Howard University Institutional Review Board

1.  
Aitza M. Haddad, J.D., LL.M.

2.  The Tuskegee Syphilis Study on rural African American males
o 1932-1972
• Cited as "arguably the most infamous biomedical research study in U.S. history,“
 National Research Act (Public Law 93-348)
o Enacted by Congress in 1974
 Two mandates:
1. Prompted the establishment of IRBs at the local level and required IRB review and
approval of all federally funded research involving human participants.
• The Institutional Review Board (IRB) is a committee established to protect the rights and
welfare of human research participants recruited to participate in research activities
conducted under the auspices of the institution with which it is affiliated. The IRB reviews
and has the authority to approve, require modifications in, or disapprove all research
activities, including proposed changes in previously approved human participant
research.
2. The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research be established.
• Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the
"Belmont Report") were published in 1979

3.  The Federal Policy for the Protection of Human Subjects (Common
Rule) covers research supported by most of the existent federal
agencies, such as, but not limited to, the Departments of Agriculture
(DOA), Justice (DOJ), Defense (DOD), Education (DOE), Veterans
Affairs (VA), Transportation (DOT), the Social Security Administration
(SSA), the Central Intelligence Agency (CIA), and the Consumer
Product Safety Commission (CPSC), and the Department of Health
and Human Services (DHHS).
o The provisions of the Common Rule are identical to the DHHS
Regulations (45 CFR 46, Subpart A).
 The Food and Drug Administration (FDA) has a separate set of
regulations governing human participants research (21 CFR 56 –
IRBs and 21 CFR 50 – Informed Consent).
o The basic requirements for IRBs and for Informed Consent are
congruent between the two sets of regulations:
• The Common Rule is based on federal funding of research; FDA regulations are
based primarily on use of FDA regulated products: drugs, medical devices for human
use, or biological products.

4.  Respect for Persons
o Respect individual autonomy to deliberate about personal goals and
acting on the basis of these deliberations;
o Affirms that persons have the right to choose what shall happen to
them;
o Protect individuals with reduced (prisoners, mentally challenged,
emotional disorders, impaired brain functions, immature {minors},
comatose, terminal illnesses) autonomy; these persons entitled to have
a legally authorized representative act in their behalf.
 Beneficence
o Maximize benefits for science, humanity, and research participants;
avoid or minimize risk or harm.
 Justice
o Equitable distribution of research burdens and benefits among persons
and groups.

5.  Under Federal regulations, any institution engaged in
federally-supported human participant research is required
to provide written Assurances of Compliance, describing the
means they will employ to comply with HHS regulations
regarding the protection of human participants in research.
 Although protection of research participants is a concern of
all federal agencies that sponsor research, leadership is
vested in the Office for Human Research Protection (OHRP)
and the Food and Drug Administration (FDA). The OHRP has
general responsibility for the protection of humans as
participants in research, and the FDA regulates the use of
drugs and medical devices in experiments.
o For human participants, research supported by the Department of Health
and Human Services (DHHS), the OHRP must approve the institution's
Assurance before the funds can be awarded.
o The University's assurance identifies its responsibilities and explains the
steps that will be taken to meet the federal regulations for research on
human subjects.

6. Howard has developed a General Assurance
as a part of the continuing effort to facilitate
research, while at the same time complying
with federal regulations regarding the
protection of humans who serve as
participants in research activities.
o These assurances affirm that all activities related to
human participants research, regardless of funding
source, will be guided by the ethical principles in the
Belmont Report. Federal Wide Assurance is an
agreement with OHRP.
o The Assurance applies to all activities initiated by faculty
or students (including thesis research).

7.  The Office of Regulatory Research Compliance (ORRC) at Howard
University facilitates the work of researchers through the management
and support of five University review and compliance committees.
 The ORRC is a partner with the Howard University research community in
the shared responsibility to ensure that research at the University is
conducted in accordance with federal, state, and local regulations and
guidelines that protect human participants, animals, students, and staff
involved with research.
 The ORRC provides support to two Institutional Review Boards (IRB) by
maintaining their policies, guidelines, and procedures involving research
with human participants:
• The Medical IRB and the Non-medical IRB.

8.  The ORRC also has the responsibility to protect the integrity of research
conducted at Howard University through its support of the Research
Misconduct Committee; supporting investigations and corrective actions
related to non-compliance and misconduct.
 The ORRC also supports the responsible conduct of research by offering
education and training in collaboration with the Graduate School and to
faculty, staff, students, and the community at large. Please contact them
at (202) 865-8597 or theorrc@howard.edu.
o Research Protections Policies, Guidelines and Compliance Information

9.  The ORRC facilitates the activities of the Institutional Animal Care and Use Committee (IACUC)
by facilitating research committee reviews and approvals of regulated experiments and teaching
activities conducted at Howard University that involve invertebrate animals.
 ORRC staff serves Howard University faculty, staff, and students by helping them ensure their
research and teaching modules comply with all applicable federal, state, and local regulations
and policies, as well as Howard University policies. ORRC staff is available to answer individual
inquiries, meet with researchers and instructors, and to present and facilitate educational
workshops and trainings.
 IMPORTANT LINKS:
o HU VETERINARY SERVICES
o USDA ANIMAL WELFARE INFORMATION CENTER
o ASSOCIATION FOR LABORATORY ANIMAL SCIENCE (AALAS)
o ASSOCIATION FOR THE ASSESSMENT & ACCREDITATION OF LABORATORY ANIMAL CARE INTERNATIONAL
(AAALAC)
o INSTITUTE FOR LABORATORY ANIMAL RESEARCH (ILAR)

10.  The Howard University Institutional Biosafety Committee (IBC) reviews
all institutional research activities involving the use of biohazardous
agents, recombinant DNA (rDNA) molecules, cell lines, and human
tissue including stem cells, viruses, vectors, and any agent that
requires approval for biosafety activities as described in current
governmental regulatory requirements. Howard University IBC approval
is required before research can begin involving any of the previously
mentioned substances.
 The IBC ensures that all persons, procedures, and facilities engaged in
these activities meet the highest standards of laboratory safety and
research efficacy in the interest of protecting the environment and the
public.
 The ORRC staff is available to assist committee members, faculty, staff,
and students. Please call (202) 865-8597 or email ORRC (send to:
theorrc@howard.edu) for more information.

11.  Howard University IRBs review and provide oversight for all research
involving human participants at Howard University and operate in
compliance with the regulations of the U.S. Department of Health and
Human Services Office of Human Research Protections 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).
o The Medical IRB Committee is generally charged with reviewing research
applications that originate in the Health Sciences division along with
research protocols that involve medical procedures, devices, and drugs.
o The Non-Medical Committee typically reviews those research applications
that originate from the Academic Affairs division along with research
protocols that are generally socio-behavioral in scope.

12.  The IRBs are thereby authorized to inspect any Howard University
research facility and to obtain records of and observe the consent
process for any research study, suspend or terminate research, or take
any action it deems necessary to ensure compliance with federal and
University policies and regulations.
 All research records and staff are accountable to external review and
monitoring by funding agencies.
o http://www.orrchoward.com/hrabouttheirb.html

13.  Each Committee is comprised of faculty members from across the various
disciplines at the University.
 Each Committee also have at least two members who are not affiliated with
Howard University.
 The ORRC currently support 5 Regulatory Research Committees:

14.  Any person who is affiliated with Howard University and who
wishes to conduct research involving human participants.
 Students, including those who are conducting research for partial
fulfillment of degree requirements, must have a member of the
faculty serve as their principal investigator.
o The principal investigator will play a supervisory role in the research
process of the student and will have responsibility for assuring the
protection of human participants involved in the study.
 Online submission is available and allows you to submit your
protocol for review via electronic delivery. You can also chose to
bring a hard copy of your protocol into the ORRC.
o http://www.orrchoward.com/submit3.html

15. 

16.  “Minimal risk means that the probability and magnitude of
harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine
physical or psychological examinations or tests.” See the
Common Rule
at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr
46.html#46.102.
o Further Guidance on what categories of research would meet minimal
risk definition can be found
at http://www.hhs.gov/ohrp/policy/expedited98.html.

17.  Most of the psychosocio-behavioral qualifies as a minimal risk
study.
o Studies that pose minimal risk to human participants can often be
processed through the "expedite review" pathway. A designated
member of the Board can review submissions for approval in those
cases. The expedited review process takes from two to three weeks (2-
3 weeks). This process should not be viewed as "hurried"
review. Expedited reviews get the same attention as any protocol
submitted to the full Board.
o Minimal risk studies that involve vulnerable populations (children,
pregnant women, fetuses and neonates, human in vitro fertilization,
prisoners, economically or educationally disadvantaged participants,
cognitively impaired persons) must go before the full Board for
consideration.

18.  Studies that do not qualify as "minimal risk" nor for expedited review under the
federal regulations are usually considered greater than minimal risk. Greater
than minimal risk studies usually involve medical procedures or devices or the
review of medical information or charts, or that create some high degree of
discomfort for participants. This discomfort can be physical, emotional, social,
or psychological. Greater than minimal risk studies not involving medical data
should complete one of the following forms:
o A1 Form: For Greater Than Minimal Risk Studies
o A2 Form: Continuation/Renewal Form For Greater Than Minimal Risk Studies
 Greater than minimal risk studies usually involve medical procedures or
devices or the review of medical information or charts should also complete
the compliance training modules conduct by the Compliance Office in the
Howard University Hospital. Studies in this category should complete one of
the following forms:

19. o B1 Form: For Greater Than Minimal Risk Studies
o B2 Form: Continuation/Renewal Form For Greater Than Minimal Risk
Studies
o Cancer Registry Forms
• All researchers who wish to access data from the Rosemary Williams
Cancer Registry (HU Cancer Center Registry) must first complete the Pre-
Screening Interview Form in conjunction with the Manager of the
Register. The approved data request form is submitted to the IRB along
with the appropriate level data application. For more information on the
cancer center registry, please click the link to the Rosemary Williams
Cancer Registry.
o The major of studies will require HIPAA authorization to review
protected health and medical information.

20. 
http://www.orrchoward.com/IRBForms-Tools.html

21.  INSTRUCTIONS AND GUIDANCE
o Ethical Guidelines and Principles
o Guidance for Faculty/Research Staff on How to Submit
o Guidance for Students on How to Submit
o IRB Catergories of Review (Expedited, Exempt, Full Board, etc.)
o Checklists for Form Submission
 CONSENT DOCUMENTS
o HU-IRB Instruction for Preparing Consent Documents
 CONFLICT OF INTEREST DISCLOSURE STATEMENT
o Conflict of Interest Disclosure Statement
 PRINCIPAL INVESTIGATOR ASSURANCE FORM
o Principal Investigator Assusrance Form
 FORMS FOR GREATER THAN MINIMAL RISK STUDIES
o Form A1: For Studies with Greater than Minimal Risk
o Form A2: Renewal/Continuation for A1 Studies

22.  FORMS FOR CHART REVIEWS/MEDICAL DATA
o Form B1: HIPAA/Chart Review Form
o Form B2: Renewal/Continuation for HIPAA/Chart Reviews
o Cancer Registry Data Request Pre-Interview Form
o Cancer Registry Data Request Applications
o Cancer Registry Available Data Fields
 FORMS FOR MINIMAL RISK STUDIES
o Form C1: For Studies with Minimal Risk Studies
o Form C2: Renewal/Continuation of C1 Studies
 EXEMPT STUDIES/NON-HUMAN PARTICIPANTS/DATA
o Form D1: Request for Exemption (Non-Research/Not Involving Humans)
 IRB INFORMATION
o HU-HPS Development
o Standard Operating Procedures

23. 

24.  HHS regulations define research at 45 CFR 46.102(d) as
follows:
o Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. Activities which meet this definition
constitute research for purposes of this policy, whether or not they are
conducted or supported under a program which is considered research
for other purposes. For example, some demonstration and service
programs may include research activities.

25.  HHS regulations define human subject at 45 CFR 46.102(f) as
follows:
o Human subject means a living individual about whom an investigator
(whether professional or student) conducting research obtains: (1) data
through intervention or interaction with the individual, or (2) identifiable
private information.
• Intervention includes both physical procedures by which data are gathered and
manipulations of the subject or the subject's environment that are performed
for research purposes.
• Interaction includes communication or interpersonal contact between
investigator and subject.
• Private information includes information about behavior that occurs in a
context in which an individual can reasonably expect that no observation or
recording is taking place, and information which has been provided for specific
purposes by an individual and which the individual can reasonably expect will
not be made public (for example, a medical record).
• Private information must be individually identifiable (i.e., the identity of the subject
is or may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research involving
human subjects (bolding added for emphasis).

26.  FULL BOARD REVIEW
o Research that does not meet the criteria for exempt of expedited review must be submitted to the IRB
for a review at a convened meeting at which a quorum of the members are present.
• Medical IRB meets twice a month and the Non-Medical IRB meets at least once a month.
o Research involving "greater than minimal risk" must go before the Full Board review process.
• There are four possible outcomes of full board review: (1) approval; (2) minor revisions/additional
information required (approval with administrative review); (3) major revisions/additional information
required (tabled); and (4) disapproval. Please allow 4 - 6 weeks for full board review.
 EXPEDITED REVIEW
o Expedited Review is a category related to research that is defined as "minimal risk." Expedited review
does not mean "rush" or "speedy" review.
o Expedited reviewers must determine the following: Do the research activities meet the definition of
"minimal risk" and do they fit within the federally mandated expedited categories? "Minimal risk" is
defined as "the probability and magnitude of harm or discomfort anticipated in the research are not
greater in and of themselves from those ordinarily encountered in daily life or during the performance
of routine physical or psychological examination or tests."
• The outcome of the review may include any of the following: (1) approval; (2) request for additional
information; (3) request for changes; (4) request that the review be conducted by the Full Board (which
would add additional time to the review process).

27.  There are six criteria for exemption. Only the IRB can make the official
determination that your project is exempt based upon 45 CRF 46. 101:
1. Research conducted in established or commonly accepted educational settings
involving normal educational practices, such
i. research on regular and special education instructional strategies, or
ii. research on the effectiveness of or the comparison among instructional techniques, curricula,
or classroom management methods
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior unless:
i. information obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to subjects; and
ii. any disclosure of the responses outside the research could reasonably place the subjects at
risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability,
or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement) survey procedures, observation of public behavior that is not exempt
under paragraph b2 of this section, if:
i. the human subjects are elected or appointed public officials or candidates for public office; or
ii. federal statute(s) require(s) without exception that the confidentiality of the personally
identifiable information will be maintained throughout the research and thereafter.

28. 4. Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available
or if the information is recorded by the investigator in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the
approval of department or agency heads, and which are designed to study, evaluate, or
otherwise examine:
i. public benefit or service programs;
ii. procedures for obtaining benefits or services under those programs;
iii. possible changes in or alternatives to those programs or procedures; or
iv. possible changes in methods or levels of payment for benefits or services under those
programs.
6. Taste and food quality evaluation and consumer acceptance studies,
i. if wholesome foods without additives are consumed or
ii. if a food is consumed that contains a food ingredient at or below the level and for a use
found to be safe, or agricultural chemical or environmental contaminant at or below the
level found to be safe, by the Food and Drug Administration or approved y the
Environmental Protection Agency or the Food and Safety and Inspection Service of the
U.S. Department of Agriculture.

29.  Certain low-risk research is exempt from the requirements of the Federal
regulations.
o Research conducted in established or commonly accepted educational settings, involving normal
or educational practices, such as 1)research on regular and special and special education
instructional strategies, or 2) research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods, Research involving the
use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior.
 These exemptions do not imply that investigators have no ethical
responsibilities to subjects in such research; they mean only that IRB review
and approval of the research is not required by Federal regulations.
 In no case should investigators make the final determination of exemption from
applicable Federal regulations or provisions of their institution's Assurance.
 The ORRC can provide an official letter of determination that your research does
not qualify as human subjects research upon request.

30. 

31.  Unless specifically authorized by the IRB, no investigator
may involve a human being as a participant in research
unless the investigator has obtained the legally effective
informed consent of the participant or the participant's
legally authorized representative.
 Informed consent is the voluntary choice of an individual to
participate in research based on an accurate understanding
of its purposes, procedures, risks, benefits, alternatives,
and any other factors that may affect a person's decision to
participate.
 Informed consent must be legally effective under applicable
state law and must include the eight specific elements
described in the Federal regulations.
 Unless specifically waived by the IRB, informed consent
must be documented in writing.

32.  The Federal Regulations detail 8 specific elements of
information, which must be provided to each human
subject participant:
o Description of the research and subject's participation,
including the identification of experimental procedures;
o Description of reasonably foreseeable risks;
o Description of expected benefits;
o Potentially advantageous alternatives to participation;
o Explanation of confidentiality protections;
o Explanation of compensation for injuries policy;
o Whom to contact with questions about the research and
research participant's rights;
o Explanation that participation is voluntary.

33.  Informed consent is not a single event or just a form to be signed.
o Rather it is an educational process that takes place between the investigator and the
prospective participants.
 The basic concepts of the consent process include:
o full disclosure of the nature of the research and the participant's participation,
o adequate comprehension on the part of the potential participants, and
o the participant's voluntary choice to participate
 The information that is given to the prospective participant, or his/her
representative, must be in language understandable to the participant or
representative.
o Consent forms should be written at a level appropriate to the understanding of the
participants to be enrolled.
• Technical language should be avoided.
o The use of “first person” is strongly discouraged in consent documents (e.g., "I have
been fully informed about") because such statements unfairly ask participants to make
statements that the participant s are not in a position to verify (e.g., the participant has
no way to verify that the investigator has provided full and complete information).

34. 

35.  All individuals seeking funds from any source, including the
university, to support any activity involving human participants in any
way, will be required to complete an online (CITI) course tutorial.
o The course takes approximately two (2) to three (3) hours to complete however, it
does not have to be completed in one session and can be completed in any order.
o There are fourteen (14) modules, and each module is followed by a quiz. Because of
the diversity of the population, which Howard University and its Hospital serve, and
the complexity of its various programs involving or potentially involving human
participants, the IRB requires that all principal investigators, other key personnel and
students complete all fourteen (14) modules.
o The cumulative score of all of them will be automatically tallied to give a final score
for the course. However, a score of 70% is required for certification of completion of
this educational requirement to be granted by the IRB.
 The content of this educational program will be periodically up-dated
to keep it current as changes or modifications in federal or
institutional policies and regulations occur. Module 14 is designed to
serve that purpose.
o Re-certification will be required every two (2) years.

36.  In addition to the online educational program, the IRB anticipates
hosting at least two workshops per year to keep the university's
constituencies apprised of the latest information on the regulations and
policies that relate to the involvement of human participation in
research and other activities.
 The purpose of these workshops include the dissemination of
institution-specific information, review of information pertinent to the
responsible conduct of research (RCR), regulations, invited intramural
and extramural guest lecturers and presentations of case reports. In
contrast to the internet-based course, these workshops will facilitate
face-to-face interactions between individuals at all levels of the
institution.

37. 

38.  Maintaining continuous IRB approval for a study is the responsibility of the Principal Investigator and the
study team. It is important to note that if you allow your study’s IRB approval to lapse, you, the IRB, and
Howard University as an institution are considered to be out of compliance with federal regulations.
 WHAT IS THE EXPIRATION DATE?
o The date noted in your approval notification – the date stamped on your consent documents by the ORRC. THE
EXPIRATION DATE REPRESENTS THE FIRST DATE THAT YOUR STUDY IS NO LONGER APPROVED.
 WHAT HAPPENS WHEN MY STUDY EXPIRES?
o At the time of expiration of IRB approval, all study activities, including recruitment, consent, data collection, and data
analysis, MUST STOP. If certain activities must be continued to ensure the safety of the participants, YOU MUST
CONTACT THE ORRC TO REQUEST PERMISSION TO CONTINUE THOSE ACTIVITIES UNTIL IRB APPROVAL IS REINSTATED.
YOU CANNOT PROCEED UNTIL YOU HAVE A WRITTEN APPROVAL TO DO SO.
 HOW TO ENSURE THAT YOUR STUDY’S IRB APPROVAL IS MAINTAINED:
o 1.60 to 45 calendar days prior to expiration date: SUBMIT YOUR RENEWAL APPLICATION TO THE ORRC
o 2.30 calendar days prior to expiration date: CONTACT THE ORRC IMMEDIATELY. IT MIGHT BE TOO LATE FOR YOU
• TO SUBMIT A CONTINUATION REQUEST. YOU MIGHT HAVE TO SUBMIT A DEVIATION/VIOLATION REPORT.
• YOU MIGHT HAVE TO SUBMIT A NEW APPLICATION FOR APPROVAL.

39.  To achieve the overarching goal of ensuring Howard University’s compliance with all federal
and regulatory requirements relating to its research enterprise, the Howard University IRB
requires people to:
o Report expeditiously any proposed changes in previously approved human participant research activities as
these changes cannot be initiated without Howard University IRB review and approval, except where
necessary to eliminate apparent immediate hazards to the participants.
o Report immediately any injuries or other unanticipated problems involving risks to participants and others,
including research staff.
o Report progress of approved research, as often as and in the manner prescribed by the Howard University
IRB on the basis of projected risks to participants, but no less than once per year.
o Identify and chronicle any modification(s) or clarification(s) in a detailed letter to the chair of the HU-IRB,
which becomes an addendum to the original application.
 TO HELP YOU MAINTAIN CONTINUOUS IRB APPROVAL:
o ORRC staff will send a Notice of Expiration of Approval to the principal investigator beginning in November
2012. This notice will be sent approximately 90, 60, and 30 days prior to the expiration of the approval.
Renewal requests must be submitted to the ORRC 90 days before the approval expiration date. Once approval
has expired, the project will be inactivated. Once a project's approval has expired, a new application MUST be
completed for review and approval before research can resume. It is very important for investigators to follow
their approved protocols. If a protocol is not followed as approved, the IRB may suspend those activities.

40. 
http://www.orrchoward.com/2013MeetingsandSchedules.html

41.  2013 IRB Meeting Schedule and Submission
Deadlines*
 2013 IBC Meeting Schedule and Submission
Deadlines
 2013 IACUC Meeting Schedule and Submission
Deadlines
 ​2012 Meeting Schedule Archives

42.  