Independent IRB, Inc. has been serving the research community for more than 20 years
and in this time has gained the knowledge that can only be attained through experience.
Our experience is reflected through:
The Independent IRB, Inc. offers a full range of services to include all aspects
of research. These include the following:
Drafting Informed Consent Form
The Independent IRB, Inc. offers drafting of informed consent forms as a service
to its clients. To request this service submit a Research Protocol, Investigator’s
Brochure/Product Information, payment information, and any other relevant information.
The IIRB, Inc. will forward a draft ICF in approximately 48-72 hours. For more information
contact the Independent IRB,
Inc. office.
Research Involving Human Subjects Determination
The responsibility for initial determination as to whether an activity constitutes
human subjects research rests with the investigator. The Independent IRB, Inc. provides
confirmation of human subject research determination as a service to its clients.
To request a confirmation for human research determination, submit a copy of the
Research Protocol. Independent IRB, Inc. determination will be forwarded to the
Investigator.
Evaluation and Exemption Determination
The Independent IRB, Inc. provides exemption determination as a service to clients.
To request this service submit a Request for
Exemption Determination Form. Independent IRB, Inc. determination will be
forwarded to the Investigator. For more information
contact the Independent IRB, Inc. office.
HIPAA Waiver
The Independent IRB, Inc. can serve as a HIPAA Privacy Board and can provide consultation
for Information Plan development.
Human Research Protection Training
The Independent IRB, Inc. offers onsite training individualized to the needs of
the Sponsor or Site. For more information
contact the Independent IRB, Inc. office.
The Independent IRB, Inc. requires that the Principal Investigator has education
and training in Human Research Protection (HRP). There are numerous programs available
to interested researchers and Independent IRB, Inc. will accept documentation from
these training programs as evidence of compliance with this requirement. If an Investigator
does not have documentation of HRP training, Independent IRB, Inc. provides access
to a program for this purpose. This training program is known as Collaborative Institutional
Training Initiative (CITI). For more information, see
HRP Training.
Participant Protection
The Independent IRB, Inc. is dedicated to ensuring that research participants are
provided with adequate information about clinical research trials. In efforts to
do this, each of our Informed Consent Form contains information to take them to
an Independent IRB, Inc. website that will provide them with additional information.
On this website research participants will be provided information about their rights
as a research participant, key terms in clinical research, additional resources
on clinical research, and a place to send their comments to the Independent IRB,
Inc.
Click
here if you like to view
this website for research participants.
Additional Participant Protection Resources
The IIRB,
Inc. endorses the use of clinicalRSVP software program to prevent dual enrollment
and further the protection of human research participants. clinicalRSVP is a web
based research participant registry used by investigators and research sites to
make better informed enrollment decisions. This tool allows participating research
sites to report the dose dates of research participants to a database for purposes
of identifying ineligible research participants at time of future screenings. Click
here to read
more.