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IBEC #: Approval Date:

Institutional Biosafety and BioEthics Committee (IBEC)IBEC Registration Number with NCBE, KSA: HAP-02-J-042.

Application for IBEC Review

When you have completed the form, please send a signed word version to [email protected] response to the section IV will determine the subsequent sections needed

General Information

Principal Investigator Name: Click or tap here to enter text.Email Address: Click or tap here to enter text.Project Title: Click or tap here to enter text.Type: Choose an item.

Section I - Research Description

The overall goal/aim of your project. Outline the overall goal(s) of the research in the space below. Give enough information to assure that the purpose of the experiments and the techniques used are clear.Explain the risk/benefit analysis of this research. Please use reasonably non-technical terms.

Click or tap here to enter text.

Section II - Research TeamList ALL personnel who will work on this proposed research project (faculty, postdocs, research scientists, graduate students, technicians, visiting investigators, etc.).

Name KAUST ID Position (Faculty, PostDoc, Student, …)

Click or tap here to enter text.Click or tap here to

enter text.Click or tap here to enter text.


enter text.Click or tap here to enter text.


enter text. Click or tap here to enter text.

mailto:[email protected]


Section III - Funding Source

Check ALL that apply:

☐ Baseline Funding☐ Grant Application to KAUST OCRF: Click or tap here to enter text.☐ Grant Application to Funding Agency. Name of Funding Agency: Click or tap here to enter text.☐ Industrial Collaboration. Name of Industrial Collaborator: Click or tap here to enter text.☐ Other, Explain: Click or tap here to enter text.

Section IV - Research Use Classification

In the table below, indicate Yes or No to describe what you are using in your research.

1-Biological Materials and Organismsa. Recombinant and Synthetic DNA Choose an item.b. Biological Toxins Choose an item.c. Microbiological agents/Organisms Choose an item.d. Environmental Samples, Potentially Infectious Choose an item.e. Organs, Tissues, Cell Cultures or Clinical Specimens (OTCC) Choose an item.f. Plants Choose an item.g. CRISPR/CAS9, ZNF, TALENS, Meganucleases Choose an item.h. Vectors/Viruses Choose an item.i. Engineered nanomaterials Choose an item.j. Human Embryonic Stem (hES) Cells or Induced Pluripotent Stem (iPS)

CellsChoose an item.

2-Human Subjects or Human-derived samples/dataa. Secondary use of existing anonymous data from sources which are

publicly available (results cannot generate identifiable information)Choose an item.

b. Surveys/Interviews of study participant Choose an item.c. Use of Existing Physiological Data, Biosamples, or Genomic Data Choose an item.d. Active collection of Physiological Data or Biosamples Choose an item.e. Human Embryonic Stem (hES) Cells or Induced Pluripotent Stem (iPS)

CellsChoose an item.

3-External Collaborationa. Will this proposal involve collaborative Research Projects with Local or

International Institutions (Not KAUST)?Choose an item.

b. Collaboration involving human Data or Biosamples Choose an item.c. Collaboration involve non-human Biosamples or Data Choose an item.

4-Enviromental Studiesa. Conducting studies that may impact the environment Choose an item.

[email protected] T: +966 (012) 808-3130

Apvd_14Apr19Page | 2



Not Applicable☐ Section V - Recombinant and Synthetic DNA

Under the “Risk Assessment”, please indicate the perceived risk of the gene expression as low, medium or high. Please refer to the following website when evaluating the risk of genes being expressed: http://atlasgeneticsoncology.org/Genes/Geneliste.html.

Name (e.g., GFP – green fluorescent protein): Click or tap here to enter text.Gene Source(s) (Genus, spices, strain): Click or tap here to enter text.Risk Assessment: Choose an item.Risk Assessment explanation (e.g., tumor suppressor, oncogene, etc.): Click or tap here to enter text.Select when applicable: ☐ Sequencing/PCR only ☐ Plasmid ☐ Viral Vector

Expression in: ☐ Cell Culture ☐ Plant ☐ Animal


To add another section click on the little plus sign (+).To remove one section, right click on the section and select “Delete Extra …”



http://atlasgeneticsoncology.org/Genes/Geneliste.html


Not Applicable☐ Section VI - Biological Toxins

Name: Click or tap here to enter text.

Nature (carcinogens, mutagens, teratogens, toxin, etc.): Click or tap here to enter text.

Highest Concentration Administered: Click or tap here to enter text.

Maximum volume/ quantity: Click or tap here to enter text.

Administered to: ☐ *Biological Agent ☐ **OTCC ☐ Animal ☐ Parasite

*Biological Agent: Bacteria, Fungi, Parasite, and Protozoa **OTCC: Organ, Tissue, Cell Cultures or Clinical Specimens

Please discuss handling, storage, and inventory logs for each biological toxins used:







Not Applicable☐ Section VII - Microbiological Agents/Organisms

Microbiological Agent/Organism known? Choose an item.

a- Name: Click or tap here to enter text. b- Risk Group: Choose an item. c- Human pathogen: Choose an item.d- Animal Pathogen: Choose an item. e- Plant Pathogen: Choose an item.f- Toxin Production: Choose an item.g- Used for Reference/Control: Choose an item. h- Recipient of r/sDNA: Choose an item.i- Administered to Plants: Choose an item. j- Administered to Animals: Choose an item.k- Large Scale Production (>10 Liters): Choose an item.

For bacteria, which are, human or animal pathogens, list any antibiotic resistance introduced (transiently or permanently):







Not Applicable☐ Section VIII – Environmental Samples, Potentially Infectious

1. Type of material (waste water, feces, etc.): Click or tap here to enter text.

2. Where will the material be gathered from? Click or tap here to enter text.

3. Will you be culturing at large scale (greater than 10L at a time)? ☐ Yes ☐ NoIf yes, describe:


4. Will you culture/incubate the whole environmental sample? ☐ Yes ☐ No

If Yes, how will you minimize the exposure of unknown pathogens to laboratory members?Click or tap here to enter text.

5. Does the sample contain any known infectious agents? ☐ Yes ☐ NoIf yes, list:


6. Will you isolate microorganisms from the sample? ☐ Yes ☐ NoIf Yes, please list the organisms of interest if they have not been listed in previous sections







Not Applicable☐ Section IX - Organ, Tissues, Cell Cultures, or Clinical Specimens (OTCC)

Cell line/Tissue (genus, species, strain): Click or tap here to enter text.Technical Name (e.g., NIH3T3, Hep2): Click or tap here to enter text.Passage (primary, established, immortal): Click or tap here to enter text.Administered to animals in vivo: Choose an item. Recipient of r/s DNA construct: Choose an item. Recipient of *Biological Agent: Choose an item. *Biological Agent: Bacteria, Fungi, Parasite, ProtozoaRecipient of Chemical: Choose an item.

For primary human cell lines and tissues:Source (e.g., clinic, another lab, etc.): Click or tap here to enter text.How screened? For which Pathogens? Click or tap here to enter text.






Not Applicable☐ Section X - Plants

Plant Name (Genus, species, strain): Click or tap here to enter text.Inoculated with virus: Choose an item.Transformed with r/s DNA construct: Choose an item. Inoculated with *Biological Agent: Choose an item. *Biological Agent: Bacteria, Fungi, Parasite, Protozoa

1. Are you importing or exporting GMO? ☐ Yes ☐ No If Yes, please specify:


2. Describe the procedure with plants, including a list of treatments: (hazardous chemicals, …)


3. Are any of the plants considered noxious seed or Invasive species? ☐ Yes ☐ NoIf yes, please specify and explain your containment procedure:


4. Do any of the plants require a special permit for entry into KSA? ☐ Yes ☐ NoIf yes, list:


5. Discuss the proposed containment for each plant or plant material used:







Not Applicable☐ Section XI - CRISPR/CAS9, ZNF, TALENS, Meganucleases

1. Can The gRNA/CRISPR nuclease infect or be expressed in human cells? ☐ Yes ☐ NoIf yes, describe:


2. Will the research involve creating a gene drive? ☐ Yes ☐ NoIf yes, describe:


3. Will the research result in a transgenic, sexually reproducing organism? ☐ Yes ☐ NoIf yes, describe:







Not Applicable☐ Section XII - Vectors/Viruses

Vector Type (plasmid, phage, etc.): Click or tap here to enter text.Vector origin (genus, species / Vector lineage): Click or tap here to enter text.Technical Name of Vector (Provide reference or source if commercially available): Click or tap here to enter text.Risk Attenuation (e.g., Replication-defective, Helper Virus, Disarmed, K-12 derivative, Reversion potential): Click or tap here to enter text.Virus System (Lentivirus, adenovirus, etc.): Click or tap here to enter text.Plasmids Used (List all): Click or tap here to enter text.Transgenes expressed (List all): Click or tap here to enter text.Packaging Line (cell lines used for packaging): Click or tap here to enter text.Virus administered to: ☐ Bacteria ☐ Cell lines/tissues ☐ Plants ☐ Animals

1. Indicate where (KAUST location, vendor, collaborator) the virus will be packaged and produced:


2. Please discuss the potential adverse effects on personnel if they are exposed to the viral vector (taking into consideration both the vector and the transgene) :







Not Applicable☐ Section XIII - Engineered Nanomaterials

Carrier Type (polymer, peptide, protein, lipid, nucleic acid, carbon nanotube, etc.): Click or tap here to enter text.Targeting Ligands (List): Click or tap here to enter text.

Payload (Drug, imaging agent, radioisotope, etc.): Click or tap here to enter text.

Relative concentration of Payload if hazardous: Click or tap here to enter text.

Administered to: ☐ *Biological Agent ☐ **OTCC ☐ Plant ☐ Animal*Biological Agent: Bacteria, Fungi, Parasite, Protozoa; **OTCC: Organ, Tissue, Cell Cultures or Clinical Specimens.

Source of nanomaterial: ☐ Produced in laboratory☐ Commercial Product☐ Received from Collaborator☐ Other (Describe): Click or tap here to enter text.

Describe the manufacturing procedure: Not all the nanomaterials may be sufficiently characterized by the above questions, please use the space in Safety Narrative (in Risk Assessment/Safety Plan section XVII at the end of the form) to provide any further information that may be helpful in our risk assessment. If the material requires special handling precautions, describe them. If the materials are being produced in your lab, please briefly describe the procedure for making them.


Delivery Method: Please describe the method by which the nanomaterials will be administrated. Include in your description, the final state of the material before use (solid, liquid, etc.) and indicate whether a solvent or other chemical matrix is used and the type.







Not Applicable☐ Section XIV - Human Embryonic Stem (hES) Cells or Induced Pluripotent Stem (iPS) Cells

Cells Line Name: Click or tap here to enter text.

Sources/Vendor: Click or tap here to enter text.

Type: ☐ Blastocyte Derived☐ Pluripotent ☐ Other (specify): Click or tap here to enter text.






Not Applicable☐ Section XV - Research Involving Human Subject Participants

1. Type of project/study: Please select ALL of the categories of work that apply to this proposed project.

Collection or use of Physiological Data or Biosamples:

☐ Active collection and use of human biological materials

☐ Use of existing human biological materials

☐ Active collection of Physiological Data

Analysis of Survey/Data:

☐ Conducting Interviews or surveys

☐ Use of existing data, not publically available

☐ Other (Please Specify)

2. Does the Protocol include any of the following study populations? Please select ALL of the categories of work that apply to this proposed project.

☐ Normal Adults:

☐ Male☐ Female☐ Saudi☐ Non-Saudi

☐ Vulnerable Populations:

☐ Children☐ Fetuses, Pregnant women☐ Cognitively impaired☐ Prisoners☐ Students or employees

☐ Other (Please Specify)







3. Explain the recruitment plan for subject participants and the inclusion/exclusion criteria for recruitment. (attach the advertisement used for the recruitment)


Study Design4. Describe the number of participants, the study design, use of blinding, analysis


Risks/Benefits5. From the list below, please select ALL of the potential risks that are involved in your study.

☐ Use of deceptive techniques☐ Use of private records (such as educational or medical records)☐ Manipulation of psychological or social state such as sensory deprivation, social isolation,

psychological stress☐ Probing for personal or sensitive information in surveys or interviews (e.g., private

behaviors, employer assessments)☐ Presentation of materials which some participants may consider sensitive, offensive,

threatening or degrading☐ Possible invasion of privacy of subject or subject’s family☐ Social or economic risk (reputational, cultural, employability, etc.)☐ Identification of child, spousal, or elder abuse☐ Identification of illegal activity☐ Risk of allergies, injury or bodily harm☐ Other risks (please specify)


☐ There are no risks of any kind to any participants enrolled in this study. This option is valid only if none of the risks above are selected.





6. Describe the nature and degree of the risks or harms selected above. All of the risks/harms must be disclosed in the consent form.


7. Describe the steps that will be taken to minimize risks or harms and to protect the welfare of participants.


8. Describe any benefits that individuals may reasonably expect from participation.


9. Describe the anticipated benefits of this study to society, academic knowledge or both.


Privacy and Confidentiality10. Will you or any member of your research team collect or have access to any of the personal

identifiers listed below? Select all that apply.

☐ Name☐ Date of birth☐ Nationality☐ Race/Ethnicity☐ Gender☐ Mailing or email address☐ Phone number☐ National identity number (e.g. Iqama)☐ Medical records☐ License, certificate or Vehicle ID☐ IP address☐ Biometric identifiers☐ Photos/images/audio recording☐ Signature, handwriting samples☐ Any unique identifier not mentioned above (please specify)






☒ No member of the research team will have access to any personal identifiers. This option is valid only if none of the other options in this question are selected.

11. If the data/specimens include personal identifiers from human subject participants, explain how you will protect the privacy and confidentiality of the participant.


Consent Process12. What informed consent document will you use?

☐ Standard KAUST Genomics Consent☐ Standard KAUST Survey/Behavioral Consent☐ Collaborator’s Consent Form☐ Other (please specify)


☐ None, I am seeking a waiver of written informed consent

13. If your study involves vulnerable populations or individuals under 18, please describe any additional consent procedures you will implement:


Data14. While at KAUST, data will be collected, analyzed, and stored:

☐ In accordance with KAUST standard practices which include: Encryption, physical and logical security

☐ Exceptions to KAUST standard practices:


☐ Other (please specify)





Not Applicable☐ Section XVI - Collaborations involving Human Data/Biosamples

Click or tap here to enter text.Name of Collaborating Institution or International Repository: Click or tap here to enter text.Collaborating PI Name (N/A for Repositories): Click or tap here to enter text.Select all that apply:

☐ Human Subject is KSA National☐ Sending Samples☐ Sending Data☐ Receiving Samples* *Required documentation from the collaborator. ☐ Receiving Data* (Note: All documents must be provided in English or

with an English translation)


1- For samples sent abroad, please explain why the research cannot be conducted within KSA

2- Data Privacy☐ Data will be shared in accordance with KAUST standard privacy protections practices for human subject’s data which include: limiting external reporting to descriptive statistics and group summary data☐Exceptions to KAUST standard practices:


☐ Other (please specify)




Preferred Documentation

Written acknowledgment from the collaborators Ethics Committee indicating that your study is within the scope of the original informed consent provided to the participants.(template) (Ctrl+clik to download)

Alternative Documentation

The template of the Informed Consent Forms Ethics committee Application Ethics committee Approval Letter



http://researchcompliance.kaust.edu.sa/ibec/forms/Certification%20of%20Ethics%20Committee%20Approval%20Form.pdf


Not Applicable☐ Section XVII - Collaborations involving Non-Human Biosamples

Sample/Data Description: Sample Description: Click or tap here to enter text.Name of Collaborating Institution or International Repository: Click or tap here to enter text.Collaborating PI Name (N/A for Repositories): Click or tap here to enter text.Select all that apply:

☐ Bio samples were collected in KSA☐ Sending Samples☐ Receiving Samples





Health, Safety and Environment

Not Applicable☐ Section XVIII – Laboratory Risk Assessment/Safety Plan

Please consult with the Biosafety Officer for completion of this section [email protected]

1. Personal Protective Equipment (PPE): check ALL that apply

☐ Single gloves: Click or tap here to enter text.☐ Double gloves: Click or tap here to enter text.☐ Laboratory Coat☐ Disposable laboratory Coat/Gown☐ Respirator (e.g., N95 or PAPR): List Type: Click or tap here to enter text.☐ Eye protection: Click or tap here to enter text.☐ Other: List: Click or tap here to enter text.

2. Locations: Where will this work be performed?

☐ Principal Investigator Laboratory

Building Room BSC* CFH** Purpose/UseClick or tap here to enter text.


☐ ☐ Click or tap here to enter text.

*BSC: Biosafety Cabinet; **CFH: Chemical Fume Hood

☐ Plant Growth Field

Location Containment PracticesClick or tap here to enter text. Click or tap here to enter text.

☐ Core Lab:

☐ Bio Science ☐ Greenhouse☐ Microscopy (Imaging & characterization) ☐ Bio-Prep (Imaging & characterization)☐ Plant Growth Facility ☐ Analytical Chemistry☐ Nanofabrication ☐ Animal Resources Core Lab☐ Coastal & Marine Resources (CMR) ☐ Radio Labeling Core Lab






3. Please describe what activities will take place in Core Lab and who will be performing the activities (lab personnel or core lab personnel):


4. Containment Equipment:

☐ Biosafety Cabinet (BSC)☐ Chemical Fume Hood (CFH)☐ Growth Chamber

☐ Other:


5. Disposal:For recommendations, see https://hse.kaust.edu.sa/Services/Pages/Hazwaste.aspx

Decontamination method Disposal Method

Solid Biohazardous Waste Click or tap here to enter text. Click or tap here to enter text.

Liquid Biohazardous Waste Click or tap here to enter text. Click or tap here to enter text.

Sharps Click or tap here to enter text. Click or tap here to enter text.

Plants Click or tap here to enter text. Click or tap here to enter text.

Surfaces Click or tap here to enter text.

Equipment Click or tap here to enter text.

6. Post Exposure Prophylaxis :For each biological agent/viral vector, consider the consequences of accidental exposure (e.g., mucosal splash, inhalation, or inoculation), which might occur during experimental handling. Consider that organisms normally not pathogenic for healthy humans may become so when the natural barriers to infection are circumvented. Prepare a response procedure. It could be a simple matter of washing the wound with soap and water. If antibiotic treatment is recommended, please include information





https://hse.kaust.edu.sa/Services/Pages/Hazwaste.aspx


about the antibiotic of choice and its availability. The exposure-response plan should be posted in the laboratory.

*Biological Agent/Viral Vector ResponseClick or tap here to enter text. Click or tap here to enter text.

*Biological Agent: Bacteria, Fungi, Protozoa.

7. Shipping and Transport

Will you be shipping or transporting any r/sNA or biohazardous material to off-campus locations?

☐ Yes ☐ NoIf Yes, List ALL destinations and describe the process you will be following:







Certifications and Signature

As the Principal Investigator of this research, I certify that the information contained in this application is accurate and complete. I am familiar with and agree to abide by all guidelines and regulations pertaining to this research. Specifically, I agree to abide by the following requirements:a. I will not initiate any biological research subject to the KAUST policies and regulations until that research has been reviewed

and approved by the appropriate committees.b. I will assure that personnel have received appropriate information about the biological hazards of the research outlined in

this application by making available copies of approved protocols, KAUST Biosafety Manual, and other documents that describe the potential biohazards and precautions to be taken to prevent exposures or release to the laboratory or the environment.

c. I am familiar with and will ensure use of appropriate biosafety level laboratory practices and procedures in the conduct of this research.

d. I certify that laboratory personnel have the appropriate technical expertise and know the procedures for dealing with incidents and spills of biological materials, and know the appropriate waste management procedures.

e. I will assure that all laboratory personnel have completed all necessary training as required by HSE and that their training records are up to date.

f. I will comply with all shipping requirements for biohazardous materials.g. I will ensure that all laboratory personnel working on this research are listed on this application, and I will report any

additions/deletions to the appropriate committee(s) promptly. h. I certify that all laboratory spaces associated with the research described in this application are listed.i. I will assure adequate supervision of personnel, and will correct work errors and conditions that could result in breaches of

KAUST policies and regulations pertaining to this research.j. I will inform the Institutional Biosafety and Bioethics Committee of any serious spills, potential exposures or breaches of the

guidelines and regulations listed above.k. I will assure the continuous and proper care and feeding of all vertebrate animals listed in this application (if applicable).l. I will uphold the rights and welfare of all study participants (if applicable)m. I confirm that undertaking this research will not breach the terms of the KAUST Conflict of Interest and Commitment

policies and that it will be conducted in accordance with the KAUST Code of Practice on Responsible Conduct of Research.

Click or tap here to enter text. Click or tap to enter a date.Principal Investigator Name Signature Date




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