Milestone 7

Instructions

Milestone 7: IRB Certifications

Work with your chair to determine any specific instructions or guidance that he or she may have for you.

You may complete this task at any time during the course.

Before submitting an IRB application for your dissertation research proposal, you will need to complete some required certifications. Although your full IRB application will be completed in BUS8105, you will need to complete any required certifications during BUS8100.

Key Information:

1. The National Institute of Health’s (NIH) training on protecting Human Research Participants: Before submitting an IRB application, all research personnel are required to take the appropriate NIH training modules and attach the completion certificates for all study personnel to their IRB application. Training expires after a three-year period. It is the principal investigator’s responsibility to ensure that all research personnel have updated certifications filed with the IRB. Please see below for instructions on how to access the NIH training modules by registering for the Protecting Human Research Participants (PHRP) course.
2. The Health Insurance Portability and Accountability Act (HIPAA): HIPAA is a federal law enacted in 1996 to reform the healthcare industry by improving the privacy and security of patient’s information. HIPPA training is required for all principal investigators who plan to assess participants’ protected health information. When completion of this module is required in order to conduct a proposed research study, the investigator (and all participating researchers) must submit documentation of their training with the IRB application.
3. Principal Investigator Responsibilities: The principal investigator must request IRB approval for any research project involving human participants regardless of sample size. The principal investigator is responsible for designing and implementing his or her research in such a way as to minimize the risk of potential harm to participants and to have a plan in place to ameliorate any adverse consequences that participants may experience. The principal investigator will not collect any data until an approval by the IRB of their project is received. The principal investigator will ensure that procedures for the protection of human subjects are followed as described in their approved applications and required by policy and federal law.
4. Education Requirements: In order to ensure an adequate understanding of the research process, the principal investigator must hold at least a master’s degree. In the case where the principal investigator does not meet this educational requirement, then he or he must have a co-investigator that meets this requirement. For students who are conducting research as part of their program requirements, this co-investigator will be the faculty member charged with overseeing their project.

Review the following:

IRB Policy Manual and IRB Overview Presentation

Register for the Protecting Human Research Participants (PHRP) course by following the instructions below. Registration is free.

• Click here to access the South University Online Library IRB site.
• Click on the Federal Regulations tab.
• Click on the link to access The Training on Ethical Practice in Research with Human Subjects.
• Complete the enrollment form in its entirety including creating a username and password to create an account.
• Please note that the Institution Name pre-populates to “South University – Columbia” for all South University online and campus students.

You may also need to complete the following:

• HIPAA Training I
• HIPAA Training II

Submission Details:

• Post completion certificates to the Milestone 7 Submissions Area.
• Notify your chair (e.g., e-mail) when you have submitted the assignment.

Note: A successful dissertation requires self-directed behaviors. To successfully pass each dissertation course, you must successfully complete (pass) each milestone presented in the course materials. Additionally, you must complete the milestones in the order they are presented in the course. The tasks in some milestones may take you more than a week to complete. Finish each milestone before you move on to the next milestone. In your planning, also allow time for feedback from your dissertation chair/committee and revisions as part of completing each task.