HHS regulations at 45 CFR 46.109 (e) require that continuing review of research be conducted by the IRB at intervals appropriate to the degree of risk and not less than once per year. The regulations make no provision for any grace period extending the conduct of the research beyond the expiration date of IRB approval.

The Board posited that if an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop and the study closed. Enrollment of new subjects cannot occur after the expiration of IRB approval. Further, data collected after the expiration date may not be used in the research project and must be provided to the administrative office of the Drew IRB.

The Board stipulated that a corrective action plan be implemented for all studies with lapsed approval dates. A detailed report outlining the plan is required by the IRB and should include the following:

1. Enact internal procedures to ensure compliance with University policy and Federal guidelines with all aspects pertaining to human subjects’ research, especially timely delivery of continuing review submission to the IRB.
2. Provision of an education plan for all study staff (i.e., Investigators and all individuals that are part of the study) regarding regulatory and ethical conduct of research involving human subjects. Specifically, the IRB requires the education plan to be comprehensive, including but not limited to education sponsored by an agency or national association. Please provide documentation for each individual and duration of the training and lecture topics discussed. Such education may include the following:
   1. Education sponsored by Public Responsibility in Medicine & Research/Applied Research Ethics National Association (PRIM&R/ARENA; http://www.primr.org)
   2. Education sponsored by the Office for Human Research Protection (OHRP; http://www.hhs.gov/ohrp/education/#activities).
   3. Review of the OHRP/PRIM&R CD-ROM, “Investigator 101”. This CD-ROM is available through the administrative office of the Drew IRB.
   4. Comprehensive review of the OHRP IRB Guidebook available online at: http://www.hhs.gov/ohrp/irb/irb_guidebook.htm

Approval of the Investigator’s education plan must occur prior to submission of any human subject research to the Drew IRB by the Principal Investigator.

Investigators are required to protect and/or disguise an individual subject's identity when using photographs, videos, or audio-tape recordings. The investigator should clearly outline in the consent form whether the tapes will be used for classroom presentations, conventions, presentations, or possibly released to news or advertising media. The consent form should also indicate when the tapes/photographs will be destroyed. In addition, the consent form should indicate the provisions for masking the subjects' identity. The Drew IRB recommends the following consent form statements for research that includes photographs, videos, or audio-tape recordings:

In the process of the research you will be videotaped (and/or photographed, and/or audio-taped). The tapes or photographs will be used for teaching and/or research purposes [indicate the types of purposes] only and your identity will not be disclosed. [The statement should also include an indication of when the tapes will be destroyed.]

Please check the appropriate box below and initial:

__________ I agree to be videotaped (and/or photographed, and/or audio-taped).

__________ I do not want to be videotaped (and/or photographed, and/or audio-taped)

If the subject is identifiable from the photographs, videos, or audio-tape recordings, the IRB suggests the following statement:

You have the right to review the tapes/photographs made as a part of the study to determine whether they should be edited or erased in whole or in part.

The NIH instituted a policy that requires all proposals for contracts and grants for research involving human subjects submitted after October 1, 2000 certify that all key personnel have received education on the protection of human research subjects. The Charles Drew University Federal Wide Assurance (FWA) with the Department of Health and Human Services/Office of Human Research Protections (DHHS/OHRP) assures the government and the public that we will ensure the protection of the rights and welfare of all human subjects participating in research regardless of funding source. To this end, Charles Drew University has required certification in biomedical research or social behavioral research of key personnel to all human research proposals prior to submission of the project to our Institutional Review Board (IRB) for review and approval or for a Claim of Exemption.

The Charles Drew University IRB has extended the certification requirements of all human research proposals to also include certification of key personnel pertaining to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) . HIPAA certification ( Research Module) for all Charles Drew University key personnel performing human research is needed by July 1, 2005.

Training and testing may be accomplished on-line and a certificate will be printed out at completion of the training and testing. Individuals can complete the training by using a web-based training program at http://www.training.ucla.edu .

If there are any questions in regard to this policy and/or assistance is needed, please contact the Drew IRB office at (323) 563-5902.

• As of January 1, 2005, all Schedule III substances, whether dispensed by prescriber or through pharmacy, must be reported to the Controlled Utilization Review and Evaluation System (CURES) [Senate Bill 151; Burton, Chapter 406, Statutes of 2003]. To comply with this procedure, complete names, addresses, and diagnosis code would be required to be reported to the CURES program, regulated by the Department of Justice. Therefore ALL studies that include TESTOSTERONE must abide by the following requirements:
• That ‘Department of Justice’ is listed with other institutions that may review subject information under the Privacy and Confidentiality section of the study informed consent form. The text within this section should read:

Authorized representatives of the Food and Drug Administration (FDA) [or a funding agency, such as the National Institutes of Health], the manufacturer of the drug [or device] being tested [insert name of company], and the Department of Justice may need to review records of individual subjects. As a result, they may see your name; but they are bound by rules of confidentiality not to reveal your identity to others.

• The method of reporting and to whom it will be reported must be included in the Application for Study Review in Section VIII. Protocol Summary, item 10c.