7.0 INVESTIGATOR, SPONSOR, AND SPONSOR-INVESTIGATOR REQUIREMENTS FOR THE CONDUCT OF RESEARCH.
7.1 Investigator, Sponsor and Sponsor-Investigator Obligations and Responsibilities. An MCW IRB may terminate a Research Study if an Investigator or a Sponsor fails to comply with the requirements of this Section.
7.1.1 Requirements and General Responsibilities of Investigators.
(a) Requirements to be an Investigator.
(i) Investigators intending to conduct Research Studies at MCW or an FWA-Affiliated Institution must be MCW faculty members. Exceptions to this requirement may be granted under special circumstances by the appropriate FWA-Affiliated Institution.
(ii) Residents and fellows may not be Principal Investigators on Research projects. They may be co-Investigators collaborating with an eligible MCW faculty member.
(iii) Nurses performing Human Subject Research Studies involving direct patient contact or care must include a physician as a co-principal Investigator.
(iv) Questions regarding eligibility to conduct Research Studies involving Human Subjects should be directed to the MCW IRB Office.
(b) General Responsibilities.
(i) Investigators shall be responsible for protecting the rights and welfare of Human Subjects and for complying with all applicable regulations including, without limitation, Title 21, Part 312 of the CFR, relating to INDs, Title 21, Part 812 of the CFR, relating to IDEs, all applicable DHHS regulations, all MCW IRB policies and procedures, as may be adopted or amended from time to time, and any conditions of approval imposed by an MCW IRB.
(ii) Investigators must submit a Research Study protocol to the MCW IRB for approval before beginning a Research Study. If the MCW IRB approves a Research Study protocol, the Investigator is responsible for reporting the progress of the approved Research Study to the MCW IRB in the interval prescribed by the MCW IRB, but no less than once per year.
(iii) Investigators must conduct the Research Study in accordance with the MCW IRB-approved Research Study investigational plan. Except as otherwise permitted in this Manual in the event of an life-threatening emergency or if necessary to eliminate an immediate hazard to Subjects, a Research Study protocol deviation requires prior FDA and MCW IRB approval. Any deviation from the Research Study investigational plan made to protect the life or physical well-being of a Subject must be in accordance with the emergency use requirements set forth in Sections 8.1 and 8.3 of this Manual, as applicable. Investigators must provide a report of any emergency use to the appropriate MCW IRB as soon as possible but in no event later than five (5) working days after the emergency occurs.
(iv) Investigators must report promptly to the MCW IRB any unexpected findings or problems involving Risks to Subjects or others, and any occurrence of serious harm to Subjects or others. (v) Investigators are expected to make every effort to prevent Scientific Misconduct. Primary responsibility for ensuring the authenticity of reported data rests with the Principal Investigator. An Investigator must not knowingly represent as empirical observation data that has been synthesized or altered.
(vi) Principal Investigators have the responsibility to ensure proper supervision of the Research not performed directly by them. Trainees must be supervised by experienced scientists and educated in the protection of Human Subjects and the ethical conduct of Research.
(vii) Publications must give credit to all Investigators involved in the Research, and all publications must be approved by all co-authors. In addition, all Investigators identified as authors of a report assume responsibility for its authenticity.
(viii) Investigators must notify the MCW IRB of the addition or deletion of co-Investigators upon occurrence during the course of a Research Study.
(ix) Investigators must provide a final report to the appropriate MCW IRB within three (3) months after Termination or Completion of a Research Study or the Investigator's part of the Research Study.
7.1.2 Responsibilities of Investigators Who Conduct Research Studies Involving Investigational Drugs. Investigators must promptly report to the appropriate MCW IRB and the FDA any Serious Adverse Event associated with the use of an Investigational Drug.
7.1.3 Responsibilities of Sponsors Who Conduct Research Studies Involving Investigational Drugs. In the event an IND is withdrawn by a Sponsor for safety reasons, the Sponsor must notify the appropriate MCW IRB, identifying the reasons for the withdrawal.
7.1.4 Responsibilities of Investigators Who Conduct Research Studies Involving Investigational Devices. The Investigator of a Research Study involving an Investigational Device must report any Serious Adverse Event that occurs during a Research Study as soon as possible, but in no event later than ten (10) working days after the Investigator first learns of the Serious Adverse Event.
7.1.5 Responsibilities of Sponsors Who Conduct Research Studies Involving Investigational Devices.
(a) A Sponsor who conducts an evaluation of a Serious Adverse Event must report the results of such evaluation to the appropriate MCW IRB within ten (10) working days after the Sponsor first receives notice of the Serious Adverse Event.
(b) The Sponsor shall inform the MCW IRB if any IRB withdraws its approval of a Research Study that has been approved by an MCW IRB within five (5) working days after receiving the notice of the approval withdrawal.
(c) The Sponsor shall inform the MCW IRB if the FDA withdraws its approval of a Research Study has been approved by an MCW IRB within five (5) working days after receiving the notice from the FDA of such withdrawal.
(d) At regular intervals, and at least yearly, a Sponsor shall provide the appropriate MCW IRB with the progress report for the Investigational Device.
7.1.6 Responsibilities of Sponsor-Investigators Who Conduct Research Studies Involving Investigational Drugs or Investigational Devices.
Sponsor-Investigators are responsible for complying with all requirements applicable to Sponsors and to Investigators conducting a Research Study involving an Investigational Drug or Investigational Device. The MCW IRB may require a Sponsor-Investigator to provide adequate assurances that proper monitoring of the Research Study will occur or to form a Data Monitoring Board.
7.2 Storage and Use of Investigational Drugs and Investigational Devices.
The Investigator is responsible for ensuring that Research Studies involving the use of investigational articles are carried out in a responsible manner and that the storage and security procedures for such articles follow all federal rules, regulations, and laws regarding controls and safety that pertain in ordinary clinical situations. Specifically, the Investigator must ensure that appropriate measures are in place to assure proper storage and distribution of any investigational articles used in connection with a Research Study. Controlled substances, such as narcotics and barbiturates, require even more stringent monitoring. Drugs that are subject to the Controlled Substances Act must be stored in a securely locked, substantially constructed enclosure to which access is limited.