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Patient Protection

Cancer Research for the Ozarks (CRO) is involved in human subject research through NCI-sponsored clinical research. Research base protocols are activated through an approved mechanism of the federal government.

CRO operates under the leadership of its Principal Investigator, Jay Carlson, DO with oversight by the Institutional Review Boards (IRBs).

An institutional review board, also known as an independent ethics committee, or ethical review board, is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

The purpose of an IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. The chief objectives of every IRB protocol review are to assess the ethics of the research and its methods, to promote fully informed and voluntary participation by prospective subjects who are themselves capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy) and to maximize the safety of subjects once they are enrolled in the project.

In the United States, IRBs are governed by Title 45 CFR (Code of Federal Regulations) Part 46. This National Research Act of 1974 defines IRBs and requires them for all research that receives funding, directly or indirectly, from what was the Department of Health, Education, and Welfare at the time, and is now the Department of Health and Human Services (HHS). IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within HHS. IRBs were developed in direct response to research abuses earlier in the twentieth century. Two of the most notorious of these abuses were the experiments of Nazi physicians that became a focus of the post-World War II Doctors’ Trial, and the Tuskegee Syphilis Study, a project conducted between 1932 and 1972 by the U.S. Public Health Service on black men in rural Alabama. Title 21 part 56 has additional requirements for IRBs that oversee clinical trials of drugs involved in new drug applications

All CRO physician investigators and research staff receive training in the protection of human subjects. All sites and patient records are available and are subject to internal auditing and Research Base audits at any time.

Each Research Base requests the data for individual trials using case report forms. The forms are submitted to the Research Base using an identifier unique to the participant, research protocol and CRO site. Access to the link between the patient’s identity and the participant ID number is limited to CRO staff.

Once a research base activates a new trial, the CRO Principal Investigator reviews the protocol or assigns it to CRO Co-Investigators for an in-depth review. New studies are presented to CRO investigators monthly for their review. The emphasis of the review is on benefits versus risk to the patient. If benefits outweigh risks, the study is thought to be scientifically sound and there are sufficient analytical cases from CoxHealth, Mercy-Springfield or other CRO Component cancer registries, the protocol may be forwarded to the IRBs.

Most protocols are reviewed by NCI’s Central IRB (CIRB) since this is an NCORP expectation.  CRO sponsors (CoxHealth and Mercy Springfield) have IRBs which are used for studies not approved by the CIRB.  CRO Components sites are given the choice of working with CoxHealth or Mercy Springfield IRB’s for coverage. All IRBs are accredited, have received federal wide assurances, and operate using policies and procedures in accordance with federal guidelines. Each IRB has a policy for Scientific Misconduct developed following the guidelines of the Office of Research Integrity and based on the requirements of PHS regulations codified at 42 C.F.R., Part 50, Subpart A.

Each institution’s IRB has appointed community members. Attention is paid to the makeup of the scientific versus non-scientific membership. Each member of the IRB is required to complete NIH Education for Research Subjects, as are all CRO investigators and staff members. IRB members are extremely dedicated to the protection and safety of research subjects.

Once a study is approved by the IRB and activated locally, all new cancer patients being seen in the medical oncologist office are screened for potential eligibility. Once eligibility has been established, staff alerts the physician that this patient may be eligible for a specific trial. The physician then decides if trial treatment options would be appropriate for the patient. If so, he/she speaks with the patient regarding the trial.

If the patient expresses interest, the research staff meets with the patient and family to discuss trial specifics and presents the Informed Consent. All CRO consents are based on NCI Informed Model Consents, which are provided by the research bases and modified according to local IRB requirements.

Patients are asked to take the consent home, think about it, and call the research staff if they have questions. Patients are asked to respond within a week if they wish to participate. After several days, contact is made with the patient to see if he/she has questions and/or wishes to enroll.

If the patient elects to participate, a copy of the signed consent is provided to the patient and placed in the patient’s clinic chart. The original informed consent is kept in the patient’s research file.

At the time a patient signs the informed consent, they are also give the CRO HIPPA or “Permission to Use or Disclose Personal Health Information for Research Purposes” form to sign. This form addresses:

· The types of health information to be used or shared;
· Why the information is needed;
· Who will see the information;
· Who from outside CRO will see the information;
· The protection provided after it is shared;
· The policy for terminating the authorization; and
· The patient’s access to his/her research-related information.

Once the informed consent and the HIPAA document are signed, source documentation is double checked by another staff member to verify eligibility and ensure all required pre-study procedures have been completed. The double-check practice assures accuracy in the data submission process.

The patient is then registered at which time he/she is given a research base number. From that point forward, the number and the patient’s initials are the sole identifiers. Any source document such as a requested pathology report for the study is de-identified before submission.

Once the chart is complete and all reviews are finished, the chart is stored with other CRO charts in a fireproof file at the CRO Administrative Office. All charts are secured and locked. Some charts are now saved and placed in a protected data base.

If information from an outside facility is requested, the patient is given a CRO “Authorization for Use and Disclosure of Protected Health Information for Research Related Purposes” form to authorize release of specific information.

The CRO research nurses and study coordinator provide oversight by reviewing safety reports and adverse events from patients enrolled through CRO as well as reports generated through the study sponsors. Research staff then checks the most recent approved consent to determine if the mentioned adverse event is included. The staff member who reviews also alerts investigators and other research staff about issues or pertinent adverse events. All local serious adverse events, both expected and unexpected are reported to the appropriate local IRB by the investigator.

CRO participates in NIH-defined phase III trials accessed through affiliated Research Bases, but CRO is not involved in the design and/or analysis of these trials, nor does the CCOP have a complete data set on any clinical trial in which it participates. Although CRO staff and investigators may propose a study and be involved in its development, the Research Base is responsible for overseeing and approving the final design and conducting the analysis of any proposed study.