clearly defined.

The consent confirms that there will be no adverse consequences (physical, social, economic, legal, or

psychological) of a participant’s decision to withdraw from research and defines procedures for such

termination of participation.

The consent process discloses that significant new findings developed during the course of the research

which may relate to the participant’s willingness to continue participation will be provided to the participant

The consent process will disclose the approximate number of participants expected to be involved in the

research study.

The circumstances of consent minimize the possibility of coercion or undue influence

The information that will be given to the participant or the representative will be in a language

Understandable to the participant or representative

45 CFR 46.404/21 CFR 50.51 - Research that involves no more than minimal risk

45 CFR 46.405/21 CFR 50.52 - Research that involves greater than minimal risk but also presents the prospect of direct benefit to individual subjects

45 CFR 46.406/21 CFR 50.53 - Research that involves greater than minimal risk and no prospect of direct benefit to the individual subjects, but is likely to yield generalizable knowledge about the subject’s disorder or condition

1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

2 Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a). Source: 63 FR 60364-60367, November 9, 1998

SECTION 8: MODIFICATIONS ARE REQUIRED TO: (please check below and attach marked

documents or list modifications)

Consent form(s)

Protocol

Protocol Summary