Skip to Main Content

Clinical Trials and Human Subjects Research

Some activities must or should be registered with the National Institutes of Health project registration system. If the activity is funded by NIH and meets the definition of a "clinical trial," then the grant contract requires registration. If there is no contractual obligation to register, researchers should consider registration with clinicaltrials.gov since it could benefit the field and health care generally.

"A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."

Learn more at ClinicalTrials.gov

Protocol Registration and Results System (PRS)

Miami maintains an institutional account with the PRS at NIH. That account is maintained by an administrator. Researchers and PIs can request that a user account be established with the PRS system by contacting the institutional administrator. Once the user account is established, the user uploads project documents and notifies the administrator. The administrator accesses the account and releases the information to NIH. NIH can then notify the adminstrator of the status.

System Organization Name

MiamiU

Responsibilities

At the request of the researcher, the Miami Research Ethics and Integrity Office (MREI) as the institutional administrator, creates an account in the Protocol Registration and Results System (PRS). Account information is sent by PRS by email to the researcher. The researcher uploads study materials and notifies MREI which releases the records for NIH review. The MREI is notified upon NIH approval that the information can be made available to the public.

Submission Requirements

Some data elements are required by ClinicalTrials.gov, while others are optional but may be required by other organizations. Users are encouraged to submit all data elements in order to provide a complete description of the study.

A ClinicalTrials.gov staff member will review the study record after it is released (submitted) and before it is published on ClinicalTrials.gov. This review will focus on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting. You may be asked to clarify items or make corrections to the record before publication. Please note that the review process may take up to a few days. Ensuring that the record is consistent with the ClinicalTrials.gov protocol review criteria (PDF) before releasing it will expedite publication on the site.

Help

For basic help with using PRS, review the Quick Start Guide found in the Help section of the PRS main menu. More detailed instructions are available in the PRS User's Guide, also found on the PRS main menu.

Required Registration Updates

Researchers should update their records within 30 days of a change to Individual Site Status and Overall Recruitment Status data elements or Completion Date (see Primary Completion Date data element on ClinicalTrials.gov). Other changes or updates to the record must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

Material Transfer Agreement (MTA)

A Material Transfer Agreement is a contract that governs the transfer of tangible research materials between two organizations, when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Miami University requires MTAs for any incoming or outgoing materials in order to monitor what materials are coming on campus, and what materials (and to whom) MU is supplying. Faculty members coming to or leaving MU need to have an MTA in place prior to transferring any materials from/to other institutions such as plasmids, cell lines, animals, etc. An Implementing Letter is executed, which denotes the biological material as well as the providing institution and receiving institution.

An incoming MTA protects a researcher's ability to use and publish research, any existing and potential intellectual property and define the use of any accompanying confidential information. The review of an incoming MTA ensures the agreement terms don't conflict with rights granted in other agreements associated with the research.

MTAs for outgoing material typically prevent the material provider from losing control over the material and its research use. If no agreement exists, then the recipient of the material has no legal restrictions on the use of the material, or on transferring the material.

MTAs (incoming and outgoing) must undergo a compliance review to ensure that the appropriate compliance protocols are in place for:

  • Live animals - Institutional Animal Care and Use Committee (IACUC).
  • Human tissue and/or data - Compliance with 45 CFR 46 (and all other applicable federal regulations), and, if required, have protocol(s) reviewed and approved by the Institutional Review Board (IRB).
  • Hazardous materials - Biosafety compliance and, if applicable, have protocol(s) reviewed and approved by the Institutional Biosafety Committee (IBC).
  • Conflict of Interest (COI) – Review needed where the decision to undertake the research is based on receiving access to the material(s) from a non-governmental or industrial provider must follow Committee requirements for financial disclosure.

Data Use Agreements (DUAs)

Data Use Agreements are contractual documents used for the transfer of nonpublic data that is subject to some restriction on its use. DUAs serve to outline the terms and conditions of the transfer. Specifically, DUAs address important issues such as limitations on use of the data, obligations to safeguard the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data. The understanding established by a DUA can help avoid later issues by clearly setting forth the expectations of the parties (provider and recipient). Having a signed DUA in place may be a required precondition to transfers of certain data, or it may simply be a good idea. Determining whether a DUA is required is necessarily context dependent. When a DUA is required, it must be study specific – i.e., data cannot be transferred pursuant to “master” or blanket sharing agreement

A data use agreement (DUA) is an agreement that is required under the Privacy Rule and must be entered into before there is any use or disclosure of a limited data set (defined below) to an outside institution or party.  A limited data set is still protected health information (PHI), and for that reason, covered entities must enter into a data use agreement with any recipient of a limited data set.

At a minimum, any DUA must contain provisions that address the following:

  1. Establish the permitted uses and disclosures of the limited data set; 
  2. Identify who may use or receive the information;
  3. Prohibit the recipient from using or further disclosing the information, except as permitted by the agreement or as otherwise permitted by law;
  4. Require the recipient to use appropriate safeguards to prevent an unauthorized use or disclosure not contemplated by the agreement;
  5. Require the recipient to report to the covered entity any use or disclosure to which it becomes aware;
  6. Require the recipients to ensure that any agents (including any subcontractors) to whom it discloses the information will agree to the same restrictions as provided in the agreement; and
  7. Prohibit the recipient from identifying the information or contacting the individuals.