About Us

Facilities

Chest Research Foundation has the state of the art facilities for research and education in the field of Obstructive Airway Diseases.

These include:

  • Pulmonary Function Laboratory
  • Sputum Induction
  • Biochemistry Laboratory
  • Pharmacy
  • Institutional Review Board
  • Quality Control
  • Archival
  • Statistics

Chest Research Foundation has one of the finest "state-of-the-art" pulmonary function laboratories in the country.

Spirometry

The instrument that measures the flow/volume of the air that we breathe in/out is called a spirometer. It is the one of the simplest tool to diagnose an obstruction in the airways.. Most widely used and most objective device used to diagnose obstructive airway diseases. (Asthma, COPD), grade their severity and monitor response to therapy. At CRF we have various types of spirometers.

  1. Volume Displacement spirometers- eg. Bellows spirometer
  2. Flow sensing spirometers
  3. Pneumotach spirometers
  4. Turbine based spirometers
  5. Ultrasonic spirometers
  6. Anemometers

Body Plethysmography

In a body plethysmograph (body box), the volumes of the lung are calculated by pressure change using Boyle’s law. This instrument measures the total lung capacity including the residual volume which is not limited by air trapping; it is one of the most advanced tools available at this time to assess lung volumes, airway resistance and conductance.

CO Monitor

Carbon monoxide is considered to be a biomarker of oxidative stress. Oxidative stress is high in asthmatics, COPD patients and smokers. This device measures CO in exhaled air hence gives an indirect measure of oxidative stress in lungs.

Impulse Oscillometry

Impulse oscillometry is a very novel technique which can very efficiently measure the resistances of the upper and lower airway and this perhaps is the only tool in pulmonary medicine to do this. It not only measures the airway resistance but also determines the elastic reactance of the lung. In short it can effectively describe the different properties of the lungs and airway which determines airway pathologies. Impulse oscillometry is relatively simple technique which requires only tidal breathing.

DLCO

It measures how well oxygen passes from the air sacs in the lungs into the blood, in order to do so carbon monoxide is used because it has 300 times more affinity for hemoglobin as compared to oxygen. There is a percent of predicted amount of carbon monoxide inhaled that should be absorbed; this amount depends upon age, height and sex of the person. Decrease in DLCO is observed particularly in interstitial lung diseases.

Bronchoprovocation Testing

Airway hyper responsiveness is a characteristic feature of atopic asthma. It may vary over time, often increasing during exacerbation and decreasing during treatment with anti-inflammatory medications. Airway hyper responsiveness can be measured by bronchoprovocation testing. In bronchoprovocation testing synthetic bronchoconstrictors like Methacholine, 5’ AMP, Histamine are nebulised through the Aerosol Provocation System which cause airway constriction. Different concentrations of bronchoconstrictors are used. Amount of constriction is measured by spirometry.

Rhinomanometry

It is difficult to determine the level of nasal resistance by rhinoscopy or by subjective assessment, which can be very misleading. A more objective measurement of nasal resistance can be made by measuring nasal pressure and flow parameters and calculating the nasal resistance indirectly. This is done with the help of a Rhinomanometer.

  1. Rhinomanometry is useful to diagnose allergic and non allergic rhinitis.
  2. To monitor patients with Rhinitis.
  3. Detect the nasal hyper responsiveness after AMP challenge.

Facility available for sputum induction.

  • Separate sputum induction room with exhaust hood to reduce particulate contamination and technician safety.
  • Ultrasonic nebulizer for sputum induction.
  • Cold storage chain to carry the sputum to sputum processing Lab.

Facility available for Sputum Processing:

Separate molecular biology laboratory to process the sputum cells and supernatant

Cell processing

  1. Separate sputum processing unit.
  2. Sputum processing Laminar flow cabinet.
  3. Vortex machines
  4. Cyto-centrifuge
  5. Cytospin slides, funnels and filters.
  6. Incubator centrifuge
  7. Light Microscope

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The pharmacy consists of various rooms according to the required levels of temperature control.

A walk in cold storage facility has separately locked steel cabinets for storage of multiple trial drugs with access to restricted personnel. The temperature of the walk in cold storage is maintained in the range of 17-22 ºC.

The Cooler Barn temperature is maintained in the range of 2-8 ºC.

A deep freezer is also available to store biological samples at -20 to -80 ºC.

Used drugs as well as expired medicines are stored at room temperature in level I, in separate cartons with respective study labels.

All research in human subjects is now guided by the principles enshrined in the Declaration of Helsinki. This is also the basis of good clinical research practices (GCP) adopted by the international conference on harmonization (ICH). The Indian Council of Medical Research (ICMR) has also issued ethical guidelines for research on human subjects.

Chest Research Foundation (CRF), Pune, was established as an institution devoted to clinical research in the field of respiratory diseases. Consequently, it conducts research involving human subjects, either patients or healthy volunteers. It was therefore necessary to form this IRB to ensure that the research carried out at CRF meets both the international and the local ethical standards, and thus complies with the principles of GCP thereby protecting the rights and safety of human subjects.

Scope

Although this IRB is formed primarily to review the proposals for research to be done at CRF, it will offer its services to investigators working in other institutions, and also to independent investigators, who do not have access to an IRB. However, the applications for review received from such investigators should expressly declare that they and the administrators of the institutions in which they are working, if that be the case, accept the authority of this IRB to lay down conditions for approving a research proposal, to oversee its conduct, and to demand its termination if the IRB detects any misconduct, fraud, violation of the approved protocol, or any reason that exposes the study subjects to unacceptable risk. Further, the Principal Investigator will need to be present at the meeting of the Board, in which his/her proposal is to be discussed, to offer clarifications on the project if necessary, unless for justifiable reasons this condition is waived by the Board.

Guiding Principles

  • Schedule Y (Drugs and Cosmetic Act 1940; amendment 20th January 2005). ICMR’s Ethical Guidelines for Biomedical Research on Human Participants (2006). WHO Operating Guidelines for Ethical Review Board that Review Biomedical Research (2000).
  • International Conference on Harmonization - Good Clinical Practices (ICH-GCP) Guidelines (1996).
  • Notification- Ministry of Health and Family Welfare (Department of Health), 30 January 2013.
  • Notification- Ministry of Health and Family Welfare (Department of Health), 08 February 2013.

Membership

A constituent meeting of the IRB, chaired by Dr. Sundeep Salvi, Director of CRF, was held on 16 November 2002, in which the following policies were adopted:

  1. The constituent meeting shall elect the Chairperson and members to form the IRB.
  2. The IRB will be multi-sectorial and multidisciplinary in composition.
  3. The IRB will have 8-12 members.
  4. The constitution of the Board will be as recommended by ICMR Ethical guidelines as follows:

    1. Chairperson
    2. One - two persons from basic medical science area (preferably pharmacologist)
    3. One - two clinicians from various Institutes
    4. One legal expert or retired judge
    5. One social scientist/ representative of non-governmental voluntary agency
    6. One philosopher/ ethicist/ theologian
    7. One lay person from the communityMember Secretary
  5. Each member shall attend or shall have attended an orientation program on GCP, with special reference to the responsibilities and functions of an IRB.
  6. Each member will have to sign a letter of acceptance of IRB membership in response to an invitation letter sent by the chairperson.
  7. The IRB will appoint a chairperson who is not from the institution to maintain the independence of the IRB. The Member- Secretary will be from the institution and will be responsible for administrative matters of the IRB.
  8. Other members will be a mix of medical/non-medical, scientific and non-scientific persons including lay persons and appropriate gender representation.
  9. The members representing medical scientists and clinicians should have Post Graduate degree and adequate experience in their respective fields and aware of their roles and responsibilities as committee members.
  10. Each member shall sign a Confidentiality agreement with CRF that he or she shall treat as confidential all information and documents made available to him or her by the IRB.

For further queries please feel free to contact us at ethics@crfindia.com

Good Clinical Practices (GCP) form the international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides assurance that the rights, safety and well- being of trial subjects are protected and are consistent with the principles that have their origin in the Declaration of Helsinki and that trial data are credible.

Hence to achieve these standards and maintain credibility of the data generated in clinical research it is essential to implement and maintain quality assurance and quality control systems.

The Quality Assurance System focuses on the following aspects.

  • Quality Assurance of clinical studies:

    • This involves monitoring and periodic auditing of clinical studies. Internal monitoring is undertaken for clinical studies initiated at CRF to verify the quality of data generated by the study. Internal Audits are conducted periodically to assess and assure the reliability and integrity of a trial’s quality control systems and measure the performance against quality standards. An internal audit plan is developed to ensure that trial related activities are performed as per the SOPs and standard guidelines.
  • Developing, implementing and upholding standard operating procedures

    • SOP is a formal document that describes in detail written instructions to achieve uniformity of the performance of a specific function.
    • Clinical trials:
      • Pulmonary function Laboratory
      • Bio-Analytical laboratory
      • Pharmacy
      • Serious Adverse Event management system
      • Imparting training In GCP/relevant regulatory guidelines
  • Training :

    • Training is an integral part of developing a quality assurance system. The trial staff is trained in Good Clinical Practices, Clinical trial operations and SOPs to be implemented. We also conduct training programs in GCP for Investigators and clinical research professionals to share and disseminate our experiences and knowledge gained by conducting clinical trial over past few years. Appropriate planning before the trial, adequate oversight and monitoring during the trial, and verification to ensure accurate reporting of results at the conclusion of the trial, create a framework for assuring quality in clinical studies.

All essential documents related to clinical trial must be archived so that the data is accessible after the trial is completed. The study documents may need to be accessed in future due to regulatory reasons such as audits, further clarifications to data submitted for regulatory approvals, for additional data requirements from regulatory bodies to assess drug safety.

The International Conference on Harmonization of Good Clinical Practice (ICH GCP) guidelines has specified the list of essential documents which is mandatory to be archived at the investigator site (ICH-GCP 4.9.4).The time period for archival should be as specified by the local regulatory requirement or as per sponsor requirement. (ICH-GCP 4.9.5)

Features of our Archival Facility:

  • Controlled environment: The facility is strictly dedicated for archival of study documents. It is ensured that the archiving facility is secure, environmentally controlled, i.e. fire protection without water sprinkler systems, water protection for humid conditions.
  • Record Keeping: Archived material is stored in legible conditions, with fax thermal paper copied to standard paper.
  • Confidentiality: The access to archival facility is strictly restricted to designated individuals responsible for the archival or to regulatory authorities. Data is stored in compact units in a way to ensure that confidentiality of participants remains protected. All storage arrangements (cupboards, racks) would be labeled appropriately and a log maintained for the same.
  • Chest Research Foundation has a functional in house department of statistics.
  • We have analyzed major in house studies using the most updated and appropriate statistical tools.
  • We also undertake statistical analysis projects from other institutes.
  • The department of statistics has extended their support to PhD and MD student for their thesis as well.