An IRB is a diverse group of scientific and non-scientific individuals who conduct the initial and ongoing review of clinical research studies in order to ensure the protection of the rights and welfare of human subjects participating in those trials. The Code of Federal Regulations Title 21, Parts 50 and 56 and Title 45 CFR Part 46 governs the composition and conduct of IRBs. (See Title 21 CFR or Title 45 CFR)
CGIRB Board meetings are held every Tuesday and Thursday with the exception of Thanksgiving week and Christmas week. (See Schedule)
We have a schedule of submission dates that must be met in order to assure CGIRB Board review at a specific scheduled meeting. Generally, the submission deadline is by 5:00 PM, one week before the scheduled Board meeting you desire. Please contact us for additional information regarding the CGIRB meeting schedule. (See Schedule)
You will first need to contact CGIRB to obtain a username and password. Once you receive this, you will be able to login to Intralinks. When you login, you will see a folder there with your company name and you may upload your information directly to this folder. CGIRB will be notified that there is an item waiting to be picked up and we will go out and retrieve the information. Future preferences and shared folders may be developed at this time.
Approval documents are sent to the Principal Investigator within 2-3 business days of an unconditional approval decision. Whenever possible, CGIRB sends decisions within 3 business days of the review meeting. In cases where there is a condition placed on approval, the condition must be met prior to processing the unconditional approval documents.
The majority of IND Safety Reports, Suspected Unexpected Serious Adverse Reaction (SUSAR) Reports, Council for International Organizations of Medical Sciences (CIOMS) Reports, and MedWatch Reports ("Reports") are unlikely to meet reporting requirements under CGIRB reporting guidelines. Reports that must be reported are those reports that indicate a new or increased risk of harm to subjects or others. Generally, to be reportable, such an event should be previously unknown to the IRB and requires an action taken to minimize the risk to other subjects, such as a change to the protocol or additional disclosure of risk information in the consent document.
If there is an agreement that the sponsor report unanticipated problems directly to CGIRB on the behalf of the PI, that is the only report that needs to be submitted to CGIRB. If there is no such agreement in place, the PI is required to submit reports to CGIRB, if they are determined to be reportable unanticipated problems.
Submit the report with the completed CGIRB IND Submission Form within 10 business days of your receipt.
A UP event is reportable if it meets all of the following:
Under the above definition, many adverse events will not meet CGIRB reporting requirements.
Submit reportable UPs on the UP Submission Form within 10 business days of the site's awareness.
You will receive an acknowledgement for UP submissions that meet the CGIRB reporting requirements.
If you decide to be in a research study, you should carefully read and discuss the CGIRB-approved Subject Information and Consent Form with the study staff and study doctor before having any procedures done. Any questions you have should be answered. The decision of whether to take part in the study is completely voluntary. You and only you should make this decision. As a research subject, you have a right to information about the study procedures, study drug, risks and benefits of the study, alternative treatment, confidentiality, and any payment that may be provided for taking part. If you do not understand why something is being done during the study... ask. If you decide to take part in a study, you also have a right to withdraw from the study at any time.
Human subject research is governed by numerous regulations and guidances. Additionally, most sponsors, CROs, SMOs, investigator sites, institutions, and IRBs have standard operating procedures (SOPs) in place to govern activities associated with the conduct of clinical research. All of these regulations, guidelines, SOPs, the IRB-approved protocol, and other procedural documents serve as standards against which compliance may be assessed. Quality assurance auditors are employed at various stages of the research and development process to assess compliance with applicable standards. The purpose of most clinical quality assurance audits is to verify, through interviews and documentation reviews, the following:
Because FDA and OHRP encourage research entities to conduct internal quality assurance activities in an effort to provide continuous quality improvement, audit reports are not routinely requested during regulatory inspections. Therefore, documentation associated with quality assurance audits does not have to be maintained and retained with the study documentation. It is preferable for audit documentation to be maintained in a separate location from research study files
"HIPAA" stands for the Health Insurance Portability and Accountability Act of 1996. This regulation includes "the Privacy Rule", which outlines the standards for privacy of individually identifiable health information. The specific regulations for HIPAA are in Title 45 CFR Parts 160 and 164.
(This answer is based on the assumption that the clinical investigator is a covered entity as defined by the regulations.) For your ongoing studies under the approval of CGIRB, your HIPAA Authorization language must be submitted to the Board for review and be approved prior to its use.
In addition, any time you plan to use or disclose PHI [private health information or individually identifiable health information] as a result of your identifying potential subjects prior to their recruitment, you must follow a plan permitted by HIPAA. For example, to identify potential subjects for inclusion in your research protocol, you would likely need to review the patient's existing health information. If any of this PHI used to identify potential subjects and/or to recruit subjects is disclosed to a third party, such as when it is reviewed by the study monitor, you must either obtain from CGIRB a Request for Waiver/Alteration of Authorization Form (see forms) See other "waiver of authorization" question.
Lastly, it is also your obligation to be aware of any state and local laws that raise the standards for privacy beyond the HIPAA requirements.
This is a specific term related to the review of a potential subject's PHI [private health information or individually identifiable health information] in order to prepare a research protocol or for similar purposes, such as to determine whether the person might be eligible for participation in a research study. By following the requirements for a review preparatory to research, you will comply with HIPAA as you seek to identify potential subjects whose PHI will not be disclosed to third parties without the subject's prior authorization. Note that this method must not be used if such PHI will be disclosed to a third party to the covered entity.
The requirements for complying with this approach are as follows:
Note that CGIRB is not involved in this activity. We only include this information as a service to you.
Yes, we do. Go to our forms section for the Subject Information and Consent Form and Authorization to Use and Disclose Personal Health Information for Research Template.
Yes, alternative Authorization language can be submitted to CGIRB for Board review. This language would need to meet the standard that CGIRB has adopted. The CGIRB Checklist for HIPAA Authorization Language can be found on our forms page.
If the investigator/site is not a covered entity, then the answer is Yes. HIPAA would not apply to a non-covered entity and therefore authorization is not required.
However, if the investigator/site is a covered entity under the provisions of HIPAA, then written authorization from the subject is required prior to disclosure of the subject's PHI. The investigator may collect the PHI, since he/she is the covered entity; however, allowing an unaffiliated monitor to view the source documents would constitute an unauthorized disclosure to a third party.
In order to determine if a site is a covered entity, consult the following federal website: http://www.cms.hhs.gov/HIPAAGenInfo/06_AreYouaCoveredEntity.asp
Who can serve as a legally authorized representative (LAR) is determined on a state-by-state basis. When a study requires consent to be provided by an LAR, CGIRB requests that the Principal Investigator (PI) confirm with a regulatory attorney or with the sponsor who may serve as an LAR for their particular state. The Sponsor is responsible for ensuring proper monitoring of investigators under Title 21 Part 312.50 and Title 45 CRF 46.102, which includes confirming that a legally effective consent process was performed. The PI and/or the person obtaining consent should verify that the person signing as LAR has the authority to provide consent on the subject's behalf; otherwise the consent may not be legally effective.
With CGIRB Board approval, subject authorization may be waived if you do the following:
Go to our forms section for the CGIRB Request for Waiver/Alteration of Authorization Form. Note that the CGIRB Board must grant this waiver if the waiver request is related to a study approved by CGIRB.
After consulting with several industry experts, attorneys, and regulatory officials, it has been determined that independent institutional review boards are NOT covered entities or business associates. As a result of this, it is our policy that we do not enter into business associate agreements.
Q: How can I determine if my organization is a covered entity?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA - The Privacy Rule) applies to any entity that is:
An entity that is one or more of these types of entities is referred to as a "covered entity" in the regulations. A decision tool to assist you in deciding whether or not your organization is a covered entity is available at: http://www.cms.hhs.gov/HIPAAGenInfo/Downloads/CoveredEntitycharts.pdf
The FDA has a Final Guidance Document for Collection of Race and Ethnicity Data in Clinical Trials that was released in September 2005. This document is available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf
Specific Categories and Definitions are listed on page 12 of this document and are as follows:
The minimum categories for data on race and ethnicity for Federal statistics, program administrative reporting, and civil rights compliance reporting are defined as follows: