The membership roster can be obtained by calling New England IRB, at 617-243-3924 and requesting a copy.
After your study is submitted to New England IRB and scheduled for Board review, an IRB Administrator will be assigned to your study. IRB Administrators are assigned to studies based on the organization submitting the study, so that if your organization has worked with New England IRB in the past, you will continue working with the same Administrator.
Authorization Agreements are required only for federally funded studies. If you have questions about the Authorization Agreement, including what it is, when it is required and where to find it, please contact New England IRB at 617-243-3924. If you wish to have New England IRB become your IRB of record for a study, submit 2 copies of the Authorization with original signatures. New England IRB will sign both copies and return one completed Authorization Agreement to you.
Information can be submitted to New England IRB via MyConnexus, our secure web portal, mail/delivery service, fax or e-mail, or to your IRB contact. Upon receipt of a new study, New England IRB will assign a study number. For documents submitted after approval has been granted, the New England IRB study number should always be referenced in the submission.
New England IRB feels that all investigative staff should be knowledgeable in the area of human research subject protections. Under the Investigators tab of this website, you will find access to information concerning human subject protection, including a link to Regulatory References. Please review this information at your leisure, and share it with your study personnel. A 20 question test is included that tests your knowledge and understanding of key ethical issues,. The test answers are also provided. This test is optional but highly recommended. Please also ensure that your staff is familiar with the Regulatory References, which is the foundation of applicable federal regulations and guidance.
When New England IRB receives a report, we follow up with an acknowledgement to the CRO, Sponsor, and/or Site, indicating that it has been received and reviewed. Since these acknowledgements do not reflect a determination made by the Board, a signature is not required.
NEW ENGLAND IRB TIMELINES
Each Board meets once a week.
A new project must be submitted, in its entirety, i.e. Protocol, Protocol Submission Form, Site Submission Form, Consent Form (or request for waiver of consent), and the Investigators’ Brochure, if applicable, by Thursday at 5:00 PM EST, for review by the Thursday Board in the following week. Studies submitted by Tuesday at 5:00 PM EST will be reviewed by the Tuesday Board in the following week.
|Item||Review Time Frame|
|New Protocol/ICF (Full Board)||If submitted by Tuesday 5:00 PM EST, reviewed the following Tuesday. If submitted by Thursday 5:00 PM EST, reviewed the following Thursday. Written notification is sent overnight the next day.|
|New Protocol/ICF (Expedited)||2-3 business days|
|Investigative Site||24-48 hours (Monday – Friday)|
|Recruitment Materials||24-48 hours (Monday – Friday)|
|ICF Changes||24-48 hours (Monday – Friday)|
INITIAL SITE SUBMISSION PROCESS
New England IRB requires CVs to show current professional affiliations and educational history. It is recommended that CVs also include previous research experience and any research training. New England IRB does not require that the CV be signed and dated.
Verification may be obtained from the appropriate state board, including via the state board’s website or a photocopy of the license. The license must be valid for the state(s) in which the investigator is conducting the study.
An Additional Location Form must be submitted for each location at which the research will be conducted under the same principal investigator. The principal investigator must have an affiliation with each additional location at which he/she is conducting the research. If more than 10 additional location forms are being submitted to New England IRB, please contact us, as additional information is required.
Immediately after reviewing the site, New England IRB will create a document addressed to the principal investigator which references the study title and lists the requested information. This document is sent via fax to the investigative site. If no immediate response is received, New England IRB will resend this fax on a weekly basis. When MyConnexus is used, the requested information is also immediately posted to it. If requested, New England IRB will provide the sponsor/CRO with a weekly update of the pending site issues.
There is no deadline for new site submissions. Submissions will be reviewed within 24 hours of receipt of all required documents.
When a site is approved by New England IRB, an approval letter will be sent to the principal investigator, with a copy to the CRO or sponsor. If consent document(s) have been approved for a study, New England IRB will also send the consent forms, customized with site specific information.
In most circumstances, New England IRB does not allow the use of legally authorized representatives. If the condition being studied requires the enrollment of a population of subjects that are unable to provide consent on their own behalf, the use of legally authorized representatives is considered. However, if it is feasible to enroll subjects who are able to provide consent, New England IRB does not routinely allow the use of legally authorized representatives.
No. New England IRB does not require that the consenting process be witnessed. However, if a site’s Standard Operating Procedures require the use of a witness, a written request may be submitted to New England IRB to have the consent form revised to include a signature line for a witness. When making this request, the site should indicate if the witness is witnessing the entire consenting process, or simply the signature of the subject. The witness should be an impartial third party.
No. New England IRB requires that only the research staff person who conducted the informed consent discussion and obtained the subject’s signature sign the consent form. If a site’s Standard Operating Procedures require that the PI sign the consent form, a written request may be submitted to New England IRB to have the consent form revised to include the signature line.
New England IRB requires that written consent be obtained in a language understandable to the subject. If you have a subject who does not understand or is not fluent in English, please notify NEIRB and NEIRB will arrange to have the consent form translated. If you wish to use your own translation service, you must submit a translated copy of the New England IRB approved informed consent, in MS Word format, to New England IRB for review and approval. You must also submit a certificate of translation from a translator certified in the United States.
TRANSLATION OF INFORMED CONSENT
The informed consent should not be translated into another language until the English version has been finalized by New England IRB.
If you have a subject who does not understand or is not fluent in English, please notify NEIRB and NEIRB will arrange to have the consent form translated. If you wish to use your own translation service, the translated consent form should be submitted to New England IRB in both hard copy and electronically in MS Word. The certification of the translation must also be submitted.
If the informed consent template is being translated for a multi-center study, New England IRB will issue a site-specific translated consent to each site that requests one.
If the consent form is being translated, other subject materials that will be read by subjects (subject instructions, diaries, etc.) should also be translated.
ENROLLMENT OF MINOR SUBJECTS
Minor subjects can be enrolled into a study only if NEIRB has specifically approved the enrollment of the minor subjects. If NEIRB has approved the enrollment of minors, the approval is documented on NEIRB’s initial approval letter.
If NEIRB has approved the enrollment of minors, consenting requirements will also be documented in NEIRB’s approval letter. Depending on the risk level of the study and the possibility of direct benefit to subjects, NEIRB will require the consent of one parent/legal guardian or the consent of both parents/legal guardians. The parent/guardian should document their consent on the informed consent form. Only the NEIRB approved consent form should be used. In rare instances, consent may be waived and this would be documented in NEIRB’s approval letter.
If one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child, then consent from only one parent is required. Questions about “not reasonably available” should be directed to NEIRB.
An assent form is the document that explains the study in simple terms. In most cases, minor subjects age 7 years and older should sign the assent form. If NEIRB has approved the enrollment of minor subjects, the assent requirements will be documented in NEIRB’s approval letter. Only the NEIRB approved assent form should be used.
Yes. If a minor subject is not yet able to sign their name, printing their name is acceptable.
Parents are not required to sign the assent form. However, the investigator should have a mechanism in place to match parents with their children, especially if the individuals have different surnames.
For multi-center studies for which New England IRB is the central IRB, the sponsor or CRO should submit updated Investigator Brochures as they are issued. If possible, a revised brochure should track the changes that were made.
If New England IRB is not the central IRB for the study, the investigator should submit updated Investigator Brochures as they are issued, and New England IRB will issue an acknowledgment to the investigator.
PROMPTLY REPORTABLE INFORMATION
STUDY/SITE CONTINUING REVIEW
The site approval period is based on the date of the original protocol approval, regardless of the date on which the site is approved. Therefore, the approval period for any given site spans from the protocol approval date until the date that New England IRB’s global approval of the study ends.
Yes. Approximately 45 days prior to the expiration date, New England IRB sends a reminder to the site to submit the renewal report, along with a copy of the New England IRB Renewal Report. New England IRB makes several attempts to reach the site via fax. If the expiration is approaching, and New England IRB has not received the necessary documentation from the site, New England IRB follows up with the site via phone.
A site may submit the Completion Report to New England IRB as soon as the site’s last subject has completed his or her last study-related procedure. For FDA regulated studies, completion forms may be submitted when all data has been collected and reviewed. If the site prefers, the Completion Report may be submitted after the sponsor has conducted the close-out visit.
No. New England IRB does not require that the sponsors or CROs submit a Completion Report. Sponsors and CROs may inform New England IRB of the study completion via letter.
MONITORING INVESTIGATIVE SITES
Yes. New England IRB has a national site visiting program, which is in place to oversee research being conducted at New England IRB approved investigative sites.
Sites are chosen based on several criteria, which include the intended population of a research study in which the site is participating, the number of studies that New England IRB is overseeing for a particular site, or a site’s FDA audit history. In addition, New England IRB selects sites at random, in order to ensure a global perspective of the research that New England IRB is overseeing.
New England IRB also conducts site visits as required by Massachusetts state regulation.
Qualified representatives of New England IRB conduct the site visits and are assigned to a particular site based on their physical proximity to the site. The site visitors have extensive clinical trial experience and have been thoroughly trained by New England IRB regarding the expectations of the site visit and confidentiality procedures.
A local IRB, usually affiliated with a hospital or research entity, is an IRB that has jurisdiction over the research being conducted at that particular institution or location.
Yes. If there is a local IRB that has jurisdiction, New England IRB can approve the investigative site for participation in a study if the local IRB waives their jurisdiction to New England IRB. This waiver must be documented in writing and signed by an authorized representative or member of the IRB. In certain circumstances, an institutional official also may need to confirm in writing central IRB jurisdiction.
No, New England IRB does not. All Covered Entities using Protected Health Information (PHI) for research must comply with HIPAA. If your institution is a covered entity, your Privacy Officer should approve and ensure your HIPAA language is in compliance with HIPAA regulations.
Anyone conducting research involving identifiable health information, regardless of funding source or sponsorship, is subject to the provisions of the Privacy Rule. If it will not be feasible to obtain an Authorization, or the consent, of the individuals whose health information you will be using or disclosing, you may need to have the Authorization requirement waived under HIPAA.
Yes. However, if your institution’s policies require you to use the institution’s IRB or Privacy Board, then you should comply with those policies.
Yes. According to HHS, the Privacy Rule (at 45 CFR 164.512(i)) permits a Covered Entity to rely on the representations of the Board that the information requested is the minimum necessary for the research purpose. This is true regardless of whether the documentation is obtained from an external Privacy Board or one that is associated with the Covered Entity.
That depends. According to HHS, under the rule, a Covered Entity is permitted to disclose protected health information to the individual who is the subject of the information, regardless of the purpose of the disclosure. Therefore, covered health care providers and patients may continue to discuss the option of enrolling in a clinical trial without patient authorization, and without an IRB or Privacy Board Waiver of Authorization.
However, where a Covered Entity wants to disclose an individual’s information to a third party for purposes of recruitment in a research study, the CE first must obtain either Authorization from the individuals or a Waiver of Authorization from an IRB or Privacy Board.