Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- University Policy on Human Research
- Whistleblower Policy
The Policies and Procedures of Marywood University's Institutional Review Board (IRB) for the Protection of Human Participants (or subjects) in research are grounded in the University's self-imposed commitment to safeguard the rights and welfare of humans in all research under its sponsorship and to serve as their protector on behalf of the community of persons of which the University is a part. The University seeks to comply with all federal, state and local laws and regulations requiring the establishment and operation of such a board (See Office for Human Research Protections, "Code of Federal Regulations," 45 CFR 46 and the Food and Drug Administration, 21 CFR 50 and 21 CFR 56).
Research by faculty, staff, or students of Marywood University involving human participants, conducted at Marywood University or under its sponsorship at another location, must comply with applicable policies, procedures and guidelines for the protection of human participants.
All research that can be defined as "a systematic investigation designed to develop or contribute to generalizable knowledge" (45 CFR 46.102) must be submitted to and reviewed and approved by the IRB or submitted as an exemption request to the Marywood Exempt Review Committee (ERC) for review and approval. All human research subject to FDA regulations must be reviewed by the IRB. Research activities that are intended only to teach research methods to students may not require IRB/ERC review, depending on the activities and populations involved. Research course instructors should obtain Guidelines for Student Research Activities by contacting the Director of Human Participants Protection and Research Compliance. The Director assists with any questions regarding student research activities.
IRB/ERC review is also required of research carried out under the sponsorship of an institution other than Marywood University but which is performed on the premises of Marywood University, even if the research has already been approved by the IRB at the sponsoring institution or elsewhere. Researchers outside of Marywood University must identify a faculty or administrative sponsor from Marywood University.
The IRB or ERC is to provide an independent determination concerning:
- The safeguarding of the rights and welfare of individual research participants, and
- Whether these participants are placed at risk, and if risk is involved, whether:
- the risks to the participant are so outweighed by the sum of the benefit to the participant and the importance of the knowledge to be gained as to warrant a decision to allow the participant to accept such risks;
- the rights and welfare of participants are protected;
- informed consent will be obtained by adequate and appropriate means;
- the conduct of the activity will be reviewed at timely intervals.
The IRB or ERC may pass judgment on research design, but only to the extent that such design affects the rights or well-being of human participants. In analyzing the risk/benefit ratio of a research activity, both the stated goals and the scientific merit of the research will be considered.
Research covered by this policy that has been approved by the IRB or ERC may be subject to further review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by the IRB or ERC.
According to federal regulations, IRBs are charged only with the protection of human research participants. As such, it is not within the IRB's (or ERC's) purview to protect investigators or members of the research team. For research conducted by students, faculty advisors (also called sponsors) are responsible for making sure that students do not put themselves in dangerous situations while conducting research.
Important Note about Research Activities
No research activities, such as subject recruitment, enrollment, the consent process, data collection or data analysis, may begin until official IRB or ERC approval has been granted.
Members of the research team (principal investigator, co-investigators, sponsors/advisors, research assistants, etc.) may not enroll in their own projects as subjects.
06/08/2017 - Updated ERC link and corrected office name
06/12/2017 - Adjusted regulatory reference
07/18/2017 - Correction to punctuation