Collaborator resources

The risk to human research subjects is minimized through a standardized review process. In accord with federal regulations, all clinical trials in the U.S. must be approved by an independent review group, called the Institutional Review Board, or IRB. IRB members include clinicians and individuals from the community who have no direct interest or participation in the study.

The IRB is responsible for evaluating the ethics and scientific value of a study as well as for protecting subjects’ rights and welfare. It has sole authority to approve, require modifications in, or disapprove of any research activity. The IRB review process ensures that the proposed study has satisfactorily answered such important questions as:

• Is the research scientifically sound?
• What are the risks to human subjects, and have the risks been minimized?
• How will subjects benefit from the research?
• Have subjects been selected in a fair and equitable manner?
• Will the data be adequately monitored?
• What will the researcher do with the subjects’ information?
• Will the subjects’ privacy and confidentiality be maintained?
• Has the study team informed potential subjects of all details of the study?
• Have the potential subjects willingly consented to be part of the study, and do they have the capacity to consent? (Some situations require additional safeguards, such as when subjects are children, are handicapped, or when there are language barriers.)

Investigators, coordinators, and assistants share in the obligation to uphold the ethical, legal, and regulatory requirements for human subject protection. The principal investigator (PI) bears direct personal responsibility for protecting every research subject enrolled in his or her study. The PI is also responsible for ensuring that all members of the study team uphold their ethical and regulatory responsibilities for human subject protection.

The organization must provide the commitment, leadership, infrastructure, continuing education and compliance oversight necessary to protect human subjects. It must also provide written assurance to the appropriate federal agencies that the organization conducts research in accord with accepted ethical standards and specific regulatory requirements (the “Common Rule”). At Atlantic Health, the IRB is staffed by dedicated professionals who monitor some 400 clinical trials. Atlantic Health requires that all investigators, study coordinators and research staff complete an IRB-approved education component in human subject protection as well as periodic continuing education programs. Additionally, all research personnel must complete a Federal Funds Compliance Education module. No investigator conducting research under Atlantic Health auspices will receive IRB approval for a new protocol or for an extension without proof that the educational requirements have been fulfilled.

Protection of participants extends to any experiment that involves a drug, device or biologic test item. This encompasses a wide range of research, including tissue specimens, medical records, genetic materials, behavioral and/or biomedical assessments, and treatments. Some examples:

• Procedures or treatments that are innovative when compared to the accepted standard
• Research on residual diagnostic specimens, including those obtained for routine patient care that would be discarded if not used for research
• Research involving private information that can be readily identified with an individual (such as retrospective chart reviews), even if the information was not specifically collected for the study in question
• Surveys and questionnaires where identifiers can link the responses to individuals or that contain questions of a sensitive or questionable nature
• Research on bodily materials such as cells, blood, urine, tissues, organs, hair or nail clippings, even if the researcher did not collect these materials
• The care of patients or the assignment of healthy volunteers to any intervention that is altered for research purposes in any way
• Research conducted in collaboration with other hospitals, universities, or research centers, even if the outside institution’s IRB has already approved the study

All human-subject research conducted at Atlantic Health facilities or by anyone as an agent of Atlantic Health must be reviewed and approved by the IRB prior to initiation of the study.

Some research involving human subjects may be exempt from regulations requiring IRB approval due to the minimal risk of the study and a lack of participant identifiers. However, the study still must be submitted for review to the IRB, which makes the final determination on whether a study is exempt. Following are some examples of minimal-risk research that the IRB may designate as exempt:

• Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified.
• Research conducted in commonly accepted educational settings involving normal educational practices, such as research on education instructional strategies.
• Research involving survey procedures, interview procedures, the use of educational tests, or observation of public behavior, as long as the information obtained is recorded in such a manner that subjects cannot be identified.

The Atlantic Health IRB is led by Roger Kurlan, MD, director of the Movement Disorders Program at Atlantic Neuroscience Institute. The vice chair is John Allegra, MD, emergency medicine, who shares in IRB oversight responsibilities.

The IRB Manager and IRB Coordinator direct the IRB’s day-to-day functions and can help you understand the regulatory requirements governing human subject research.