Clinical studies may be conducted at DCMH only to the extent that they are part of a systematic program that meets accepted standards of clinical research to produce data that are valid, reliable, and significant.  In conducting clinical studies, the investigator should demonstrate the same concern for the welfare, safety, and comfort of the person as is required in delivery of care independent of a clinical study.

Dunn and Chadwick, in Protecting Study Volunteers in Research (CenterWatch, Boston, 1999) describe the role of the clinical investigator as follows:

Investigators bear the ultimate ethical responsibility for their work with human subjects.  Society entrusts them with the privilege of using other humans to advance scientific knowledge.  In return, society expects that investigators will show respect for research subjects. (p. 13)

While the purpose of clinical practice is prevention, diagnosis, and treatment to enhance the wellbeing of the patient, the purpose of research is to contribute to generalizable knowledge (p. 42).  The researcher is responsible for maintaining both the integrity of the research and adequacy of care for the subject (p.43).

I.      Initial Review of a Study

A.     The following documents must be submitted to the IRB at least ten days before the IRB meeting:

1.      A copy of the study in its unabridged form;

2.      A copy of the consent form to be used;

3.      A completed Request for IRB Review and Approval (Attachment #6) including a one-to-two page summary of the study in lay language;

4.      Any additional materials that would affect the Committee’s ability to evaluate the study; and

5.      An Investigator’s Brochure (if applicable).

NOTE: Attachment #7 delineates the criteria by which studies and consent forms are evaluated.

B.     The Clinical Investigator (or his/her designee) is responsible for presenting the study to the IRB, unless excused by the Chairman, and for answering questions raised by the members.

C.     The Clinical Investigator is responsible for submitting a copy of the Request for IRB Review and Approval, including a one-to-two page summary of the study in lay language, to the Pharmacy and Therapeutics Committee Chairman and Secretary if the study involves use of an Investigational New Drug. 

II.   Ongoing Conduct of a Study

A.     Unless waived, informed consent must be obtained from each participant (or his/her legal representative) prior to enrollment in the study, utilizing the approved consent form and ensuring that the participant’s rights are fully protected.

1.      A copy of the signed consent and the protocol must be maintained in the patient’s medical record; and

2.      The IRB may request copies of any or all signed consents, and/or a member of the IRB may observe the consent process.

B.     The study will be run using qualified personnel.  In the prolonged absence of the Principal Investigator, a Co-Investigator will be named.

C.     Changes in research activity may not be initiated without IRB review and approval, except where necessary to limit apparent immediate hazards to participants.  A copy of all proposed changes must be submitted to the IRB, along with a cover letter summarizing proposed changes.

D.     All unexpected and/or significant risks to patients or others resulting from research studies must be reported to the IRB. 

1.      A description of the nature of the problem must be submitted to the IRB, as well as an assessment of the relationship of the problem to the research.

2.      All significant (grade 4 or grade 5) or unexpected complications or other research-related injuries occurring in participants through DCMH must be reported immediately to the IRB Secretary (Attachment 8), to the Director of Risk Management, and to the Pharmacy (as an Adverse Drug Reaction) if appropriate.

3.      Reports of Data Safety Monitoring Committees or similar groups are to be submitted promptly to the IRB.

4.      Complaints from subjects regarding the conduct of the research should be reported in a timely manner to the Coordinator at (610) 284-8182 394-4722 or the Chairman at (610) 394-9860.

E.      A periodic update regarding the status of the study must be submitted to the IRB at the Committee’s direction.  Study (re)approvals will be granted for a period not to exceed 365 days.

1.      The Update on Research Previously Approved for Use at DCMH form (Attachment #9) must be completed, signed by the investigator, and submitted to the IRB Secretary, along with a current copy of the protocol in its entirety, the consent form, any changes in the study or consent not previously approved by the IRB, and any new information or publications relevant to the study review. 

2.      Updates must be submitted to the IRB as long as the study remains open to accrual at DCMH, as long as patients who participated in the study remain alive and in follow-up for the study, and/or as along as subject-identifying information is being used.

3.      If the investigator desires to extend the study beyond the initial (or current) approval period, a request for extension must be made to the IRB before the end of the approval period, using the form titled Update on Research Previously Approved for Use at Delaware County Memorial Hospital (Attachment #8).

4.      Approval of studies by the IRB terminates automatically at the end of the approval time unless extended.

5.      Retroactive reapproval is not granted.

F.      Copies of outside audits or evaluations performed on research activities shall be forwarded to the IRB in a timely manner.

III.           Advertising

The IRB shall review any direct advertising to be used in the recruitment of subjects prior to publication.  This includes (but is not limited to) printed advertisements, and radio or television broadcasts.

A.     The final copy of printed advertisements, as well as audio and/or video tapes, shall be submitted to the IRB prior to public use.

1.      The IRB may review the wording of a taped advertisement prior to taping to reduce the need for re-taping.

2.      The review of a taped message prepared from IRB-approved text may be accomplished through expedited procedures.

B.     In reviewing advertisements, the IRB shall consider the following issues:

1.      Information may not be presented in a way which is misleading to potential subjects.

2.      The procedures for recruiting subjects may not be coercive.

3.      The advertisement may not state or imply a certainty of favorable outcome or other benefits beyond what is described in the approved consent form and protocol.

4.      No claim may be stated or implied that a drug, biologic, or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic, or device.

IV. Termination of a Study

A.     The IRB must be notified when a study closes to accrual, when no subjects from DCMH are currently being treated on the study, when no subjects from DMCH are currently in long-term follow-up, and when no subject-identifying information is being used.  A final “Update” report, summarizing the life of the study at DCMH, must be submitted when these conditions are met.

B.     The IRB may withdraw approval for a study if any of the following occur:

1.      Updates, study/consent modifications, and/or toxicity reports are not submitted as required;

2.      The investigator materially fails to comply with IRB requirements;

3.      The study has zero accrual over a period of 18 to 27 months; or

4.      The committee comes to believe that the risks of the study outweigh the potential benefits for the participants.