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Introduction to IRB | Standard Operating Procedures | Assurances | Membership Roster | Ethical Principles & Responsibilities | Contact IRB | Calendar

INTRODUCTION TO IRB

The Howard University Institutional Review Board (HUIRB) has prepared these guidelines as a mechanism for providing the entire Howard University community with information regarding the university's Human Research Participant Protections Program (HRPPP). For the purposes of these guidelines, the term "research" applies to all activities including training, demonstrations and other activities which involve human participants at this institution. They were prepared with the intent of promulgating resources for use not only in the preparation of docume ts for HUIRB review but also to assure institutional compliance with pertinent federal regulations governing the responsible conduct of research (RCR) and other activities involving human participants .

These guidelines are the official governance documen ts for all such activities conducted at Howard University and Howard University Hospital under Federal Wide Assurance (FWA) number 00000891 issued to Howard University by the Office of Human Research Protections (OHRP) of the Department of Health and Human Services. They reflect the recommendations of the National Commission for the Protection of Human Subjects (Participants) of Biomedical and Behavioral Research and all pertinent Federal regulations including 45 CFR 46, 21 CFR 50 and 21 CFR 56, which govern human participant research as amended to include the Common Rule (FR 56. No. 117, 28002). They do not limit or compromise the authority of physicians or any other health care personnel to administer emergency or routine medical care to their patients to the extent they are licensed to do so under applicable Federal and local law.

 

STANDARD OPERATING PROCEDURES

for

New Submissions

HOWARD UNIVERSITY
INSTITUTIONAL REVIEW BOARD

STANDARD OPERATING PROCEDURES
FOR NEW SUBMISSIONS

 

I. OVERVIEW
II. ACCESS THE APPLICATION
III. APPLICATIONS AND INSTRUCTIONS
IV. THE PROTOCOL
V. VOTING OPTIONS
VI. OTHER OPTIONS

I. OVERVIEW:

All individuals at Howard University, seeking to conduct research involving human participant(s), as defined in 45 CFR 46.102 (d)(f) and 21 CFR 50.3 (c)(g), must first have their research proposals approved by the Howard University Institutional Review Board (HUIRB) prior to the initiation of the study. The HUIRB operates in compliance with the Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) regulations for the protection of human research participants, including 45 CFR 46, 21 CFR 50 and 21 CFR 56, which govern human participant research as amended to include the Common Rule (FR 56, No. 117, 28002). The HUIRB operates under the Federal Wide Assurance No. 00000891 which expires November 30, 2009.

The HUIRB will review and oversee all research involving human participants at the University and is authorized to inspect research facilities, obtain records, observe the consent process, suspend or terminate research, and take other actions as necessary to comply with federal regulations. The HUIRB is also responsible for providing assurance to the federal government that Howard University is in compliance with federal regulations. Further detailed instructions regarding HUIRB responsibilities, procedures and regulations can be found in the HUIRB website www.huirb.howard.edu.

Research activity MUST NOT PROCEED UNTIL: 1) The University’s IRB has reviewed and approved the research proposal; 2) An official letter has been issued to the research investigator by the Chairman or designee of the Board; and/or, 3) the research investigator is in possession of IRB-approved consent documents as well as any accompanying recruitment materials, if applicable.

In the event that research is undertaken without the intention of involving human participants, but it is later proposed to involve human participants in the research, the above review and approval procedures must be followed prior to instituting the human participant research.

NOTE: All research that is conducted involving human participants must be reviewed by the HUIRB. Although some types of research on human participants may be eligible for an exemption, under federal regulations. Such exemptions can only be determined by the HUIRB.

II. ACCESS THE APPLICATION:
Obtain the Application for Projects Involving Human Participants from the HUIRB website - www.huirb.howard.edu.

III. APPLICATIONS AND INSTRUCTIONS:
Select the type of Application to be completed.

A. If it is a funded research project (the application has already been completed for the funding agency/source), a few component parts must be completed. These “parts” include but are not limited to: a study protocol, the Human Participants Section for the Howard University participants and possibly a consent document.

B. If it is a doctoral/thesis project (the dissertation or thesis) application has already been completed, a few component parts must be completed. These “parts” include but are not limited to: the Human Participants Section for the Howard University participants and possibly a consent document.

C. If it is a chart review or if archival data is being used, an application is still required. The determination of the exempt status of a project is the responsibility of the HUIRB. All activities involving humans in any way must be submitted to the Board for review.

THE APPLICATION SHOULD BE TYPED.

The “Face Page” of the application must be signed by the following:
- Principal Investigator (PI)/Faculty Advisor (FA)
- PI’s /FA’s Departmental Chairperson
- PI’s /FA’s Dean

NOTE: Student Investigators are not required to sign the Face Page.

The PI/FA must provide an e-mail address. If the application involves a Student Investigator (S), their name, telephone number and e-mail address should also be listed on the Face Page.

If the proposed project is being undertaken by a Graduate Degree Candidate in partial requirement for the Master’s or Ph.D. degree, a document from the appropriate School’s or College’s Thesis/Dissertation Committee must be included. Projects from Post-Doctoral Candidates must have an accompanying letter of approval from their sponsor.

NOTE: The HUIRB ONLY accepts protocols from Howard University faculty members. Students, staff, or other non-faculty investigators must identify a Howard University faculty member who agrees to be responsible for oversight of the research protocol.

IV. THE PROTOCOL:

One (1) original and three (3) copies of the completed protocol (including attachments and instruments) should be forwarded to the HUIRB Office located in Annex II, which is located at 515 W Street, N.W., Room 214. (See Investigator’s Checklist for layout)

Under normal circumstances the HUIRB reviews protocols every first and third Wednesday of every month except December. The deadline for submissions is the preceding Thursday at 5:00 p.m. (Consult web page for the IRB meeting schedule.)

V. VOTING OPTIONS

APPROVE: Recommended when protocols meet all qualifications for
compliance.

APPROVE WITH MINOR OR ADMINISTRATIVE REVISIONS:
Recommended when slight modifications or clarifications are required to bring the protocol into
compliance. May be handled administratively upon a
satisfactory written response by the PI to the Board’s
critique.

REVISE: Recommended when major modifications are required
that will result in alteration of protocol content. Only the
requested revisions are necessary. Must be submitted to
the full Board for consideration.

DEFER: Recommended when additional information is required
for a more accurate determination or if information is
missing or not enough information was included to make
an accurate determination. Must be resubmitted to the
full Board for consideration.

DISAPPROVE: Recommended when the proposal has significant
deficiencies and does not meet the requirements for
compliance. A new protocol must be submitted for full Board consideration.

EXEMPT: Recommended when the protocol does not involve
human participants except as unidentifiable chart or
record (chart) review.

When submitting revisions, provide four copies of the revisions (highlighted or underlined as appropriate), not the entire application. In addition, a cover letter signed by the PI/FA should accompany all revisions.

VI. OTHER OPTIONS:

ADMINISTRATIVE REVIEW:
Recommended when there is an urgent request for review. The determination is made on an individual basis at the Chairman’s discretion.
NOTE: Drug studies can not be
administratively reviewed.

EXPEDITED REVIEW:
Recommended when the PI/FA forwards a written
request to review outside of the normal review
process with an appropriate
explanation/justification.
NOTE: Drug studies can not be expedited
reviewed.

Slight modification(s) or clarification(s) should be detailed in a letter to the IRB Chairman. The letter then becomes an addendum to the original application.

May, 2007

ASSURANCES

Department of Health and Human Services Federalwide Assurance for Protection of Human Subjects (View/Download)

INSTITUTIONAL REVIEW BOARD (IRB)
MEMBERSHIP ROSTER
Annex II, Room 214
202-806-7812 FAX: 202-483-8042

INSTITUTIONAL REVIEW BOARD (IRB) MEMBERSHIP ROSTER

ETHICAL PRINCIPLES, POLICIES AND APPLICABILITY

• Ethical Principles, Institutional Policy & Applicability (View/Download)
• Responsibilities (View/Download)