A business relationship is commonly based on a signed agreement for provision of services. Many of our clients however, face time constraints that make negotiating a contract through the system impossible. To resolve this issue, E&I may elect to request an indemnification form that obtains the minimum necessary information to begin a working relationship with a client.
The following sets out E&I's expectations when working with a client. By placing a study with our IRB, you are agreeing to the following:
Confidentiality by the IRB: E&I makes every effort to maintain all materials as confidential. Members and staff are aware of this requirement, and work under a formal agreement of such. Auditors from the FDA and other regulatory bodies have the right to audit files and to make copies of them. Sponsors auditing the IRB will have access only to their own records. Accreditation requires that the accreditation team have access to all records.
Consent: See Guidance / Informed Consent section. The obligation to obtain informed consent from subjects rests with the investigator, who is charged with considering fully the consent process as well as documentation of consent. The duty can be delegated but not with impunity.
Consultants: E&I strives to retain diversely experience members on each of its boards. When necessary to meet the needs of a specific study however, E&I reserves the right to select consultants, and to charge directly for such services. Consultants will give advice and counsel to the IRB but cannot vote.
Education: See Guidance / Investigator Training Requirements section. Investigators are charged with the ethical conduct of research for which they are responsible. All investigators will complete a recognized course of study regarding the Responsible Conduct of Research at least every three years. (Specialty courses, if approved in advance, may substitute.) Investigators must assure that their key personnel are adequately trained.
Fees: Contact us to request a copy of E&I's standard fee schedule. Volume discounting may be available upon request. E&I clients are responsible for payment of all charges based on the fee schedule assigned to their project.
Good Clinical Practice – Good Research Practice: The principal investigator should be principled. All investigators are charged with knowledge and understanding of the conduct of research and protection of subjects. Clients conducting FDA regulated investigations are charged with knowing and following the GCP requirements.
Human Research Protection Program: Clients are expected to have a program with a written policy statement concerning protection of subjects.
Indemnification of E&I and its IRB: E&I may require indemnification from the applicant. If the applicant is an investigator, indemnification should come from the sponsor. If the applicant is a sponsor with multiple sites, the indemnification will need to apply to all sites reviewed for the study. Indemnification only has value if there is some assurance that the entity indemnifying has the ability to back it up. Applicants may be asked to provide evidence of adequate means to support their indemnification promise.
Injury: E&I should be given a clear statement of the sponsor’s and/or investigator’s policy regarding compensation to subjects for harms incurred. Should a sponsor not include a statement, the relevant information on the consent document will apply.
Relationships: All human subjects requirements set by performance sites must be met. E&I must be informed of any changes required by institutional officials.
Reports: See Investigator / Reporting Problems section. E&I clients are responsible for submitting complete and honest reports and responses. E&I must be informed of all adverse events or problems or device effects that are serious, related and unexpected, all serious or repeated protocol violations, FDA warning letters, and monitoring reports describing serious or continuing non-compliance.
Safety: IRB review is to assure compliance with federal human subjects protection standards and with ethical research practice; it cannot assure safety or freedom from harm. Investigators are expected to provide full and complete disclosure of all pertinent facts, including those which may not be specifically requested in the application but which are nevertheless relevant.
State and Local Law: See State Regulation section. E&I attempts to notify clients of applicable state or local law but makes no claims to provide legal counsel. Clients are advised to be aware of local and state laws.
Sponsor Special Responsibilities: Sponsors are expected to select and train qualified investigators. Sponsors are presumed to have provided complete, honest and objective information. Sponsors will have a clear policy regarding compensation for injury that does not require a subject to resort to forceful measures. Sponsors shall assure that clinical studies undertaken meet ethical and regulatory standards for protection of human subjects. Sponsors will conduct appropriate on-site monitoring and will report any serious and any continuing non-compliance or problems.
Surveillance and Monitoring: The regulatory requirement for IRB monitoring states, "An IRB shall conduct continuing review of research . . . and shall have authority to observe or have a third party oversee the consent process and the research." (21 CFR 56.109(c)) Continuing review is a committee process. E&I expects that sponsors will monitor the conduct of all investigations as required by FDA and ethical standards. The IRB has the right to conduct on-site review of a random sample of sites and of selected sites. E&I's clients will be responsible for the direct expenses plus a percentage.
Ethical & Independent Review Services (E&I) is a business entity that fulfills the role of an institution as defined in the Common Rule, and FDA regulations. This institution provides IRB services for research regulated by other agencies.'
The following identifies E&I's commitments and responsibilities to its clients:
- E&I is the contracting institution.
- E&I assures sufficient staff and resources for the IRB's operation.
- E&I receives the application package and submits it to the IRB for review.
- E&I may authorize exemption from IRB review or may allow submission of a grant.
- E&I maintains communication with the relevant federal agency and shall respond to all valid requests for IRB inspection.
- E&I may "monitor" the ongoing investigation. E&I also expects industry clients to monitor sites as required under Title 21, sections 312 and 812 and to report to E&I and the FDA any serious or continuing non-compliance in a timely manner.
- E&I retains the authority to terminate or suspend a study regardless of the decision of the IRB; it may not approve a study disapproved by the IRB.
- E&I retains expert consultants when the IRB requests outside assistance.
- The Director of Regulatory for E&I will usually be designated the "impartial third party" to whom subjects can turn for assistance.
- THE INSTITUTIONAL REVIEW BOARDS (IRBs) are a standing committee of E&I.
- The IRB is charged with conducting an objective review of applications.
- The IRB must act as defined in its operating policies and procedures.
- When issues arise that members recognize go beyond the expertise of the board, the IRB may request consultation with specialists.
- The IRB may request that E&I arrange for a site visit to any investigator.
- The IRB may approve, approve with conditions or contingencies, request modifications or may disapprove an application.
- The IRB has the authority to terminate or suspend approval of a study.
- While the IRB will seek to confirm facts contained in the submission, the IRB must presume that all information is truthful and honest.
- E&I will take appropriate and immediate action should it learn that this faith is misplaced.
- The IRB has the authority to observe the consent process.