I. A Message to Investigators
The conduct of research with controlled substances (CS) is subject to extensive Federal and Massachusetts (MA) law. To ensure compliance with these regulations, and make better use of its research and administrative resources, Boston University (BU) has revised its CS Program. This CS Program Investigator Q&A Handbook is a summary of the BU program as it applies to you, the investigator.
BU uses several site designated Federal (DEA) and MA registrations to obtain CS. This arrangement has allowed the CS Program Office to standardize the way our research community orders, receives, and records its use of CS in the conduct of research, while also reducing the administrative burden on that community.
The program’s continued success rests upon your strict adherence to all BU CS policies. This handbook uses a question-and-answer format to describe the process of obtaining CS privileges, as well as the procedures to be followed when acquiring, storing, using, and disposing of controlled substances.
II. Getting Started
How do I sign up for the new CS Program?
Previously, each investigator needing CS for use in a study would need to seek his or her own Federal (DEA) and MA CS registrations. At a current cost of $184 (DEA) and $150 (MA) annually, and with an initial waiting period of up to three months, this process was inconvenient for investigators and inefficient administratively. Now, BUMC investigators order CS under the auspices of the entire Medical Center and the department for which they work. To gain CS privileges, the investigator simply applies to participate in the BUMC CS Program using the form Application for CS Privileges. This form requests information about who will have access to the CS (Authorized Handlers) as well as proposed CS storage facilities. It also plainly spells out the investigator’s obligations to
- Ensure security of the CS
- Record CS receipt and use in a logbook
- Accommodate and perform annual physical CS inventories
- Notify CS Program Office of Changes and Respond to Requests for Information
- Report Any Loss or Diversion of Controlled Substances
After the CS Program Office reviews the information, the applicant is sent a formal email detailing the terms of approval, including the names of authorized handlers and approved storage facilities.
Once I’m registered with the CS Program, can I request any drug?
All requests for CS must support legitimate, authorized studies. Authorization in this context is conferred in one of two ways:
- When an investigator requires CS for use in any in vivo animal study, approval of that study by the Institutional Animal Care and Use Committee satisfies this requirement.
- For all in vitro studies, the investigator must submit a brief description of the proposed study to the CS Program Office, and that description must be signed by the investigator’s Unit Head or Department Chair.
The protocol or study description must identify specific CS and how they will be used. An investigator can only order CS cited in such authorized project descriptions.
III. Ordering, Receiving, and Disposing CS
How do I request CS for use in my authorized study?
The paperwork for requesting CS depends upon the schedule of CS being requested:
- One requisition for each Schedule I or II CS, accompanied by one Request for Controlled Substances in Research for each Schedule I or II CS
- One requisition for all Schedule III—VI CS, accompanied by one Request for Controlled Substances in Research for each Schedule III—VI CS
Schedules are determined by the DEA and the MA Department of Public Health; the lower the Schedule number, the greater the abuse potential of the substance (see the Schedules List at the DEA website).
The CS Program Office fills out all additional paperwork and forwards the complete order to the CS Purchaser. After forwarding the order, the CS Program Office sends an electronic notification of order email to the investigator. This email:
- Shows the content of the order
- Shows where the shipment will be delivered
- Reminds the investigator of his or her responsibilities upon delivery
Investigators are advised to keep these emails in a separate, secure email folder as an easy method of tracking what CS they have acquired, and when. In the event that a designated vendor cannot supply an approved request, the CS Purchaser is authorized to contact the investigator and modify the order to prevent delays. Significant modifications to the request will be referred to the investigator before the order is placed.
What if the supplier is non-commercial—a research sponsor, NIDA, etc.?
Even if the CS is being provided gratis by a governmental organization or industrial research sponsor, a University requisition in the amount of less than one cent is required.
How will I know when my shipment arrives, and where do I pick it up?
The ordering investigator is contacted as soon as the CS shipment is received at BUMC. Only the authorized investigator or his/her authorized handlers are allowed to pick up the CS shipment. Anyone who picks up a shipment will be asked to present a valid University or Hospital ID and sign a release log before receiving the CS shipment.
When my study is over, how do I get rid of my expired or superfluous CS?
Expired or otherwise unusable CS must be transferred to the CS Program Office for appropriate disposal. The CS Program Office may charge a disposal fee if it is unable to arrange for an internal, supervised disposal. For this reason, investigators are encouraged to be prudent and conservative when submitting requests for CS.
IV. Record-keeping: Logbook and Inventories
When I receive a CS shipment, how do I document that I received it?
When an investigator obtains CS privileges, that investigator receives a hardbound, preprinted logbook (Sample Logbook Pages). The investigator must use this logbook to document all additions to and subtractions from his or her CS stocks. When a CS shipment is received by the investigator, it must be recorded in the Record of Receipt section of the logbook. This logbook must be carefully maintained, since it must be available for review without prior notice. Not only can the CS Program Office request to look at this logbook, but so can officials from the MA Department of Public Health, as well officials from the Drug Enforcement Administration (DEA). If any CS shipment differs from the investigator’s original CS request, the investigator should immediately report that discrepancy to the CS Program.
When I use CS in my research, what do I need to record?
All subtractions from an investigator’s CS stocks must be recorded in the Record of Use section of the investigator’s logbook (Sample Logbook Pages). Each small administered volume need not appear as a separate entry in the logbook—a total subtraction from the stock in one day, for instance, is an acceptable entry. However, it should be possible to determine for any given entry in the logbook for what purpose that volume of CS was used—by cross-reference with a laboratory notebook or written protocol. The recording of experiments in a bound laboratory notebook is common practice, and the BUMC CS Program Office may ask to review lab notebooks and other protocol descriptions to verify entries in the CS logbook.
Do I need to perform inventories, and if so, how often?
Within one month of the investigator’s initial CS Privileges approval date, and biennially thereafter, the investigator must conduct a thorough physical inventory—using the form Biennial CS Investigator Inventory—and forward the results of that inventory to the CS Program Office. On alternate years, the CS Program Office conducts the inventory, during which the investigator must be present.
V. Security and Storage
Can I give my CS to other investigators?
An investigator may only provide CS access to his or her authorized handlers, as listed in the Application for CS Privileges. All other investigators must apply separately for CS Privileges. In some cases, the CS Program Office may allow one investigator to transfer CS to another investigator, provided that the recipient is both internally registered and requires the CS for an authorized use. The CS Program Office must oversee all such transfers, and both investigators must make appropriate entries in their logbooks to document the transfer.
How do I make sure that my CS are not accessible to unauthorized people?
When CS are being actively used in the conduct of the authorized study, the investigator must provide appropriate supervision to ensure that no one except authorized handlers can access the CS. Normal security precautions include locking doors to the laboratory while CS are out in the open, and using only small working volumes of CS. When not in use, CS must be secured in appropriate storage facilities designated by the CS Program Office. The CS Officer designates appropriate storage areas based upon: the type and quantity of CS to be stored, consultation with the investigator, and Federal and MA regulations. In some cases, the CS Officer may allocate a drawer or locker in a CS Program safe, for the sole purpose of storing CS stocks.
VI. Diversion, Loss, and Noncompliance
What should I do if I become aware of a theft, loss, or deliberate diversion of CS?
In the event that an investigator becomes aware of any diversion or loss of CS-or any other noncompliance-through his or her own observation, reports from research staff or results of audits, or other avenues, the investigator must notify the CS Program within 24 hours after the occurrence, or first awareness of it. Investigators should have in place adequate systems to ensure that they will be made aware of any such matters known within the research staff.
What is the consequence of noncompliance?
All BUMC CS policies are designed to facilitate investigators’ easy access to CS for use in authorized studies, while complying with myriad Federal and Commonwealth of Massachusetts laws and maintaining a safe and secure research environment.
Because BUMC now maintains a single set of Institution-wide Federal registrations, a serious infraction could lead to drastic consequences for our research community—including suspension of all Medical Campus orders for CS. Because the Institution and its research community benefit greatly by maintaining this single pair of Federal registrations, the Institution will go to great lengths to keep those registrations in good standing.
Alleged infractions will be referred to the Associate Vice President for Research Compliance (See CS Policies Regarding Noncompliance), and the Associate Vice President for Research Compliance will impose any punitive or corrective measures. Possible consequences of investigator noncompliance include suspension or revocation of ordering privileges, reprimand, suspension, and even termination
Policies: BUMC Controlled Substances Program Policies Regarding Noncompliance – Investigator’s Responsibility for Monitoring and Reporting
In the event that the Investigator becomes aware of any loss, diversion, or noncompliance with regard to controlled substances—through his or her own observation, reports from research staff, results of audits, or other avenues—the Investigator must notify the CS Officer within 24 hours after the occurrence, or first awareness of it. Investigators should have adequate systems in place to ensure that they will be made aware of any such matters known within the research staff.
If an Investigator or a member of his or her staff knows or suspects that a forced entry has occurred in a laboratory or CS storage area, the Investigator or staff member must immediately notify Security and the CS Officer.
CS Officer Response to Potential Loss, Diversion, or Noncompliance
(i) Preliminary Review: In the event that the CS Officer becomes or is made aware of a potential loss, diversion, or noncompliance with regard to controlled substances, the CS Officer will report all such matters to the Associate Vice President for Research Compliance.
Upon receiving notice of the matter, the, Associate Vice President for Research Compliance in consultation with and assisted by the CS Officer, will take appropriate steps to attempt to obtain promptly any additional information needed to assess the seriousness of the matter and determine if (1) immediate suspension of Investigator’s CS Privileges is warranted, and (2) the matter is reportable under Federal or MA regulations. If it is determined that the matter is reportable, the Associate Vice President for Research Compliance or the CS Officer will so immediately notify the Institutional Official and legal counsel from Boston University or Boston Medical Center as appropriate. In most cases, the Associate Vice President for Research Compliance or CS Officer will also inform the Investigator of the matter and seek a response from the Investigator.
(ii) Suspension by Associate Vice President for Research Compliance: As deemed warranted by the circumstances, including the seriousness and nature of the alleged noncompliance, the Associated Vice President for Research Compliance may immediately suspend the Investigator’s CS Privileges, including acquisition of and access to controlled substances.
If, at any time, as a result of further review and assessment, circumstances that warrant
suspension come to the attention of the Associate Vice President for Research Compliance, then suspension may be imposed in accordance with the foregoing paragraph.
(iii) Further Review and Assessment by Associate Vice President for Research Compliance: Whether or not immediate suspension is deemed warranted, the Associate Vice President for Research Compliance will consult the CS Officer and legal counsel for Boston University or Boston Medical Center, as appropriate, and shall determine what, if any, further facts or information is required to assess the matter and the most appropriate method of doing so. Methods may include, but are not limited to, the following: (1) special audit; (2) and/or consultant review.
The Associate Vice President for Research Compliance, with assistance as indicated above, will gather further information as needed. The Investigator will ordinarily be given an opportunity to respond to information gathered in the course of such a review by the Associate Vice President for Research Compliance.
(iv) Imposition of Corrective Action: The results of the review, including any response by the Investigator, will be assessed by the Associate Vice President for Research Compliance and the CS Officer. The Associate Vice President for Research Compliance will determine whether to accept the findings of the report or to request further review and assessment.
The Associate Vice President for Research Compliance may take appropriate steps to impose corrective action, as necessary, to ensure that noncompliance is corrected and not repeated, including, but not limited to, the following: (1) corrective action plan or educational measures; (2) intensive CS Program monitoring including direct observation, short approval period or periodic special audits for a designated time; (3) increased reporting by the Investigator of his/her controlled substance activities; (4) suspension or revocation of approval or use of controlled substances in one or more of the Investigator’s studies; and/or (5) suspension or revocation of the Investigator’s CS Privileges.
Reporting of Evidence or Allegations of Scientific Misconduct
In accordance with the Boston University and Boston Medical Center Policies and Procedures Concerning Allegations of Misconduct in Scholarship and Research, the Associate Vice President for Research Compliance and all others involved in conducting and overseeing research should ensure that all evidence and allegations of scientific misconduct, as defined in the applicable institutional policies, are transmitted to the appropriate Dean or Director for handling under these separate institutional policies and procedures.