COMPLIANCE TOPICS: IRB | OHRP | NIH | FDA | HIPAA | Appendices


Howard University Institutional Review Board (IRB)

  • Projects Involving Human Participants in Howard University Hospital (View/Download)
  • Institutional Review Board Flyer Requirements (View/Download)
  • Institutional Review Board Policy on Archival Tissue and Sub-Projects (View/Download)
  • Data and Safety Monitoring Board (View/Download)


Office for Human Research Protections


National Institute of Health (NIH)


Food and Drug Adminstration (FDA) Code of Federal Regulations


Health Insurance Portability and Accountability Act (HIPAA)


Appendices

Appendix A

Glossary of Lay Terms for Use in Preparing Protocols for the IRB

Appendix B

Annual Submission of Biographical Sketches

Appendix C

Projects Involving Human Participants in Howard University Hospital

Appendix D

IRB Flyer Requirements

Appendix E

IRB Policy on Archival Tissue & Sub-Projects

Appendix F

Annual Status Report Form

Appendix G

Conflict of Financial Interest Policy

Appendix H

Allegations of Scientific Misconduct  

Appendix A 

Glossary of Lay Terms for Use in Preparing Protocols for the IRB  

A B C D E F G H I  L M N O P Q R 

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

 

APPENDIX B          

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.

 

 

APPENDIX C

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

   

APPENDIX D

  INSTITUTIONAL REVIEW BOARD

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.


APPENDIX E

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.

 

APPENDIX F

  ANNUAL STATUS REPORT

FOR PROJECT INVOLVING HUMAN PARTICIPANTS (View/Download)

 

APPENDIX G

Conflict of Financial Interest Policy

February 9, 2001

 MEMORANDUM FOR INTERIM PROVOST

All Deans, Directors,

Senior Vice Presidents,
            Vice Presidents and
            General Counsel        

FROM:                      President H. Patrick Swygert

SUBJECT:                 Directive on Conflict of Interest in Research Funded by Public Health
                                   Service
, United States
Department of Health and Human Services, or by the 
                                   National Science Foundation

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 June 6, 1998 (“Code of Ethics”), this Directive sets forth instructions for Investigators (as defined herein) on Conflicts of Interest.