Research at Salisbury University
IRB/Committee on Human Research
Definitions (Based on definitions in the Federal
Regulations 45 CFR 12/13/01)
“Research”: a systematic investigation,
including research development, testing and evaluation, designed
to develop or contribute to generalizable knowledge.
We would not consider it to be research, when evaluation, using
instruments designed to test on-going success of programs (e.g.
alumni surveys) or employing routine classroom activities that
involve informal surveying.
“Human Subject”: a living [human] individual
about whom an investigator (whether professional or student)
conducting research obtains data through intervention or
interaction with the individual or identifiable private
information. “Intervention” includes both physical procedures by
which data are gathered and manipulation 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 take 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 (e.g., 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. N.B. Only research
involving human subjects as defined above comes under the
purview of the Committee on Human Research.
“Risk”: any harm or discomfort (physical,
psychological, social or legal) that is anticipated in the
“Minimal Risk”: probability and magnitude of
risks anticipated 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
“Children”: persons who have not attained
the legal age for consent to treatment or procedures involved in
the research under the applicable laws of the Jurisdiction in
which research will be conducted. The legal age in Maryland for
consent is 18 years. For Children 10 and over their assent is
“Informed Consent”: a written document that
human subjects, or their legally authorized representatives,
both understand the nature and purposes of the research and
freely give their consent to be participants in the study. (In
certain specific cases, such as blind and double blind research
protocols, some elements of disclosure may be waived or altered.
Consult the committee for details.)
To meet this requirement, the investigator must provide the
subjects with the opportunity to consider whether or not to
participate and no coercion, explicit or implicit, must be used
to obtain or maintain cooperation. Some of the basic elements
for disclosure are as follows:(see sample form in this packet):
(1) Wherever possible, language
must be put in terms of which a layperson can understand.
(2) A statement that the study
involves research, an explanation of the purposes of the
research and the expected duration of the subject’s
participation, a description of the procedures to be followed,
and identification of any procedures which are experimental.
(3) A description of any reasonable
foreseeable risks to the subject.
(4) A description of any benefits
to the subject or to others that may reasonably be expected from
(5) A statement describing the
extent if any, to which confidentiality of records identifying
the subject will be maintained.
(6) For research involving more
than minimal risk, an explanation as to whether any compensation
or medical treatments are available if injury occurs and, if so,
what they consist of, or where further information may be
(7) An explanation of whom to
contact for answers to pertinent questions about the research
and research subjects’ rights, and whom to contact in the event
of a research related injury to the subject.
(8) A statement that participation
is voluntary, refusal to participate will involve no penalty
[such as lowered grade] or loss of benefic to which the subject
is otherwise entitled.
“Confidentiality”: the requirement that any
information about the subjects and obtained in interaction with
the subjects in a research protocol be protected and safeguarded
against disclosure that would be unwanted or presents possible
embarrassment or harm to the subjects.
Some of the basic elements for maintaining confidentiality are
(1) The instruments for procuring
data should be carefully constructed to ensure that only
personal information that is essential to the study is acquired.
(2) Any information that reveals
the identity of human subjects should be stored in files
accessible only to the researcher and authorized personnel.
(3) Information about the identity
of the subject should be changed into coded form as soon as
possible. (Social Security numbers, even the last four digits
are not adequate protection.)
(4) Publication of the data must
carefully safeguard the identity of the subjects and care must
be taken to protect the identity of institutions in the research
(5) Information that might link the
subjects to the research must be disposed of in a timely fashion
and in a way that safeguards the privacy of the subjects.
(6) Special care must be taken with
information that asks subjects about sensitive or illegal
activities (such information could be obtained by a government
subpoena) and subjects need to know the limits of protecting
Classifications of Research Review
Code of Federal Regulations 45 CFR 12/13/01
- Research Requiring
Full Committee Review: The conditions listed on the cover
sheet and application are not exclusive nor exhaustive but
are offered as examples of the most common types of research
at Salisbury University that require full committee
approval. Additional criteria identified in the
Code of Federal
Regulations 45 Part 46 “Protection of Human Subjects”
(effective 12/13/01) may require the CHR Chair to designate
a particular protocol as needing full committee review.
Research: Additional research that qualifies as expedited is
- Collection of hair and nail clippings, in a
non-disfiguring manner; deciduous teeth; and permanent
teeth if patient care indicates a need for extraction.
- 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.
- Recording of data from subjects 18 years of age or
older using non-invasive
procedures routinely employed in clinical practice
(including the use of physical
sensors that are applied either to the surface of the
body or at a distance and do no
involve input of matter or significant amounts of energy
into the subject or an invasion of the subject’s
privacy; also including such procedures as weighing,
testing sensory acuity, electrocardiography,
electoencephalography, hermography, detection of
naturally ocurring radioactivity, diagnostic echography,
and electroretinography; but not including exposure to
electromagnetic radiation outside the visible range [for
example, x-rays and
- Collection of blood samples by venipuncture, in
amounts not exceeding 450 milliliters in an eight-week
period and no more often that two times per week, from
subjects 18 years of age or older and who are in good
health and not pregnant.
- Collection of both supra and subgingival dental
plaque and calculus, provided the procedure is not more
invasive than routing prophylactic scaling of the teeth
and the process is accomplished in accordance with
accepted prophylactic techniques.
- Research on drugs or devices for which an
investigational new drug exemption or an investigational
device exemption is not required.
- Exempt Research: These six categories have been defined
by federal regulation as exempt from full committee review.
- Research conducted in established or commonly
accepted educational settings, involving normal
educational practices, such as:
- research on regular and special education
instructional strategies, or
- 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 unless:
- information obtained is recorded in such a
manner that human subjects can be identified,
directly or through identifiers linked to the
- 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. (Should the linkages
be removed by authorized person other than the
researcher, the protocol would still be considered
- Research involving the use of educational tests, surveys
or interview procedures which is not exempt under Section 2, and
in which respondents will be elected or appointed public
officials or candidates for public office.
- 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.
- Research and demonstration projects which are conducted by
or subject to the approval of the department or agency heads,
and which are designed to study evaluate, or otherwise examine:
- Public benefit or service programs;
- procedures for obtaining benefits or services under
- possible changes in or alternatives to those programs
or procedures; or
- possible changes in methods or levels of payment for
benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance
- (i) wholesome foods without additives are consumed, or
- (ii) a food is consumed that contains a food ingredient or
agricultural chemical or environmental contaminant 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
Sample Disclosure Form
I am currently
conducting a study on
(purpose of proposed research)
I am seeking the assistance of
in completing a questionnaire concerned with
(focus of questionnaire)
is brief and should take about
(length of time)
of your time to complete.
Every effort will be made to keep the information provided confidential.
You name does not appear on the questionnaire.
and participation are strictly voluntary and your choice to participate or not
to participate will in no way affect your grade.
You may leave any particular questions unanswered or may choose not to
complete the questionnaire. Your
participation is very valuable and will help me
(contribution of the proposed research)
If you have any
questions about this study or would be interested in the results, please contact
(name, title, affiliation)
Thank you for your cooperation.
If you have any
adverse effects or concerns about the research, please contact the primary
investigator or the Office of Graduate Studies and Research
University at 410-548-3549 or toll free 1-888-543-0148.
Subject’s Bill of Rights
To be told what
the study is trying to find out
To be told what
will happen to you and whether any of the procedures, drugs, or
devices is different from what would be used in standard
To be told about
the frequent and/or important risks, side effects or discomforts
of the things that will happen to you for research purposes
To be told if you
can expect any benefit from participating and, if so, what the
benefit might be
To be told the
other choices you have and how they may be better or worse than
being in the study
To be allowed to
ask questions concerning the study, both before agreeing to be
involved and during the course of the study
To be told what
sort of medical treatment is available if any complications
To refuse to
participate at all or to change your mind about participating
after the study is started. This decision will not affect your
right to receive the care you would receive if you were not in
To receive a copy
of the consent form
To be free of
pressure when considering whether you wish to agree to be in the