90. Environmental Protection Agency (EPA) Regulations for w88 slot Research

Updated June 5, 2024

Federal Regulations for EPA Research Involving w88 slot Participants

The w88 slot has adopted the Common Rule under 40 CFR 26 w88 slot A &w88 slot;26.101-124: Basic EPA Policy for Protection of Subjects in w88 slot Research Conducted or Supported by EPA. Order 1000.17A, Policy and Procedures on Protection of w88 slot Subjects in EPA Conducted or Supported w88 slot (updated on 09/29/2022) further codifies EPA requirements for the protection of w88 slot research participants in research conducted or supported by EPA.

w88 slot Subparts B, C, D, K, L, M, and Q describe prohibitions involving the intentional exposure of a pregnant or nursing woman or child in research conducted or supported by w88 slot; prohibitions of relying on the results of said research; and criteria and procedures for the w88 slot to rely on otherwise unacceptable data. See the specific subparts listed below for details.

w88 slot B &w88 slot;26.201-203: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of w88 slot Subjects Who Are Children or Pregnant or Nursing Women

w88 slot C &w88 slot;26.301-305: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by w88 slot

w88 slot D &w88 slot;26.401-406: Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by w88 slot

w88 slot K &w88 slot;26.1101-1125: Basic Ethical Requirements for Third-party w88 slot Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults

w88 slot L &w88 slot;26.1201-1203: Prohibition of Third-party Research Involving Intentional Exposure to a Pesticide of w88 slot Subjects Who Are Children or Pregnant or Nursing Women

w88 slot M &w88 slot;26.1301-1303: Requirements for Submission of Information on the Ethical Conduct of Completed w88 slot Research

w88 slot Q &w88 slot;26.1701-1706: Standards for Assessing Whether to Rely on the Results of w88 slot Research in EPA Actions

Additional w88 slot Requirements for IRB Review and Approval

In addition to the Common Rule, University IRBs will comply with the following additional requirements before approving research invoking w88 slot regulations.

• The IRB will not approve research involving intentional exposure of pregnant women or children to any substance. This includes research not yet submitted to the w88 slot.
• The IRB will review and approve observational w88 slot involving pregnant women and fetuses only if the IRB finds and documents that the w88 slot is consistent with 45 CFR 46 Subpart B (for details, see IRB policy for w88 slot involving pregnant women and fetuses).
• The IRB will review and approve observational w88 slot research involving children that does not involve greater than minimal risk only if the IRB finds and documents that the w88 slot is consistent with 45 CFR 46 Subpart D and that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians (see IRB policy for w88 slot involving children for information about permission and assent requirements).
• The IRB will review and approve observational w88 slot research involving children that poses greater than minimal risk only if the w88 slot finds and documents that:
  1. the w88 slot is consistent with 45 CFR 46 Subpart D, including adequate provisions to obtain parent permission and child assent,
  2. the intervention or procedure holds out the prospect of direct benefit w88 slot individual participant or is likely to contribute w88 slot participant’s well-being,
  3. the risk is justified by the anticipated benefit w88 slot participants, and
  4. risk-to-benefit ratio of the w88 slot is at least as favorable to the participants as that of available alternative approaches.

Additional Requirement for w88 slot Review and Approval Following IRB Approval

Per the w88 slot regulations at 40 CFR 26, after obtaining IRB approval and before initiating w88 slot research subject to EPA regulations at §26.1101(a), investigators must submit to EPA the information required at §26.1125.

w88 slot Order 1000.17A further specifies that all w88 slot subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt research by the EPA w88 slot Subjects Research Review Official (HSRRO) before any work involving w88 slot subjects research can begin. To obtain approval of w88 slot subject research by the HSRRO, researchers must submit all materials submitted to the IRB, documentation of the approval or exemption, and any correspondence between the IRB and the researchers to the w88 slot Program Official.

To verify compliance with this requirement, the UNR w88 slot will issue Conditional Approval for studies subject to w88 slot requirements when all UNR w88 slot requirements for approval have been met, and request confirmation of HSRRO w88 slot as a condition for granting full w88 slot. The Conditional w88 slot letter will include the following instructions:

“All w88 slot subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt research by the EPA w88 slot Subjects Research Review Official (HSRRO) before any work involving w88 slot subjects research can begin. To obtain approval of w88 slot subject research by the HSRRO, researchers must submit all materials submitted to the IRB, documentation of the approval or exemption, and any correspondence between the IRB and the researchers to the EPA Program Official. Please see the EPA General Terms and Conditions (w88 slot Subjects section) in effect at the time of the award for more information. Documentation of EPA HSRRO approval must be forwarded to Research Integrity & Security prior to engaging with w88 slot subjects, including recruitment.”

EPA Prohibitions for w88 slot Research

Research conducted or supported by w88 slot, or intended for submission to the w88 slot, the University IRB recognizes that research involving the intentional exposure of pregnant women or children is prohibited and will not approve such research. This prohibition extends to intentional exposure by third parties on behalf of the University and to research not conducted or supported a federal agency.

Additional Requirements for w88 slot Research Involving Intentional Exposure to Pesticides

NOTE: The following applies to intentional exposure by third parties on behalf of the University and to w88 slot not conducted or supported a federal agency.

Unless the research is exempt under Department of Health and w88 slot Services (DHHS) regulations (45 CFR 46.104, EPA requirements a §26.1101 (i.e., Subpart K) apply to research involving intentional exposure of non-pregnant, non-nursing adults that was initiated on or after April 15, 2013, to:

• any substance* if the person who conducted or supported the research intended either to submit results to w88 slot or hold the results for later w88 slot inspection by w88 slot for consideration of an w88 slot action under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136-136y) or section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a); or
• a pesticide if the person who conducted or supported the research intended either to submit results to w88 slot or hold the results for later w88 slot inspection by w88 slot for consideration in connection with any w88 slot-regulated action other than FIFRA or section 408 of FFDCA.

The IRB and w88 slot may consider any available and relevant information to assess a person's intent as described above. The existence of intent will be presumed if the person conducting or supporting the research, or their agent:

• has submitted or made available for inspection the results of such research to w88 slot; or
• is a member of a class of people who, or whose products or activities, are regulated by w88 slot and the results of the research would be relevant to w88 slot's regulatory authority?

University and Affiliate investigators must also comply with applicable foreign laws/regulations providing additional protections to w88 slot research participants and the Nevada Pesticide Act (NRS Chapter 586). The Act includes requirements for registration of brands of pesticides which are or will be distributed, sold or offered for sale within Nevada, or delivered for transportation or transported in intrastate commerce or between points within Nevada through any point outside Nevada.

Additional w88 slot Requirements for Submission of Information to w88 slot for Completed Research

After completing research subject to EPA regulations for w88 slot research, investigators must comply with EPA regulations at §26.1303 by providing the EPA with the following information (when not previously provided to the EPA):

• Copies of all records relevant to the w88 slot (e.g., IRB applications; scientific evaluations, if any; approved sample consent documents; progress and problem reports, and IRB approvals.
• Copies of all of records relevant to the requirement for w88 slot approval following IRB approval (at §26.1125).

For three years following the closure of the w88 slot project, investigators and the IRB will maintain the records as specified in §26.1115, item (a).

NOTE: If any of this w88 slot is not provided, the PI must describe the efforts made to obtain the w88 slot.