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					Attachment 3-3 Sample Letter from DDIR

New Member




Dear Dr.:

Dr.               and Dr.       have recommended you to serve as a member of the
Institutional Review Board (IRB), and I am pleased to confirm this 3 year this appointment.

The role of NIH's IRBs is described in the NIH Multiple Project Assurance (MPA), which
incorporates the ethical and regulatory requirements for human subject protections that
are outlined in The Belmont Report and the Federal Regulations for the Protection of
Human Subjects (45 CFR 46). IRB members are expected to have a thorough knowledge
of these requirements, and a copy of the MPA is attached.

The NIH Office of Human Subjects Research (OHSR) has designed a new Computer Based
Training (CBT) program in addition to the CBT program for intramural researchers and other
personnel on the protection of human subjects. The new CBT, which takes about an hour
to complete, has been designed especially for IRB members, and is a requirement for
service on an NIH IRB. Please call OHSR’s Dr. Alison Wichman at 402-3444 to discuss how
you can access the CBT and to schedule a brief member orientation session.

The IRBs play a vital part in ensuring that the clinical research done at NIH is of the highest
scientific and ethical standards, and that the safety and welfare of the people who
participate in the research are protected. I am grateful that you are willing to take part in
this very important process.


                                               Sincerely yours,



                                               Michael M. Gottesman, M.D.
                                               Deputy Director for Intramural Research

Attachment

cc:    Dr.               Clinical Director
       Dr.               Scientific Director
       Dr.               Chair,        IRB
       Ms.                Protocol Coordinator
Attachment 3-3 Sample Letter from DDIR

New Chair



Dear Dr.:

Dr.               and Dr.       have recommended you to serve as a member of the
Institutional Review Board (IRB), and I am pleased to confirm this 3 year this appointment.

The role of NIH's IRBs is described in the NIH Multiple Project Assurance (MPA), which
incorporates the ethical and regulatory requirements for human subject protections that
are outlined in The Belmont Report and the Federal Regulations for the Protection of
Human Subjects (45 CFR 46). IRB members are expected to have a thorough knowledge
of these requirements, and a copy of the MPA is attached.

The NIH Office of Human Subjects Research (OHSR) has designed a new Computer Based
Training (CBT) program in addition to the CBT program for intramural researchers and other
personnel on the protection of human subjects. The new CBT, which takes about an hour
to complete, has been designed especially for IRB members, and is a requirement for
service on an NIH IRB. Please call OHSR’s Dr. Alison Wichman at 402-3444 to discuss how
you can access the CBT and to schedule a brief member orientation session.

The IRBs play a vital part in ensuring that the clinical research done at NIH is of the highest
scientific and ethical standards, and that the safety and welfare of the people who
participate in the research are protected. I am grateful that you are willing to take part in
this very important process. I hope that you will also interact with the other IRB chairs in
providing me with advice and input at the meetings of the Human Subjects Research
Advisory Committee (HSRAC). The HSRAC usually meets every two months, and the next
meeting will take place on ____ at 3:00 in the Medical Board Room.


                                               Sincerely yours,



                                               Michael M. Gottesman, M.D.
                                               Deputy Director for Intramural Research

Attachment

cc:    Dr.               Clinical Director
       Dr.               Scientific Director
       Dr.               Chair,        IRB
       Ms.                Protocol Coordinator
Attachment 3-3 Sample Letter from DDIR


Appointment of Vice-Chair

Dear Dr.:

Dr.      and Dr.    have recommended you to serve as the Vice Chair of the
Institutional Review Board (IRB), and I am pleased to confirm this 2 year appointment.

The role of NIH's IRBs is described in the NIH Multiple Project Assurance (MPA), which
incorporates the ethical and regulatory requirements for human subject protections that
are outlined in The Belmont Report and the Federal Regulations for the Protection of
Human Subjects (45 CFR 46). IRB members are expected to have a thorough knowledge
of these requirements, and a copy of the MPA is attached.

The NIH Office of Human Subjects Research (OHSR) has designed a new Computer Based
Training (CBT) program in addition to the CBT program for intramural researchers and other
personnel on the protection of human subjects. The new CBT, which takes about an hour
to complete, has been designed especially for IRB members, and is a requirement for
service on an NIH IRB. Please call OHSR’s Dr. Alison Wichman at 402-3444 to discuss how
you can access the CBT and to schedule a brief member orientation session.

The IRBs play a vital part in ensuring that the clinical research done at NIH is of the highest
scientific and ethical standards, and that the safety and welfare of the people who
participate in the research are protected. I am grateful that you are willing to take part in
this very important process.


                                               Sincerely yours,



                                               Michael M. Gottesman, M.D.
                                               Deputy Director for Intramural Research

Attachment
cc:
Dr.Clinical Director
Dr.Scientific Director
Dr.Chair, NICHD IRB
Ms.Protocol Coordinator
Attachment 3-3 Sample Letter from DDIR

Appointment of Alternate



Dear Dr.

Dr.                and                 have recommended you to serve as an alternate
member for Dr.______ of the        Institutional Review Board (IRB), and I am pleased to
confirm this one year appointment.

The role of NIH's IRBs is described in the NIH Multiple Project Assurance (MPA), which
incorporates the ethical and regulatory requirements for human subject protections that
are outlined in The Belmont Report and the Federal Regulations for the Protection of
Human Subjects (45 CFR 46). IRB members are expected to have a thorough knowledge
of these requirements, and a copy of the MPA is attached.

The NIH has three educational requirements that must be completed before becoming a
voting IRB member. Please complete two computer-based training programs (CBTs) that
are available on the web site of the NIH Office of Human Subjects Research (OHSR) at
<http://ohsr.od.nih.gov> Both take about one hour to complete. One CBT is designed
specifically for IRB members and the other is a general introduction to the NIH's human
subjects protection program (to access this CBT on the OHSR web site click on Researchers
and Research staff. This is an NIH access only CBT so you will need to use an NIH
computer). Also, please call Dr. Wichman in OHSR at 301-402-3444 to arrange a brief
member orientation.

The IRBs play a vital part in ensuring that the clinical research done at NIH is of the highest
scientific and ethical standards, and that the safety and welfare of the people who
participate in the research are protected. I am grateful that you are willing to take part in
this very important process.


                                               Sincerely yours,



                                               Michael M. Gottesman, M.D.
                                               Deputy Director for Intramural Research

Attachment

cc:    Dr.         Clinical Director
       Dr.         Scientific Director
       Dr.         Chair,        IRB
       Ms.          Protocol Coordinator
Attachment 3-3 Sample Letter from DDIR

Reappointments



Dear Dr.:

Dr. _______________ and Dr. ______________ have recommended you for reappointment as
______ of the _______ Institutional Review Board (IRB). I am very pleased that you are willing
to continue to serve for an additional two-year term, and I am happy to confirm the
appointment.


From my participation in the Human Subjects Research Advisory Committee meetings, I
have become even more keenly aware of the importance of the IRBs in fostering and
sustaining NIH's reputation for high quality clinical research and for protecting the safety
and welfare of the people who are research subjects. I also know that considerable time
and dedication is required to lead an IRB effectively. Thank you for your past contributions
to the _____ IRB; I look forward to working with you in future, and welcome any advice or
suggestions you may have with regard to the operation of the IRBs.


                                              Sincerely yours,




                                              Michael M. Gottesman, M.D.
                                              Deputy Director for Intramural Research


cc:    Dr. ___________, Clinical Director
       Dr. ___________, Scientific Director
       Dr. _____________, Chair, NCI IRB
       Ms. _______________, Protocol Coordinator
Attachment 3-3 Sample Letter from DDIR


Thank you Letters


Dear :

On behalf of the Director, NIH and the NIH Intramural Research Program, I want to thank
you for your service as a ______ of        Institutional Review Board (IRB). As you know, IRBs
not only help to foster and sustain the high quality of NIH's clinical research, but also
protect the safety and welfare of the people who are research subjects. NIH is fortunate
that busy people like you are willing to devote considerable time and effort to the work of
the IRBs, and I am grateful that you were able to take part in this very important process.
Thank you again.

                                              Sincerely yours,



                                              Michael M. Gottesman, M.D.
                                              Deputy Director for Intramural Research

cc:      Dr.                Clinical Director
         Dr.                Scientific Director
         Dr.                Chair,        IRB
         Ms.                Protocol Coordinator

				
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