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20. What are the Investigator’s Obligations after IRB approval?

 

 

 

See: Guidance for Investigators and Research Staff - Responsibilities

 

 1.    Personally conduct or supervise the Human Research: Do not begin Human Research Activities until you have documented IRB approval.

  • Conduct the Human Research in accordance with the relevant current protocol as approved by the MMC IRB.
  • When required by the MMC IRB, ensure that consent or permission is obtained in accordance with the relevant current protocol as approved by the MMC IRB.
  • Do not modify the Human Research without prior MMC IRB review and approval unless necessary to eliminate apparent immediate hazards to participants.
  • Protect the rights, safety, and welfare of participants involved in the research.
  • A qualified physician (or dentist, when appropriate), who is an investigator or a co- investigator for the clinical trial, is responsible for all clinical trial-related medical (or dental) decisions during and following a subject's participation in a clinical trial
  • The investigator ensures that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the clinical trial.
  • Investigators inform subjects when medical care is needed for other illnesses of which the investigators become aware.
  • The investigator follows the clinical trial's randomization procedures, if any, and ensures that the code is broken only in accordance with the protocol. If the clinical trial is blinded, the investigator promptly documents and explains to the sponsor any premature unblinding.The investigator informs the subject's primary physician about the subject's participation in the clinical trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.
  • Although a subject is not obliged to give his or her reasons for withdrawing prematurely from a clinical trial, the investigator makes a reasonable effort to ascertain the reason, while fully respecting the subject's rights.The investigator provides written reports to the sponsor, the IRB, and, where applicable, the Organization on any changes significantly affecting the conduct of the clinical trial or increasing the risk to subjects.
  • If the investigator terminates or suspends a clinical trial without prior agreement of the sponsor, the investigator informs the Organization, sponsor, and the IRB.
  • Promptly report to the IRB any information that indicates a change to the risks or potential benefits of the Human Research

 

2.      Submit to the IRB:  Proposed modifications as described in this manual See "How to submit protocol modifications/ changes with an Amendment"

3.      Submit to the IRB: a request for continued approval as described in this manual See How to Submit an Annual Progress Report for Continuing Review .

4.      Submit to the IRB notification that a study will be closed See How to Close Out a Study.

5.      Unanticipated problems (other than those events captured above) involving risks to subjects or others. 

For example:

  • An interim analysis, safety monitoring report, publication in the literature, or revised investigator brochure that indicates an increase in the frequency or magnitude of harm, uncovers a new risk, or provides more information about the benefits of the Human Research.
  • Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a Human Research protocol.
  • Protocol violation that harmed participants or others or that indicates participants or others might be at increased risk of harm.
  • Complaint of a participant that indicates participants or others might be at increased risk of harm or at risk of a new harm.
  • Local/internal adverse event which in the opinion of the investigator are unexpected and at least probably related to the study procedures.
  • A harm that is "unexpected" when its specificity and severity are not accurately reflected in the consent document.
  • A harm that is "at least probably related to the study procedures" if in the opinion of the investigator, the research procedures more likely than not caused the harm.
  • External adverse event which in the opinion of the sponsor or investigator requires changes to the protocol or informed consent form.
  • Finding of Non-Compliance or Allegation of Non-Compliance.
  • Audit, inspection, or inquiry by a federal agency.
  • Failure to follow the protocol due to the action or inaction of the investigator or study staff.
  • Breach of confidentiality.
  • Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a participant.
  • Incarceration of a participant in a protocol not approved to enroll prisoners.
  • Complaint of a participant that cannot be resolved by the research team

 

6.      Do not accept or provide payments to professionals in exchange for referrals of potential participants ("finder's fees.")

7.      Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment ("bonus payments.")

8.      Maintain signed and dated HIPAA authorizations and consent documents that include HIPAA authorizations for a minimum of 6 years after completion of the research.

9.      For studies involving drugs being studied under an IND or devices being studied under an IDE or abbreviated IDE.

  • Inform any potential subjects of all drugs or devices being used for investigational purposes.
  • Review and understand the information in the investigator's brochure/manual, including the potential risks and side effects of the drug or device.
  • Prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the Human Research on each individual administered the investigational drug or device, or employed as a control in the Human Research. Case histories include:
  • Case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes.
  • Retain all records for six years after study completion, i.e., closure of the Human Research protocol, or longer if required by the sponsor.
  • Control the investigational drugs and devices being used in the research.
  • Personally supervise the administration of the drug or device to enrolled participants subjects.
  • Do not supply the drug or device to any person not authorized under this part to receive it.
  • Maintain adequate records of the disposition of the drug or device, including dates, quantity, and use by participants.
  • If the investigation is terminated, suspended, discontinued, or completed, return the unused supplies of the drug or device to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under 21 CFR §312.59.
  • If the investigational drug is subject to the Controlled Substances Act, take adequate precautions, including the secured storage of the investigational drug.
  • Furnish all reports, such as adverse events, progress report/final report, and financial disclosures, to the sponsor according to the protocol or sponsor agreement.
  • Upon request from appropriate federal government agencies, such as FDA and NIH, at reasonable times, permit such officers or employees to have access to, and copy and verify any records or reports.
  • Assure that an IRB complies with the requirements set forth in 45 CFR 46 or 21 CFR 56 and will be responsible for the initial and continuing review and approval of the proposed clinical study.
  • Ensure that all associates, colleagues, and employees assisting in the conduct of the Human Research are informed about their obligations in meeting the above commitments.
  • When required by sponsor, comply with the International Council on Harmonization - Good Clinical Practice Guidelines.

  See :

"Guidance for Investigators - Investigator & Research Staff Responsibilities"  

 

"Guidance for Investigators Using an FDA Regulated Product - Adhering to Federal Regulations"

 

 "Guidance for Investigators - Investigational New Drug (IND) Sponsor - Investigator Responsibilities"

 

"Guidance for Investigators -Physician/Investigator as Sponsor of an IDE - Non-Significant Risk Device"

 

"Guidance for Investigators - Physician/Investigator as Sponsor of an IDE - Significant Risk Device"

 

 

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