ALABAMA A&M UNIVERSITY
Office of Research and Sponsored Programs
Carnegie Building, 2nd Floor
Normal, AL 35762
IRB#__________
Application for Approval of a Research Project
Involving Human Subjects
I,
(Principal Investigator’s Name: typed or printed) submit to the Institutional Review
Board (IRB) this form along with one copy of a research proposal entitled:
,* as well as
one copy of a one page abstract in lay terminology and the informed consent document.
I understand the need to protect the rights of human subjects in biomedical and
behavioral research and assure that I will:
1. obtain informed consent of subjects who are to participate in this research project.
2. report to the Institutional Review Board any unanticipated effects harmful to subjects
which become apparent during the research.
3. cooperate with the continuing review of this research project by submitting annual
reports and a final report.
4. obtain prior approval from the IRB before amending or altering the project or
implementing changes in the approval consent form.
5. maintain all documentation such as consent forms, progress reports, data as required
by the institution and Federal Regulations.
Signature: ____________________________________________________Date:____________
Title:
Department:
Phone#: (Office)
(Home)
E-Mail:
By my signature above, I declare the above named research involving human subjects to
be: (Check one)
1. Exempt according to category number
listed in Appendix 1 **
2. Expeditable according to category number
listed in Appendix 2 **
3. Other and must be reviewed by the IRB.
*Short Title:
** From 45 CFR 46, Subpart A: Federal Policy for the Protection of Human Subjects and
attached to this application
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Funding Source:
(if applicable)
Purpose of the Study:
Questions or Hypotheses:
Description of the Subjects (Include # of Controls):
Description of Procedure:
Instrumentation (Brief Description or Attachment):
Duration of the Study:
a. Total Amount of Time with each Subject:
b. Time to Complete the Study:
Benefit(s) of the Study:
Possible Risks to the Subjects and the Precaution Taken to Avoid the Risks (Monitoring):
Confidentiality / Anonymity
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*Criteria for IRB approval of research:

risks to subjects are minimized;

risks are reasonable in relation to anticipated benefits;

selection of subjects is equitable;

informed consent is sought from each subject;

informed consent is appropriately documented.
Institutional Action:
IRB Review: ____ Exempt
____ Expedited
____ Full
____ Application Approved.*
____ Application denied at this time. Additional information requested and consists of the
following:
____ Application denied
Signature:
___________________________________
IRB Chair
05/05/16
_____________
Date
3
45 CFR 46, Subpart A: Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for
Protection of Human Research Subject) 6/18/91.
APPENDIX 1
RESEARCH ACTIVITIES THAT MAY BE EXEMPT FROM IRB REVIEW AND
APPROVAL
Research Activities in which the only involvement of human subjects will be in one or more of the
following categories are exempt from this policy:
(1)
Research conducted in established or commonly accepted educational setting, involving normal
education practices, such as:
(i)
(ii)
(2)
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior, unless:
(i)
(ii)
(3)
research or regular and special education instructional strategies
research on the effectiveness of/or the comparison among instructional techniques,
curricular, or classroom management methods.
information obtained is recorded in such a manner that human subjects can be identified,
directly or through identifiers linked to the subjects
any disclosure of the human subjects’ 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.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public behavior that is not exempt
under paragraph (b) (2) of this section, if:
(i)
(ii)
the human subjects are elected or appointed public officials or candidates for public
office
federal statute(s) require(s) without exception that the confidentiality of the personally
identifiable information will be maintained throughout the research and thereafter.
(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)
(ii)
(iii)
(iv)
(6)
public benefit or service programs
procedures for obtaining benefits or services under those programs
possible changes in or alternatives to those programs or procedures
possible changes in methods or levels of payment or levels of payment for benefits or
services under those programs
Taste and food quality evaluation and consumer acceptance studies,
(i)
if wholesome foods without additives are consumed
(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 contaminated at or below the
level found to be safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection Service of the U.S.
Department of Agriculture.
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45 CFR 46, Subpart A: Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for
Protection of Human Research Subject) 6/18/91.
APPENDIX 2
RESEARCH ACTIVITIES THAT MAY BE REVIEWED THROUGH
EXPEDITED REVIEW PROCEDURES
Research activities involving no more that minimal risk and in which the only involvement of
human subjects will be in one or more of the following categories (carried out through standard
methods) may be reviewed by the Institutional Review Board through the expedited review
procedure authorized in 46.110 of 45 CFR Part 46.
(1)
Collection of hair and nail clippings, in a nondisfiguring manner; deciduous teeth; and
permanent teeth if patient care indicated a need for extraction.
(2)
Collection of excreta and external secretions including sweat, uncannulated saliva,
placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane
prior to or during labor.
(3)
Recording of data from subjects 18 years of age or older using noninvasive procedures
routinely employed in clinical practice. This includes the use of physical sensors that are
applied either to the surface of the body or at a distance and do not involve input of
manner or significant amounts of energy into the subject or an invasion of the subject’s
privacy. It also includes such procedures as weighing, testing sensory acuity,
electrocardiography, electroencephalography, thermography, detection of naturally
occurring radioactivity, diagnostic echography, and electroretinography. It does not
include exposure to electromagnetic radiation outside the visible range (for example, xrays, microwaves).
(4)
Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in
an eight-week period and no more often than two times per week, form subjects 18 years
of age or older and who are in good health and not pregnant.
(5)
Collection of both supra- and subgingival dental plaque and calculus, provided the
procedure is not more invasive than routine prophylactic scaling of the teeth and process
is accomplished in accordance with accepted prophylactic techniques.
(6)
Voice recordings made for research purpose such as investigations of speech defects.
(7)
Moderate exercise by healthy volunteers.
(8)
The study of existing data, documents, records, pathological specimens, or diagnostic
specimens.
(9)
Research on individual or group behavior or characteristics of individuals, such as studies
of perception, cognition, game theory, or test development, where the investigator does
not manipulate subjects’ behavior and the research will not involve stress to subjects.
(10)
Research on drugs or devices for which an investigational new drug exemption is not
required.
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