The Johns Hopkins School of Medicine abides by the following contractual
requirements for sponsor-initiated clinical studies:
The sponsor of the clinical study must indemnify Johns Hopkins
University, its employees, its agents, and its affiliated hospitals
from any liability, loss, or damage resulting form the performance
of a study.
The sponsor must reimburse Johns Hopkins University for any cost
that is necessitated, as a direct result of participation in the
study and that is not covered by the participant’s medical insurance.
View the School of Medicine’s Model
Clinical Trial Agreement
View the School of Medicine’s list of Master
Clinical Trial Agreements
For information on TDC rates, please refer to the Sponsored
Projects Handbook, published by the School of Medicine’s Office
of Research Administration.
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The Johns Hopkins University School of Medicine, The Johns
Hopkins University School of Nursing, the Johns Hopkins Hospital,
and the Kennedy Krieger Institute require that no research project
involving human subjects be initiated until the project has been reviewed
and approved, or declared exempt from review.
The Joint Committee on Clinical Investigation (JCCI) is the
Institutional Review Board (IRB) charged with the responsibility for
review and approval of human subjects research conducted by faculty
members (full or part-time) of The Institutions, and all research
involving patients and/or employees of The Johns Hopkins Hospital
or The Kennedy Krieger Institute, and/or employees or students of
the School of Medicine. Review is required regardless of source (or
lack of source) of funding for a project and regardless of the site
at which the research is performed. The JCCI operates in compliance
with the U.S. Code of Federal Regulations, Department of Health and
Human Services (DHHS) Title 45 Part 46, entitled "Protection of Human
Subjects", as well as the Food and Drug Administration (FDA) regulations
on human subjects research.
The JCCI has a useful and informative website:
Here you can find direct links to most JCCI forms. It's also a great
resource to familiarize yourself with guidelines and operating procedures.
Some forms you might need for your IRB submission would be:
Research Project RPN application
Consists of a form and questionnaire
Should be on pastel blue colored paper
The radiation committee is so helpful. Call them!
Drug data form
Is it an IND study? Remember to submit a copy of the protocol and
Investigator's brochure for studies of investigational drugs or devices.
A new application is called an RPN (Research Project Notification).
If your study is an industry-initiated project, you are typically
required to fill out the application form, obtain the sponsor's IND#,
protocol, investigator's brochure, investigational new drug form and
the radiation forms. Tip: To save time, submit the consent form
for review by the sponsor at the same time that you submit to the
IRB. You can always make changes later. If your study is NIH-funded,
be sure to submit the Human Subjects Section of the grant along with
the application, as well as a full copy of the grant.
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We have seen medical reports regarding male enhancement pills.
There are many clinical tests made on hundreds of products, and only
a few of them were successful. If you look at the recent clinical
trials, you will find out about the real benefits of using pills:
• You get more powerful and longer lasting orgasms
• Your erections become harder and wider day by day
• You can recover faster after each intercourse
• Your penis becomes bigger when erected by 1-4 inches
• You can get multiple orgasms
Why use male enhancement pills?
Those pills have not been approved by FDA, but you can take them
without a prescription because their formula is natural and safe. It
consists of herbs and natural extracts. If you look closer at the
formula and check those ingredients, you will see they 100% herbal.
You will need to take those pills 3-6 months before you see any
significant changes in your sexual life.
If you’re suffering from erectile dysfunction, you need nutrition
and sport, healthy diet. You need to change your lifestyle before
you lose your sexual appetite.
Your erection hardness depends on your age, testosterone production,
and your libido. Try to increase your male sexual power and become
healthy. It’s important to visit a doctor and make some tests to
find out the reason for your sexual problems.