Version Date 09/01/2005
NOTE: Only institutions or organizations that have their own Institutional Review Board(s) (IRB) or Independent Ethics Committee(s) (IEC) should submit an IRB/IEC Registration form. Institutions that do not have their own IRB/IEC but rely on the IRB/IEC of another institution should not submit an IRB Registration.
Follow the instructions below for each item on the IRB/IEC Registration form. If you have further questions, after reading these instructions, please go to the staffing guide on the OHRP website at http://www.hhs.gov/ohrp/daqi-staff.html (bottom of page), to determine the name and phone number of the staff member assigned to your region to contact.
PLEASE TYPE OR PRINT THE IRB REGISTRATION FORM LEGIBLY
TOP RIGHT-HAND CORNER - New Filing,Update or Renewal
Indicate by an [X] whether this is a "New Filing" or an "Update or Renewal" of an already existing IRB/IEC Registration. Also indicate by an [X] if the update or renewal includes the "Addition of New IRB(s)." If the IRB/IEC is already registered with OHRP, please provide your institution's/organization's IRB Organization (IORG) number. If you do not know your institution's/organization's IORG number, you may obtain this number from this website at http://ohrp.cit.nih.gov/search/asearch.asp#IORG. (See Update and Renewal instructions at http://www.hhs.gov/ohrp//humansubjects/assurance/renwirb.htm)
ITEM #1 - Organization Operating the IRB(s)/IEC(s)
Type or print the full legal name of the institution or organization that is registering the IRB/IEC and full mailing address, including country if outside the United States. Also, include the street address if it is different than the mailing address.
ITEM #2 - Senior or Head Official of Organization Operating the IRB(s)/IEC(s)
Type or print the full name, degree(s), organizational title (e.g., President, Provost, Chief Operating Officer), telephone number, fax number, e-mail, and full mailing address for the senior or head official of the organization operating the IRB/IEC [i.e., the person in your organization who is ultimately responsible for the performance and conduct of the IRB(s) or IEC(s)].
ITEM #3 - Person Providing this Information
Type or print the name, title, telephone number, fax number, and e-mail for the person providing the information submitted on the IRB/IEC Registration form. For electronic submissions, the person providing the information must have an e-mail address.
ITEM #4 - Information on Each IRB/IEC to be Registered, Updated, or Renewed
Indicate how many IRBs/IECs are to be
registered, updated or renewed with your submission.
Type
or print the following information [items 4(b) through 4(f)] for
each IRB/IEC to be registered. If you are registering more
than one IRB/IEC, provide the information requested in item #4 for
each IRB/IEC and clearly identify the information for each IRB/IEC.
IRB
Number - If your submission is an
update or renewal, type or print the IRB Registration number of the
IRB/IEC. The IRB Number assigned by OHRP (e.g., IRB0000xxxx)
can be found at http://ohrp.cit.nih.gov/search/asearch.asp#IORG .
For each new IRB/IEC, provide the sequence number (e.g.,
IRB#1, ... IRB#4) of the IRB.
IRB
Name - For first time submissions of an IRB/IEC Registration,
OHRP will name each IRB/IEC using the name of the IRB/IEC
Organization in item #1 followed by a sequential number (e.g.,
IRB#1, IRB#2) for each IRB/IEC registered. For example, if ABC
University registers three IRBs, OHRP will name the IRBs: ABC
University, IRB#1; ABC University, IRB#2; ABC University, IRB#3.
If you would like to customize or add a descriptive
Suffix (e.g., Behavioral, Biomedical) to the name given by OHRP,
then provide your entry or additional name in this section of the
IRB Registration form.
For an update or renewal of an
IRB Registration, the IRB name registered with OHRP (or modification
of the name) should be entered in this section of the IRB
Registration form. The IRB name as registered with OHRP can be found
at http://ohrp.cit.nih.gov/search/asearch.asp#IORG .
Provide the city and state or country for each IRB/IEC,
if different from the location in item #1.
In this section you are asked to provide optional information related to the IRB/IEC. If you choose to answer these questions, indicate your choice with either an [x] or a check mark. The responses to these questions will not appear on the OHRP website that lists all registered IRBs.
Indicate
whether or not the IRB or its parent organization has been
accredited by a human subject protection accrediting organization.
If yes, also provide the name of the accrediting organization
and the date of accreditation.
Provide
the approximate total number (none = 0; small = 1-25; medium =
26-99; or large = 100 or more) of currently active protocols. An
active protocol is defined as any protocol or study for which an
IRB conducted an initial review or a continuing review during the
preceding calendar year.
Provide
the approximate number of full-time positions devoted to the IRB's
administrative activities. This number should include the sum
of all full-time and part- time positions, to include professional,
administrative, and support staff.
Respond
with whether or not the IRB reviews or intends to review (within
the 3-year period covered by the IRB Registration) research
supported by the U.S. Government.
Provide
the approximate number of currently active protocols supported by
the U.S. Department of Health and Human Services (DHHS). DHHS
includes the National Institutes of Health (NIH), Centers for
Disease Control (CDC), Public Health Service (PHS), Agency for
Healthcare Research and Quality (AHRQ), Substance Abuse and Mental
Health Services Administration (SAMHSA), Health Research Services
Administration (HRSA), and Center for Medicare Services (CMS)].
Provide
the approximate number of currently active protocols supported by
other Federal Departments and Agencies [(i.e., Department of
Defense; Department of Energy; Education Department; National
Science Foundation; Environmental Protection Agency; Department of
Justice; International Development Cooperation Agency, Agency for
International Development; Department of Veterans Affairs; National
Aeronautics and Space Administration; Department of Agriculture;
Department of Commerce; Consumer Product Safety Commission;
Department of Housing and Urban Development; Department of
Transportation).
Indicate
whether or not the IRB reviews or intends to review (e.g., within
the 3-year period covered by the IRB Registration) research that is
regulated by the Food and Drug Administration (FDA) (e.g., research
involving investigational drugs, biologics, or devices).
Provide the approximate number of currently active protocols involving products regulated by the FDA (e.g., research involving investigational drugs, biologics, or devices). An active protocol is defined as any
protocol or study for which an IRB conducted an initial review or a continuing review during the preceding calendar year.
Check the categories of products that are
studied in active FDA-regulated protocols that are reviewed by the
IRB. An active protocol is defined as any protocol or study
for which an IRB conducted an initial review or a continuing review
during the preceding calendar year.
Type
or print the full name, degree(s), organizational title, telephone
number, fax number, e-mail and full mailing address for the IRB/IEC
Chairperson. Please make sure to include an e-mail address to
facilitate future correspondence (e.g., regarding the registration,
forwarding of new or revised OHRP guidance documents, etc.).
IRB
Roster Form:
General
Information - Completion of
the IRB Roster form is required if your IRB/IEC is designated on an
assurance submitted to OHRP.
Otherwise, completion and submission of the IRB Roster form is
optional. If more space is needed, you may attach additional
pages.
If the IRB/IEC is designated under an OHRP
assurance, be sure your IRB/IEC meets the minimum requirements for
membership. As detailed at 45 CFR Part 46, an IRB shall:
Have
at least five members, with varying backgrounds to promote complete
and adequate review of research activities commonly conducted by
the institution. The IRB shall be sufficiently qualified
through the experience and expertise of its members, and the
diversity of the members, including consideration of race, gender,
and cultural backgrounds and sensitivity to such issues as
community attitudes, to promote respect for its advice and counsel
in safeguarding the rights and welfare of human subjects.
Be
able to ascertain the acceptability of proposed research in terms
of institutional commitments and regulations, applicable law, and
standards of professional conduct and practice. The IRB shall
therefore include persons knowledgeable in these areas.
If
an IRB regularly reviews research that involves a vulnerable
category of subjects, such as children, prisoners, pregnant women,
or handicapped or mentally disabled persons, consideration shall be
given to the inclusion of one or more individuals who are
knowledgeable about and experienced in working with these subjects.
Include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
Include at least one member who is not
otherwise affiliated with the institution operating the IRB and who
is not a part of the immediate family of a person who is affiliated
with it.
Make
every nondiscriminating effort will be made to ensure that no IRB
consists entirely of men or entirely of women, including the
institution's consideration of qualified persons of both sexes, so
long as no selection is made to the IRB on the basis of gender. No
IRB may consist entirely of members of one profession.
Have
no member participate in the IRB's initial or continuing review of
any project in which the member has a conflicting interest, except
to provide information requested by the IRB.
An IRB
may, in its discretion, invite individuals with competence in
special areas to assist in the review of issues which require
expertise beyond or in addition to that available on the IRB.
These individuals may not vote with the IRB.
Instructions
- At the top of the IRB Roster form, please include the name of the
IRB Organization designated in item #1 and the IRB Registration
Number and/or Sequence Number [see instructions for item 4(b) on page
2].
For each listed IRB/IEC member:
Type or print the list of members on your
IRB/IEC. Primary members should be listed in the top section of the
form and alternate members in the lower section. Note: Do not list
non-voting individuals who attend IRB meetings. Their attendance
may be documented in minutes of the meeting.
Type
or print the "Gender" [e.g., male (M) or female (F)] and
the highest "Earned Degree(s)" (e.g., Ph.D., M.D., MSW,
B.A.).
Type
or print the IRB/IEC member's "Primary Scientific or
Nonscientific Specialty" (e.g., Sociology, Internal Medicine,
Library Services). Also, either in the "Primary
Scientific or Nonscientific" field or in "Comments"
indicate if a given member provides special representation for the
IRB (e.g., prisoner representative, advocate)
Type
or print the IRB/IEC member's "Affiliation with
Institution(s)" (e.g., employees, students, board members,
alumni, etc., should be listed as "Y" or "Yes";
members with no affiliation or relationship with the institution
operating the IRB other than being an active IRB member should be
listed as "N" or "No").
Type or print any additional relevant
information regarding a given IRB/IEC member in the "Comments"
section (e.g., prisoner representative, advocate).
When listing the alternate members, designate the corresponding number or name of the regular member(s) which a given alternate member represents. This information may be entered in the comments section.
SUBMITTING AN IRB/IEC REGISTRATION TO OHRP -
Please review and proofread all materials to be submitted and ensure that all parts of the registration form are complete and accurate. Incomplete or incorrect documents may delay processing and registration of your IRB/IEC.
Manually completed IRB/IEC registrations should be mailed, faxed, or e-mailed, single-sided, to OHRP. The mailing address is below. Registrations may be faxed to (240) 453-8202. If you would like to e-mail your registration, please go to the staffing guide on the OHRP website at http://www.hhs.gov/ohrp/daqi-staff.html (bottom of page), and e-mail the IRB registration to the staff member assigned to your region.
Electronically submitted IRB/IEC registrations should NOT be mailed or faxed to OHRP. Once you have clicked the "Submit" button, there is nothing more to do. The electronic submission area is monitored by OHRP, and if there are any questions about the registration, someone from OHRP will contact the submitter of the electronic document. Submissions are processed as they are received.
Once you have submitted an IRB/IEC registration, you may track the progress of your document until the IRB/IEC is registered. Once your institution's IRB/IEC registration has been processed, it will be listed on the OHRP website at http://ohrp.cit.nih.gov/search/asearch.asp#ASUR.
IRB
Registration
Division
of Policy and Assurances
Office for Human Research
Protections
1101 Wootton Parkway, Suite 200
Rockville, MD
20852
Sample
IRB Registration Document [RTF
- 361KB]
Sample IRB Registration Document [HTML]
Return to IRB Registration & Assurance Filing Main Page
If
you have questions about human subject research, notify ohrp@
hhs.gov.
If you have
questions/suggestions about this web page, notify H.
Larry Niemoeller.
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