The Institutional Review Board
(IRB) has been established to assure the protection of human subjects involved
in the conduct of biomedical, clinical and behavioral research. The IRB is
designated to review and monitor research involving human subjects. The IRB
is a committee, composed of members from a variety of scientific disciplines
as well as community members. The purpose of the 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 the research.
The IRB has the authority to approve, require modifications in (to secure approval),
or disapprove research. All human research projects must be reviewed and approved
by the IRB prior to initiation and then conducted in full compliance with the
IRB guidelines. IRB approval of research is required for research involving
human subjects conducted by anyone on the premises of the Institution and to
research conducted elsewhere by faculty, students, staff, or other representatives
of the Institution in connection with their Institutional responsibilities.
The Office for Protection of Human Subjects provides administrative services
in support of the IRB functions and duties. As the administrative office
for the IRB, the office staff assists researchers in complying with federal,
state and University policies regarding experimentation involving human subjects.
Also, staff members conduct numerous education and training on the federal
regulatory mandates, research integrity and ethical standards and ‘how-to’ sessions
on preparing the documents for IRB review to investigators, staff, faculty
and students during the year. A monthly newsletter, entitled, “ IRB
MATTERS ” is written and distributed monthly on specific topics and
news impacting the conduct of research with human volunteers. This office
conducts audits on behalf of the IRB to ensure compliance.
Drew IRB Policy on Lapsed Approval
Dates - effective February 02, 2005
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:
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.
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:
Education
sponsored by Public Responsibility in Medicine & Research/Applied
Research Ethics National Association (PRIM&R/ARENA; http://www.primr.org)
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.
Confidentiality of Audio/Video-Tapes
and Photographs, Effective June 1, 2005
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.
Institutional Review Board
Scheduled Meetings and Due Date for Investigator Materials
January - December 2010
Contact:
Diane Nelson IRB Coordinator (323) 563-5902
IRB Office: Cobb Building Conference Room 281
IRB Meeting Date Wednesdays
Last Day to Submit Materials – Friday by 12:00 Noon
January 6, 2010
December 25, 2009
January 20, 2010
January 8, 2010
February 3, 2010
January 22, 2010
February 17, 2010
February 5, 2010
March 3, 2010
February 19, 2010
March 17, 2010
March 5, 2010
April 7, 2010
March 26, 2010
April 21, 2010
April 9, 2010
May 5, 2010
April 23, 2010
May 19, 2010
May 7, 2010
June 2, 2010
May 21, 2010
June 16, 2010
June 4, 2010
July 7, 2010
June 25, 2010
July 21, 2010
July 9, 2010
August 4, 2010
July 23, 2010
August 18, 2010
August 6, 2010
September 1, 2010
August 20, 2010
September 15, 2010
September 3, 2010
October 6, 2010
September 24, 2010
October 20, 2010
October 8, 2010
November 3, 2010
October 22, 2010
November 17, 2010
November 5, 2010
December 1, 2010
November 19, 2010
December 15, 2010
December 3, 2010
It is recommended that the investigators do not wait until the deadline but send their required materials as soon as possible to get a pre-review from the analysts (3 to 4 weeks). This should give time for analysts to review, send comments back, and for the investigators to respond. IRB submissions must have all relevant attachments and sufficient information for the IRB reviewers to make determinations required for approval of research. Due to the fact that OPHS receives many submissions, OPHS makes no guarantee that submission of the protocol by the deadline will ensure review at the next convened IRB meeting, although we will make every attempt to do so.
So, please consult with OPHS during the design of your protocol and send the submission material early for pre-review!