IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Board Authority and Composition
- Board Determinations
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Dietary Supplements
- Exempt Review
- Expedited Review
- Full Review
- General Data Protection Regulation
- Incentives in Research
- Informed Consent and Assent
- International Research
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History and Journalism
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Research Advisors
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- Whistleblower Policy
The purpose is to outline the policies and procedures for research advisors.
A research advisor (or sponsor) is an individual who works as mentor to a student, part-time or unaffiliated investigator. This individual shares the responsibility for the ethical conduct or research, making adequate time for consultation with the advisee and monitoring research progress.
An advisee is the principal investigator of a project who requires mentorship by an advisor.
A research advisor is responsible for the overall management of a research protocol in collaboration with the advisee. Management of the research encompasses the ethical, administrative, fiscal, and applied elements of a project.
A research advisor is expected to discuss the general principles of human research ethics and assist the student investigator through the research process. By agreeing to serve on a project, the advisor affirms that s/he has thoroughly read the application materials and that the investigator has not recruited or collected any data prior to application. The advisor must also support the advisee in the conduct of the research project after attainment of IRB or ERC approval and throughout the life of the project until its completion.
The research advisor:
- Serves as an active mentor to the student
- Shares responsibility for ethical conduct of the research
- Ensures that the project is appropriate to the student’s training and experience
- Ensures a sound research design and methods
- Helps the student determine whether a project requires IRB or ERC review
- Guides the student through the application process
- Supports the student in the conduct of the project after approval is attained, including all reporting to the IRB or ERC, until closure
The following investigators must identify a research advisor among Marywood University's full-time faculty, staff or administration:
- All student investigators
- All adjunct or part-time investigators
- All unaffiliated investigators wishing to recruit MU populations or conduct research at MU
Doctoral student investigators usually select their chair as advisor. The full-time requirement for the advisor is waived for adjunct professors teaching research courses only (e.g., usually two-semester courses such as SSW 701/702).
An immediate family member of an investigator may not serve as research advisor. If an advisor separates from Marywood University during the life of a project, a new advisor must be identified and approved by the IRB or ERC by submission of a revision request (see related policies).
A research advisor must complete all appropriate human subjects training. An advisor must also register with IRBNet at www.irbnet.org and apply his/her electronic signature to all initial research applications and any annual renewals.
- The PI obtains an advisor and identifies the advisor on the application form.
- The PI shares the project with the advisor in IRBNet (www.irbnet.org).
- The advisor applies his/her e-signature to the initial submission package and annual renewals (if applicable).
- If there are any changes to an advisor's status, the PI submits a revision request to the IRB or ERC via IRBNet and obtains approval prior to implementation.
- Mandatory Training
- Responsibilities of Investigators and Advisors
- Student Research
05/25/2018 – Updated definitions, requirements and procedures