Information Annexure

It is our pleasure to inform you that ILBS with the support of DBT has established the National biobank facility for clinical and basic research in the field of HCV and other liver diseases.This facility includes both cryo-storage as well as the high end analytical services including NGS, FACS, OMICS, Pathological, IHC, IF, ISH, Molecular analysis facility. Biobank core committee and operational management that are independent of host institute to ensure the neutrality runs it. This is a nodal center to the clinical and basic researchers to carry out their research from start to end in one go under one roof along with human resource training. In order to deliver cutting edge services for collaborative liver disease research and academia-industry partnership in India, this facility will acquire a non-profitable business and financial model, where a nominal charges are in place against the utilization of Biobank services.

The aim is “To establish an advancedopen resource sharing National Biobank for HCV research in an institute dedicated to patient care and research in liver diseases. The biobank collects high quality samples with clinical data (including demographic, epidemiology, pathology, progression, vital status, and therapy and outcomes related data). Collectionsare standardized; to ensure uniformity, consistency, and quality of collected data. Based on standardized data collection a model of informatics is developed and utilization of resources/access to the advance research equipments are made available to fulfill all the needs of researchers under one roof. This facility will provide a launch pad for advanced research in the field of HCV related liver diseases in India.”

Offered services:

Research Based

a. Processing/ storage charges of samples from other institutes.
b. Intellectual services.
c. Giving a freezer or Freezer space on Rental/ lease to organizations.
d. Investigators should include tissue/specimen procuring costs in contracts and grants.
e. Clinical trials may add the cost of tissue banking/storage to the contracts.
f. Pharma companies can utilize these specimens at reasonable cost.
g. Per sample or a set of samples (e.g. blood) could be levied.
h. Levied for special “on demand” tissues that require additional involvement of physician/surgeon time.
i. Charges levied upon the publication of any article that originated from the use of samples from the Biospecimen core depending on the number of tissues used.
j. Charges levied on human and experimental animal tissues/ specimens both.
k. Tissue bank material if utilized to develop patented items for diagnostics or therapeutics of HCV, a part of which will be levied for biobank
HCV, a part of which will be levied for biobank

Commodities based:
a. Having high end instruments in the Biobank facility will deliver the following services to researcher for the biomedical research.
b. Providing Customized datasets.
c. Offering molecular and proteomic analysis.
d. Performing custodial collection services.
e. Providing pathology validation services.
f. Offering customized collection and/or processing services in the areas of DNA/RNA expression profiling.
g. Genotyping.
h. NGS.
i. Omics.
j. Microarrays.
k. Providing the experimental animal tissue for life science related institutes and technical institutes.
l. FACS facility.

Academics and Education Based
a. Starting technical training courses
b. Development of atlases and texts using whole slide scanner.
c. Providing consultancy services to other institutes.
d. Academic courses for Medical professionals

Using the Biobank facility for storage process:
Charges: You may please calculate the charges according to your sample size by using: annexure-1
Terms/Conditions and sharing plans are given in: annexure-2
Please fill the complete client information sheet: annexure -3
Consent Policy: annexure-4
Material & Information Handling: Annexure-5
Annexure-1

Tentative Fees Provision

• Per project (average 200 samples) the charges for sample storage, software module maintenance, quality control and utilization of high-end instruments (consumables to be provided by the PI)- 5 LACS Rupees
• Student’s protocol samples will not be charged, if they donate aliquot vial samples at to common biobank pool, which will be used other than the objectives mentioned in their protocol.
• PI will get a waiver of upto 50% based on number and quality of samples they provide in the common pool of biobank.
• Industrial usage will be charged as per the biobank standard charges.
• Co-authorships and acknowledgements.
Annexure-2

Terms/Conditions and sharing plans

1. Sharing within the institute
Consent and Ethical Clearance- Consent form used to obtain specimens will include the information to the participants that their specimen will be shared. Biobank will verify of Ethical Approval from the institute’s ethical committee. Under no circumstances patient’s confidentiality will be shared.
Evaluation of Research Plans- Evaluation will be done on the basis of scientific merit, priority, statistical power and data requested. A specimenutilization committee will be constituted to evaluate the research plan.
Recouping Cost- Bio bank will be permitted to recover the costs within the institute for expenses associated with collection, processing, storage, and distribution. Cost will be included in their grant proposals.
Disposition of Unused Specimens- Unused portions of the specimen can either be returned to the tissue bank or it can be used by other researchers with mutual agreement with prior biobank approval.
Publications- Requester can consider the option of co-authorship if the bank provides scientific inputs.
2. Sharing outside the institute
A written agreement, executed by the office of Sponsored Research, will be required before patients specimen collected at Biobank can be shared with researchers outside the institute. The office of Sponsored Research assists researchers by carefully negotiating and executing contractual agreements with academic institutes, nonprofit organizations and industry to ensure the Institute’s and the researchers financial concerns and intellectual property rights are protected.
Consent and ethical clearance- Consent form used to obtain specimens will include the information to the participants that their specimen will be shared and after the verification of Institutional Review Board Approval, request for biospecimen release application will be considered.
Evaluation of Research Plans- Evaluation will be done on the basis of scientific merit, priority, statistical power and data requested. A specimenutilization committee will be constituted to evaluate the research plan.
Written agreements pertinent to sharing human biospecimens outside the institute will include: - Material transfer agreement, clinical trial agreement, and clinical services agreement
Financial concerns to sharing human biospecimens outside the institute - Biobank will be permitted to recover the costs the institute by charge system for expenses associated with collection, processing, storage, and distribution. Cost will be included in their grant proposals.
Disposition of Unused Specimens- Unused portions of the specimen can either be returned to the tissue bank or it can be used by other researchers with mutual agreement with prior biobank approval.
Protection of Intellectual property (IP) Right- IP rights will be protected in collaborative research projects involving humanbiospecimens.
3. Applications will be invited through website, depending upon the availability of resources. It Advertisement will specify whether it is for academia or industry and other details – number of resources, services, terms and conditions, fee structure.
1. Process to Receive Biospecimens from the Biobank
Procedure of biospecimens receiving from the biobank is summarized in the below flowchart. All the requests are subjected to ethical clearance, biobank feasibility of issuance of the desired samples and external peer review of the project regarding its scientific merit, priority, statistical power and data requested. Whole procedure will be time bound after the ethical approval. Biobank will give clearance within three days regarding availability and feasibility then it will send to the panel of external reviewers. Reviewers will be requested to give their comment within 21 days. If Biobank receives comments/ clearance from any of the three reviewers, within the given time frame of 21 days, biobank will release biospecimens/ dataset requested or both within four days. If there is a request for customized dataset or commodities or procedures biobank will release within 15 days. If PI requests for special processing then the time taken by the biobank will be in accordance to the particular procedure or process but will not be more than 30 days.
Flow chart of process to receive Biospecimens from the Biobank
2. Biospecimens Receiving and Sample Donation from other Institutes/PI
Sharing and receiving from the other institute will be according to the following flowchart

Flow chart for receiving the samples from the Institutes/ PI

a. PI/institute who participates in the strengthening process of biobank will be given certificate of participation.
b. Extent of involvement in the biospecimen will be discussed at the time of participation.
c. Provisions of discounts on processing cost will be made to encourage the active participation.
d. A buffer period of 1 year will be provided to utilize 50% of their specimens of without any rental cost.
e. Students’ protocol samples will not be charged, if they donate samples to common biobank pool, which will be used other than the objectives mentioned in their protocol.
f. PI will get a waiver of upto 50% based on number and quality of samples they provide in the common pool of biobank.
g. Industrial usage will be charged as per the biobank standard charges
h. Co-authorships and acknowledgements.
i. Issue of benefitting the participating PI/institute will be discussed in ethics committee and core committee and finalized.

3. Collection where applications can be made before or after funding and ethical approval is secured.
a. Letter of intent may be issued with a guarantee of reserve sample for three, six, twelve and/or twenty four months and provision of caution money willbe there alongwith application processing fees.
b. Letter of intent without guarantee will be issued without any caution money and the availability of samples is not guaranteed. Nominal application processing fees will applicable.

4. Terms and conditions for sharing the resources.
a. Specimens will be used only for the purposes cited in the application
b. No attempt to obtain participants identity
c. No specimens will be sold or shared with a third party without the prior written permission of the repository
d. All specimens will be treated as potentially infectious
e. There will be no implied warranty on the specimens
f. Publications resulting from the use of these; will acknowledge the repository
g. Researcher/institution using the tissue assumes responsibility for all risks associated with the receipt, handling, storage, and use of the tissue.
h. Biobanks will have the principle of ‘‘minimum amount of tissue’’

5. Initial raw data and after publication of the final study results to be informed to biobank so that same can be incorporated in database to strengthen it and to avoid repeatability. This will essentially not poses any risks for the publication of the results/ study and will ensure the optimum utilization of resources.

5. Initial raw data and after publication of the final study results to be informed to biobank so that same can be incorporated in database to strengthen it and to avoid repeatability. This will essentially not poses any risks for the publication of the results/ study and will ensure the optimum utilization of resources.

6. Academics/ Knowledge sharing and Human Resource training:
a. Knowledge gained about the biobanking will be shared through regular CME, symposium and conferences.
b. Biobank will also serve as consultancy agency for developing and designing other biobanks.
c. Biobank will also develop capacity of human resources in the country by training paramedical and medical staffs
d. Publication of atlases, and images using whole slide imaging system

7. Contact source: for any query regarding the sharing of resource the biobank manager will be the primary contact person.

Annexure-3
Client information sheet
Procedures for shipping samples to the bio-bank

Delivery Contact/Address Information
Name:
Shipping Address: Bio- Bank, Phase-II Building
Institute of Liver and Biliary Sciences
D-1, Vasant Kunj, Delhi-110070
Phone: +911146300000

Schedule:
Shipments of biological materials sent to and shipped from the NLDB Biobank from Monday – Friday only to ensure delivery by Saturday.

Notification:

On the date of shipment, please send an email that includes the electronic manifest listing the contents of your shipment as well as the courier used and the tracking and/or air waybill numbers to

and

Name1
Invalid Input

This information will provide the necessary information so personnel can track your shipment until delivery is confirmed.
Name2
Invalid Input

Electronic Manifest-

An electronic manifest will allow us to efficiently inventory your shipment and upload the data directly into our inventory tracking system. The manifest may be in Excel, comma delimited or text delimited formats. The following fields are required:
ID on vial (Unique ID for each specimen/vial
Invalid Input

Material Type
Invalid Input

Study ID or Source Code for which the sample was collected
Invalid Input

Volume (or Qty of material in vial)
Invalid Input

Volume Unit
Invalid Input

Only required fields are listed above, however, additional information is often recommended and may also be included in the manifest and uploaded to our system. If you would like to track specific data points, please contact us, we would be happy to discuss it with you and determine the best way to assist you.
Box and grid or Row and column location within the box (Only required if samples are not uniquely labeled)
Invalid Input

Remarks
Invalid Input

Labeling of vials:

We recommend that each sample vial be labeled with a bar-code that contains only a unique ID. The unique ID should also be printed (eye-readable) on the label to provide for human visual comparison. Specific types of labels are needed to be able to stand-up to the harsh freezer environment. If you do not currently print and apply barcode labels, we would be happy to assist you in implementing barcodes for your study/site. We are also able to pre-print labels and send them to you. Information regarding guidelines for label choice can be found from NLDB Biobank.

Study Initiation:

The more information we know at study initiation, the better we will be able to serve your needs. Below is a list of some standard pieces of information we will need in order to provide you with accurate price quotes and to get your project started as quickly as possible.

What Services are you interested in? (Please mark all that apply)
Storage and Distribution
Invalid Input

Fresh Specimen Processing
Invalid Input

Aliquoting of frozen material:
Invalid Input

What is the project/study name?
Invalid Input

How many vials/samples will you be sending to us?
Invalid Input

What are the volumes/tube size(s)?
Invalid Input

How are sampleslabeled?
Invalid Input

Are they bar-coded? If not, would you like us to add a barcode upon receipt at the repository? Are there patient identifiers (Protected Health Information) on the vials?
Invalid Input

Is an electronic file/dataset available for our use in comparing inventory received to what you have sent to us?
Invalid Input

At what temperature do you want your samples to be stored? (Ambient, +40C, -200C, -800C -1800C)
Invalid Input

When would you like to initiate shipments toNLDB biobank? How often should we expect shipments and how many samples/boxes of samples and packages should be expected for each? At what temperature will the material be shipped?
Invalid Input

How many sites/organizations will be shipping samples to us for your project?
Invalid Input

Who are the contacts at each site?
Invalid Input

What are the shipping addresses, email addresses and phone numbers for each site?
Invalid Input

What material types are involved and are they infectious? If infectious, what pathogen is present?
Invalid Input

Will you need us to provide supplies for shipment? Would it be beneficial to you for us to decontaminate and return empty shipping containers to you for reuse?
Invalid Input

Will an import/export permit be required?
Invalid Input

Do you have a courier preference?
Invalid Input

Who has permission to add and withdraw samples from your collection?
Invalid Input

Annexure-4

Consent Policy

  1. Obtaining Consent for Specimen Collection

The following principles should guide the NLDB biobank and members in the process ofobtaining consent.

  • Ø The collection and use of human tissue for research should be undertaken with voluntary and informed consent of competent participants. Consent should also be obtained to collect or access personal and clinical information from medical records.
  • Ø Consent should be obtained voluntarily, without manipulation, influence orcoercion. It must also be made clear that a participant can revoke consent at anytime, and that a decision not to participate in the program will in no waycompromise the standards of medical care the patient will receive.
  • Ø Under certain circumstances, an REB may provide a waiver of consent.
  • Ø In the case of minors or incompetent participants, consent should be obtained froman authorized third party (Legally Acceptable Representative).
  • Ø Consent should be obtained in writing.
  • Ø When seeking consent, information for participants, legally acceptablerepresentatives, impartial witnesses or an intermediary should be presented in aclear form that can be easily understood. Lack of proficiency in the operatinglanguage should not disqualify participants. In this case, an intermediary competentin the language should translate the relevant information and the participant shouldacknowledge in his or her language an understanding of the project, the extent ofhis or her participation, the risks involved and freely give consent.
  • Ø Participants should be aware of financial consideration. It should be made clearthat they will not receive any compensation for their participation in the program. Ifany new tests, discoveries or products with potential commercial value result fromresearch on their tissue, they will not share in financial benefits.
  • Ø Issues of privacy and confidentiality should be discussed with the participant. Ifrelevant, the participant should be informed about identifying information attachedto specific tissue and its potential traceability. How this could affect privacy shouldalso be covered. Safeguards to protect the individual’s privacy and confidentialityshould be outlined.
  • Ø The written informed consent form and any other written information to be providedto the participants should have the written approval/favorable opinion of anappropriate REB. Any revisions to the informed consent form or the writteninformation should receive the REB approval/favorable opinion in advance of use.
  • Ø During the consent process participants should also be provided with informationabout:
  1. The purpose of the program
  2. The type and expected amount of the tissue to be taken, if applicable
  3. The manner in which the tissue will be taken, the safety and invasivenessof acquisition, and the duration and conditions of storage.
  4. The potential uses for the tissue as known (objectives of research)
  5. The potential users of the biobank (academic and commercial users)
  6. Potential risks and benefits if any to the participant
  7. As known, who will access tissue, personal clinical and researchinformation, what information will be obtained and how the patient’s privacyand confidentiality will be protected.
  8. How surplus material will be disposed of, should it be no longer needed

------------------------------------------------------------------------------------------------------------------

  1. Consent for Existing Collections

The following principles should guide the NLDBbiobank consent issues relating to existing collections.   

  • Ø There are historical collections held within the NLDB biobank. Consent forthese collections may have been obtained for a single research project, forteaching, or for use as clinical assay controls. Alternatively, the consent may notmeet the current standards for informed consent, or the parameters of consent maynot have been adequately documented, or consent may not have been obtained.
  • Ø Since obtaining consent retrospectively is often impossible or impractical, theultimate use of these collections should be guided by the Ethical committee.Therefore, biobanks must ensure that the status of such collection is reviewed Periodically (e.g. annually) Consideration should be given to their value, theparameters andconditions under which they were collected, and the issues and difficulty involved inobtaining re-consent for such samples.
  • Ø Any new research projects that involve access to such collection should be reviewed by an ethical committee, as is the case for use of all biobank materials. The researchers seeking access to these tissues should be made aware, if historicalcollections are provided, about the potential deviations, if any (or lack of information),from the currently established Standard Operating Procedure.(SOPs). Thisinformation should be disclosed to researchers if the conditions of accrual and storage are documented.

 

Annexure-5

Material and Information Handling

 

  1. Material handling – General Considerations

The aims to provide users of the tissue biobank standardized, high quality biological samples that are readily accessible for their research needs.

  • To meet the needs of the users, the HBMs will be collected, processed and stored inmanner that optimally maintains the architecture of the tissue and the molecular integrity of the DNA, RNA, and proteins in the specimens.

  •  All steps will be performed by staff that are suitably qualified or have adequate training to perform the tasks. 
  • Established standard operating procedures (SOPs) will be in place for all procedures involved in collection, processing, storing and retrieving HBMs and annotated informationat the biobanks.
  • Laboratory equipment and infrastructure will be appropriate to ensure proper collection, storage, processing, quality control and distribution.
  • Computer/Informatics infrastructure will be appropriate to enable each biobank to collect, store and share data in an efficient and secure method.
  • Quality Assurance (QA) procedures such as routine audits and quality control analysiswill be performed to ensure that integrity and quality of the collection is maintained.

 -----------------------------------------------------------------------------------------------------------------

  • Ø Tissue Collection

  • Tissue for the biobank will be obtained only after all patient diagnostic needs have been met and will be accompanied by documented, informed consent or a waiver of consent from the Ethical committee.
  • Tissue samples will be collected from a wide range of patients (with matched normal specimens whenever possible). The collection process will attempt not to exclude a sub-set of the patient population. If possible, specimens will be collected in sufficient quantity and diversity to be of value in a variety of study designs.
  • Broader molecular profiles can be obtained from samples that have been collected using rigorous and standardized procedures. Collection procedures will be geared to allow use of the samples in genomic and proteomic research.
  • To ensure suitability for genomic and proteomic research the time elapsed between surgical resection and freezing ideally should be rapid to ensure preservation. Adequate documentation should capture the time frame for quality assurance purposes.

------------------------------------------------------------------------------------------------------------------

  • Ø Tissue Processing
  • To ensure suitability for genomic and proteomic research, the processing of the Tissue sample or blood will be done in a manner to protect tissue architecture and the integrity of molecular products.
  • HBMs will be handled as being potentially bio hazardous and laboratory staff should take appropriate precautions when handling tumour tissue or whole blood and blood products.
  • Desiccation and degradation of specimens will be avoided. The method of transport of the tissue sample from the operating room to the pathology or processing lab will be documented.
  • All precautions to avoid cross-contamination of specimens during processing, product isolation or aliquoting will be employed. This should include using fresh containers, pipette tips and blades between specimens and between different areas of the same specimen (e.g. between malignant and associated uninvolved tissue).
  • Snap freezing or freezing in a cryoprotectant will be done by suitable means.
  • Specimens in the collection are useless if incorrectly identified. All samples will be accurately labeled.

 Ø Tissue Storage and Retrieval

The storage method of the tissue sample, or derived product, affects the suitabilityof the sample for use in specific genomic or proteomic studies.

  •  Storage procedures will be geared to protecting the integrity of the collection and should allow for efficient and accurate retrieval of samples.
  • Samples will be stored in a manner optimal for their intended category and use. This should be documented.
  •  Frozen samples will be stored in screw-capped, plastic containers or cryovials that can be sealed. Vials should permit appropriate labeling, prevention of contamination or samples desiccation and should withstand freezing in liquid nitrogen.
  •  Mechanical or liquid nitrogen systems are used for storage of frozen samples, adequate back-up capacity will be in place to ensure that operating temperatures are maintained at all times. Events such as equipment failure or power-outage emergency will be planned for and processes will be in place to deal with possible emergencies.
  • For mechanical freezers, manual defrost feature is optimal as freeze-thaw cycles of automatic units can degrade biologic samples.
  • Ideally, alarm systems should be used to monitor temperatures in the storage freezers and procedures should be in place to permit corrective action before the temperatures falls out of range.
  • Proper procedures will be followed for sample retrieval to ensure that proper conditions are maintained to protect the sample, and that documentation is completed to record any change in inventory.
  •  Shipping and transportation procedures will be established to ensure that containers, labels, conditions and methods are optimal for sample protection.
  • Tracking and auditing of HBMs is critical. A high quality inventory will be employed so that every sample can be tracked and audited. All records pertaining to sample retrieval, use, or removal will be maintained to facilitate tracking.
  1. Informatics – Collection and Handling
  • Ø Annotation data (e.g. person, lifestyle, diagnosis, laboratory, clinical and research generated) should be accurate, quality-controlled and standardized as far as possible.
  • Ø Data collected may contain common data elements from the following categoriesincluding, for example:
  1. Personal
  2. Longitudinal clinical and diagnostic information
  3. Treatment and outcome information
  4. Sample information
  5. Lifestyle and family history

 Ø Computerized inventory and bioinformatics systems used to handle and storeannotated data should:

  1. Be responsive to the needs of multiple users
  2. Be available for a long period of time
  3. Use standardized terms to categorize specimens and enter data, acrossmember biobanks.
  4. Use an automated data extract system or permit multiple checks of dataentry to ensure accuracy.
  5. Have the ability to feed back or link standard research results and genomicand proteomic results into the system.
  6. Allow for dissemination of information to others as needed.
  7. Be searchable at varying levels for certified users.
  8. Provide security and access control to ensure privacy rights are protected.
  9. Have an inventory management system.
  10. Support integration and expansion if needed.
  11. Have maintenance features and back-up capabilities.

    Safety considerations

All personnel coming in contact with HBMs or involved in the operations of the NLDB biobank will be trained in safety procedures to minimize injuries to them and protect the material and information held in the biobank. Safety training should be:

  1. Given to staff before they begin their work
  2. Updated as needed
  3. Lead by knowledgeable trainers
  4. Appropriate for the background of each employee and to the risks to whicheach employee is exposed
  •  Ø Relevant personnel will handle all HBMs as being bio hazardous.The use of liquid nitrogen and dry ice poses specific safety hazards. Appropriate gloves, a face shield and a protective garment will always be used when handling these materials. When dry ice is used, controls to ensure sufficient air and oxygen levels should be ensured.
  • Ø Precautions will be taken to minimize risks to injury and damage from biological, chemical, physical, electrical hazards and fire
  • Ø Written guidelines will be developed to ensure safety precautions based on national, regional and local regulations.
  • Ø Personnel coming in contact with patients and patient information will be trained in maintaining privacy and confidentiality.
  • Ø Overall biobank security will be implemented by limiting access of unauthorized personnel to the workplace.

Search Here

Related Links

Welcome to NLDB

You are welcome to contact us for any
query, suggestion or feedback.
Kindly address the communication to
Reception/ Enquiry
+91-11-46300000 Extn. 24813, 24814

Design for NLDB