Federal regulations require all research projects involving human subjects to be reviewed 和 approved by a qualified Institutional Review Board (IRB). The IRB provides oversight of all scholarly research activities involving human subjects to ensure that ethical st和ards are followed 和 that the rights, welfare 和 well-being of participants are protected. This is outlined in the Code of Federal Regulations (45 CFR Part 46, subparts A-D) for the protection of human subjects in biomedical 和 social-behavioral research, 和 in accordance with institutional policy 和 procedures. This includes any research involving human subjects, conducted under the auspices of AACC, in which the principal investigator intends to present or publish findings outside of AACC to contribute to a larger body of generalizable knowledge. 

IRB review may not be required for research conducted for internal assessment purposes 和/or to fulfill state or federal requirements unless the intent includes publishing findings to a broader audience beyond AACC.                                                                                                         

Application Procedures

All research involving AACC faculty, students or staff requiring IRB review must receive IRB approval prior to the initiation of the proposed research study. This includes research proposed by third parties such as individuals 和/or institutional review boards outside of AACC.   

Investigators must submit the following documentation (as applicable):

• Fully completed IRB application, which includes a detailed description of the research protocol (e.g., the rationale for the study, 研究问题, 假设, 研究方法, selection of subjects including sampling methods, potential benefits/risks, managing confidentiality, compensation of subjects, 等.)
• Copies of questionnaires/survey instruments, interview/focus group guides or other materials that will be used with research participants over the course of the proposed study
• Evidence of completion of the CITI (Cooperative Institutional Training Initiative) Human Subjects Research-Social-Behavioral-Educational (SBE) Comprehensive training. Contact the IRB administrator at priairb@dctdsj.com for CITI program training information.
• Informed consent forms 和 related materials, including any advertisements/recruitment documents
• Copy of any external IRB approvals
• Approval forms from applicable government agencies

IRB应用程序

Investigators should submit one of the following applications for IRB approval:

1. Request for Exempt Status
   Research in which the only involvement of human subjects will be in one or more of the categories eligible for exemption under 45 CFR 46 or 21 CFR 56.104. Exempt research requires IRB initial approval but is then exempt from further review. If there are any substantive changes made to exempt research, the new proposed study must be submitted to 和 approved by the IRB.
2. Proposal for Expedited Review
   Research that (1) presents no more than minimal risk to human subjects, 和 (2) involves only procedures listed in one or more of the categories eligible for expedited review under 45 CFR 46.110 和 21 CFR 56.110.
3. Proposal for Full Board Review
   All research that does not qualify for exempt status or expedited review requires full board review.
4. Proposal for Continuing Review or Protocol Modification
   Previously approved research studies that require IRB reapproval.

电子邮件 priairb@dctdsj.com to request the application that best suits your needs. Send your completed application form 和 supporting materials as an attachment back to priairb@dctdsj.com 要求提交.

鸣谢

You will receive an acknowledgment within 48 hours from our IRB Coordinator 和 your project will receive a unique number for tracking purposes.

Project Status 和 Notification

Once logged, members of the IRB will review your project 和 make a decision. Allow up to 25 business days. Should the IRB require further editing or additional documents, you will be asked to provide this information.

Once a decision has been reached, the IRB coordinator will communicate the decision to you in writing.