December 2020

In 1996, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed “Guidance for Industry Good Clinical Practice (ICH GCP E6 (R2)).”   This document provides a unified standard for the European Union (EU), Japan, and the United States to comply with the regulatory authorities in these countries.  

The JHM IRBs comply with ICH GCP guidance (E6) only to the extent that it is compatible with FDA and DHHS regulations. GCP standards contained in the ICH document are not regulatory requirements in the United States. 

However, for industry-sponsored studies with contract requirements for institutional adherence to ICH GCP guidance (E6), the JHM IRBs will comply with all of the GCP statements outlined in ICH-GCP guidance (E6), provided that (i) the PI indicates in the eIRB application that the sponsor requires the IRB review process to comply with ICH standards (ICH GCP E6 R2 3.1), and (ii) ORA confirms it is a contractual requirement.

ICH GCP requires the following:

• completion of additional training for study team members.
• The available nonclinical and clinical information on an investigational product is adequate to support the proposed clinical trial.
• confirmation that all GCP standards will be followed during the research
• submission of additional materials and information in eIRB to complete the review (PI’s CV)
• PI responsibility for reporting requirements, including termination or suspension of the research study by the PI, sponsor, or IRB (see 4.12 of ICH GCP guidance E6)
• additional elements of informed consent (see 4.8 of ICH GCP guidance E 6)

A sample investigator checklist that may be used when a study is to be done in accord with ICH GCP requirements can be found at:  http://www.hopkinsmedicine.org/institutional_review_board/about/compliance_monitoring/researchers_tool_kit/sample_gcp_checklist.doc.

The ICH has published a list of the 20 required elements for consent forms used in studies of investigational pharmaceutical agents (ICH GCP E6 R2 4.8.10). When applicable, pharmaceutical sponsors write consent forms to meet the GCP standard.

Note: The GCP document of required elements for consent is not a regulatory requirement in the United States. FDA regulations on consent do not require all consent elements recommended by GCP guidance. The additional elements for GCP are bolded and italicized in the list below.

The required elements under GCP for oral and written informed consent are the following:

(a)That the trial involves research.
(b)The purpose of the trial.
(c)The trial treatment(s) and the probability for random assignment to each treatment.
(d)The trial procedures to be followed, including all invasive procedures.
(e)The participant's responsibilities.
(f)Those aspects of the trial that are experimental.
(g) The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant.
(h)The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this fact.
(i)The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks. Note: FDA regulations do not require a list of benefits and risks associated with alternatives to participation.
(j) The compensation and/or treatment available to the participant in the event of trial related injury
(k) The anticipated prorated payment, if any, to the participant for participating in the trial.
(l) The anticipated expenses, if any, to the participant for participating in the trial.
(m)That the participant's participation in the trial is voluntary and the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled.
(n) That the monitor(s), the auditor(s), the IRB/IEC [Institutional Ethics Committee], and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by applicable laws and regulations and that, by signing a written informed consent form, the participant or the participant's legally acceptable representative is authorizing such access.  Note: if applicable, the role and responsibility of an independent witness for illiterate subjects or Legally Acceptable Representatives are to be IRB reviewed.
(o) That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant's identity will remain confidential.
(p)That the participant or the participant's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the trial.
(q)The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury.
(r)The foreseeable circumstances and/or reasons under which the participant's participation in the trial may be terminated.
(s)The expected duration of the participant's participation.
(t)The approximate number of participants involved in the trial. Note: This is an optional element in FDA regulations, guided by whether including this information could influence enrollment.