Procedure

Application Procedures

  • All proposals should be submitted on any working day 2 weeks in advance of scheduled meeting in the prescribed application form.
  • All relevant documents should be enclosed with application form.
  • Required number of copies of the proposal along with the application and documents in prescribed format duly signed by the Principal Investigator (PI) and Co-investigators / Collaborators / Research Scholars shall be guided to the member secretary.
  • Every application will be allotted an IRB registration number to be used for all future correspondence and reference. The date of SRMDC-IRB meeting will be intimated to the Principal Investigator to attend the meeting and to make a brief presentation of the proposal and to clarify the points raised by the members.
  • The decision of the committee on the proposal will be communicated in writing. If revision is to be made, the revised document in required number of copies should be submitted within a stipulated period of time as specified in the communication or before the next meeting.
  • All research proposals/clinical trials funded/sponsored by Pharmaceutical companies, Agencies, Multinationals etc. will be charged an administrative fee/ processing fee as specified by the Research Secretariat / Office of IRB of SRMDC. In general, waiver of administrative fee is possible at the discretion of Chairperson, SRMDC-IRB.

All Research proposals (15 copies along with 1 CD) shall be submitted along with the information and documents as specified.

Review Procedures

  • The meeting of the SRMDC-IRB will be held on periodic intervals. Additional review meetings can also be held with short notice as and when required. Meetings will be planned in accordance with the need of the work load.
  • The proposals should be sent to the SRMDC-IRB at least 2 weeks in advance of schedule meeting.
  • The IRB’s member-secretary or secretariat will screen the proposals for their completeness and depending on the risk involved categorize them into three types, namely, exemption from review, expedited review and full review (explanation is given below).
  • Decisions will be taken by consensus after discussion, and whenever needed voting will be done. Decision of chairperson will be final.
  • Researchers will be invited to offer clarifications if need be. The Principal investigator / Research Scholar will then present the proposal in person in the meeting. When the PI is not available due to unavoidable reasons the Co PI will present the proposal.
  • Independent consultants/experts will be invited to offer their opinion on specific research proposals if needed.
  • The decisions will be minuted and Chairperson’s approval taken in writing.

A. Exemption from review

Proposals which present less than minimal risk fall under this category as may be seen in following situations:
i. Research on educational practices such as instructional strategies or effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Exceptions:

i. When research on use of educational tests, survey or interview procedures, or observation of public behavior can identify the human participant directly or through identifiers, and the disclosure of information outside research could subject the participant to the risk of civil or criminal or financial liability or psychosocial harm.
ii. When interviews involve direct approach or access to private papers.

B. Expedited Review

The proposals presenting no more than minimal risk to research participants may be subjected to expedited review. The Member- Secretary and the Chairperson of the IRB or designated member of the Committee or Subcommittee of the IRB may do expedited review only if the protocols involve

  • Minor deviations from originally approved research during the period of approval (usually of one year duration).
  • Revised proposal previously approved through full review by the IRB or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis.
  • Research activities that involve only procedures listed in one or more of the following categories.

a. Clinical studies of drugs and medical devices only when
i. research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or
ii. Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is reported.

  • Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical) purposes.
  • When in emergency situations like serious outbreaks or disasters a full review of the research is not possible, prior written permission of IRB may be taken before use of the test intervention. Such research can only be approved for pilot study or preliminary work to study the safety and efficacy of the intervention and the same participants should not be included in the clinical trial that may be initiated later based on the findings of the pilot study.

C. Full Review

All research presenting with more than minimal risk, proposals/ protocols which do not qualify for exempted or expedited review and projects that involve vulnerable population and special groups shall be subjected to full review by all the members. While reviewing the proposals, the following situations may be carefully assessed against the existing facilities at the research site for risk/benefit analysis:

a. Collection of blood samples by finger prick, heel prick, ear prick, or venipuncture
i. from healthy adults and non-pregnant women who weigh normal for their age and not more than 500 ml blood is drawn in an 8 week period and frequency of collection is not more than 2 times per week;
ii. from other adults and children, where the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected has been considered and not more than 50 ml or 3 ml per kg, whichever is lesser is drawn in an 8 week period and not more than 2 times per week;
iii. from neonates depending on the hemodynamics, body weight of the baby and other purposes not more than 10% of blood is drawn within 48 – 72 hours. If more than this amount is to be drawn it becomes a risky condition requiring infusion/blood transfusion;
iv. Prospective collection of biological specimens for research purposes by noninvasive means. For instance:

  • Skin appendages like hair and nail clippings in a non-disfiguring manner.
  • Dental procedures – deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction of permanent teeth; supra and sub-gingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth.
  • Excreta and external secretions (including sweat).
  • Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum or by applying a dilute citric solution to the tongue;
  • Placenta removed at delivery.
  • Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor.
  • Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings.
  • Sputum collected after saline mist nebulization and bronchial lavages.
  • b. Collection of data through noninvasive procedures routinely employed in clinical practice.
    Where medical devices are employed, they must be cleared/ approved for marketing, for instance

    i. physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy;
    ii. Weighing or testing sensory acuity;
    iii. Magnetic resonance imaging;
    iv. Electrocardiography, echocardiography; electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow,
    v. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

    c. Research involving clinical materials (data, documents, records, or specimens) that will be collected solely for non-research (clinical) purposes.
    d. Collection of data from voice, video, digital, or image recordings made for research purposes.
    e. Research on individual or group characteristics or behavior not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

    DECISION-MAKING

    • Members will discuss the various issues before arriving at a consensus decision. When consensus is not arrived at, the decision will be made by voting procedure.
    • A member should withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises and this should be indicated to the chairperson prior to the review of the application and recorded in the minutes.
    • Decision will be made only in meetings where quorum is complete.
    • Only member can make the decision. The expert consultants will only offer their opinions.odifications and reasons for modifications and reasons for rejection will be given.
    • In cases of conditional decisions, clear suggestions for revision and the procedure for having the application revised will be specified.
    • Modified proposals will be reviewed by an expedited review through identified members.
    • Procedures for appeal by the researchers will be clearly defined.
    • COMMUNICATING THE DECISION

      • Decision of the meeting on the proposals will be communicated by the Member Secretary in writing to the PI / Research Scholar within 10 working days after the meeting at which the decision was taken in the specified format (Annexure-5). A certificate of approval will be sent to the applicant within 2 weeks (Annexure-6). All the approvals will be valid for one year or for the duration of the project whichever is less. Investigator has to get his or her project reapproved after one year if necessary.

      The communication of the decision will include:

      a. Name and address of IRB.
      b. The date, place and time of decision.
      c. The name and designation of the applicant.
      d. Title of the research proposal reviewed.
      e. The clear identification of protocol no., version no., date, amendment no., date.
      f. Along with protocol, other documents reviewed- Clear description of these documents along with Version No. and Date.
      g. List of IRB members who attended the meeting- clear description of their role, affiliation and gender.
      h. A clear statement of decision reached.
      i. Any advice by the IRB to the applicant including the schedule / plan of ongoing review by the SRMDC-IRB
      j. In case of conditional decision, any requirement by IRB, including suggestions for revision, and the procedure for having the application re-reviewed.
      k. In case of rejection of the proposal, reason(s) for the rejection will be clearly stated.
      l. Signature of the member secretary with date.