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Presentation prepared by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman, IRB at King Fahad Medical City
DEFINITION OF BIOLOGICAL SAMPLE:
Human biological samples are
defined as any parts of the human body, or human biological material, including
organs and parts of organs, cells and tissues, and body fluids, such as:
1. Blood and blood fractions (plasma, serum, Buffy coat, red blood cells)
2. Tissue (from surgery, autopsy, transplant)
3. Urine
4. Saliva/ buccal cells
5. Placental tissue
6. Cerebrospinal fluid (CSF)
7. Bone marrow
8. Breast milk
9. Ova and Embryonic stem cells
10. Embryos
11. Cell lines
12. Feces
13. Fluids from cytology (ascites, pleural fluid, synovial fluid, etc.)
14. Hair
15. Nail clippings
16. Semen
17. Extracted material from cells e.g. nucleic acids, cytoplasmic fractions, cell lysates, organelles, proteins, carbohydrates and lipids.
TRANSFERRING HUMAN BIOLOGICAL SAMPLES ABROAD:
Materials that require a permit include:
1. Animal tissues, blood, cells, or cell lines
2. RNA/DNA extracts, hormones, enzymes, and monoclonal antibodies for IN VIVO use in non-human species
3. Certain polyclonal antibodies
4. Some Biological test kit reagents
5. Microorganisms including bacteria, viruses, protozoa, and fungi
6. Plant pests
7. Plant-feeding insects, mites, snails, slugs, and plant pathogenic bacteria, viruses, fungi, etc.
8. Biological control organisms of plant pests and weeds
9. Bacteria and viruses
10. Parasitic plants
REGULATIONS OF BIOLOGICAL SAMPLES
TRANSPORT & TRANSFER:
General Regulation:
- There is a need to send the sample abroad as
the test cannot be done in Saudi Arabia
- The receiving agencies should be known for
their research experience in the relevant research fields;
- The project should be approved by the local IRB,
- The researcher should obtain written approval from
the IRB for sending samples abroad after submitting an official request
indicating reasons for sending, quantity, type of samples, and information
about the receiving institute.
- Samples must in all cases be sent in a coded
form so that no identifiable information is sent with
- In all cases, the sender must keep a record of
when the samples were transferred and to whom.
- Samples sent should not exceed the normal
quantity required for such a test
- The National Committee should be notified in
writing of:
Ø
Research
content,
Ø
Objectives,
Ø
Sponsors,
Ø
Approval
of the local committee.
- The researcher should follow the regulation of
packaging biological and Non-Infectious samples
- The National Committee may terminate or
discontinue the research if it is found that such research has no value
for Saudi society or is directly or indirectly detrimental thereto.
AGREEMENT BETWEEN THE LOCAL AND THE
INTERNATIONAL INSTITUTE:
An
agreement should be signed between the local institute sending the samples and
any other foreign agency with the following conditions:
a) The
sender should agree in writing the terms of what the recipient is permitted to
do with the samples and specify in the agreement that only the agreed analyses
should be done on the samples.
b) The
sender should inform the recipient of what should happen to the samples
following recipient use (discard or return).
c) If
discard, the agreement should specify how they should be discarded of. If return,
specify how they should do this
d) In all
cases, the agreement should specify that the recipient is not allowed to use the
samples for their own commercial gain or to send the samples to any other
third party.
e) In all cases,
the sender should agree with the recipient how the donation of samples will be
acknowledged in future publications – authorship if relevant or
acknowledgment.
f) In all
cases, the sender must inform the recipient of how the sample is preserved and of
any biological hazards associated with the sample, and the recipient takes
responsibility for the appropriate management, appropriate preservation, and
handling of the sample.
g) Where an
agreement is required (see standards 6-11), the sending and receiving
organizations must both sign the agreement before any samples are sent.
SPECIAL ITEMS REQUIRING SPECIAL
ATTENTION:
§ Etiologic Agents
Ø
Any
infectious agent known or suspected to cause disease in humans
§ Biological Materials
Ø
Unsterilized
specimens of human and animal tissues containing an infectious or etiologic
agent
§ Hosts and Vectors
Ø
Any
animal known or suspected of being infected with an organism capable of causing
disease in humans
Ø
All live
bats
Ø
Any
living arthropod infected with an etiologic agent
Ø
Snail
species capable of transmitting a human pathogen
SAMPLES TRANSFER CHECKLIST:
- Is there a need to send the sample abroad
- Is the receiving agency an expert in the
research fields
- Having the right consent form
- The project proved by the local IRB
- An agreement was signed between the local institute and the international agency
- Having written approval from the IRB to send samples abroad
- Having all the steps to assure all samples are in a
coded form
- Having a record of when the samples send and to
whom.
- Samples do not exceed the normal quantity required
for such a test
- The National Committee notified in writing
- Following the regulation of packaging of
biological samples
APPENDIX 3b:
Objections of a private commercial
laboratory:
a) The MTA
states we will use materials for non-profit research and education purposes
only which is a false statement and technically we would be immediately in
breach of contract if we signed this,
b) “This” Lab
is not in charge of obtaining IRB approvals on this project,
c) The MTA
states that only our “investigators” could use the materials and any other
transfer is prohibited in the absence of specific written approval from the Provider,
d) The MTA
contains confidentiality terms that could collide with the sponsor’s right to
own the results,
e) If the
site terminates for convenience, we would have to return or destroy the
samples, potentially contrary to our obligations under the sponsor agreement.
f) Due to the
above we want to edit the MTA but we agree to keep the Law of Saudi Arabia as
the Binding Law
APPENDIX 4:
CASE SCENARIO - 1:
§ A consultant using usual laboratory channels has been sending tissues overseas for diagnostic purposes over a period of years. He applied to IRB and got approval for research that involved some of the diagnostic tests he regularly used. He did not specify whether the tests would be done locally or overseas and IRB did not also ask. He sent coded research specimen along the diagnostic ones as usual and got results back.
CASE SCENARIO - 2:
§ A hot argument broke out between a researcher and the local genome laboratory. The researcher wanted to send specimens for sequencing overseas because he got results quickly and at a cheaper rate. The laboratory argued that it could carry out the same tests taking a long time but that it needed support from local researchers. The researcher countered that he did not trust the local laboratory had made a mistake a couple of years ago that led to a very misleading diagnosis.
CASE SCENARIO - 3:
§ The sponsor refused to sign the MTA and returned it edited such that disputes arising would be settled according to the law in his country. The Chairman of IRB refused to accept and asserted on the basis of sovereignty that Saudi law must be used and decided to reject the study. Eventually, both sides were advised to refer any disputes to the International Arbitration Center in Dubai.
CASE SCENARIO - 4:
§ The sponsor refused to specify a specific laboratory to which the specimen will be sent arguing that he uses several laboratories. The IRB chairman refused to sign the MTA. The sponsor then suggested that he acts as the recipient of the specimens.
CASE SCENARIO - 5:
§ A researcher doing work on the genetic basis of a pediatric condition took saliva samples from children on a blotting paper that he dried and sent by ordinary mail to his colleague overseas for genetic sequencing.