60. Department of Defense (DoD) Regulations for Human w88 online casino betting

Updated June 5, 2024

Human w88 online casino betting that is supported or conducted by the Department of Defense (DoD) or that involves DoD personnel must comply with the Common Rule, Subparts B, C, and D (32 CFR 219), DoD requirements, including those specific to the separate DoD components: Army, Navy, Air Force and Marine Corps (see Additional Resources at the end of this policy), and other regulations as applicable.

A DoD researcher form and review worksheet are used to assess DoD-supported w88 online casino betting projects for the additional DoD regulations. In presenting the protocol to the IRB, the primary reviewer will address the additional DoD regulatory requirements.

Additional DoD Requirements for Ethics Training and Risk Assessment

Each DoD component has educational requirements in the conduct of human w88 online casino betting for personnel involved in the conduct, review, or approval of w88 online casino betting sponsored by DoD. The type and extent of training depend upon the duties and responsibilities of the persons involved in the w88 online casino betting. Initial and continuing w88 online casino betting ethics education is required for all personnel who conduct, review, approve, oversee, support, or manage human w88 online casino betting supported by the DoD or its components. Individual DoD components may have stricter or specific educational requirements and may require re-certifications more frequently. Researchers should contact their Program Officer at the DoD, or DoD component, to ensure adherence to any unique requirements. It is the Principal Investigator’s responsibility to ensure that w88 online casino betting staff has completed all appropriate educational requirements as mandated by DoD policy.

University and affiliate PIs are advised to consult with the DoD component sponsoring or involved in the w88 online casino betting to identify the specific or additional educational or certification requirements.

University and affiliate Principal Investigators (PIs) are responsible for

• Conveying additional DoD training requirements to the IRB
• Providing the DoD Component and the IRB with verification that the additional training requirements have been met. IRB approval is contingent on this verification

The DoD component may evaluate the University’s HRPP training policies to determine that, based on the complexity and risk of the w88 online casino betting, personnel are qualified to perform the w88 online casino betting.

Assessing Risk in DoD-supported w88 online casino betting

Federal regulations at 45CFR46.102, item (i) and 32CFR219.102, item (i) state that “minimal risk means the probability and magnitude of harm or discomfort anticipated in the w88 online casino betting are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” However, additional constraints apply to the definition of minimal risk under DoD requirements (DoD Instruction 3215.02 11/09/2011 ver, p 19). For DoD w88 online casino betting, when making minimal risk determinations, PIs may NOT consider the inherent risks certain categories of participants face in their everyday lives. Specifically, when w88 online casino betting involves a special population, the risks imposed by the w88 online casino betting must not be evaluated against

• the inherent risks encountered in the populations’ work environment (e.g., emergency responder, pilot, soldier in a combat zone); or
• the inherent risks of having a medical condition (e.g., frequent medical tests or constant pain).

Additional DoD Review Requirements

Requirements for Review of Non-exempt DoD Classified w88 online casino betting.

• The involvement of classified information must be limited to information needed for IRB approval and oversight of the w88 online casino betting, and to inform the participant during the consent process; and information provided by the participants during the course of the w88 online casino betting.
• Classified non-exempt human w88 online casino betting must be approved by the Secretary of Defense; the w88 online casino betting is submitted by the Head of the OSD or the DoD Component conducting the w88 online casino betting.
• Waivers of informed consent are prohibited for DoD Classified w88 online casino betting.
• Informed consent procedures for greater than minimal risk w88 online casino betting must identify the DoD as the supporting institution unless the requirement is waived by the Secretary of Defense.
• Informed consent procedures must identify the w88 online casino betting as classified and explain the impact of the classification.
• All classified DoD w88 online casino betting will be reviewed by the convened IRB.
• During the review, at least one voting IRB member must be a non-Federal employee.
• Any IRB member who disagrees with the Board’s determination may appeal the determination to the Secretary of Defense.
• The IRB must determine whether prospective participants need access to classified material to make a valid, informed consent decision.
• Disclosure or use of classified information must comply with the requirements for access to and protection of classified information (see Executive Order 13526, “Classified National Security Information,” December 29, 2009).
• Non-exempt classified w88 online casino betting must be conducted following the requirements of Instruction 3216.02 13

Requirements for Non-DoD Institutional Review

• As with all w88 online casino betting, the University IRB will consider the scientific merit of DoD-w88 online casino betting and may rely on outside experts to provide an evaluation of same.
• Substantive changes to approved DoD-sponsored w88 online casino betting, including modifications to w88 online casino betting reviewed by expedited procedures, must undergo scientific review prior to IRB review.

Requirements for Concurrence or Administrative Review by DoD HRPO or Component Representative

HRPO or DoD Component Concurrence/Administrative Review

The DoD HRPO (Human w88 online casino betting Protection Official) mustconcurwith all w88 online casino betting Integrity & Security or IRB determinations of “not human w88 online casino betting” or “exempt w88 online casino betting” before project activities may be initiated.

If the University IRB determines an activity is non-exempt w88 online casino betting involving human participants, the DoD HRPO mustadministratively reviewand approve the w88 online casino betting, including substantive revisions requested by the IRB, as specified in DoDI 3216.02 Enclosure 3, 4.c.(2)(a)-(3)beforethe activities that involve human participants can begin. The purpose of this approval is to confirm the w88 online casino betting is compliant with DoD regulations and directives; and all applicable laws and requirements, and cultural sensitivities for DoD w88 online casino betting conducted in a foreign country.

The DoD HRPO must administratively review and approve surveys developed for administration to DoD personnel,afterIRB review and approval and before activities involving human participants may commence. When a survey crosses DoD Components, additional review is required.

The following conditions require administrative review and approval by the DoD component:

• Collaborative w88 online casino betting in which a DoD institution will rely on a University IRB.
  NOTE: Also requires a written agreement specifying the responsibilities and authorities of both organizations, use of the University’s FWA, and that the involvement of DoD personnel is secondary to that of the University.
• DoD-supported w88 online casino betting permitting a waiver of informed consent (see Informed Consent section for details).

NOTE: University and affiliate investigators have never and are not expected to engage in DoD-supported fetal w88 online casino betting, making requirements for DoD administrative review of fetal w88 online casino betting moot.

Also see the section “Additional DoD Reporting Requirements” at the end of this policy.

IRB Notification of DoD HRPO or Component Concurrence/Administrative Review

In all cases when DoD HRPO or Component concurrence or administrative review is required, the PI must provide documentation of the required concurrence/review in a subsequent package. The IRB will acknowledge the documentation and confirm that w88 online casino betting activities involving human participants may commence.

Additional DoD Requirements for w88 online casino betting Monitors

A medical monitor must be appointed for w88 online casino betting involving more than minimal risk. The IRB may require a w88 online casino betting monitor for a portion of and for all aspects of studies involving no more than minimal risk.

• The medical monitor is appointed by name.
• University and affiliate PIs must name the medical monitor in the application.
• The monitor may be an ombudsman or a member of the data safety monitoring board.
• The medical monitor must be independent of the team conducting the w88 online casino betting.
• There may be more than one w88 online casino betting monitor if different skills or experiences are needed.

The IRB must approve a written summary from the Principal Investigator regarding the monitors’ duties, authorities, and responsibilities. The duties of the w88 online casino betting monitor are determined on the basis of specific risks or concerns about the w88 online casino betting and may include the following:

• Observing recruitment, enrollment, and consent processes;
• Overseeing study interventions and interactions;
• Reviewing monitoring plans and unanticipated problems involving risks to participants or others;
• Overseeing data collection and analysis;
• Discussing the w88 online casino betting protocol with investigators;
• Interviewing human participants;
• Consulting with others outside of the study; and
• Reporting observations and findings to the IRB or a designated official.

The w88 online casino betting monitor may take any steps necessary to protect the safety and well-being of participants until the IRB can assess the situation or incident including

• Stopping a w88 online casino betting study in progress, or
• Removing individuals from the study.

Additional DoD Requirements for Command Permission, Recruitment, and Informed Consent

Requirements for Command Permission for Service Members to Participate in Human w88 online casino betting

Service members must follow their command policies regarding the requirement to obtain command permission to participate in w88 online casino betting involving human participants while on-duty. Additionally, a Service member’s ability to perform his or her military duties may be affected by participating in w88 online casino betting during off-duty time (i.e., on leave or during non-duty hours). Therefore, Service members shall follow their Component and command’s policies for approving off-duty employment or activities. The University IRB requires the PI to indicate if command permission is required and if so, to describe how the PI will confirm each Service member’s commander supports that member’s participation in DoD-supported human w88 online casino betting.

Requirements for Recruitment

• Officers are not permitted to influence the decision of their subordinates.
• Officers and senior non-commissioned officers cannot be present at the time of recruitment.
• Officers and senior non-commissioned officers must be given a separate opportunity to participate (when applicable).

Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.

When w88 online casino betting involves service members and recruitment will take place in a group setting, an independent ombudsman must be present when risk is greater than minimal. Under similar conditions when w88 online casino betting risk is no greater than minimal, the IRBmayrequire that an ombudsman be appointed. In the latter case, The IRB will base its decision to require an ombudsman on the sample population, and recruitment and consent processes.

Requirements for Informed Consent

Consent document requirements specific to DoD w88 online casino betting include:

• A statement that the DoD or a DoD organization is funding the study.
• A statement that representatives of the DoD are authorized to review w88 online casino betting records.

w88 online casino betting-related injury language in consent documents must follow the requirements of the DoD component. University and affiliate PIs conducting DoD w88 online casino betting are advised to contact the DoD component for details about component-specific language. Stricter requirements for disclosure of w88 online casino betting-related injury language may apply: See item 10.b. in the DoD Instruction 3216.02: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported w88 online casino betting.

For individuals with impaired consent capacity when consent is to be obtained from participants’ legal representative, the intent of the w88 online casino betting must be to benefit the individual participant, and an IRB must make the determination that the intent of the w88 online casino betting is to benefit the individual experimental subject.

Waivers of informed consent are prohibited for classified w88 online casino betting.

Waivers of informed consent are prohibited for non-exemptw88 online casino betting involving a human being as an experimental subject(see Policy Manual Definitions) unless a waiver is obtained from the Assistant Secretary of Defense for w88 online casino betting and Engineering. The waiver may only be obtained when the w88 online casino betting

• is necessary to advance the development of a medical product for the Military Services,
• may directly benefit the individual experimental subject, and
• is conducted in compliance with all other applicable laws and regulations.

If the w88 online casino betting participant does not meet the definition of “experimental subject” as defined in DODI 3216.02, the IRB may waive the consent process.

NOTE:Neither University nor Affiliate investigators conduct planned emergency w88 online casino betting. Therefore, the DoD prohibition against waiving informed consent for planned emergency w88 online casino betting does not apply.

Additional DoD Requirements for Special or Vulnerable Populations

w88 online casino betting involving pregnant women, prisoners, and children is subject to the DHHS requirements in Subparts B, C, and D respectively.

The DHHS exemption for w88 online casino betting involving survey or interview procedures or observation of public behavior does not apply to w88 online casino betting with children, except for w88 online casino betting involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

See informed consent (above) for DoD requirements for obtaining consent for individuals with impaired consent capacity.

DoD Prohibitions on w88 online casino betting Involving Prisoners of War or Detainees

• w88 online casino betting with prisoners of war is prohibited. Investigators should refer to the definition of “prisoner of war” for the particular DoD component supporting the w88 online casino betting.
• w88 online casino betting involving a detainee is prohibited unless
  • an investigational new drug or investigational device is offered to detainees with the detainees’ informed consent, and
  • the same product would be offered to members of the U.S. Military Services in the same location for the same medical condition.

Additional DoD Requirements for w88 online casino betting Involving Prisoners

• DoD w88 online casino betting involving prisoners cannot be reviewed by the expedited procedure and the IRB prisoner representative must be present for the quorum. The prisoner representative may be a prisoner, an employee of the prison, or an individual not affiliated with the prison.
• In addition to allowable categories of w88 online casino betting on prisoners in Subpart C, DoD allows epidemiological w88 online casino betting involving prisoners when the following are true:
  • The w88 online casino betting describes the prevalence or incidence of a disease by identifying all cases, or studies potential risk-factor associations for a disease.
  • The w88 online casino betting presents no more than minimal risk and presents no more than an inconvenience to the participant.
• When a w88 online casino betting participant becomes a prisoner while enrolled in DoD w88 online casino betting, the PI must notify the IRB of the change in the participant’s status to prisoner.
• If the PI asserts it is in the incarcerated participant’s best interest to continue in the w88 online casino betting, the IRB chair may determine that the participant may continue to participate until both of the following occur:
  
  1. The convened IRB reviews and approves a change in the w88 online casino betting protocol to allow the participant to continue in the study while a prisoner. (See below for the role of the prisoner representative for the review.
  2. The University or affiliate Institutional Official (IO), and the DoD component review and agree with the IRB’s decision.
• If the PI cannot assert it is in the prisoner-participant’s best interest to continue in the w88 online casino betting, the IRB chair shall require that all w88 online casino betting interactions and interventions with the prisoner-participant cease until the convened IRB can review the change in the w88 online casino betting protocol.
• Upon receipt of notification that a previously enrolled human participant has become a prisoner,the prisoner representative at a convened IRB meeting:
  
  1. shall promptly re-review the w88 online casino betting protocol to ensure that the rights and wellbeing of the human participant, now a prisoner, are not in jeopardy;
  2. shall review the request to modify the protocol; and
  3. may recommend approval of the modification if all of the following conditions are met:
     
     • The prisoner-participant can continue to participate voluntarily and fully informed.
     • The prisoner participant is capable of meeting the w88 online casino betting protocol requirements.
     • The terms of the prisoner-participant’s confinement does not inhibit the ethical conduct of the w88 online casino betting.
     • There are no other significant issues preventing the w88 online casino betting involving human participants from continuing as approved.

NOTE: This review and approval is limited to the continued participation of the individual prisoner-participant and does not allow recruitment of prisoners as participants.

Additional DoD Requirements for w88 online casino betting Involving Pregnant Women, Human Fetuses and Neonates

• For purposes of these requirements, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge” and be interpreted to have the same meaning.
• The applicability of 45 CFR 46 subpart B is limited to w88 online casino betting that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus, or fetuses or neonates (i.e., newborns as defined in §46 subpart B).
• Fetal w88 online casino betting must comply with US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.

Additional DoD Requirements for Compensation in w88 online casino betting

• US military personnel are prohibited from receiving compensation for w88 online casino betting participation during duty hours but may be compensated when participation occurs when personnel are involved in the w88 online casino betting when not on duty.
• Federal employees while on duty and non-Federal persons may be compensated for up to for each blood draw for w88 online casino betting.
• Non-Federal persons may be compensated for w88 online casino betting participation other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the w88 online casino betting.

DoD Requirements for Multi-site or Transnational w88 online casino betting

For multi-site DoD-sponsored w88 online casino betting, the participating organizations must have a formal agreement that specifies the roles and responsibilities of each party.

University and affiliate investigators proposing to conduct transnational DoD-w88 online casino betting must complete and submit an application for international w88 online casino betting. This form requests information about the foreign government’s standards of review, identification of the host site and local mentor, and the name of the local IRB or ethics board with contact person.

• The investigator must have permission to conduct w88 online casino betting in that country by certification of local ethics review and provide the IRB with documentation of that approval.
• Documentation of local ethics review must address specific local requirements for human participant w88 online casino betting and identify any legal issues that bear consideration.
• If local review is not required, the PI must verify to the IRB that local review is not required.
• If local review is not possible, the PI must submit a letter to the IRB explaining why local review is not possible.
• The investigator must agree to abide by all applicable local law’s regulations, customs, and practices, and all requirements of the local IRB or ethics board reviewing the w88 online casino betting.

Periodically, but no less than annually, the w88 online casino betting Integrity & Security w88 online casino betting Compliance Officer, qualified designee, or local entity must conduct a systematic and independent examination to assess whether the w88 online casino betting activities were implemented; and the data were recorded, analyzed and accurately reported according to the IRB protocol.

• The examination may involve a review of materials and documents provided by the investigator.
• The assessment may include interviews with the local mentor, monitoring body (if present) or w88 online casino betting participants, or a site visit.

DoD Prohibition on Human w88 online casino betting Involving Chemical or Biological Agents

DoD w88 online casino betting involving use of humans for testing of chemical or biological agents is generally prohibited.

Additional DoD Reporting Requirements

University and affiliate principal investigators are responsible for informing the DOD-component human w88 online casino betting protection officer within 30 days of any of the following:

• significant changes to the w88 online casino betting protocol that are approved by a University IRB (including amendments approved by expedited procedures);
• results of IRB continuing review (including continuing review by expedited procedures);
• change of reviewing IRB;
• change of reviewing IRB.
• IRB determinations of unanticipated problems involving risks to participants or others, or serious or continuing noncompliance;
• suspension or termination DoD w88 online casino betting; and
• notification that any part of the University HRPP is under for-cause investigation by any Federal department, agency, or national organization for a DoD w88 online casino betting protocol.

The University IRB will ensure records documenting compliance and noncompliance with DoD regulations are accessible for inspection and copying by representatives of the DoD at reasonable times and in a reasonable manner as determined by the relevant DoD component. The University IRB will retain those records for at least 3 years after the completion of the w88 online casino betting.

Additional Resources

DoD Instruction 3216.02, effective April 15, 2020
Dual Compensation Act
SECNAVINST 3900.39D
OPNAVINST 5300.8C
10 U.S.C. 980: Limitation on use of humans as experimental subjects
Minimum Education Requirements for DoD Personnel Involved in Human w88 online casino betting Protection Guidance (August 16, 2012)