Owner: Vice President of Academic Affairs 

Author: IRB Policy Subcommittee (2019 - 2021)

Effective Date: October 8, 2021

Next Review Date: Periodically at the discretion of the IRB Chair and VPAA

 

Applicable Laws, regulations, compliance: U.S. Code of Federal Regulations (CFR), Title 45 Part 46, and 21 CFR part 50 and 56, and the following core historical reports: Nuremberg Code, Declaration of Helsinki, and the Belmont Report

 

1. Purpose

As a Catholic institution of higher learning, The College of Saint Scholastica (CSS) recognizes the need for research activities that involve human beings serving as participants. CSS is aware of its obligation to protect the rights of individuals who participate in human subjects research studies. Consequently, CSS has established and empowered an Institutional Review Board (IRB) to review all research investigations, externally funded or not, conducted by its students, faculty, staff, and administration involving human beings as research subjects. CSS, through its IRB, meets its responsibility for ensuring that the safety, welfare, and rights of all subjects are adequately protected. 

The components within this policy are intended to comply with the Federal Policy for the Protection of Human Subjects, also known as The Common Rule and outline in the U.S. Department of Health and Human Services Code of Federal Regulations Title 45 Part 46, and 21 CFR part 50 and 56, and the following core historical reports: 

• Nuremberg Code (1949)
• Declaration of Helsinki (1964)
• Belmont Report (1976)

 

II. Definitions

Research: A systematic investigation designed to develop or contribute to generalizable knowledge.  

Systematic Investigation Systematic means using a careful system or method. In other words, systematic research is formal and planned, rather than haphazard and done randomly. Here are some suggestions of what a systematic investigation may include: ●   The activity attempts to answer research questions/test hypotheses.

• The activity is methodologically driven, i.e., it collects data or information in an organized and consistent way.
• Data are analyzed or information collected in some way, be it quantitative or qualitative. 
• Conclusions are drawn from the results.

Generalizable Knowledge The intent to develop or contribute to generalizable knowledge makes an activity research.  Generalizable knowledge is knowledge that is expressed in theories, principles, or statements of relationships that can be generally applied to our experiences.  Activities designed to contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program.  The information is collected to share with others in a discipline and is created to make a broad statement (conclusion) about a group of people, procedures, programs, etc.

   To be considered “generalizable knowledge” the activity would include the following concepts:

• The information gained is intended to contribute to a theoretical framework of an established body of knowledge.
• Results are expected to be generalized to a larger population beyond the site or population studied.
• Results are intended to be replicated in other settings.
• The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study.
• Most academic institutions consider a thesis or dissertation to be generalizable knowledge (relevant only if it includes human research).

Human subject is defined as a living individual about whom an investigator obtains: 

• Information or biospecimens through intervention or interaction with the individual. 
• Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.  

A human subject means an individual who is or becomes a participant in a clinical investigation, either as a recipient of the test article or as a control. A subject may be in normal health or may have a medical condition or disease. The FDA has another caveat: for research subject to FDA device regulations, subject means a human on whose specimen an investigational device is used or as a control (21 CFR §50.3(g).

Informed Consent: The ethical principle of respect for persons requires that persons who participate in research have the opportunity to choose what will or will not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.  The informed consent process involves three key features: (1) disclosing to potential research subject’s information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether to participate in the research. 

Risk: The relative probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both probability and magnitude may vary from minimal to significant. Minimal risk is when the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 

IRB Composition: The IRB must have at least five (5) members with sufficiently diverse race, gender, and cultural backgrounds to promote adequate review of CSS sponsored or conducted research. Collectively, the IRB shall possess the competence and experience and diversity of its members’ backgrounds necessary to: 1) review research activities from the point of view of the subjects as well as the researchers; and 2) discern whether proposed research is consistent with CSS standards for professional conduct, and applicable law and regulations. Consistent with these goals and the federal regulations (45 CFR §46.107), the composition of the IRB shall therefore consist of: 

• At least two faculty members from each School.
• At least one person with advanced training and experience in conducting scientific investigations.
• At least one person whose primary work is not in the area of scientific investigations.
• At least one person who is not, and whose immediate family are not, affiliated with CSS. 

At its own discretion, the IRB may invite experts on specific topics as needed to attend and serve in a consultant capacity on a specified review to provide additional information and guidance. These individuals may not serve as voting members. 

Signatory Official: The President of the College of St. Scholastica is the Signatory Official in accordance with the provisions of the Federal Wide Assurance. The Institutional Official is the individual authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. The VPAA of the College of St. Scholastica is the Human Subjects Contact Person and also serves as an Institutional Official.

 

Human Subjects Contact Person / Institutional Official (IO): The Vice President of Academic Affairs is the Human Subjects Contact Person in accordance with the provisions of the Federal Wide Assurance.  The VPAA, together with the President of The College of St. Scholastica, serving as Institutional Officials, are ultimately responsible for the following:  

1. Foster, support and maintain an institutional culture supporting the ethical conduct of all research involving human subjects. 
2. Ensure the CSS IRB has the resources and support necessary to comply with all institutional policies and with federal regulations and guidelines that govern human subjects research, including:  
   1. Ensure CSS IRB staffing is commensurate with the size and complexity of the research enterprise. (45 CFR § 46.108(a)(1)).
   2. Ensure adequate CSS IRB space, equipment, materials, and technology.
   3. Ensure sufficient resources for the production, maintenance, and secure storage of CSS IRB records. 
   4. Ensure sufficient resources for compliance activities and investigation of noncompliance. 
   5. Ensure access to legal counsel. 
   6. Support educational opportunities related to human research protections for CSS IRB members, CSS IRB staff, and all members of the research community. 
3. Oversight of the CSS IRB within The College of St. Scholastica and ensuring the CSS IRB functions independently. 
4. Appointment and oversight of the CSS IRB Chair. 
5. Oversight over the conduct of research conducted by all researchers within the Organization. 
6. Ensure investigators fulfill their responsibilities.  
7. The VPAA and the CSS President have the authority to further review and disapprove research but cannot approve research that has been disapproved by the IRB (45 CFR § 46.112). The VPAA is kept informed of research activities and decisions of the CSS IRB through on-going and proactive discussions with the CSS IRB Chair, CSS IRB Administrator and the CSS IRB Annual Report.
8. Advise Organizational officials on key matters regarding research conducted within the Organization.   

CITI: The Collaborative Institutional Training Initiative (CITI) Program is dedicated to promoting the public’s trust in the research enterprise by providing high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organizations and individual learners.  All researchers and IRB members are required to submit proof of this training. Specific training modules and renewal periods vary by role. 

IRBNet: Our electronic review and submissions research management and compliance software. IRBNet was adopted by the CSS IRB in 2019.

III. Policy

Federal Wide Assurance: It is the policy that the CSS IRB will file and maintain an agreement with the Department of Health and Human Services (HHS) through the Office of Human Research Protection (OHRP) through a Federal Wide Assurance (FWA). CSS has declared that all institutional components listed under CSS FWA Assurance Number: FWA00027482 must comply with this assurance. In addition, the CSS IRB is registered with HHS, CSS OHRP Registration Number: IRB00011463.

IRB Review and Approval: Human subject research requires IRB review and approval.  Investigators cannot begin research involving human subjects without IRB approval. In accordance with §46.109, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. In accordance with 46.111, the IRB shall determine that all of the following requirements are satisfied in order to approve research under this policy: ●   All research programs which involve human subjects must be reviewed by, and receive the approval of, the CSS IRB prior to initiation of the protocol. 

• Participation of a human subject in any experiment must be voluntary and the information provided to gain subject consent must be adequate and appropriate. Potential participants must be informed that they are not obligated to participate and that appropriate alternatives to participation may be available.
• The risks to the subject must be acceptable when measured against any possible benefit and by the importance of the knowledge to be gained as a result of participation.
• Research and training activities involving human subjects must be supervised by qualified persons.    

Policy Authority: The IRB is an autonomous entity that issues binding decisions. By federal regulation, institutional officials may not approve research that has been disapproved by the IRB. Research that has been approved by the IRB may be subject to further appropriate 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 an IRB. (§ 46.112 Review by institution.)

Policies and procedures are outlined in The College of St. Scholastica Manual Governing Research Involving Human Subjects and detailed in the IRB’s 40 Standard Operating Procedures enumerated below:

CSS IRB SOP #01 - CSS IRB Federalwide Assurance (FWA) CSS IRB Registration and Administration

CSS IRB SOP #02 - IRB Charter, Appointments, and Administrative Structure 

CSS IRB SOP #03 - IRB Records       

CSS IRB SOP #04 - CSS IRB Meeting Management, Function, and Operation                                

CSS IRB SOP #05 - IRB Membership 

CSS IRB SOP #06 - Defining Research v Quality Improvement w/ Checklist 

CSS IRB SOP #07 - Determination of Human Subjects Research and Guide

CSS IRB SOP #08 - CSS Students as Research Subjects and School Age Children as Research

Subjects – Coercion and Undue Influence

CSS IRB SOP #09 - Student Class Assignments v Research

CSS IRB SOP #10 - Exempt Determination Review Process and Checklist

CSS IRB SOP #11 - Expedited Review Procedure / Checklist  

CSS IRB SOP #12 - Criteria for IRB Approval Of Research and Checklist

CSS IRB SOP #13 - IRB Determination of Minimal Risk                                                            

CSS IRB SOP #14 - Deception in Research w/ Sample Debriefing Scripts             

CSS IRB SOP #15 - Waiver or Alteration of Consent (Waiver Request Form Reviewer Checklist)                        

CSS IRB SOP #16 - Informed Consent w/ Checklist and Templates 

CSS IRB SOP #17-  IRB Meeting Minutes (Expedited/Exempt Approval Form) 

CSS IRB SOP #18 - Waiver Documentation of Consent  

CSS IRB SOP #19 - Cooperative Research Authorization Agreements and Sample Agreements

CSS IRB SOP #20 - Continuing Review of Approved Research  

CSS IRB SOP #21 - Limited IRB Review (LIRB) 

CSS IRB SOP #22 - Modifications to Previously Approved or Exempt Research

CSS IRB SOP #23 - Vulnerable Subjects/Populations 45 CFR 46 Subpart B, C and D  

CSS IRB SOP #24 - Reporting an Unanticipated Problem Involving Risks to Subjects or Others /

Adverse Event and Report Form 

CSS IRB SOP #25 - Focus Groups / Video/Audio and Digital Recordings with Review

Application Template/Sample Consent Forms

CSS IRB SOP #26 - Survey Research and Internet Research  

CSS IRB SOP #27 - Initial Review 

CSS IRB SOP #28 - Controverted Issues   

CSS IRB SOP #29 - Extending the CSS FWA To Cover Collaborating Independent Investigators or Institutional Investigators and Sample Agreement

CSS IRB SOP #30 - Non-Compliance with Human Subjects Research Policies/ Guide and Report Form  

CSS IRB SOP #31 - Suspension or Termination of IRB Approval and Report Form   

CSS IRB SOP #32 - Study Closure  

CSS IRB SOP #33 - Research Involving Children and Investigator/Reviewer Checklist 

CSS IRB SOP #34 - Research Involving Prisoners  

CSS IRB SOP #35 - Research Involving Pregnant Women and Reviewer Checklist   

CSS IRB SOP #36 - Conflict of Interest (COI) and COI Disclosure for IRB Members 

CSS IRB SOP #37 - IRB Human Subjects Research Required Education    

CSS IRB SOP #38 - Confidentiality and Privacy 

CSS IRB SOP #39 - International Research / Community Based Research  

CSS IRB SOP #40 - Research Studies Involving Investigational Medical Devices.