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8.8 Summary
The IRB/IEC represents the unbiased third‐party reviewer for all the essential documents which comprise the clinical trial plan. The protection of the rights, well‐being and safety of human subjects is the primary role of the IRB/IEC.
In order that this role is performed in a manner which is credible the ICH E6(R2) guideline calls for certain criteria to be in place so that as needed the procedures that were followed, the qualification of the people who followed the procedures and the records maintained of the work are complete, reliable, and accurate.
Avoiding ethical pitfalls should be inherent in the culture of the medical community that conducts human clinical trials, but history has shown that is not always the case. The IRB/IEC requirements are necessary and not likely to be set aside.
Knowledge Check Questions
1 Why do you think that the IRB/IEC requirements call for one member to be independent of the institutional/trial site? Please provide a brief narrative explaining your answer.
2 While not a common practice today, in the past prisoners were often called upon to participate in clinical trials. Would you consider prisoners to be a vulnerable population? If so, what might be some of the issues which would envision arising when an IRB/IEC is reviewing a protocol which allows them to be subjects in a clinical trial?
3 According to ICH E6(R2) the IRB/IEC must have written standard Operating procedures in place for all the functions they implement. True or False?
4 A quorum for an IRB is always three members being present, Correct? If not where is the number for a Quorum found?
5 According to regulatory authority reports one common deficiency for IRB/IECs is inadequate ongoing review of studies. Can you briefly explain how you might avoid such a deficiency if you were part of an IRB/IEC.
References
1 1 FDA (2002). Code of Federal Regulations Title 21 CFR 56.115 (b). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.115 (accessed 6 April 2020).
2 2 EU Regulation (2014). REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECEU Regulation 536, Article 58 ‐ Archiving of the clinical trial master file. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol‐1/reg_2014_536/reg_2014_536_en.pdf (accessed 6 April 2020)
3 3 FDA Bioresearch Monitoring (BIMO)(2021). Inspection Metrics. https://www.fda.gov/science‐research/clinical‐trials‐and‐human‐subject‐protection/bimo‐inspection‐metrics (accessed 6 April 2020)
9 Investigator and Sponsor Roles and Responsibilities
Karen A. Henry
GCP Key Point
Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s). Source: ICH [1]
9.1 Introduction
The ICH GCP guidance (E6(R2)), as it is today, reflects the attempt to prevent harmful consequences of experimentation on humans over centuries (Chapter 1 History). In societies, there have always been someone seeking to sell the next “wonder drug” and a “scientist” who is curious about how human bodies work and how they would respond to new or modified vaccines, treatments, or potential cures. Per ICH E6(R2), the sponsor is “an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial” (ICH E6(R2) 1.53) and the investigator is “a person responsible for the conduct of the clinical trial at a trial site” (ICH E6(R2) 1.34). ICH has provided guidance on the responsibilities of the sponsor (ICH E6(R2) 5) and of the investigator (ICH E6(R2) 4). Although the sponsor and investigator essentially collaborate to create and execute a clinical trial with an aim to discover new or improved vaccines, treatments, or potential cures new treatments, the sponsor and investigator have specific and independent responsibilities that are stipulated by ICH (E6(R2)) and perhaps regional or local regulatory requirements.
In this chapter, we will present the responsibilities of sponsors and investigators in the context of the general trial process and provide the reader with references to book chapters that describe the responsibilities in greater detail. Plate 4 Individual Clinical Trial – Overview of Investigator and Sponsor Responsibilities displays the individual responsibilities in the context of the chapter content in the book and the reader may refer to the relevant sections of ICH E6(R2) for lists of the responsibilities by player.
9.2 Objectives
The objectives of this chapter are to:
Define sponsor and investigator and various forms
Describe sponsor and investigator responsibilities in the context of the clinical trial process
9.2.1 Definitions
Here are some important definitions for the sponsor and investigator players involved in conducting a clinical trial. A clinical trial will have,
1 The Sponsor:A sponsor who is “an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial” (ICH E6(R2) 1.53). The sponsor will be interested in collecting data from a series of clinical trials to prove the safety and efficacy of an investigational product so that they may apply to the governing regulatory authority(ies) for approval to market the product. The sponsor will seek out investigators who have access to the study population, i.e., healthy volunteers or the patients who have the indication being studied in the trial.The sponsor for a clinical trial may contract with a Contract Research Organization(s) (CRO), which is a person or an organization (commercial, academic, or other) contracted to perform one or more of a sponsor's trial‐related duties and functions (ICH E6(R2) 1.20). The CRO will bear the GCP and regulatory responsibilities for the contracted tasks (Chapter 15 Trial Resourcing and Outsourcing).
2 The Investigator:The investigator is “a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator” (ICH E6(R2) 1.34). The investigator, or a qualified designee, will administer the investigational product to the study subjects.The investigator may subcontract or delegate tasks to others; however, unlike the sponsor, the investigator maintains full GCP and regulatory responsibilities for the delegated
