Investigator Manual: 6. Post approval responsibilities

In addition to the requirements described elsewhere in this document, you are responsible for the following after you receive IRB approval:

Do not start human research activities until you have the final IRB approval letter.
Do not start human research activities until you have obtained all other required institutional approvals, including approvals of departments or divisions that require approval prior to commencing research that involves their resources.
Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
1. Delegate responsibility to the research staff in accordance with the staff’s training and qualifications.
2. Assure that all procedures associated with the research are performed, with the appropriate level of supervision, only by individuals who are licensed or otherwise qualified to perform them.
3. Monitor the research study and perform quality management activities to ensure the protection of subjects and the quality of the research data.
Obtain the legally effective informed consent from human subjects or their representatives, using only the currently approved informed consent documents, and provide a copy to the subject, if applicable.
1. Ensure that only IRB-approved investigators obtain informed consent from potential subjects.
If unavailable to conduct this research personally, as when on sabbatical leave or vacation, arrange for another IRB-approved investigator on this study to assume direct responsibility, or notify the IRB of alternate arrangements.
Maintain accurate and complete research records, including but not limited to, entire copies of signed informed consent and authorization documents (original, wet-ink version is required when study is FDA regulated), and retain these records according to IRB policy and the applicable regulatory retention terms.
Fully inform the IRB of all locations in which human subjects will be recruited for this project and obtain and maintain current IRB approvals/letters of agreement when applicable
Retain a current list of research team members, this includes collaborators. Submit a revised Research Team form when people are added or removed from the study team.
Personally conduct or supervise the human research. Recognize that the investigator is accountable for the failures of any study team member.
Do not implement changes to your research methods until a modification has been submitted to and approved by the IRB (unless necessary to eliminate apparent immediate hazards to subject.)

After receiving written approval from the NU IRB to begin a research project, investigators may follow the protocol procedures and use only the versions of the recruitment materials, consent and assent forms, and study instruments as approved. However, if you need to make changes to the study, you may do so by completing the modification form and providing all new and revised documents. Depending on the requested modification and risk to study participants, modifications may either be reviewed via Expedited review procedures or by a convened IRB. All documents are to be submitted to [email protected]. The modification must be approved by the NU IRB before you institute the change.

If the IRB determines that a study meets one or more of the Exemption categories, the study team may edit project procedures and documents without re-submitting to the IRB, so long as the research remains minimal risk and remains within the boundaries of the exemption categories that the IRB found applied to the research. Changes in the protocol PI and new funding source information are to be submitted through the modification process.

If your study requires continuing review, you must submit your continuing review no later than 45 days before the last day of approval to allow sufficient time for IRB review. When completing the continuing review form, if your study enrolls subjects, you will be required to specify enrollment totals. Enrollment is defined as eligible, appropriately informed individuals agreeing to participate in a study who have provided informed consent and initiated study procedures. Alternatively, your protocol can define enrollment as appropriate for the study. In both cases, enrollment totals should be reported consistently from year to year. For data and/or specimen-only protocols, this number should reflect the total number of data and/or specimens accessed for research purposes. This number should not exceed the total number of subjects requested in the approved protocol. If you wish to request additional subjects, you should submit a review change.

If the approval of human research expires because you have failed to submit the continuing review application or you submitted the continuing review application without enough time for IRB review before expiration, all human research procedures related to the protocol or study under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.

It is critical to let the IRB know when you have completed your research so study records are accurate. Please complete and submit a signed closure form indicating the reason for closure. Investigators will receive an acknowledgment letter noting the study has been closed.

The IRB considers a study concluded when the following conditions are met:

All participants have completed all research-related visits and procedures;
There is no further contact with participants needed for reasons related to research; and,
All data sets must be completely deidentified with no existing identity key.

There are other circumstances when a PI may initiate protocol closure, such as:

The PI is leaving the University.
The student affiliated with the protocol has graduated.

Research was never initiated.

If your study expires and your IRB approval lapses for more than thirty (30) business days, the IRB Office may administratively close your study. However, allowing a study to expire is not an appropriate mechanism to close a study and is considered non-compliance. Lapsed studies should either be renewed or closed.

Note: For a project to be eligible for closure, all data must be completely deidentified with no existing identity key or linkage between research data and identifiable information.

If you are planning to leave Northeastern University, you must notify the IRB Office. You may decide to transfer responsibility for your research to another Northeastern researcher, close your research at Northeastern University before your move, or transfer IRB oversight of your research to another IRB.

Maintain your human research records, including but not limited to source data, signed and dated consent documents, consent documents that integrate or have stand-alone HIPAA authorization, and screening materials documenting subject eligibility for at least seven years after completion of the research.

During a research study, unintentional mistakes in following the IRB-approved protocol or unexpected issues may occur. The PI is responsible for the accurate documentation, timely reporting, investigation, and follow-up of these events.

The mission of the IRB and the Department of Human Research (DHR) is to support the University’s research enterprise by ensuring the protection of research participants; monitoring compliance with all applicable federal, state, and local laws and regulations; fostering ethical conduct of human subject’s research; and, providing education and guidance to the University’s researchers regarding regulatory requirements. One way in which these goals are met is by conducting ongoing oversight of human research activities.

The program aims to ensure research staff have the educational resources and guidance necessary to successfully conduct research; and provide the research community with the study support, tools, and other resources needed to perform compliant research.

Monitoring consists of a PI self-assessment followed by a site visit, either in-person or remote, by a member of the DHR team. All active human research subject protocols, including those that have IRB oversight by an external audit IRB are subject to routine monitoring. In addition, protocols closed within three (3) months of the notification may be subject to an audit.

The Principal Investigator (PI) and their research personnel must fully cooperate with all routine monitoring. In addition, the PI must implement the appropriate corrective and preventative actions to resolve any observations and ensure that their research aligns with applicable federal regulations, state laws, and institutional policies.

Step 1: Contact and scheduling

The PI will be sent an Audit Notification via email. This will serve as formal notification of an audit as well as a request for availability. The notification will list the study selected for review. NOTE: For-cause audits may require an immediate or short turn-around with little notification depending on the level of concern for subject safety.

Step 2: Complete and submit the protocol self-assessment checklist

The PI will be requested to submit a completed self-assessment checklist before the scheduled audit. After reviewing the checklist, the DHR may request additional materials to prepare for the audit.

Step 3: Prepare for the audit

During the audit, the DHR team may request study material. It is advised that the research team ensure all study documents are available and easily accessible.

Step 4: Site visit [virtually or in-person]

At a mutually agreed upon date, the DHR will review the documents as requested with members of the research team.

Step 5: Audit report and PI response

The PI will receive a written report detailing observations made during the audit and a summary of findings. The report may include recommended or required actions such as submitting an Incident, AE, or Reportable new information form or a Corrective and Preventative Action (CAPA) plan. Any issues identified that may pose an immediate threat to research subjects or constitute serious non-compliance will be shared with the IRB and NU senior research leadership as appropriate.

Step 6: Audit closeout

The post-approval monitoring audit will be closed once all required actions are addressed and the PI will be notified accordingly.

The University IRB has the authority to suspend or terminate IRB approval of research that is not being conducted by IRB requirements and the approved IRB protocol or that may pose unexpected, serious harm to participants. The authority to suspend or terminate IRB approval is retained regardless of whether the research was approved by the convened IRB, through the expedited procedure, or is exempt. The IRB retains the ability to suspend or terminate research even when continuing IRB review is not required.

The IRB considers the best interests of research participants in deciding whether to temporarily or permanently halt a research study. The IRB will require that procedures for the withdrawal of enrolled participants consider their rights and welfare (e.g., planning for medical care of a research study, transfer to another researcher, and continuation of the research under independent monitoring).

The Northeastern University IRB has the authority to suspend or terminate IRB approval of research that is not being conducted by IRB requirements, an approved IRB protocol or that may pose unexpected, serious harm to participants. The authority to suspend or terminate IRB approval is retained regardless of whether the research was approved by the convened IRB, through the expedited procedure, through limited IRB review, or is exempt. The IRB retains the ability to suspend or terminate research even when continuing IRB review is not required.

During suspension or following termination of IRB approval, no new participants may be enrolled; no research drugs, devices, treatments, or procedures may be administered (unless necessary for the safety of enrolled participants); and no data to which a participant identifier is attached may be collected or analyzed. Exceptions include partial suspension and temporary continuation of research activities for safety reasons. NOTE: The terms “suspension” and “termination” do not apply to interruptions in research resulting solely from the expiration of a protocol approval period.

Investigators should make a good faith effort to promptly respond to and try to resolve any study-related complaint or concern that you receive or of which you are aware.

Some complaints and concerns that an investigator may receive are relatively minor (e.g., a subject complaint about a late payment that can be quickly resolved). One-time, minor complaints that can be quickly resolved generally do not require reporting to the IRB.

Complaints or concerns may be submitted directly by anyone, including but not limited to research subjects, family members, representatives, and study team members.