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 human research performed by students.
An advisee is the principal investigator of a project who requires mentoring by an advisor.
A research advisor (or sponsor) is an individual who works as mentor to specific types of investigator. This individual shares the responsibility for the ethical conduct or research, making adequate time for consultation with the advisee and monitoring research progress.
A student for the purposes of this policy is any individual studying at Marywood University at the undergraduate, graduate, or doctoral level or for personal enrichment, transfer credit, and other non-degree purposes.
All student investigators are bound by the same human research policies and procedures as the rest of the research community at Marywood University. Faculty, staff, administration, or students conducting research with human subjects at Marywood University, or under its sponsorship at another location, must comply with applicable policies, procedures and guidelines for the protection of human subjects.
All research that can be defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge" (45 CFR 46) must be reviewed and approved by the Institutional Review Board for the Protection of Human Participants (IRB) or submitted as an exemption request for review to the Marywood Exempt Review Committee (ERC).
All student applicants must identify a full-time faculty, staff or administrative member as advisor for their proposed project (see Research Advisors policy). For dissertation or thesis committees, this person is usually the chairperson. Both the student researcher and the research advisor must complete all required online training. In addition, the student researcher must apply his/her electronic signature to all submissions via IRBNet, while the advisor must apply an electronic signature to initial and annual renewal/continuing review submissions.
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
In addition to identifying an advisor, a student conducting a study that proposes to involve medical procedures (i.e. medical screening, medical chart determination, blood draws, echocardiography, ultrasound, etc.) must obtain medical supervision. The student must describe who will be conducting such procedures and what their qualifications are to perform such procedures.
Thesis or Dissertation Activities
Because they are typically designed to develop or contribute to generalizable knowledge, all thesis or dissertation activities involving human subjects must be submitted for review by the IRB or ERC. Projects labeled as professional contributions must also be submitted if they meet the definition of research and involve human subjects.
Students wishing to graduate in a given semester need to apply to the IRB or ERC by the end of the semester prior to the one in which they plan to graduate, for example, by the end of the fall semester for a planned spring graduation. This allows ample time for initial review, submission and review of modification(s), approval, implementation and analysis. The only exception is research courses spanning two semesters (e.g., SSW 701/702, PSYCH 421/422), which have a course deadline of February 1 each year.
Students conducting a research project as part of a course which requires review should be mindful of a semester’s timeline. Such students should apply as early in the semester as possible to allow the entire research process to be completed by the semester’s end.
Classroom Research Activities
Student research activities that are intended only to teach research methods may not require IRB/ERC review, so long as certain conditions apply (e.g., no vulnerable populations, no more than minimal risk, results will not be presented or published outside of the classroom, etc.). Research course instructors are asked to review the Classroom Guidelines for questionable projects. The Director of Human Participants Protection and Research Compliance, or his/her designee, will assist with any questions regarding classroom projects.
- 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
- Research Advisors
- Responsibilities of Investigators and Advisors
06/16/2016: Updated sponsor employment status
05/25/2018: Added definitions, information about advisors and reference to Research Advisor policy