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What is a review preparatory to research?

This is a specific term related to the review of a potential subject’s in order to prepare a research protocol or for similar purposes such as to determine whether the person might be eligible for participation in a research study. By following the requirements for a review preparatory to research, you will comply with HIPAA as you seek to identify potential subjects whose PHI will not leave your site without the person’s prior authorization. Note that this method must not be used if such PHI will leave your site without the person’s prior authorization.

As a Clinical Investigator, do you need to be compliant with HIPAA?

As a Clinical Investigator you need to ensure that you obtain proper authorization from the patient/subject entering a research protocol to use his/her PHI for research. This authorization must be obtained by you from all research subjects who are enrolled into clinical trials. For your ongoing studies under the approval of the IRB, you must use the IRB’s approved authorization form, or your authorization must be submitted to the IRB for review and be approved prior to its use.

What is Quality Assurance in research?

There is a system of checks and balances in place for the conduct of clinical research. Regulations and guidelines make up part of this system. Quality assurance (QA) professionals use these tools as they conduct audits to assess compliance with Good Clinical Practice (GCP).

What protocol deviations or violations are required to be reported?

Protocol deviations or violations that either increase the risk to subjects or affect the integrity of the study data must be reported to the IRB. IRBs deem any deviation/violation from the protocol that increases the risk to subjects or affects the integrity of the study data to be significant. An isolated issue may not be significant by itself but significance may increase with numerous deviations of the same nature. Significant deviations may be events such as: enrollment of subjects who did not meet inclusion/exclusion criteria, use of the wrong informed consent document, or failure to perform appropriate procedures at a study visit. Submissions should be made on the IRB’s Protocol Deviation Report Form and Investigators should submit information to the IRB within 10 working days after becoming aware of a significant protocol deviation.

What are the responsibilities of the Principal Investigator?

The principal investigator is responsible for personally conducting or supervising the conduct of human-subjects research and for protecting the rights, safety, and welfare of the subjects enrolled in the research. The PI must ensure that all human-subjects research is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and requirements:

• Ensuring that the research protocol has sound design, minimizing risks to subjects while maximizing research benefits.
• Protecting the rights and preserving the safety and welfare of prospective subjects.
• Ensuring that research subje nt of the research.
• Conducting the study and enrolling subjects in accordance with the IRB and R&D approved current protocol and making changes to the protocol only with approval of the sponsor, IRB, and R & D Committee, except in emergent situations when the changes are necessary to protect the safety, rights or welfare of subjects.
• Ensuring appropriate data safety and monitoring for the protocol, monitoring of subjects for potential harm, promptly modifying the research design to mitigate any potential risks, and reporting any changes in the risk-benefit ratio to the IRB.
• Reporting to the sponsor and the IRB any unanticipated problems involving risk to subjects or others that occur in the course of the research in compliance with applicable policies.
• Maintaining appropriate documentation (enrollment, research progress, and termination notes) in the subject’s electronic medical record.
• Maintaining adequate and accurate source documentation and regulatory records in accordance with the Sponsor’s regulations and GCP.
• Disclosing any financial Conflict of Interest relevant to the study
• Ensuring that recruitment of subjects is performed in a fair and equitable manner.

Are there any groups of subjects that need special consideration when planning study recruitment strategies?

Yes, these are “vulnerable populations”, or special classes of subjects that require special consideration for inclusion in a study.

Vulnerable populations under Federal regulation include:

• Fetuses and human in-vitro fertilization
• Women-potentially pregnant, pregnant, lactating
• Children, minors (under 18 years of age)
• Prisoners
• Persons who are HIV+ (State regulations)

Vulnerable populations within common sense guidelines include:

• Cognitively impaired persons.
• Traumatized patients.
• Comatose patients.
• Terminally ill persons.
• Elderly/aged persons.