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
- Departmental Review Boards
- 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
Departmental Review Boards
The purpose is to outline the policy and procedures concerning Departmental Review Boards.
A Departmental Review Board is an ethical body which reviews human research exemption requests for projects to be conducted within a specific department. A DRB is granted review authority by the Office of Planning and Institutional Effectiveness.
Exempt is a type of review allowed under federal regulations for research activities where the involvement of human subjects fits into one or more of the exemption categories as defined in the regulatory requirements at 45 CFR 46.101 (b).
The Exempt Review Committee (ERC), comprised of staff of the Office of Planning and Institutional Effectiveness, is the central clearinghouse which provides oversight for all campus DRBs and the submissions they receive and review. The ERC is also the name of the entity in IRBNet which receives human research exemption requests.
Not Research with Human Participants is a determination which is made by IRB staff if the project does not meet the federal definition of research with humans. When this determination is made, it means that no further review is required and that the investigator may begin the project as written, assuming that the institution has not disapproved.
Review of exemption requests may only be conducted by Departmental Review Board (DRB) members who are not affiliated with the research activities to be conducted.
All individuals responsible for review of exemption requests must have a thorough understanding of regulations and laws (federal, state and local) and institutional policies concerning human research, and they should be well-acquainted with interpretation of the regulations and the exemption categories. Therefore, ethical training for all DRB members, both through the Collaborative Institutional Training Initiative (CITI), and as provided by the Director of Human Participants Protection and Research Compliance, is required.
A DRB must utilize the online submission and management system, IRBNet (www.irbnet.org), to retrieve and review exemption request applications, which are received through the ERC at the website.
A DRB may not review projects involving:
- Educational tests, surveys, interviews or observations of public behavior, where data obtained will be recorded by the investigator/s in such a manner that human subjects can be identified (directly OR via codes), AND any disclosure of their responses outside the research may reasonably place them at risk of criminal or civil liability, or be damaging to their financial, employability, or reputation
- Prisoner research
- Research with children under age 18 involving surveys, interviews or observation of public behavior where the investigator participates in the activities being observed
- Fetus or neonate research
- Collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are not publicly available OR if the information is recorded by the investigator in such a manner that subjects can be identified, directly OR through identifiers (e.g., codes) linked to the subjects
- Audio/visual recording of subjects
- Deception of subjects
- Drugs, internally taken substances, investigational devices, or biologics
- Prospective bio-specimen collection (e.g., tissue, blood, plasma, urine, saliva, etc.)
- Procedures routinely employed in clinical practice (e.g., sensory testing, sensors on skin, EKG, MRI, etc.) or physical activities (e.g., moderate exercise, muscular strength testing, body composition assessment, etc.)
Marywood University currently does not have any active Departmental Review Boards (DRBs).
Please see our Exempt Review of Research policy for a list of exemption categories and exceptions for certain types of research.
Procedure for Submission to and Review by a DRB
- The Principal Investigator (PI) submits a research exemption request application and all necessary materials via IRBNet at www.irbnet.org, selecting Exempt Review Committee (ERC) as the recipient.
- Once reviewed, the ERC publishes an official decision letter to IRBNet. The decision may be:
- not research with human participants
- modifications required
- The IRBNet system sends the PI and all individuals who have been granted full access to the project by the PI an automated e-mail notification, after which the PI logs into IRBNet to access the official determination letter.
- If the project requires modifications, the PI submits them in a follow-up package for the project in IRBNet.
- If the project is approved, the ERC also publishes stamped versions of materials which are part of the informed consent process. Stamped copies must be used by the PI in the research.
Procedure for Establishing a DRB
Any department wishing to establish a DRB must first apply to the Associate Vice-President for Planning & Institutional Effectiveness. It must submit:
- A description of the types of research involving human participants which would normally be undertaken in a School or department, and for which there is sufficient experience to be able to review as minimal risk.
- A statement of the ethical standards with which such activities must comply.
- A description of the reviewing process at the school or departmental level and the mechanisms for forwarding to the IRB those applications which involve more than minimal risk to the human participants. This description must include an identification of the School or departmental members involved in the reviewing committee, and a description of the forms and/or other materials used by the investigators.
- Assurance that current ERC forms, templates and instructions will be utilized.
- Assurance that participation of human participants is voluntary.
- Assurance that the anonymity of participants will be protected and that appropriate procedures for maintaining confidentiality of participants' responses have been made.
- Assurance that records will be maintained, allowing the IRB to perform periodic review of the school or department's experiences in the reviewing process.
- Assurance that the board will consist of an appropriate number of persons as deemed by the IRB.
- Deception in Research
- Exempt Review of Research
- Mandatory Training
- Prisoner Research
07/25/2013 - Updated
07/18/2017 - Removed references to ORSP and former titles; updated prohibited activities to match Exempt Review policy