561. w88 online casino betting Projects: Expedited Review

Updated June 7, 2024

Review of research by the w88 online casino betting procedure is an alternative to review by the convened IRB for a limited class of research as specified by DHHS. The categories of research that may be reviewed using the w88 online casino betting review procedure are listed at the end of this policy. For w88 online casino betting Review, one or more qualified IRB members are assigned to review a project outside of a convened IRB. In general, requirements and criteria to conduct review using the w88 online casino betting procedure are identical to those for review by the convened IRB. Research Integrity & Security staff may assign additional reviewers or a consultant if additional expertise is required (for more information, see the Human Research Protection Program (HRPP) Policy Manual for reviewer assignment).

w88 online casino betting Project Review Materials

Expedited Reviewers complete a comprehensive review of all documents in the w88 online casino betting project submission package (or those flagged for review by Research Integrity & Security staff). The materials available for Expedited Review are the same as those required for Full Committee Review except for documents specific to greater than minimal risk research (e.g., plans for safety reviews). Specifically, the materials include:

The full protocol, application, or a protocol summary containing the relevant information to determine whether the proposed w88 online casino betting fulfills the criteria for approval.
Proposed consent document.
Recruitment w88 online casino betting.
Topic Specific applications, (e.g., children, prisoners, international, etc.)
Permission site letters.

The materials in the submission package are sufficient to ensure the w88 online casino betting Reviewer can determine whether the research meets the DHHS regulatory criteria for approval, and any additional requirements under Subparts B, C, and D, other applicable federal agency regulations, and Nevada state law.

See the online HRPP w88 online casino betting for information about reviewer recommendations and documentation.

Expedited Review Evaluation of w88 online casino betting Project Materials

Expedited Reviewers evaluate w88 online casino betting project materials submitted for initial review and confirm that:
1. If the research appears on the list of w88 online casino betting review categories, it is deemed to be no more than minimal risk;
2. If research appearing on the w88 online casino betting review list is greater than minimal risk, the reviewer documents the rationale for this determination and the rationale for review by the convened IRB.
The w88 online casino betting does not involve more than minimal risk;
The research represents one or more approvable categories of w88 online casino betting research, as listed below.
The w88 online casino betting does not include activities where identification of the participants or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the participants’ 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 project does not involve classified w88 online casino betting.
When w88 online casino betting involves vulnerable populations, additional safeguards have been included in the study to protect the rights and welfare of these participants.

w88 online casino betting Review Actions

The range of IRB Actions for Expedited Review of w88 online casino betting projects include w88 online casino betting, w88 online casino betting with Conditions, and Deferred. If the w88 online casino betting Reviewer determines a project may not be approvable, the project is placed on the agenda for Full Committee Review. w88 online casino betting reviewers are prohibited from disapproving research.

Before approving a w88 online casino betting project under expedited review procedures, Research Integrity & Security staff or designated IRB member confirms the research meets the criteria for Expedited Review under the DHHS expedited categories and Flex-Exempt under the University IRB Flexibility Policy. Research Integrity & Security staff members are experienced and serve as members of the IRB. The assigned reviewer may determine that the study does not meet the expedited category or determine that the w88 online casino betting project should be reviewed as an exempt or scheduled for Full Committee Review at the next convened IRB meeting.

NOTE: Following notification of the w88 online casino betting review determination, if the researcher disagrees with the recommendations or requested revisions, the project/package may be placed on the agenda for Full Committee w88 online casino betting.

Determining Approval Periods for w88 online casino betting Projects

Generally, the approval period for projects approved by w88 online casino betting Review is one year. Shorter approval periods are only required when participant risks are determined to be frequent or severe, or greater than minimal risks are not justified by the benefits of the research. Under either of these conditions, the project would not be eligible for w88 online casino betting Review.

w88 online casino betting Review Criteria

w88 online casino betting 1

w88 online casino betting studies of drugs and medical devices only when condition (a) or (b) is met.

Research on drugs for which an investigational w88 online casino betting drug application (21 CFR Part 312) is not required. (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.)
w88 online casino betting 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.

w88 online casino betting 2

w88 online casino betting blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

from healthy, nonpregnant adults who weigh at least 110 pounds. For these w88 online casino betting, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
from other adults and children, considering the age, weight, and health of the w88 online casino betting, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these w88 online casino betting, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

w88 online casino betting 3

Prospective collection of biological specimens for w88 online casino betting purposes by noninvasive means. Examples:

hair and nail clippings in a nondisfiguring manner;
deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
permanent teeth if routine patient care indicates a need for extraction;
excreta and external secretions (including sweat);
uncannulated saliva w88 online casino betting either in an unstimulated fashion or stimulated by chewing

gum base or wax or by applying a dilute citric solution to the tongue;

placenta removed at delivery;
amniotic fluid obtained at the time of rupture w88 online casino betting membrane prior to or during labor;
supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling w88 online casino betting teeth and the process is accomplished in accordance with accepted prophylactic techniques;
mucosal and skin cells w88 online casino betting by buccal scraping or swab, skin swab, or mouth washings;
sputum w88 online casino betting after saline mist nebulization.

w88 online casino betting 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 w88 online casino betting indications.) Examples:

physical sensors that are applied either to the surface w88 online casino betting body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion w88 online casino betting participant’s privacy;
weighing or testing sensory acuity;
magnetic resonance imaging;
electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health w88 online casino betting individual.

w88 online casino betting 5

w88 online casino betting involving materials (data, documents, records, or specimens) that:

have been collected for nonresearch purposes (such as w88 online casino betting treatment or diagnosis), or
will be collected solely for nonresearch purposes (such as w88 online casino betting treatment or diagnosis).

(Some w88 online casino betting in this category may be exempt from the DHHS regulations for the protection of human participants.)

w88 online casino betting 6

Collection of data from voice, video, digital, or image recordings made for w88 online casino betting purposes.

w88 online casino betting 7

w88 online casino betting on individual or group characteristics or behavior including, but not limited to:

w88 online casino betting on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior, or
w88 online casino betting employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

w88 online casino betting 8

Continuing w88 online casino betting of research previously approved by the convened IRB as follows:

the research is permanently closed to the enrollment of w88 online casino betting participants;
all participants have completed all w88 online casino betting-related interventions; and the w88 online casino betting remains active only for long-term follow-up of participants; or
where no w88 online casino betting have been enrolled and no additional risks have been identified; or
where the remaining w88 online casino betting activities are limited to data analysis

Continuing review is not required for research reviewed using the w88 online casino betting procedure, and the IRB must provide justification for conducting continuing review of research deemed to meet w88 online casino betting criteria.

w88 online casino betting 9

Continuing review of research, not conducted under an investigational w88 online casino betting 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 identifi