Human Subject Research Guidelines
Institutional Review Board for the Protection of Human Subjects in Research
Guidelines and Procedures for Handling Human Subject Research Proposals (November 2008)
Morehouse College IRB Guidelines (pdf document)
OHRP Human Subjects Assurance Training
Who Must Submit Proposals to the IRB
Investigators Unaffiliated with Morehouse College
Approval Notification, Criteria, Conditions, and Termination
Watchdog Function of the Human Subjects Administrator
Statement of Ethical Principles
Morehouse College seeks to ensure that
activities related to human subject research, regardless
of funding source, will be guided by the ethical principles
set forth in The Belmont Report: Ethical Principles
and Guidelines for the Protection of Human Subjects.
Who Must Submit Proposals to the
IRB
In accordance
with Federal Government Regulations, Morehouse College
has established an Institutional Review Board to ensure
the protection of human subjects in research projects. All
researchers intending to work with human subjects must submit
an application to the IRB prior to the start of research
activities. Human subject research includes
any study involving human subjects, including survey
questionnaires. All human subject studies are subject
to IRB review regardless of the purpose, extent, context,
or source of funding for the study. Class projects
and studies that do not receive any external funding
also require IRB review. Research initially undertaken
without the intent of using human subjects, which later
propose to do so, must comply with these procedures. Researchers
from other institutions wishing to conduct studies on
students, faculty or staff at Morehouse College must
submit an application to the Morehouse College IRB even
if an IRB review was completed at their home institution
(in accordance with Protection of Human Subjects, 45
CFR 46, part 46.114).
Researchers from other institutions: Human subject researchers who are not Morehouse College students, faculty or staff, must submit an Unaffiliated Investigator Agreement Form with their application for IRB review (see Investigators Unaffiliated with Morehouse College below).
All research, including that conducted by students and professors in the classroom, is subject to IRB review. Types of research that require IRB review are:
- Questionnaires/inventories administered in class by the professor or another researcher
- Observational research of behavior in a laboratory or field setting
- Experimental research that requires manipulation of subjects
Researchers who plan to conduct human subject research that they believe is exempt from IRB review must submit a full application to the IRB prior to conducting research activities. Federal regulations state that only the IRB may determine whether a research activity is exempt from full review (see below Exempt Research).
For information about the Federal Law concerning human subject research, click this link to the Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services.
Faculty Research
For faculty research, e-mail
submission of the research protocol, questionnaires to
be administered, and proposed Informed Consent Forms
must be submitted at least four (4) weeks prior to the
initial decision date desired. A copy of the Proposal
Cover Sheet (available at the Morehouse College IRB website)
must accompany the proposal. Faculty and Staff
researchers must obtain the signature of their immediate
supervisor (Department Chair) on the Proposal Cover
Sheet. The IRB will complete initial reviews of
faculty research projects within four weeks of their
submission.
Student and Classroom Research
Projects
Proposals for student research
projects and classroom projects must
be submitted via e-mail two (2) weeks prior to the
initial decision date desired. This proposal
should include a brief description of the research
protocol, questionnaires, and the proposed Informed
Consent Forms. Proposals for student research
projects and classroom projects must be submitted by
the Faculty Advisor. The signature of the advisor
is required on the Proposal Cover Sheet. Approval
of the Department Chair is also required prior to the
submission of a student research proposal. The
Department Chair must indicate approval on the Proposal
Cover Sheet. The IRB will attempt to
complete initial reviews of student research within two
weeks of the time of their submission.
Human Subjects Training Requirement
All
students, faculty, and staff who submit proposals to the
IRB also must submit a copy of the Human Subjects Assurance
Training certificates for training modules 1-3 to document
that they are informed of their responsibilities to protect
the subjects they wish to study. This training is available on-line
and must have occurred within the past 3-years of the
date a proposal is submitted to the IRB. All three
modules must be completed and certificates of completion
printed with your name on them. These certifications
only are available if you log-in to the OHRP
Human Subjects Assurance Training website.
Investigators
Unaffiliated with Morehouse College
Human
subject researchers who are not affiliated with Morehouse
College (individuals who are not Morehouse College students,
faculty or staff) must submit to Morehouse
College IRB review prior to conducting any research activity
or subject recruitment at Morehouse College. IRB approval
from your home institution does not substitute for review
by the Morehouse College IRB and does not influence the
independent review that will be conducted by the Morehouse
College IRB. The research protocol, questionnaires to
be administered, and proposed Informed Consent Forms
must be submitted by e-mail at least four (4) weeks
prior to the initial decision date desired. Researchers
not affiliated with Morehouse College also
must submit an Unaffiliated Investigator
Agreement Form with their application for IRB review. Approval
of a human subject research proposal by another IRB does
not assure approval by the Morehouse College IRB.
Investigators unaffiliated with Morehouse College who submit proposals to the Morehouse College IRB also must submit copies of the Human Subjects Assurance Training certificates for training modules 1-3 to document that they are informed of their responsibilities to protect the subjects they wish to study. This training is available on-line and must have occurred within the past 3-years of the date a proposal is submitted to the IRB. All three modules must be completed and certificates of completion printed with your name on them. These certifications only are available if you log-in to the OHRP Human Subjects Assurance Training website.
E-mail Submission
All IRB applications must be submitted by e-mail and must conform to the following requirements:
A cover sheet, the entire proposal and all materials submitted as part of the application must be sent as a single PDF document attached to an e-mail to the Human Subjects Administrator. Proposals consisting of multiple separate documents will delay review or will simply be returned to the proposer without review.
Electronic submissions to the IRB will be acknowledged within 2 days of receipt with an e-mail from the Human Subjects Administrator.
Proposals to the IRB must be submitted
to:
Ms. Alana Veal
Human Subjects Administrator
Morehouse College
830 Westview Drive, S.W.
Atlanta, GA 30314
e-mail: aveal@morehouse.edu
All materials submitted will be stored in the office of the Morehouse College Human Subjects Administrator, 109 Gloster Hall. Ms. Veal or her staff will initially forward proposals to the IRB chair (or co-chairs) to determine whether the proposal requires full IRB review. If the IRB chair determines that a full review is required, Ms. Veal or her staff will distribute proposals and related materials to the Principal Reviewer (PR) and all IRB members. The PR is an IRB member who will lead the review of the proposal. Each IRB member will have responsibility for leading reviews of proposals. Each proposal will be handled by a different PR on a rotating basis.
Proposal
Content
Generally, a proposal to the IRB for
approval of a human subjects research project should
consist of a brief description of the purpose of the
study and its justification, but a complete copy of a
submitted grant proposal is seldom necessary.
The following questions must be addressed in every proposal for IRB review:
What do you propose to do and why?
Who are you recruiting and how?
How
many participants do you plan to recruit?
What
are the criteria for recruitment?
How
will you ensure that participation is voluntary?
What do you want subjects to do?
How
much time will it take?
Where
will it take place?
Will
there be a follow-up activity?
Will
participants be compensated and if so how?
If
you plan to use a questionnaire, you must provide that in the proposal.
Do
you plan to make an audio or video tape of participants?
What
is the purpose of such recordings?
How will you obtain Informed Consent?
Attach
the Informed Consent Form you propose to use
What are the risks to participants?
If
you think there are no risks, think again.
How
will risks to participants be minimized?
Will
participant responses be anonymous?
What are the benefits to participants?
IRB
Review of Proposals
Expedited Review:
The Morehouse College Institutional Review Board does
not have authority to conduct expedited reviews. All
proposals will be subject to a full review by the IRB.
Full Review: Full reviews will be conducted in accordance with the guidelines provided by the Office for Human Research Protections (OHRP) of the US Department of Health and Human Services (Protection of Human Subjects, 45 CFR 46, part 46.109). Copies of the proposal will be sent to each IRB member for full review. A review meeting of the IRB will be held approximately one week after a proposal is sent to IRB members. The PR will lead the discussion of the proposal at meetings of the IRB. The PR will complete a full review form that reports the decision of the IRB and advises the principal investigator of required changes to the protocol or consent forms. A completed full review form will be sent to the Human Subjects Administrator who will retain a copy and forward it to the principal investigator. Annual and ongoing reviews of revised proposals and consent forms will be led by the same PR. The IRB Chairperson and PR will sign the Notification of Approval and submit the same to the Human Subjects Administrator who will retain a copy and forward it to the principal investigator.
Exempt Research
Exempt Research: Some research
activities with human subjects is exempted from Full IRB
Review, but that determination can only be made by the IRB
chairperson in accordance with Federal regulations (45CFR46,
part 46.101). If proposed human subjects research is
found to be exempt from full review, the IRB Chairperson
will sign a Notification of Approval, indicating that the
research is exempt, and submit that form to the Human Subjects
Administrator who will retain a copy and forward it to the
principal investigator.
Federal-wide Assurance of Protection of Human
Subjects (FWA)
The Morehouse
College IRB has a currently valid Federal wide Assurance
of Protection of Human Subjects. The
IRB is authorized to approve human subject research
supported with funds from federal agencies. Researchers
whose IRB application is for a federally funded proposal
must indicate the federal agency from which funds are
sought on the Proposal Cover Sheet. Principal
Investigators are responsible for ensuring that IRB
instructions are followed, that problems with human
subject research are promptly reported to the IRB,
and that refinements, changes, or any modification
to research protocols are reported to the IRB prior
to their use in research. Institutions at which
human subject research is not conducted in compliance
with Federal regulations are subject to the loss of
all federal funding.
Notification
of Approval
Following
review by the IRB for initial or continuing approval,
written notification will be sent to the principal
investigator by the Morehouse College Human Subjects
Administrator (Alana Veal). Written
notification will clearly indicate either approval or
non-approval. When
a proposal is not approved, the IRB will provide a
statement of the reasons for its decision, provide
the principal investigator with an opportunity to respond
in writing and typically will provide instructions
to principal investigators on proposal modifications
that would increase the likelihood of approval upon
resubmission. However, the IRB is not
obliged to approve any research proposals that may
present risks to human subjects, regardless of the
proposed benefits foreseen by the principal investigator.
IRB approvals only are made in writing and have a duration no greater than 12 months. Federal government agency grants typically require IRB approval documentation communicated directly to the granting agency by the Human Subjects Administrator. It is the responsibility of the principal investigator to provide the IRB with the contact information for their granting agency Program Director, in writing, when such documentation is needed.
Criteria for IRB approval
In order to approve research, the IRB
must determine, within its sole discretion, that the
following requirements are satisfied: (1) there are no
unnecessary risks to subjects; (2) the risks to subjects
are reasonable; (3) the selection of subjects will be
equitable; (4) informed consent will be sought and appropriately
documented; (5) adequate provision has been made for
monitoring data collection to ensure safety of subjects;
(6) adequate provision has been made to protect the privacy
of subjects; and (7) when subjects are likely to be vulnerable
to coercion or undue influence, additional safeguards
have been included.
Conditions of IRB Approval
IRB
approval of a proposed study is limited to the specific
study described in the proposal reviewed by the IRB. Approval
is limited to 12 months. An extension of IRB
approval for an additional 12 month period requires
that the principal investigator notify the IRB of the
following information (1) number of subjects seen,
(2) location and number of consent forms obtained,
(3) adverse reactions encountered and corrective measures
taken, and (4) any changes in the research protocol. Proposals
for extensions for an additional 12 month period may
be submitted no later than two months prior to the
start of the second 12 month period. Researchers
must report to the IRB any changes made to protocols,
questionnaires, or informed consent forms during a
study prior to the initiation of such
changes. Changes in protocols, questionnaires,
or informed consent forms must be approved by the IRB prior to
use with human subjects, except when such change is
necessary to eliminate apparent immediate hazard to
the subjects. If any such immediate changes are
made, the IRB must be immediately notified and approval
of the change must be sought. Any incident in
which a human subject is injured must be reported immediately
to the IRB. In all cases, researchers must report
to the IRB on the status to their project at the end
of each 12 month approval period or at shorter intervals
as specified by the IRB.
Projects that pose a high level of risk to human subjects or that have had problems complying with IRB requirements in the past may be subject to continuing reviews at intervals more frequent than 12 months and/or verification of research activities by individuals other than the principal investigator.
Termination of Approval
The
IRB has the authority to suspend or terminate approval
of any research that is not being conducted in accordance
with these guidelines or that is associated with unexpected
serious harm to the subjects. When
approval is either suspended or terminated, the IRB will
provide the principal investigator with a statement of
the reasons for its decision.
Watchdog
Function of Human Subjects Administrator
The following circumstances will result
in immediate reporting to the Morehouse College IRB,
the Senior Vice President for Academic Affairs, the Director
of Sponsored Programs, the Office for Human Protections
(OHRP) at the U.S. Department of Health and Human Services,
and to the relevant funding and regulatory agencies specific
to a given research project:
1. Serious or continued noncompliance with Federal Regulations or the Morehouse College IRB requirements.
2. Suspension or termination of IRB approval.
3. Unanticipated problems involving risks to research subjects or others.
Record Keeping
Copies
of all proposals submitted, IRB review results, and minutes
of IRB meetings will be stored in the Human Subjects
Administrator Office. All
correspondence between the IRB and human subject researchers
will be handled by the staff of the Human Subjects Administrator
Office. All records will be retained for at least
3 years after the completion of each approved research
project (in accordance with the guidelines in the Protection
of Human Subjects, 45 CFR 46, part 46.115).
Copies of the Protection of Human Subjects guidelines are available at the Office of the Morehouse College Human Subjects Administrator located Room 109 Gloster Hall and the Office of Sponsored Programs located in the Wheeler Hall.
This website was last updated 19 November 2008 and the IRB guidelines are effective immediately.
