Frequently Asked Questions (FAQs)
Please use the links below to access the FAQs included on this page:
GENERAL INFORMATION
I would like to submit a study to New England IRB. How do I start?
If you would like to submit a study through our online web portal, FastTrack™ , you must first contact us to set up a secure, password-protected account. If you already have an account on FastTrack, you may submit your study anytime. Our Forms link will take you to all the appropriate submission forms that must be filled out in order to submit a protocol to New England IRB for review. If you are submitting a study for review that only involves one site, be sure to fill out both the Protocol Submission Form and a Site Submission Form. If you are submitting a study for review that involves multiple sites, you may begin by just filling out the Protocol Submission Form. If you are submitting a study to have New England IRB review the data analysis portion of the study only or requesting an IRB exemption, please contact us.
Does New England IRB have more than one Board?
Yes. New England IRB consists of two Boards. The Thursday Board has been in existence since 1988, and the Tuesday Board was added in 2007.
How often does New England IRB update the membership roster?
New England IRB updates the membership roster only when the membership changes. The date of the revision to the roster can be found in the footer of each page.
How is the membership roster obtained?
The membership roster can be obtained at New England IRB Boards, or by calling New England IRB, at 617-243-3924 and requesting a copy.
How is New England IRB’s Compliance Statement obtained?
The Compliance Statement can be obtained by going to Regulatory Status and scrolling to the bottom of the page. It can also be obtained by e-mailing your IRB contact to request a copy, or by calling New England IRB, at 617-243-3924 and requesting a copy.
How do I know which Board reviewed my study?
The first paragraph of the approval letter will document which Board (Tuesday or Thursday) reviewed the study. Once the study is reviewed by a Board, it is likely that all future study-related items will be reviewed by the same Board. All studies conducted via expedited review fall under the jurisdiction of the Thursday Board.
How do I know who my IRB contact is?
After your study is submitted to New England IRB and scheduled for Board review, an IRB Administrator will be assigned to your study. The IRB determination letter will be signed by this individual and the IRB Administrator will remain your IRB contact throughout the course of the 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.
How do I get my Authorization Agreement signed?
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. New England IRB’s signatory official is James Saunders, New England IRB Vice President.
What methods can I use to submit information to New England IRB?
Information can be submitted to New England IRB via FastTrack™ , 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.
Does New England IRB require that any New England IRB-specific forms be used when submitting various study documents?
The only New England IRB-specific forms that are required are the Site Submission Form, the Protocol Submission Form and the Study Renewal Report. All other information may be reported to New England IRB in the most convenient method available to the investigative site, sponsor or CRO, as long as New England IRB is provided with all required information.
What information is available to investigators to learn about conducting research?
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.
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NEW ENGLAND IRB TIMELINES
How often do the Review Boards meet?
Each Board meets once a week.
What is the deadline for submitting a new project to New England IRB?
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 Friday at 12:00 PM EST, for review by the Thursday Board in the following week. Studies submitted by Wednesday at 12:00 PM EST will be reviewed by the Tuesday Board in the following week.
What are New England IRB's timelines for the review of study documents?
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Review Time Frame
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New Protocol/ICF (Full Board)
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If submitted by Friday 12 PM EST, reviewed the following Thursday. If submitted by Wednesday 12:00 PM EST, reviewed the following Tuesday. Written notification is sent overnight the next day.
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New Protocol/ICF (Expedited)
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2-3 business days
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Investigative Site
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24-48 hours (Monday - Friday)
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Recruitment Materials
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24-48 hours (Monday - Friday)
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ICF Changes
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24-48 hours (Monday - Friday)
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Serious Adverse Event Reports
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2+ weeks
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Protocol Deviations
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2+ weeks
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1572 Changes
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2+ weeks
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Investigative Brochure Updates
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2+ weeks
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INITIAL SITE SUBMISSION PROCESS
What documents are required for initial site submission?
For the initial site submission, the following must be submitted: the completed and signed Site Submission Form, along with CV and current medical license for the principal investigator.
What information, at a minimum, must be included on the CV?
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.
What forms of licensure verification does New England IRB accept?
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.
What is required if the research is being conducted at more than one location under the same principal investigator?
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.
If information is missing from the site submission materials, how does New England IRB obtain this additional information?
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 FastTrack™ 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.
What is the deadline for submitting new site submissions?
There is no deadline for new site submissions. Submissions will be reviewed within 24 hours of receipt of all required documents.
How are investigators, CROs and sponsors informed of site approvals?
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.
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INFORMED CONSENT
Does New England IRB allow Legally Authorized Representatives to provide consent?
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.
Does New England IRB require a witness to the consenting process?
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.
Does New England IRB require that the principal investigator sign the consent form?
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.
How do I obtain consent from a non-English speaking subject?
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.
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TRANSLATION OF INFORMED CONSENT
What is the process for having the informed consent translated into another language?
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.
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ENROLLMENT OF MINOR SUBJECTS
Can minor subjects be enrolled into a study?
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.
How is consent obtained?
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.
What if the consent of both parents/legal guardians is required but one parent/guardian is deceased or otherwise unavailable?
If one parent is 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.
What is an assent form?
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.
Can minor subjects print their name on the assent form?
Yes. If a minor subject is not yet able to sign their name, printing their name is acceptable.
Must the parent(s) sign the assent form too?
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.
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INVESTIGATOR BROCHURES
What is the process for submitting and reviewing updated Investigator Brochures?
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.
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MODIFICATIONS AND DEVIATIONS
If a protocol is being amended, what information must be submitted to New England IRB?
The proposed amendment should be submitted in a manner that clearly documents the changes that are requested, the rationale for those changes, and how the revised document differs from the document that received prior approval from the Board.
A cover letter should be included, (or attachment to the formal amendment) detailing, in an itemized format, the requested modifications, along with any modified items such as consent forms, protocols, Investigator Brochures, study instruments, recruitment tools, etc., with the application.
What types of protocol deviations should be reported to New England IRB?
Protocol deviations which constitute an unanticipated problem must be promptly reported to NEIRB. The definition of an unanticipated problem can be found under the Unanticipated Problem FAQs section or on the Unanticipated Problem Report. Protocol deviations which do not constitute an unanticipated problem are not required to be reported to NEIRB.
How should protocol deviations be reported to New England IRB?
Protocol deviations which constitute an unanticipated problem should be reported to NEIRB using the Unanticipated Problem Report, which is available on NEIRB’s website, in the Forms section.
How do I submit a change of principal investigator?
If you have a new principal investigator (PI), you must inform New England IRB in writing prior to the new person taking over as PI. The change can be made using New England IRB’s Change to Investigative Site or Research Staff form, or in a memo to New England IRB. If the new PI is not currently a member of the research staff, his/her curriculum vitae and current medical license (if applicable), must also be submitted. Please also state if the old PI will be a sub-investigator or will no longer be part of the study staff.
If the 1572 form is updated, does New England IRB require a copy of the updated form?
No. New England IRB does not require that revised copies of the FDA Form 1572 be submitted to New England IRB. However, New England IRB requires reporting of changes to the location and changes to the research staff including: a change of principal investigator, addition or removal of a sub-investigator, addition or removal of an individual who obtains informed consent, change to study location and addition or removal of an additional location.
Changes made should be submitted using NEIRB’s Notification of Change to Investigative Site or Research Staff form. The changes can also be submitted via a letter or memo, as long as the following information is provided: the specific change(s); the principal investigator at the site; and the study(s) for which the change(s) are being made. Additions to study staff or a change of principal investigator may not take effect until approved by NEIRB.
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SERIOUS ADVERSE EVENTS
What are New England IRB's reporting requirements for Serious Adverse Events?
All deaths, life-threatening problems, or serious adverse events, whether related to the study article or not, must be reported to New England IRB, as soon as possible.
New England IRB defines a serious adverse event (SAE) as: (1) death, (2) a life-threatening adverse drug experience, (3) inpatient hospitalization or prolongation of existing hospitalization, (4) a persistent or significant disability/incapacity, or (5) a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
What is the process for submitting and reviewing Serious Adverse Events?
SAEs should be reported to New England IRB, in writing, as soon as the investigator becomes aware of the event. The SAE may be reported using New England IRB's SAE Report Form, the sponsor or CRO reporting form, or in a letter detailing the event.
New England IRB will issue an acknowledgment of the SAE report, and will inform the submitter if any additional actions are needed.
What is the process for submitting and reviewing IND Safety Reports?
New England IRB does not require that IND Safety Reports, CIOMS or MedWatch reports be submitted, unless they constitute an unanticipated problem. Only IND Safety Reports or MedWatch reports that meet the definition of an Unanticipated Problem must be reported to NEIRB. The definition of an unanticipated problem can be found on the Unanticipated Problem Report Form, which is located on the forms section of this website.
If IND Safety Reports, CIOMS or MedWatch reports are submitted to NEIRB, they should be accompanied by an Unanticipated Problem Report Form and explain why the event is both a problem and is unanticipated. It is helpful to include an analysis or summary which may be relevant to the protection of human subjects.
NEIRB does not acknowledge receipt of submitted IND Safety Reports or MedWatch reports. However, NEIRB is cognizant of the fact that some sponsors, CROs and investigators do have policies and procedures which require that the IRB acknowledge receipt of the report. In order to receive the standard IRB acknowledgment, please contact your IRB Administrator.
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UNANTICIPATED PROBLEMS
Do unanticipated problems with the study have to be reported to New England IRB?
Yes. Unanticipated problems should be reported to New England IRB when they occur, or as part the renewal report. Unanticipated problems may be reported using the Unanticipated Problem Report Form. or on forms provided by the sponsor or CRO, or in a letter or log format. The report should include possible explanations as to why the problem occurred, and what procedures have been put in place to prevent similar problems from occurring in the future. Examples of unanticipated problems include: difficulty recruiting subjects, higher than expected adverse events, higher than expected subject drop-out rate, higher than expected protocol deviation rate, or subject difficulty understanding the informed consent.
STUDY/SITE RENEWAL
Why is the approval period for the site less than one year?
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.
Does New England IRB provide notification of a pending study/site expiration?
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.
When can a site submit a Completion Report?
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.
Are sponsors/CROs required to submit Completion Reports?
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.
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MONITORING INVESTIGATIVE SITES
Does New England IRB monitor New England IRB-approved 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.
How are sites chosen for a site visit?
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.
Who conducts the site visit?
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.
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LOCAL IRBs
What is a local IRB?
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.
Can I still use New England IRB if I have a local IRB?
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.
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HIPAA
Does New England IRB approve HIPAA forms?
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.
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