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Policies and Procedures

Misericordia University (MU) established an Institutional Review Board (IRB) to review all research involving human subjects and to implement institutional policies and procedures regarding such research. The use of human subjects in research imposes both ethical and legal responsibilities upon the university, the IRB, and those conducting the research to ensure that the rights and welfare of those subjects are adequately protected. The primary function of the IRB is to protect the rights of human subjects. Review and approval by the IRB are meant to aid both the subjects and the researchers by bringing scrutiny to research protocols by a group of peers who can objectively assess the potential risk and accommodations made to minimize them.

The Misericordia University IRB is located within the Office of the Vice-President of Academic Affairs (VPAA) and the University President serves as the Institutional Official (IO) to maintain a separation from real or perceived conflicts of interest at the University. The IRB must act autonomously as an objective body and uphold the highest ethical standards in the conduct of human subjects research.

Applicability

According to 45 CFR 46, research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, and a human subject means a living individual about whom an investigator (whether professional or student) conducting research:

1.   Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 

2.   Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens 

It is the responsibility of researchers to refer their protocols (planned research studies) to the IRB whenever human subjects are used in research, even if the researcher does not consider the subjects to be at risk. Current law places the burden for negligence and harm directly on the researcher and the university. These policies and procedures are executed for the specific purpose of protecting human subjects.

Once initiated, all human subjects research must be conducted in full compliance with IRB policies and procedures.  This includes research that is conducted on or off campus by University employees or students. Questionnaires, interviews, surveys, tests, observations, and experiments constitute research, even if the work is preliminary (pilot work) to a more extensive study.  For information as to whether a project requires IRB review or if you have questions about these policies and procedures, please contact the IRB office by visiting the MU IRB website (http://www.misericordia.edu/irb).

 

The Policies and Procedures below have recently been updated and will be implemented 10/1/2020.  The overview tables provide an abbreviated description of the revised and newly added policies.

Policy Name

Old Policy/Procedure

Updated Policy/Procedure

Debriefing

Described when debriefing was required

Now also outlines specifically what is to be included in the debriefing

Documentation of Informed Consent

Outlined the criteria for qualification

Now includes the definition of a digital signature

HIPAA

Provided links to guidance documents 

Comprehensively outlines the regulation as well as HIPAA authorization and waiver or alterations of HIPAA authorization

Cooperative Research with Another Institution

Reviewed the process for review of research to determine whether a cooperative agreement is optimal and documentation of said cooperation

Now states a required use of a single IRB-of-Record for inter-institutional research, exclusions, and required paperwork

Institutional Board Membership

Job responsibilities were bulleted

Job responsibilities more explicitly outlined in regard to position requirements/recommendations, removal, training, application review, responsibilities at meetings, quality assurance monitoring, reporting, assurance of IRB independence, assistance to investigators, appointment, and policy.

An optional vice-chair position has been added as well as new and existing member and staff training requirements.

Appealing an IRB Review

Reviewed the appeal process

Now provides clarification that this is not a formal appeal procedure

Protocol Deviations/Modifications

Outlined the review process for modifications, unanticipated risk, and noncompliance separately

Now, modifications, unanticipated risks, and noncompliance are in one section.  The noncompliance/research misconduct section has been revised to outline a thorough process, decisions, definitions including examples, and reporting.

 

New Policy Name

Brief Description

Recruitment and Advertising

Specific guidance regarding what should be included in advertisements, flyers, etc. has been outlined.

Informed Consent

The policy now states that informed consent will be required for all levels of review.  Nothing has changed as this was already in practice.

Student Research

A new policy that addresses the responsibilities and expectations of both the student researcher as well as the faculty/advisor

Research with MU Students as Participants

A new policy that specifically outlines recruitment, voluntariness, research during class time, confidentiality, and privacy concerns/guidance when using MU students as research participants

Audiovisual Digital Data

A new policy that addresses the collection and use of audio, video, or digital recording including images or voices of research participants. Guidance and policy surrounding archiving, secondary data analysis, and use for educational/presentation purposes are outlined. 

Internet-Based Research

A new policy that specifically outlines recruitment, data collection and survey research, procedures, informed consent, data storage and disposal, research with children, incentives/compensation, and deception guidance when conducting internet-based research

Research Involving Non-English Speaking Participants

A new policy that reviews considerations when including Non-English speaking participants as well as the short form informed consent method and policy regarding translated documents and the use of interpreters

Confidentiality of IRB Proceedings

Although already in practice, IRB member responsibility to maintain confidentiality, attendance at IRB meetings, confidentiality of minutes, protocols, study documents, and informed consent forms were outlined.

Quality Assurance and Audit Procedures

Fully outlines the audit procedure, who can perform an audit, what and who may be audited, and procedures following an audit

Definitions

Numerous new definitions have been added

Policies and Procedures