In determining the annual permit fee required by this section, the director shall not require additional payments for multiple units of the same method of storage, treatment, or disposal or for individual units that are used for both storage and treatment.
Conflict of interest identification and management; and HRPP quality improvement; and Community outreach activities.
Part of this evaluation is monitoring how appropriate the composition of the IRB office and IRB boards is in relation to that needed for review of the type and volume of research submitted.
Examples of information that might indicate action is needed are significant changes in study review times, investigator satisfaction, frequency of noncompliance, or federal or institutional policies The HRPP Director is responsible for developing a plan in response to changing needs and for initiating the process of obtaining institutional support for the changes.
Disapprovals, restrictions, or conditions imposed by the IRB cannot be rescinded or removed by any entity other than the IRB. For research overseen by an external IRB see Section 2.
IRB Chairs, IRB members, and IRB Office staff treat all individuals in the research community with equal respect and without bias based on funding success, positions of power, or any other improper factor.
Investigators and research staff are not permitted to offer monetary incentives, favors, or other rewards to, or to threaten retaliation against, IRB members or IRB Office staff in connection with decisions concerning IRB submissions.
Any IRB member or IRB Office staff experiencing such undue influence on their independent decision-making process from any source is encouraged to make a confidential report.
Disruptions may occur with varying scope, severity, and duration. The scope of the disruption may be effects on personnel, records, or both. The duration of the disruption may be hours, days, weeks, or months. In considering the timing of recovery from a disruption, the goal is to be able to return to normal operations within a week of the beginning of the disruption.
Principal Investigators are expected to submit progress reports for continuing review to the IRB well before the expiration date of the study; however, some Principal Investigators who submit less than a week before expiration may be required to cease study operations if a disruption occurs.
Principal Investigators are also expected to submit well in advance of any need for IRB approval for funding purposes; however, a funding deadline may be missed if a submission was made less than a week before the deadline and a disruption occurs.
Unanticipated Problems involving a fatal or life-threatening event may require actions sooner than one week after being reported to the IRB; however, the IRB response does not rely on the availability of electronic records and can be coordinated by a number of different personnel: A disruption would be unlikely to render all of those individuals unavailable.
For IRB functions, the electronic system is used as the system of record, and no records that are essential to IRB oversight are maintained only in paper or only in other forms such as email correspondence. The electronic system would be restored within the one-week goal.
For disruptions where the local backup has not been compromised, the process will be to have the IRB Director make the determination that restoration from the local backup is required and to have IRB staff coordinate with the Boston University Information Technology IT department for the restoration of the electronic system and reconstruction of any records that were added to the system after the time of the backup.
For disruptions where backup from the remote SunGard tape is required, the responsible individual at Boston University will make the determination that a disaster requiring recovery has occurred, and the IRB Director and IRB staff will coordinate with SunGard and the Boston University IT department for restoration of the electronic system as well as reconstruct any records of IRB actions after the time of the backup.
In the specific instance where the disruption results from the inability of IRB staff and members to travel to the IRB office location, as long as electricity and internet access are available, they may use the electronic system from home and participate in convened meetings via teleconference.
For disruptions limited in scope, severity, and duration, the role of the commercial IRB will be to provide services on behalf of the Boston Medical Center and Boston University HRPP, following the policies and procedures in this document, which would not constitute transfer of oversight to the commercial IRB.
Otherwise, the transfer of oversight, either temporarily or for the life of the study, will follow the FDA recommendations for transferring research oversight. In the situation where one of the Directors is unavailable, the other Director has both responsibilities.
As soon as a personnel disruption is identified, the responsible individual will: Determine the services needed to maintain oversight of research given the scope, severity, and likely duration of the disruption, including, if necessary, services needed for restoration of the electronic system; and Assess whether or not existing internal resources will be sufficient to provide these services; and If external resources are necessary: Consult with the IOs to determine the funding available for obtaining external services; and Contact one or more commercial IRBs to enter into an agreement for the commercial IRB to provide the necessary services; and If appropriate, communicate to investigators and research staff any necessary actions on their part associated with use of the services of the commercial IRB or include such communication in the services provided by the commercial IRB ; and If appropriate, communicate to OHRP, FDA, and sponsors about transfer of oversight or include such communication in the services provided by the commercial IRB ; and Monitor the response to the disruption to assess the impact on research oversight and adjust as necessary; and Determine when the disruption has resolved and as appropriate terminate any responses.
Boston Medical Center or Boston University Medical Campus receives a direct award through a grant, contract, or cooperative agreement for human subjects research, even where all activities involving human subjects are carried out by employees or agents of another institution; or Boston Medical Center or Boston University Medical Campus employees or agents: Obtaining identifiable private information or identifiable specimens includes, but is not limited to: Assisting with the recruitment of subjects by: Obtaining coded private information or biological specimens from another institution, provided that the recipient investigators will be unable to readily ascertain the identities of the subjects to which the coded information or specimens pertain for example, by having a written agreement prohibiting the release of the key to the code ; or Authoring a paper, journal article, or presentation describing a human subjects research study without obtaining access to identifiable private information; or Accessing or using identifiable private information when visiting an institution that is engaged in the research, provided that their research activities as visitors are overseen by the IRB of the institution that is engaged in the research; or Performing commercial or other services for investigators provided that all of the following conditions also are met: The National Institutes of Health expects that grant applications and contract proposals with due dates on or after January 25, will include a plan for the use of a single IRB.
The Principal Investigator should contact the Boston Medical Center or Boston University grants office prior to submission to the IRB to ensure that the consent form has the correct compensation for injury language, and, if Boston Medical Center services are used, the correct costs language.
The Principal Investigator should complete as much of the form s as possible and submit them with their request for reliance on an external IRB see Section 7. These must have, at a minimum, the following components: Evaluation of requests to cede review see Section Investigators are required to report their financial interests according to Section 6.
The process for ceding review includes providing training for investigators and research staff see Section 6. Performing the scientific review of the protocol; and Ensuring concordance between any applicable grant and the protocol; and Reviewing potential noncompliance, including complaints, protocol deviations, and results of audits and making determinations of noncompliance according to the policies and procedures of the IRB of record; and Evaluating the protections provided by management plans for conflicts of interests and imposing additional requirements if necessary to protect the rights and welfare of subjects; and Obtaining any additional approvals from DHHS when the research involves pregnant women, fetuses, and neonates; or children; or prisoners; and Reporting to regulatory agencies and sponsors concerning serious or continuing noncompliance, unanticipated problems, and suspensions or terminations of IRB approval.
In addition, the Principal Investigator must:HRPP Policies (Effective Date ) Boston Medical Center and Boston University Medical Campus Human Research Protection Program Policies and Procedures.
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