![]()
|
|
Glossary of Lay Terms for Use
in Preparing Protocols for the IRB |
|
|
Annual Submission of
Biographical Sketches |
|
|
Projects Involving Human
Participants in Howard University Hospital |
|
|
IRB Flyer Requirements |
|
|
IRB Policy on Archival Tissue
& Sub-Projects |
|
|
Annual Status Report Form |
|
|
Conflict of Financial Interest
Policy |
|
|
Allegations of Scientific
Misconduct
|
| A | |
|
ABSORB |
Take
up fluids, take in |
|
ACIDOSIS |
Condition
when blood contains more acid than normal |
|
ACUITY |
Clearness,
keenness, esp. of vision - airways |
|
ACUTE |
New,
recent, sudden |
|
ADENOPATHY |
Swollen
lymph nodes (glands) |
|
ADJUVANT |
Helpful,
assisting, aiding |
|
ADJUVANT
TREATMENT |
Added
treatment |
|
ANTIBIOTIC |
Drug
that kills bacteria and other germs |
|
ANTIMICROBIAL |
Drug
that kills bacteria and other germs |
|
ADVERSE
EFFECT |
Side
effect |
|
ALLERGIC
REACTION |
Rash,
trouble breathing |
|
AMBULATE
-ATION -ORY |
Walk,
able to walk |
|
ANAPHYLAXIS |
Serious,
potentially life threatening allergic reaction |
|
ANEMIA |
Decreased
red blood cells, low red blood cell count |
|
ANESTHETIC,
(general) |
A
drug or agent used to
decrease the feeling of pain
or eliminate the feeling of pain by putting you to sleep |
|
ANESTHETIC,
(local) |
A
drug or agent used to decrease the feeling of pain or by numbing an area
of your body, without putting you to sleep |
|
ANGINA |
Pain
resulting from insufficient blood to the heart |
|
ANGINA
PECTORIS |
Same
as above |
|
ANTECUBITAL |
Area
inside the elbow |
|
ANTIBODY |
Protein
made in the body in response to foreign substance; attacks the foreign
substance and protects from infection |
|
ANTICONVULSANT |
Drug
used to prevent seizures |
|
ANTILIPIDEMIC |
A
drug that decreases the level of fat(s) in the blood |
|
ANTITUSSIVE |
A
drug used to relieve coughing |
|
ARRHYTHMIA |
Any
change from the normal heartbeat (abnormal heartbeat) |
|
ASPIRATION |
Fluid
entering lungs following vomiting |
|
ASSAY |
Lab
test |
|
ASSESS |
To
learn about |
|
ASTHMA |
A
lung disease associated with tightening of the air passages |
|
ASYMPTOMATIC |
Without
symptoms |
|
AXILLA |
Armpit |
| B | |
|
BENIGN |
Not
malignant, usually without serious consequences, but with some exceptions
e/g/ benign brain tumor may have serious consequences |
|
BINDING/BOUND |
Carried
by, to make stick together, transported |
|
BIOAVAILABILITY |
The
extent to which a drug or other substance becomes available to the body |
|
BLOOD
PROFILE |
Series
of blood tests |
|
BOLUS |
An
amount given all at once |
|
BONE
MASS |
The
amount of [calcium in a given amount of] bone |
|
BRADYARRHYTHMIAS |
Slow
irregular heart beats |
|
BRADYCARDIA |
Slow
heartbeat |
|
BRONCHOSPASM |
Breathing
distress caused by narrowing of the airways |
| C | |
|
CARCINOGENIC |
Capable
of causing cancer |
|
CARCINOMA |
Type
of cancer |
|
CARDIAC |
Pertains
to the heart |
|
CARDIOVERSION |
Restoration
of normal heart beat by electric shock |
|
CARIES |
Cavities |
|
CATHETER |
A
tube for withdrawing or introducing fluids |
|
CATHETER
-(indwelling epidural) |
A
tube placed near the spinal cord used for anesthesia during operation |
|
CEREBRAL
TRAUMA |
Damage
to the brain |
|
CHD |
Coronary
heart disease |
|
CHEMOTHERAPY |
Treatment
of disease, usually cancer, by chemical agents |
|
CHRONIC |
Continuing
for a long time |
|
CLINICAL |
Pertaining
to medical care |
|
CLINICAL
TRIAL |
An
experiment in patients |
|
COMPLETE
RESPONSE |
Total
disappearance of disease |
|
CONSOLIDATION
PHASE |
Treatment
phase intended
to make
a remission permanent,
follows induction |
|
CONTROLLED
TRIAL |
Study
in which the experimental treatment of procedure is compared to a standard
(control) treatment or procedure |
|
COOPERATIVE
GROUP |
Association
of multiple institutions to perform clinical trials |
|
CORONARY |
Pertains
to the blood vessels that supply the heart |
|
CT
SCAN (CAT)
(computerized tomography) |
Computerized
series of x-rays |
|
CULTURE |
Test
for infection or organisms that could cause infection |
|
CVA
(cerebrovascular accident) |
Stroke |
| D | |
|
DIASTOLIC |
Lower
number in blood pressure reading |
|
DISTAL |
Toward
the end, away from the center of the body |
|
DIURETIC |
“Water
pill” or drug that causes increase in urination |
|
DOPPLER |
Sound
waves |
|
DOUBLE
BLIND |
Study
in which neither investigators nor participants know what drug the subject
is receiving |
|
DYSPLASIA |
Abnormal
cells |
| E | |
|
ECHOCARDIOGRAM |
Sound
wave test of the heart |
|
EDEMA |
Increase
fluid |
|
EEG
(electroencephalogram) |
Electric
brainwave tracing |
|
EFFICACY |
Effectiveness |
|
ELECTROCARDIOGRAM
(ECG or EKG) |
Electrical
tracing of heartbeat |
|
ELECTROLYTE
IMBALANCE |
Imbalance
of minerals in the blood |
|
EMESIS |
Vomiting |
|
EMPIRIC |
Based
on experience |
|
ENDOSCOPIC |
Examination
of an
internal part
of the
body with
a |
|
EXAMINATION |
lighted
tube; looking at a part of the body with a lighted tube |
|
ENTERNAL |
By
way of the intestines |
|
EPIDURAL |
Outside
the spinal cord |
|
EXPEDIATED
REVIEW |
Rapid
review of a protocol by the IRB chair without full committee approval ,
permitted with certain low-risk research |
|
EXTRAVASATE |
To
leak outside of a blood vessel |
| F | |
|
FDA |
U.S.
Food and Drug Administration, the branch of the federal government which
approves new drugs |
|
FIBRILLATION |
Irregular
beat of the heart or other muscle |
| G | |
|
GENERAL
ANESTHESIA |
Pain
prevention by induction of drugged sleep, as in surgery |
| H | |
|
HEMATOCRIT |
Amount
of red blood cells in the blood |
|
DEMATOMA |
A
bruise, a black and blue mark |
|
HEMODYNAMIC
MEASURING |
Measuring
of blood flow |
|
HEMOLYSIS |
Breakdown
in red blood cells |
|
HEPARIN
LOCK |
Needle
placed in the arm with blood thinner to keep the blood from clotting |
|
HEPATOMA |
Cancer
or tumor of the liver |
|
HOLTER
MONITOR |
A
portable machine for recording heart beats |
|
HYPERCALCEMIA |
High
blood calcium level |
|
HYPERKALEMIA |
High
blood potassium level |
|
HYPERNATREMIA |
High
blood sodium level |
|
HYPERTENSION |
High
blood pressure |
|
HYPOCALCEMIA |
Low
blood calcium level |
|
HYPOKALEMIA |
Low
blood potassium level |
|
HYPONATREMIA |
Low
blood sodium level |
|
HYPOTENSION |
Low
blood pressure |
|
HYPOXEMIA |
A
decrease of oxygen in the blood |
|
HYPOXIA |
A
decrease of oxygen in the blood |
| I | |
|
IATROGENIC |
Caused
by a physician or by treatment |
|
IDE |
Investigational
device exemption, the license to test an unapproved new medical device |
|
IDIOPATHIC |
Of
unknown cause |
|
IMMUNOGLOBULIN |
A
protein that makes antibodies |
|
IMMUNOSUPPRESSIVE |
Drug
which suppresses the body’s immune response, used in transplantation and
diseases caused by disordered immunity |
|
IMMUNOTHERAPY |
Giving
of drugs to help the body’s immune (protective) system; usually used to
destroy cancer cells |
|
IND |
Investigational
new drug, the license to test an unapproved new drug |
|
INDUCTION
PHASE |
Beginning
phase or stage of a treatment |
|
INDURATION |
Hardening |
|
INFARCT |
Death
of tissue because of lack of blood supply |
|
INFUSION |
Introduction
of a substance into the body, usually into the blood |
|
INGESTION |
Eating;
taking by mouth |
|
INTRAMUSCULAR |
Into
the muscle; within the muscle |
|
INTRATHECAL |
Into
the spinal fluid |
|
INTRAVENOUS
(IV) |
Through
the vein |
|
INTRAVESICAL |
In
the bladder |
|
INTUBATE |
The
placement of a tube into the airway |
|
INVASIVE
PROCEDURE |
Puncture,
opening or cutting of the skin |
|
ISCHEMIA |
Decreased
oxygen in a tissue (usually because of decreased blood flow) |
| L | |
|
LEUCOPENIA |
Low
white blood cell count |
|
LIPID
CONTENT |
Fat
content in the blood |
|
LOCAL
ANESTHESIA |
Creation
of insensitivity to pain in a small, local area of the body |
|
LOCALIZED |
Restricted
to one area, limited to one area |
|
LUMEN |
The
cavity of an organ or tube (e.g., blood vessel) |
|
LYMPHANGIOGRAPHY |
An
x-ray of the lymph nodes or tissues after injection of dye in lymph
vessels (e.g., in feet) |
|
LYMPHOCYTE |
A
type of white blood cell important in immunity and defense against
infection |
|
LYMPHOMA |
A
cancer of the lymph nodes (or tissues) |
| M | |
|
MALAISE |
A
vague feeling of bodily discomfort, feeling bad |
|
MALIGNANCY |
Cancer
or other progressively enlarging and spreading tumor, usually fatal if not
successfully treated |
|
MEDULLOBLASTOMA |
A
type of brain tumor |
|
MEGALOBLASTOSIS |
Change
in red blood cells |
|
METABOLIZE |
Process
of breaking down substances in the cells to obtain energy |
|
METASTASIS |
Spread
of cancer cells from one part of the body to another |
|
MI |
Myocardial
infarction |
|
MINIMAL |
Slight;
the smallest increment of risk. |
|
MINIMIZE |
Reduce |
|
MONITOR |
Check
on; keep track of; watch carefully |
|
MOBILITY |
Ease
of movement |
|
MORBIDITY |
Undesired
result or complication |
|
MORTALITY |
Death
or death rate |
|
MOTILITY |
The
ability to move |
|
MRI |
Magnetic
resonance imaging, body pictures created using magnetic rather than x-ray
energy |
|
MUCOSA,
MUCOUS MEMBRANE |
Moist
lining of digestive, respiratory, reproductive, and urinary tracts |
|
MULTIPLE
PROJECT ASSURANCE |
Agreement
between institutions and
OHRP regarding
institutional policies on the use of human participants in research |
|
MYOCARDIAL |
Pertaining
to the heart |
|
MYOCARDIAL
INFARCTION |
Heart
attack |
| N | |
|
NASOGASTRIC
TUBE |
Tube
from the nose to the stomach |
|
NCI |
The
National Cancer Institute |
|
NECROSIS |
Death
of tissue |
|
NEOPLASIA |
Tumor,
may be benign or malignant |
|
NEUROBLASTOMA |
A
cancer of nerve tissue |
|
NEUTROPENIA |
Decrease
in the main part of the white blood cells |
|
NIH |
The
National Institutes of Health |
|
NON-INVASIVE |
Not
breaking, cutting or entering the skin |
|
NOSOCOMIAL
PNEUMONIA |
Pneumonia
acquired in the hospital |
| O | |
|
OCCLUSION |
Closing;
obstruction |
|
OHRP |
Office
of Human Research Protections, Department of Health and Human Services,
oversees IRBs and related matters (formerly OPRR) |
|
ONCOLOGY |
The
study of tumors for cancer |
|
OPHTHALMIC |
Pertaining
to the eye |
|
OPTIMAL |
Best,
most favorable or desirable |
|
ORAL
ADMINISTRATION |
By
mouth |
|
ORTHOPEDIC |
Pertaining
to the bones |
|
OSTEOPETROSIS |
Rare
bone disorder characterized by dense bone |
|
OSTEOPOROSIS |
Softening
of the bones |
|
OVARIES |
Female
sex glands |
| P | |
|
PARENTERAL |
Administration
by injection |
|
PATENCY |
Condition
of being open |
|
PATHOGENESIS |
Causative
mechanism in a disease |
|
PERCUTANEOUS |
Through
the skin |
|
PHARMACOKINETICS |
The
study of the way the body absorbs, distributes and gets rid of a drug |
|
PHASE
I |
Initial
study of a new drug in humans to determine limits of tolerance |
|
PHASE
II |
Second
phase of study of a new drug intended to obtain initial information |
|
PHASE
III |
Large
scale trials to confirm and expand information on safety and usefulness of
a new drug |
|
PHLEBITIS |
Irritation
or inflammation of the vein |
|
PLACEBO |
A
substance of no medical value; an inactive substance |
|
PLACEBO
EFFECT |
Phenomenon
of improvement seen with the administration of a placebo |
|
PLATELETS |
Small
particles in the blood that help with clotting |
|
POTENTIATE |
Increase
or multiply the effect of a drug or toxin by administration of another
drug or toxin at the same time |
|
POTENTIATOR |
An
agent that helps another agent work better |
|
PROPHYLAXIS |
A
drug given to prevent disease or infection |
|
PER
OS (PO) |
By
mouth |
|
PRN |
As
needed |
|
PROGNOSIS |
Outlook,
probable outcomes |
|
PRONE |
Lying
on the stomach |
|
PROSPECTIVE
STUDY |
Study
following patients forward in time |
|
PROTOCOL |
Plan
of study |
|
PROXIMAL |
Closer
to the center of the body, away from the end |
|
PULMONARY |
Pertaining
to the lungs |
| R | |
|
RADIATION
THERAPY |
X-ray
or cobalt treatment |
|
RANDOM |
By
chance |
|
RANDOMIZATION |
Change
selection |
|
RBC |
Red
blood cell |
|
RECOMBINANT |
Formation
of new combinations of genes |
|
RECONSTITUTION |
Putting
back together the original parts or elements |
|
REFRACTORY |
Not
responding to treatment |
|
REGENERATION |
Regrowth
of a structure or of lost tissue |
|
RELAPSE |
The
return of a disease |
|
REMISSION |
Disappearance
of evidence of cancer or other disease |
|
RENAL |
Pertaining
to the kidneys |
|
REPLICABLE |
Possible
to duplicate |
|
RESECT |
Remove
or cut out surgically |
|
RETROSPECTIVE
STUDY |
Study
looking back over past experience |
|
Annual Submission of Biographical Sketches
Investigators presenting applications for review by the
Institutional Review Board (IRB) may submit one copy of a current
biographical sketch to the IRB office.
Subsequent applications will not require a biographical sketch
during that year. It should
be noted in the personnel listing of all subsequently submitted proposals,
that a current biographical sketch is a matter of record with the IRB
office.
Thereafter, at the beginning of each calendar year, each
investigator is required to submit an updated copy of his/her biographical
sketch to the IRB. In
addition, if during the year major changes occur that may reflect an
investigator’s expertise to conduct a given research project, an updated
version of the biographical sketch should be submitted to the IRB.
The Board is optimistic that this procedure will reduce the amount
of copying required by investigators and faculty advisors, and also reduce
the Board’s request for copies of updated biographical sketches.
Your cooperation in this matter is greatly appreciated.
Projects Involving Human Participants in Howard University Hospital Projects
involving human participants in the Howard University Hospital (i.e.,
in-patients or out-patients) must be reviewed by the Pharmacy and
Therapeutics Committee (PTC) of the Howard University Hospital. This review by the PTC must be conducted before a proposal is
submitted to the Howard University Institutional Review Board for review.
This process is necessary for two major reasons: 1.
To provide a system for monitoring projects being conducted in the
hospital which involved patients whether in the clinics or the wards; 2.
To provide information for the hospital administration regarding
the conduct for such projects within the hospital. Protocols
from the College of Medicine and Howard University Hospital are to be
forwarded to the Office of the Associate Dean for Research, College of
Medicine, Room 533, Seeley G. Mudd Building.
Those from other units of the University are to be forwarded to the
Office of the Institutional Review Board, Room 214, Annex II. The Investigators will be responsible for distributing the
documents to the Secretary of the Pharmacy and Therapeutics Committee for
review by that Committee. Correspondence
regarding the PTC should be addressed to its Chairman, in care of the
Director of Pharmacy, Room BB06, Howard University Hospital cc:
Chairman, Pharmacy and Therapeutics Committee
FLYER REQUIREMENTS Advertisements may
state that participants will be paid, but should
not emphasize the payment or the amount to be paid. It can be stated
that the participants will be given $XX.00 per visit for X number of
visits. The wording should be
in the same size print as the other statements in the document.
Include, the name
and/or location of the investigator and/or research facility. If the study is
“research” it must be so stated. State the
eligibility requirements of the study and/or its’ purpose. Summarize the
criteria that will be used to determine a participant’s eligibility for
the study. It should be
stated that the laboratory tests are free. A brief listing of
the benefits, if any. The time or other
commitment required of the research participants. The individual
and/or office to contact for further information. This information
should be so placed on the flyer as to allow for the IRB date-stamp and
the IRB number to be visible. Advertisements
should not promise “free treatment” when the intent is only to advise
prospective participants that they will not be charged for taking part in
research studies. INSTITUTIONAL REVIEW BOARD POLICY ON ARCHIVAL TISSUE AND SUB-PROJECTS
1.
Consent form addendum
required addressing “yes” and “no” options.
Suggested wording is, “...
you have my permission to use my tissue in other projects as they
are approved by the IRB ...” Or
“... If I do not wish for my blood, etc., to be used in future IRB
approved research studies, I will check the “no” box below ...”
If participants respond with “no” then the tissue is not
to be used for other projects, but re-contact can occur.
(e.g., use actual example).
2.
IRB approval required for
new protocols as a sub-projects.
Investigators must prepare a normal IRB submission for the full
Board’s review, using archival material as a new source which they
intend to study. They must
identify the number of “yes” consents
they have obtained. This
includes external and internal collaborations.
3.
Letters of collaboration
and curriculum vitaes for all outside investigators with a brief
proposal. For
example, if a Howard University investigator wants to collaborate with
Georgetown on a project, a letter of collaboration is required
describing what they propose to do along with a curriculum vitae that
verifies the competency level of the investigators in the proposed area.
4.
Investigators are required
to re-consent all participants that have not agreed in the past.
For example, if you have 400 participants in your sample and you
did not previously have the archival options in your consent form, then
you must go back and re-contact all of those 400 participants.
If upon re-contact they do not agree to sign the new consent
form, then those participants must be dropped from future research.
If the participant has died, they will be considered as a
participant who signed the “no” option, and their material can not
be used.
5.
Samples cannot be sold
by principal investigators or collaborators.
The gross advertising of the availability of tissue is strictly
prohibited and that includes advertising on the Internet prior to
advising the IRB.
6.
An annual report is
required on the sub-projects.
7.
For tissue collected prior
to this policy change, the IRB requires that no identifiers be
distributed with the tissue. If the investigator un-links the identifiers, the tissue can
be used in sub-projects if approved by the IRB.
8.
These policies applies to
tissue, DNA and other reduced or extracted tissue material.
This applies to any and all biological materials.
9.
If significant (i.e.,
treatment enhancement) results are found, participants and their
physicians should be notified.
For example, if an investigator goes back and does a gene test
and find the gene that predicts survival, the participants should be
notified, especially if the participant is alive and undergoing
treatment. This would be a benefit to the participant.
Any and all results should be made available to the participants,
not just “treatment enhancing” developments, for example, if disease
progression or outcome results are found.
10.
External review to support
new collaboration. At
least one letter of support is required from a external peer reviewer,
not at the originating Institution.
A letter from the community of scientists who agree that this is
a worthwhile endeavor. A
letter from Investigator(s) doing a similar type of work would be
appropriate as long as they are not collaborating or consulting on the
project. These will be
reviewed in the IRB process.
FOR PROJECT INVOLVING HUMAN PARTICIPANTS
Conflict of Financial Interest Policy
All Deans, Directors, Senior
Vice Presidents, FROM: President H. Patrick Swygert SUBJECT:
Directive on Conflict of Interest in Research Funded by Public Health
Background
and Purpose
Federal
law requires that institutions performing Public Health Service
(“PHS”) or National Science Foundation (“NSF”) funded research
must adopt and enforce certain policies on conflicts of interest that are
consistent with regulatory requirements found in Titles 42 and 45 of the
Code of Federal Regulations. The purpose of this Directive is to ensure
that the University is fully compliant with its responsibility under those
regulations. Authority
Pursuant
to Section VII of the University Code of Ethics and Conduct, adopted by
the Board of Trustees on |