551. w88 casino games login Types

Updated June 7, 2024

This policy identifies the available w88 casino games login types and describes the applicable circumstances under which each w88 casino games login type is used.

w88 casino games login Integrity & Security staff will select the applicable w88 casino games login Type from the w88 casino games login and Minutes page in IRBNet (as specified below). The selected w88 casino games login type will auto-populate when the meeting minutes are generated. NOTE: Depending upon the outcome of the w88 casino games login, Research Integrity & Security staff may need to update the w88 casino games login Type in IRBNet.

Requests to Use the University w88 casino games login: Circumstances may arise in which an investigator at an external site that does not have an IRB, or an external investigator collaborating on a University research project asks to use the University IRB as the Reviewing IRB. Such requests are reviewed by expedited w88 casino games login procedures or at a convened IRB meeting according to the relevant policy as described below.

Full Committee w88 casino games login

Full committee w88 casino games login is required for new projects that involve any of the research activities itemized below; and continuing reviews and reviews of amendments for research projects previously approved at a convened IRB meeting.

Research Activities that Require w88 casino games login at a Convened IRB Meeting (i.e., Full Committee w88 casino games login)

• w88 casino games login activities present greater than minimal risk to participants. (Federal regulations do not define greater than minimal risk. Risk is assessed by extrapolating from the definition for minimal risk(see Policy Manual Definitions);
• w88 casino games login Revisions in response to convened IRB deferred w88 casino games login of new projects, continuing w88 casino games login, or amendments. At the discretion of Research Integrity & Security Staff, the revisions may be sent to the primary reviewer or IRB Chair for preliminary confirmation of completeness before the revisions are placed on the agenda for w88 casino games login at the next convened meeting.
• The project is classified w88 casino games login (in accordance with the Policy Manual Definitions).
• The w88 casino games login involves an FDA-regulated test article (e.g., investigational drug, biological product, or device).
• Continuing w88 casino games login of research previously approved at a convened meeting unless expedited w88 casino games login category 8(a), 8(b), 8(c) or 9 applies (see DHHS Categories of research eligible for w88 casino games login by expedited procedures).
• Amendments to w88 casino games login previously approved at a convened meeting. (NOTE: At the discretion of the IRB-member reviewer, minor amendments to research previously approved at a convened meeting may be reviewed by expedited procedures if the changes do not affect criteria for IRB approval, and fall within the list of categories of research eligible for expedited w88 casino games login.)
• Amendments to w88 casino games login previously approved by expedited procedures if an IRB-member determines the changes may increase participant risk to greater than minimal, decrease research benefits, or involve research activities that are not among those eligible for expedited w88 casino games login.
• Allegations of serious or continuing noncompliance.
• Unanticipated problems involving risks to participants or others.
• Suspension or termination of w88 casino games login activities.
• Sponsor, investigator or other regulatory body requests for suspension or termination of w88 casino games login activities.
• Other submissions that warrant w88 casino games login and discussion by the convened IRB, as determined on a case-by-case basis.

Expedited w88 casino games login

Expedited reviews are completed by one or more IRB members and may be used for new projects involving w88 casino games login activities as itemized below; and continuing reviews and reviews of amendments for projects initially reviewed and approved by expedited procedures; and continuing reviews and reviews of amendments for w88 casino games login previously approved at a convened meeting (as specified below).

NOTE: Under the University's IRB Flexibility Policy (IRB-Flex), minimal risk research that is not conducted, supported, or otherwise subject to regulation by a federal agency; and does not involve prisoners or incomplete disclosure may be eligible for Flex-Exempt w88 casino games login (as described in the next section).

w88 casino games login Activities that May be Reviewed by Expedited Procedures:

• w88 casino games login activities that present no more than minimal risk to participants (in accordance with the Policy Manual Definitions for minimal risk).
• Research activities that are represented by one or more of the DHHS Categories of research eligible for w88 casino games login by expedited procedures.
• w88 casino games login activities in which reasonable and appropriate protections are implemented to reduce risks related to invasion of privacy and breach of confidentiality to no greater than minimal, when identification of participants and disclosure of their responses w88 casino games login place them at risk of criminal or civil liability; damage their financial standing, employability, insurability, reputation; or be stigmatizing.
• In limited circumstances, continuing reviews of research initially approved by expedited procedures when the IRB reviewer requests and justifies a need for ongoing expedited w88 casino games login (in accordance with the Continuing w88 casino games login, Expedited policy).
• Minor Revisions submitted by investigators following w88 casino games login Action Approved with Conditions.
• Minor amendments for w88 casino games login previously approved at a convened IRB meeting (in accordance with the Policy Manual Definitions for minor amendments). Examples:
  • Addition or removal of research personnel (if not the PI, may receive administrative w88 casino games login)
  • Changes to study sites (may receive administrative w88 casino games login)
  • Edits to correct spelling or grammar, or to update telephone numbers or email addresses;
  • Variations to the amount of blood being drawn for a research sample, as long as these do not exceed the thresholds for blood draws as described under expedited w88 casino games login categories 2(a) and (b); Change to methods for presenting materials such as from interview to questionnaire format;
  • Reductions in procedures that would reduce risks to participants without concomitantly reducing benefits;
  • Addition of new advertisements; or
  • Increasing the duration of a study
  • Increasing enrollment numbers for the study.
• Continuing w88 casino games login of research previously approved at a convened IRB meeting when research activities are in one of the categories eligible for expedited w88 casino games login: 8(a), 8(b), 8(c) or 9. For details, see DHHS Categories of research eligible for w88 casino games login by expedited procedures.
• Under flex policy, non-invasive collection of biospecimens in w88 casino games login category 4 w88 casino games login be expanded to include skin biopsy (without sutures); ionizing radiation (<100 mrem/yr [1 Sv]); blood draws via indwelling catheter (regardless of frequency); blood draw 5 mL/kg/day or 9.5 mL/kg/8 weeks; additional collection of blood, cerebrospinal fluid, bone marrow during a clinically indicated procedure; additional endoscopic gastro-intestinal biopsies

Exempt w88 casino games login

Qualifying w88 casino games login activities may be exempt from federal regulations for the protection of participants (see 45CFR46.104) with the following caveats:

• An IRB member determines a particular w88 casino games login activity is exempt from the federal regulations for the protection of participants.
• w88 casino games login Integrity & Security may require that specific w88 casino games login activities or classes of w88 casino games login activities conducted, supported, or otherwise subject to regulation by the University comply with some or all the federal regulations for the protection of participants.
• University and affiliate researchers conducting w88 casino games login must comply with pertinent federal, state and local, and foreign laws and regulations that apply to the w88 casino games login activities and which provide additional protections for participants.
• When University and affiliate researchers conduct exempt w88 casino games login in foreign countries, w88 casino games login Integrity & Security requires compliance with applicable US federal regulations in addition to those of the host country.
• IRB members may consider Flex-Exempt w88 casino games login with equivalent protections for minimal risk research when that research is not conducted, supported, or regulated by a federal agency and does not involve prisoners or incomplete disclosure/deception.

Conditions for Human w88 casino games login Activities to Be Exempt

• w88 casino games login activities as initially proposed or if modifications to ongoing exempt w88 casino games login are later proposed present no more than minimal risk to participants (in accordance with Policy Manual Definitions for minimal risk).
• w88 casino games login activities as initially proposed or if modifications to ongoing exempt w88 casino games login are later proposed in one or more of DHHS categories for exempt w88 casino games login.
• The w88 casino games login does not involve prisoners as an intended population.
• w88 casino games login involving observations of public behavior does involve children unless the investigators do not participate in the activities being observed.
• w88 casino games login involving educational tests, surveys, interviews collecting identifiers and for which disclosure of information outside the w88 casino games login poses potential risks to participants does not involve children.
• w88 casino games login involving benign behavioral interventions is limited to adults as the population.
• Research involving benign behavioral interventions with collection of identifiers where the IRB conducts a limited w88 casino games login to confirm there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data including when changes are proposed in the privacy and confidentiality measures.
• Proposed changes in the w88 casino games login activity continue to meet no more than minimal risk to participants.

NOTE: FDA-regulations for exempt w88 casino games login differ from the DHHS categories. Refer to the FDA Exempt Categories policy for details.

DHHS Categories for Exempt w88 casino games login (per §46.104 item (b))

DHHS-Exempt 1:

w88 casino games login conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most w88 casino games login on regular and special education instructional strategies, and w88 casino games login on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

DHHS-Exempt 2:

w88 casino games login that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if 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 w88 casino games login subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects' responses outside the w88 casino games login would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
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 w88 casino games login to make the determination required by §46.111(a)(7).

DHHS-Exempt 3:

1. w88 casino games login 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 w88 casino games login subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   2. Any disclosure of the human subjects' responses outside the w88 casino games login would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   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 w88 casino games login to make the determination required by §46.111(a)(7).
2. 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 w88 casino games login, and the investigator has no reason to think the w88 casino games login will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the w88 casino games login 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.
3. If the w88 casino games login involves deceiving the subjects regarding the nature or purposes of the w88 casino games login, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in w88 casino games login in circumstances in which the subject is informed that they will be unaware of or misled regarding the nature or purposes of the w88 casino games login.

DHHS-Exempt 4:

Secondary w88 casino games login for which consent is not required: Secondary w88 casino games login uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

1. The identifiable private w88 casino games login 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 w88 casino games login 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 w88 casino games login involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under HIPAA, for the purposes of "health care operations" or "w88 casino games login" or for "public health activities and purposes"; or
4. The w88 casino games login is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-w88 casino games login activities, if the w88 casino games login generates identifiable private information stored on systems maintained according to applicable privacy regulations.

DHHS-Exempt 5:

w88 casino games login 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 w88 casino games login 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.

• Each Federal department or agency conducting or supporting the w88 casino games login and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the w88 casino games login and demonstration projects that the Federal department or agency conducts or supports under this provision. The w88 casino games login or demonstration project must be published on this list prior to commencing the w88 casino games login involving human subjects.

DHHS-Exempt 6:

Taste and food quality evaluation and consumer acceptance studies if (a) wholesome foods without additives are consumed; or (b) a food is consumed that contains a food ingredient or agricultural chemical or environmental contaminant which is or below the level and for a use found to be safe by the FDA or approved by the EPA or Food Safety and Inspection Service w88 casino games login USDA.

NOTE: The following DHHS-Exemption Categories 7 and 8 reference broad consent for secondary w88 casino games login with identifiable private information or identifiable biospecimens.

DHHS-Exempt 7:

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB w88 casino games login and makes the determinations required by §46.111(a)(8).

DHHS-Exempt 8:

Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §46.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117; (iii) An IRB conducts a limited IRB w88 casino games login and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Administrative w88 casino games login

w88 casino games login activities that do not require an assessment of the IRB criteria for approval may be reviewed and acknowledged by trained w88 casino games login Integrity & Security staff, an IRB member or Chair, or the w88 casino games login Compliance Officer (RCO) as applicable. These include but are not limited to the following activities:

Annual Status Reports: Annual status reports on research reviewed by expedited procedures receive administrative w88 casino games login unless the reviewer has requested and justified ongoing expedited w88 casino games login at initial w88 casino games login. See the expedited continuing w88 casino games login policy for details on when studies will continue to receive expedite w88 casino games login.

w88 casino games login to Study Sites: w88 casino games login to study sites that do not include the addition of vulnerable populations.

Certificates of Confidentiality: Once approved by the issuing agency, PIs must submit documentation of Certificates of Confidentiality to the IRB for administrative w88 casino games login and acknowledgement.

Changes in Study Personnel: Routine changes to study personnel (e.g., addition or removal of researchers) constitute administrative actions that only require confirmation that training requirements are met and that relevant researcher forms and recruitment and consent materials are updated correctly to reflect the changes (as appropriate). Changes in the PI receive expedited w88 casino games login as project amendments by an IRB member. The IRB member will assess the PI's qualifications for overseeing the research.

Closures: Investigator requests to close research projects receive administrative w88 casino games login by Research Integrity & Security staff to confirm the request is complete and compliant. Expirations of IRB approval occur automatically in IRBNet by notice to the PI that IRB approval or exempt status has expired and all research activities involving participants must cease.

Determinations of Not Human Subjects w88 casino games login: New projects submitted for determinations of human subject w88 casino games login, and projects submitted for: Exempt or Expedited w88 casino games login when these do not meet the federal definitions of w88 casino games login or involve participants as defined by the regulations.

Emergency Use of a Test Article: The w88 casino games login Chair or other designated w88 casino games login Member administratively reviews and acknowledges documentation from a clinician who is reporting or proposing use (if time is not sufficient to convene a quorum of the w88 casino games login) of an FDA-regulated test article in a life-threatening or severely debilitating situation. w88 casino games login Chair/Member may seek counsel from a physician or pharmacist as needed.

External Site Approval or Permission to Recruit: Research Integrity & Security staff administratively w88 casino games login and acknowledge documentation from external sites granting approval or permission to proceed with the w88 casino games login (e.g., WCSD) or to recruit at the site (e.g., TMCC).

Preliminary w88 casino games login of Problem Reports: The IRB Chair or Research Integrity & Security Director complete an administrative w88 casino games login to evaluate problem reports, or requests for suspensions or terminations to determine if immediate action is warranted and to make recommendations for Full Committee w88 casino games login by the convened w88 casino games login or Expedited w88 casino games login by a subcommittee of the w88 casino games login.

Routine or Required Sponsor Amendments: The Research Integrity & Security RCO or an IRB member administratively reviews routine (e.g., annual) amendments to sponsor protocols or investigator brochures when the amendments do not identify changes to participant risks or benefits or require substantive changes to the IRB application or consent materials or processes. Sponsor amendments with no changes to participant risks that require minor changes to study materials may receive expedited w88 casino games login by the IRB as an Amendment. Sponsor amendments that are substantive, or that identify increased risks will receive w88 casino games login as an Amendment at the next convened IRB meeting.

Sponsor Safety Reports: The w88 casino games login Integrity & Security RCO administratively reviews and acknowledges receipt of routine safety reports from sponsors. When reports do not identify changes to participant risk, or require substantive changes to an IRB application, or consent processes or materials, PIs may submit the reports at the time of continuing w88 casino games login to be reviewed by the IRB.

Safety reports identifying increased risks or requiring substantive changes to an w88 casino games login application, or consent processes or materials will be reviewed as an Amendment or Unanticipated Problem (as indicated by the content of the safety report and according to w88 casino games login policy) at the next convened w88 casino games login meeting.

Use of External IRBs: An w88 casino games login member administratively reviews and acknowledges requests by University and affiliate investigators for w88 casino games login by an external IRB. At its discretion, Research Integrity & Security may require IRB w88 casino games login for investigators to use an external IRB. Once the Administrative w88 casino games login is complete, the PI will receive written acknowledgment of the external IRB as the IRB of Record or notice that w88 casino games login by the University IRB or by both IRBs is required.

Facilitated w88 casino games login

This w88 casino games login type is reserved for specific situations. For example, facilitated w88 casino games login may apply when an external IRB, designated as the Reviewing IRB, asks the University IRB to augment the external IRB's w88 casino games login process.