Research Contracts and Industry Agreements - RCIA Updates

Allocating Contractual Liability

One of the fundamental elements of a valid contract is a clear identification of the parties involved. This requirement helps to determine who is legally responsible for performance and who may be liable in the event of a breach. When BMC enters into an agreement, it does so under its legal name, “Boston Medical Center Corporation.” BMC Researchers, regardless of their employment status with BMC, BU, or a faculty practice plan corporation, are not included as parties to institutional agreements and must not sign on behalf of the institution.
The professionals in the BMC Research Enterprise ensure that contracts to which BMC is a party address contractual liability according to institutional policy and applicable law, protecting the institution, its staff, and its patients. BMC will generally require for-profit sponsors or funders to indemnify and defend the institution, its employees and researchers against any claims or liabilities arising from the performance of the sponsored research. On the other hand, as a Massachusetts non-profit and federally designated safety hospital, BMC’s liability is subject to statutory limits, and the institution is not in a position to indemnify or hold harmless any outside party against such claims.
When BMC engages in interventional, industry-sponsored clinical trials, the institution requires for-profit sponsors to pay for the medical expenses of study subjects that are injured as a result of their participation in the trial. It is particularly important that the Informed Consent Form (ICF) signed by the study subject include language that explicitly aligns with this requirement as addressed in the relevant Clinical Trial Agreement.
If you have any questions about contractual liability, institutional policies, or the process for getting an agreement in place, please reach out to Asa Lopatin, Director of Research Contracts & Industry Agreements.

Exchanging Confidential and Proprietary Information

BMC often enters into confidentiality agreements with external parties to facilitate candid discussions and open collaboration while protecting each party’s intellectual property and other non-public information. These agreements—sometimes referred to as Confidential Disclosure Agreements (CDAs) or Non-Disclosure Agreements (NDAs)—outline the specific subject matter of the information to be exchanged, relevant restrictions on access and use, applicable timelines, and many other details.

Given the number of confidentiality agreements to which BMC is a party, it is not feasible for the institution to agree to indefinite durations for these agreements. Similarly, because trade secret information receives unique legal protections—and is often unnecessary to facilitate the desired discussion—BMC generally will not agree to receive such material or afford it different treatment from other non-public information. In order to alleviate the administrative burdens associated with maintaining external confidential information, BMC will generally insist that all non-public information be clearly marked or otherwise identified at the time of disclosure to ensure that it is handled appropriately during the term of the agreement. 

Although the purpose of many CDAs is straightforward (a BMC researcher or administrator receiving a research plan or protocol in order to evaluate BMC’s capacity to participate in a project or study), the terms and enforcement mechanisms are often complex. Even if the incoming information is intended for a specific researcher, all confidentiality agreements must be referred to BMC Research Operations for review, negotiation, and execution in BMC’s name. This requirement ensures that the institution has clear records of its contractual partners and obligations, and that BMC and its staff are adequately protected from liability.

If you are interested in executing a confidentiality agreement or have any questions about the process, please reach out to Asa Lopatin, Director of Research Contracts & Industry Agreements.

The HIPAA Privacy Rule's Impact on Sharing Clinical Data Outside of BMC for Research Purposes

Collaboration with peers at other institutions often requires the exchange of clinical data in various forms. Institutional policies, state and federal law, and BMC’s commitment to equitable care create a number of obligations of which BMC Researchers should be aware.

There are many factors involved in determining whether a proposed use or transfer of BMC data is permissible. An explanation of the relevant legal and regulatory landscape is a helpful foundation for understanding the processes and requirements over which BMC lacks meaningful discretion. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that mandated that the U.S. Department of Health and Human Services (HHS) create rules and standards designed to protect sensitive health information. Among these rules is the HIPAA Privacy Rule (45 C.F.R. Parts 160, 162, and 164), enacted in 2002, which imposes stringent requirements on Covered Entities, including healthcare providers like BMC, as well as their Business Associates.

The HIPAA Privacy Rule protects any individually identifiable health information relating to an individual’s past, present, or future physical or mental condition, treatment for the condition, or payment for the treatment. Such information, when maintained in a designated record set, is known as Protected Health Information (PHI). With few exceptions (some of which are discussed in this article), an individual’s PHI may not be used (shared, employed, applied, utilized, examined, or analyzed) or disclosed (released, transferred, granted access to, or divulged in any manner to) any outside entity without a valid authorization from the subject of the information.

A valid authorization must be written in plain language, with a copy provided to the individual subject, and include at least: (i) a specific and meaningful description of the information to be used; (ii) specific information about who is requesting the use or disclosure of the information; (iii) specific information about the recipient or class of recipients who will be authorized to use or disclose the information; (iv) a description of each purpose of the use or disclosure of the information; (v) an expiration date or event that relates to the permitted purpose; (vi) the subject of the information’s signature and date thereof; (vii) acknowledgment of the individual’s right to revoke authorization; (viii) in the case of research, acknowledgment by the individual of their authorization being a condition of receiving treatment; and (ix) acknowledgment of the potential for redisclosure.

When BMC engages in prospective clinical research, it generally tailors the Informed Consent Form (ICF) required for subject enrollment to meet the requirements of a valid HIPAA authorization for the purposes contemplated by the research. In cases where information was not collected for research purposes, or if the authorization otherwise fails to identify the specific purpose of a proposed disclosure, there are limited avenues available for using or disclosing PHI:

• If the use or disclosure is for research purposes, BMC may proceed if:
  • the Institutional Review Board (IRB) approves a waiver of authorization;
  • the PHI will be reviewed internally for the purpose of preparing a research protocol; or
  • the use or disclosure is limited to information on decedents.
• ALL identifiers are removed such that the risk of re-identification is very small—and the information therefore no longer constitutes PHI; or
• BMC executes a Data Use Agreement (DUA) for research purposes; and the information constitutes a Limited Data Set (names, postal addresses, phone/fax numbers, email addresses, social security numbers, MRNs, health plan beneficiary numbers; account numbers; certificate/license numbers; vehicle identifiers, device identifiers, URLs, IP address numbers, biometric identifiers, facial photographic images have been removed, leaving only dates and geographic identifiers no smaller than city, state, and/or zip code).

In practice, these regulatory requirements mean that in cases where the subject of the information has not expressly consented to their health information being shared, BMC researchers seeking to access or share any patient data with external colleagues must seek IRB approval for the specific use or disclosure. As an institutional practice, BMC requires that any transfer of clinical data—regardless of whether it contains patient identifiers and which identifiers it may contain—be documented in a formal agreement with the external recipient. Researchers must coordinate their proposed transfers with BMC Research Operations (please reach out to Asa Lopatin, Director of Research Contracts & Industry Agreements) to ensure that all applicable requirements have been met.

Managing Research Materials

Boston Medical Center researchers are involved in a diverse range of groundbreaking scientific exploration. Collaboration with colleagues at government, industry, and fellow academic institutions is often vital to the success of these advancements, and such collaboration frequently requires exchanging clinical data as well as biological materials. Similar to patient data, the handling of biological and other research materials is subject to a robust framework of legal, regulatory, and administrative requirements. It is important that BMC researchers are aware that the Research Operations office is available to advise and assist in navigating the applicable processes.

As a threshold matter, any time a BMC researcher intends for biological materials to enter or leave BMC facilities—even if the materials will remain in the custody of a traveling researcher—they should reach out to the Research Contracts & Industry Agreements (RCIA) team to determine whether a Material Transfer Agreement (MTA) or other documentation is necessary or desirable. This is true no matter how routine the transfer may appear. MTAs serve many important purposes, but the consultation with RCIA is also vital to identifying any unique factors that need to be addressed in order to protect the interests of the institution and individual staff members, avoid personal liability, and ensure that all parties involved are meeting their respective academic and legal obligations. The specialists in RCIA can help identify any additional actions that need to be taken prior to a transfer and consult with relevant stakeholders within the BMC community, such as the Compliance Office, IACUC, IRB, and others.

Like any contract, an MTA is simply an exchange of promises. In its simplest form, one party commits to providing specific research materials, while the other party undertakes to make particular use of the materials. The benefits of a formal written agreement are that it allows those involved in the transaction to clearly identify the parties and materials, confirm simple but uncertain details (e.g., who pays for preparation and shipping), and perhaps most importantly, address contingencies. If something goes wrong, an MTA allows the parties to allocate liability so that conflicts can be resolved before they arise. If something goes particularly well, and the research leads to a breakthrough publication or the development of some commercially viable product, a contract ensures that no party’s academic or property interests are ignored. 

MTAs clearly document appropriate use and handling of materials, as well as indemnification and limitations of liability to protect the parties from unnecessary legal disputes. They eliminate doubt as to applicable laws, regulations, ethical guidelines, safety practices, publication expectations, disposition of intellectual property rights, and much more.

Identifying the appropriate parties is an essential function of MTAs as well. Although the ingenuity of BMC researchers and their peers at other organizations is vital to the development of valuable research materials, the use of institutional resources in the creation of these materials—as reflected in the conditions of employment at many comparable research facilities—means that the institution is generally the legal owner of the product. For that reason, while academic collaborations may be carried out between investigators, the contracts themselves are executed between their respective institutions.

Another benefit of executing an MTA for every transfer of research materials is that it allows BMC to keep track of what materials are in the institution’s possession, the origin of the materials, and any restrictions or requirements on the use of the materials. If the institution receives a request for materials that originated elsewhere, an MTA allows RCIA to determine the conditions under which the materials can be redistributed. 

The Boston Medical Center Research Operations office is committed to making the contracting process as efficient and accessible as possible. We encourage researchers and administrators to reach out early and often when considering materials transfers, as well as any other research transaction.