Standard Operating Procedures

Objectives

Standard Operating Procedures – Objectives

The Standard Operating Procedures (SOP) aim to define the procedures that the IRB will follow to ensure quality, consistency and transparency in the ethics review and approval of research proposals, and the monitoring of ongoing research at Sangath. These SOPs are based on ICMR’s ethical guidelines for biomedical research.1
1 ICMR guidelines for preparing SOP for IEC’s for human research.

Role of IRB

Role Of IRB

  • The IRB shall review and monitor all types of research proposals conducted in Sangath involving human participants with a view to safeguard the rights, dignity, safety and welfare/ well-being of all actual and potential research participants.
  • The IRB shall take care that the four cardinal principles of research ethics viz autonomy, beneficence, non-maleficence and justice are explicitly considered during the planning, conduct, reporting, monitoring and review of proposed research.
  • The IRB shall consider all aspects of the informed consent process (e.g. risk-benefit ratio, justice, privacy, confidentiality, distribution of burden / benefit and provision for appropriate compensation) with the utmost detail wherever required. Particular attention to this process will be paid where there is involvement of vulnerable groups (pregnant women, infants/children, disabled groups, prisoners, students of institutions, etc) as study participants.
  • All proposals shall be reviewed before the start of the study. After due clearance from the IRB, the study shall be monitored periodically (the timeframe for which shall be decided, and notified promptly, as demanded by individual protocols) throughout its implementation and until after the completion of the study. The minimum requirement is for annual periodic review- with a study report submitted at the end of one year of approval for the ethics committee to look at. The approval after the first submission will be for a period of one year only. The principal investigator will have to table his report for the IRB meeting before the one year period is over so that he has continuous approval for the project. However, if he fails to do so he has to provide a written explanation to the IRB Chair who has the authority to then provide an extension of the approval until he gets the formal approval for the next year of operations. The IRB requires that periodic/ annual update reports and final report(s) be submitted during and after the completion of the project respectively.
  • Site visits for monitoring purposes might be initiated at the discretion of the board. The board shall also aim to ensure compliance with all regulatory requirements, applicable guidelines and laws.
  • The IRB shall be responsible for acting in the full interest of the research participants and concerned communities, while taking into account the interests and needs of the researchers, and having due regard for the requirements of relevant regulatory agencies and applicable laws.

Composition

IRB-Composition

The IRB shall be cross-disciplinary and multi-sectoral in composition.

  • The board shall consist of 7-10 members.
  • A minimum of 5 persons shall be required to constitute a quorum without which the holdings and businesses of the IRB shall stand adjourned until such a number is available to conduct the same.
  • The chairperson of the board shall be from outside the institution (Sangath).
  • Other members shall be a blend of medical / non-medical, scientific and non-scientific persons including at least one lay person representing the community to reflect different viewpoints.
  • The member secretary shall be from Sangath and shall coordinate the secretariat of the board in all its business.
    Guided by the ICMR guidelines, the composition of the IRB shall thus be as follows:
    – Chairperson from outside Sangath
    – Member secretary from Sangath.
    – At least 4 chairpersons from different specialties/disciplines as specified below:
    Health scientists / researchers
    Clinicians / health practitioners
    Legal/ethics expert
    Social scientist / philosopher/ writer / priest
    Lay person (representative of community)
    At least half of the committee members will be non-Sangath (not employed) and at least half of preferably more of the quorum would be constituted by external chairpersons.

Authority under which the IRB is constituted

IRB-Authority

The IRB is constituted under the institutional head (Chairperson of Sangath).

Responsibilities of members and terms of membership

IRM-Responsibility

-All members shall be required to undertake the review of research proposals, participate in meetings and businesses of the IRB and monitor any ongoing research.
-Members shall commit to spending a minimum of two- days in a year which includes (two hours for each quarter) on meetings for ethical review and additional time needed for reviewing proposals and visiting projects. All members, irrespective of whether they are appointed as primary or secondary reviewers for specific proposals, shall be required to read all protocols sent to them and participate in the discussion during the meeting for ethical review to ensure that they conform to the guidelines used by the IRB. The only exception is for any member with a conflict of interest with a particular proposal as noted below.
-All members shall be expected to allocate the required time for meetings as per the agreed annual calendar of the meetings. If, for some unavoidable reasons, a member is not able to attend the meeting, s/he should give prior intimation to the member secretary at the earliest so as to make arrangements for her/his substitution if required. The member shall communicate to the member secretary the review report with respect to the proposals allocated for review in advance before the meeting.
-Members should attend at least one of the four meetings in the year in person. He/ she can attend other meetings from their own location (other than the location of the meeting) through a telephonic conference or online conferencing mode. The member shall promptly make arrangements to send scanned/e mailed/ printed copies of any documentation that shall be required during such a process. However, the quorum requirement will be met by committee members being present in person during the IRB meeting.
-The duration of appointment of members shall be initially for a period of two years. A member cannot be on the IRB for more than two consecutive terms.
-At the end of the stipulated two years, as the case may be, the board shall be reconstituted, and new members shall replace those who wish to discontinue or need to be replaced. New members should regularly be invited to join the IRB so that we have enough members to replace ones that have to step down.
-A member can be replaced in the event of: death; resignation; long-term non-availability; inability to attend/ participate in even one meeting during the year; or if her/his actions are not commensurate with the responsibilities of the IRB membership as judged by a 2/3rd majority of the IRB members.
-All members must maintain absolute confidentiality of all discussions during the meeting and sign a confidentiality form at the time of joining of IRB. The members should not discuss matters related to IRB deliberations with anyone other than other IRB members. All personal copies of documents and emails related to the proposal should be destroyed immediately.
-Conflict of interest(s), if any, should be declared by members of the IRB. As a rule, any member who is directly associated with a research proposal must excuse themselves from discussions and decisions related to that particular protocol. An example of a conflict of interest would be when a member of the IRB is also the principal investigator/research team member of the study of which the proposal is being considered by the IRB.

Quorum requirements

RB-Quorum

-A minimum of five members are required to compose a quorum.
-All decisions should ideally be taken in meetings except in case of expedited review required in special circumstances.

Offices

IRB-Offices

The chairperson shall conduct all meetings of the IRB. In the absence of the chairperson, an alternate chairperson shall be elected by the members present who shall conduct the meeting.
– The member secretary is responsible for organising meetings, maintaining records and communicating with all those concerned. S/he shall maintain a copy of the minutes/proceedings of the meetings prepared after approval by the chairperson, before communicating the same to the researchers. He/she shall issue decision notices to the research team whose project(s) has/have been reviewed after obtaining approval from the chairperson within two weeks of the IRB meeting.
All IRB records will be maintained by the secretary for a period of five years from the date of the end of the project.

Independent consultants

IRB-Consultants

The IRB may call upon such subject experts as independent consultants who may add or provide a valuable special review of selected research protocols, if need be. These experts may be specialists in ethical or legal aspects, specific diseases or methodologies, or represent specific communities; patient groups or special interest groups e.g. cancer patients, HIV/AIDS positive persons or minorities. They are required to give their specialised views but do not take part in the decision making process of the IRB.

Application Procedures

IRB-Application Procedures

All proposals should be submitted in the prescribed application form. Click here for details.
– All relevant documents should be enclosed with the application form.
– The application form in the prescribed format and duly signed by the principal investigator (PI) (and co-investigators/ collaborators, where appropriate) along with all relevant documents should be electronically submitted to the IRB secretary at least two weeks before the date of the IRB meeting. The application should include dates and records of all relevant permissions, including that of the Sangath managing committee (MC). All meeting dates will be announced to Sangath investigators at least three months in advance.
– The date of the meeting shall be intimated to the researcher/PI. On that day, the PI or person designated by PI will have to make an oral presentation to the IRB and take questions for clarifications. Presentations over Skype or oral presentations through conference mode are also acceptable. He/she will then leave the room while the proposal is being discussed by the IRB.
– A prescribed fee of Rs 15,000 shall be remitted along with the application. (First time fee for approval of a new project proposal will be Rs 15,000 and annual review charges will be Rs 2,500). It will be the prerogative of the IRB to revise these figures as deemed fit which would then have to be approved by the Sangath MC.
– The decision of the IRB shall be communicated in writing to the PI/researcher. If any revision is to be made in the proposal, the revised document should be submitted electronically within a stipulated period of time as specified in the communication or before the next meeting.

Documentation

IRB-Documentation

For a thorough and complete review, all research proposals should be submitted with the following documents:
– Name of the applicant with designation.
– Name of the institute/ hospital / field area where the proposed research is to be conducted.
– Detailed protocol of the proposed research.
– Ethical issues in the study and plans to address these issues.
– The proposal should be submitted with all relevant enclosures like proformae, case report forms, questionnaires, follow-up cards, etc.
– Informed consent process, including patient information sheet and informed consent form/ assent in local language(s).
– For any drug/ device trial, all relevant pre-clinical in-vitro and animal data and clinical trial data from other centres within the country/ countries, if available.
– Curriculum vitae of all the investigators with relevant publications in last five years.
– Any regulatory clearances required.
– Sponsor(s) and source(s) of funding; budget of the study.
– Other financial issues including those related to insurance.
– An agreement to report serious adverse events (SAE) to the IRB.
– Statement of conflict(s) of interest, if any.
– Agreement to comply with the relevant national and applicable international guidelines, as applicable.
– A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related injuries); a description of the arrangements for insurance coverage for research participants, if applicable; all significant previous decisions (e.g. those leading to a negative decision or modified protocol) by other ethics boards or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The reasons for negative decisions should be provided.
– Plans for publication of results – positive or negative – while maintaining the privacy and confidentiality of the study participants.
– Any other information relevant to the study.

Review procedures

IRB-Review Procedures

The meeting of the IRB shall be held four times a year and any additional meetings may be held if and when required. Such additional meetings will be convened by the chairperson of Sangath in consultation with the chair of the IRB.
The proposals shall be sent to members at least 10 days in advance of the scheduled IRB meeting.
The secretariat of the IRB can allocate proposals to 1-2 primary reviewers to prepare a detailed evaluation which can then be discussed by all members at the meeting if necessary.
The researcher/ principal investigator should make an oral presentation to the IRB and take questions for clarifications.
Researchers shall be invited to offer clarifications if need be.
Independent consultants/ experts shall be invited to offer their opinions on specific research proposals if and when needed.
Decisions shall be taken by consensus after discussions.
The decisions shall be recorded and signed by members present at the meeting and the chairperson will provide an approval in writing.
All members, including those not present at the meeting, will be informed of the decision via email.

Elements of review

IRB-Elements of review

Scientific design and conduct of the study.
– Approval of appropriate scientific review boards.
– Examination of predictable risks/ harms.
– Examination of potential benefits.
– Procedure for selection of subjects in methodology including inclusion/ exclusion/ withdrawal criteria and other issues like advertisement details. Criteria for withdrawal of patients, suspending or terminating the study
– Management of research related injuries, adverse events and serious adverse events.
– Compensation provisions.
– Patient information sheet and informed consent form in local language.
– Protection of privacy and provision of confidentiality.
– Involvement of the community, when and where necessary.
– Plans for data analysis and reporting, along with safety and quality assurance report(s).
– Competence of investigators, research and supporting staff.
– Facilities and infrastructure of study sites.
In case of clinical trials:
– Justification for placebo in control arm, if any.
– Availability of products after the study, if applicable.
– Adherence to all regulatory requirements and applicable guidelines.

Expedited review

IRB-Expedited Review

In exceptional circumstances an application requires urgent review and IRB approval (e.g. an urgent call for proposal which cannot wait for the next quarterly meeting), an expedited review may also be taken up after consideration of the circumstances by the chairperson and the member secretary.
The principal investigator should approach the chairperson through the member secretary and convince the chair of the need for an expedited review. A sub-committee will then be convened by the chairperson to review the proposal and make a decision. Approval given in such situations will be provisional and subject to ratification at the next full committee meeting.
Expedited reviews are considered acceptable in minimal risk studies where minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (United States Department of Health and Human Services Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects)

Decision-making procedures

IRB-Decision Making Procedures

-Members shall discuss the various issues before arriving at a consensus.
– 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.
-Decisions shall be made only in meetings when quorum is complete.
-Only IRB members can make decision(s). The expert consultants shall only offer their opinions.
-Decision(s) may be to a) approve, b) reject or c) conditionally accept subject to receipt of further information/ modifications. Specific suggestions for modifications and reasons for rejection should be duly communicated to the researcher.
-In cases of conditional decisions, clear suggestions for revision and the procedures for having the application re-reviewed, if deemed necessary, should be specified.
-Modified proposals may be reviewed by an expedited review by the chairperson and he/ she can invite other members to examine the revised application and if the IRB recommendations have been adhered to the applicant will be given the required approval by the chairperson.

Communication

IRB-Communication

Decision(s) taken by the IRB shall be duly communicated by the member secretary in writing to all members and those concerned directly/ indirectly with such decisions.
– Suggestion(s) for modifications in the proposal/ protocol, if any, should be duly communicated to the researcher by the IRB.
– Reason(s) for rejection of the proposal/ protocol should be duly informed to the researcher(s).
– The schedule/ plan of the ongoing review by the IRB should be communicated to the principal investigator.

Appeal procedures

IRB-Appeal Procedures

This procedure is designed to deal with the following two situations:
i) Where the IRB has rejected an application for ethics approval (for reasons other than the application being incomplete) and the researcher applicant wishes to appeal.
ii) Where the IRB has approved an application for ethics approval, subject to some changes being made and the researcher disagrees with the proposed changes. In this case, before making a formal appeal, the researcher should initially confer with the chairperson for clarification of the board’s reasoning. After this consultation, if the researcher is not satisfied then s/he can make a formal appeal as outlined below.
– If the researcher wishes to appeal a decision made as part of the approval process, s/he must notify the IRB chairperson through the member secretary. The appeal should be in writing and must be sent via post or email within 14 days of being notified of that decision.
– The chairperson can appoint a committee independent of the IRB who will then review the application and give recommendations to the IRB.
– The membership of the panel shall be at the discretion of the IRB chairperson.
– Once the panel has reached its decision, the panel chairperson can give the recommendations of the committee to the IRB, based on which the IRB can make an amended decision. This decision cannot be appealed against, using the procedure described above.

Follow-up procedures

IRB-Follow Up Procedures

All ongoing projects that have been given ethical approval have to submit their annual reports to the IRB 12 months after approval was granted. These would then be tabled at the next IRB meeting.
– The final report should be submitted at the completion of the study.
– All severe adverse events (SAEs) and the action interventions undertaken for the same should be intimated to the IRB chairperson and/ or member secretary, ideally immediately, and within 72 hours of occurrence. In the event of non-availability of the chairperson and/or the member secretary, the same shall be notified to other member(s) of the IRB, which shall be notified to the chairperson and/or the member secretary not exceeding one week after the reporting of the SAE by the researcher/research team member. If case of delay in reporting the SAE by the researcher/research team member, prompt and appropriate action against the researcher shall be initiated by the IRB. It can even be decided to suspend/ terminate the project as decided by the IRB. The decision of the IRB shall be final.
– All protocol deviation(s), if any, should be promptly informed with adequate justifications for the same to the IRB chairperson. The chairperson will then decide if fresh approval is indicated. Any major deviations (such as change in design, target sample, inclusion of a new intervention component) will require resubmission for fresh approval.
– Minor amendment(s) to the protocol (such as increasing or decreasing number of people to be interviewed) do not need fresh approval from the IRB – the chair and secretary can give the necessary permission for inclusion of the change to the original protocol. All such information should be recorded and communicated to the IRB through the annual reports.
– Premature termination/ suspension of study should be duly notified with appropriate and adequate justifications along with the summary of the data obtained so far.
– Any change of investigator(s) / site(s)/ sponsor(s) / funding(s) should be duly informed to the IRB within one week failing which appropriate and prompt action against the investigator shall be initiated by the IRB.

Records and archiving

IRB-Records and archiving

The IRB shall be required to maintain the following records for a period of at least five years (or as the quorum deems it necessary). The member secretary shall be responsible for the same.
– Curriculum Vitae (CV) of all members of IRB.
– Copy of all study protocols with enclosed documents, progress reports, reports on serious adverse events, protocol deviations and any further documents/ reports that the IRB may require the researcher to provide.
– Each application will be provided with a unique ID number which will be maintained for all documents related to that particular project/ application. All documents related to a particular project will be saved in hard as well as soft copy in a designated folder on the Sangath server. The folder will be password protected and accessible only to IRB members. (Example of id: VP_2011_01 that is initial alphabet of First and Last Name of principal investigator _year of submission of application_ serial number of application received in that year.). All hard copies will be kept under lock and key.
– Minutes of all meetings duly signed by the chairperson of the IRB. The minutes shall be noted down by the personal secretary and consequently typed. It is the duty of the member secretary to duly maintain the minutes.
– A copy of all existing relevant national and international guidelines/ updates/ amendments on research ethics and laws amendments.
– A copy of correspondence with members, researchers and other regulatory bodies.
– Annual and final report(s) of all the approved projects.
– All publications related to a particular proposal should be submitted to the IRB for record purposes. Ethics approval should be acknowledged in all research manuscripts arising from the approved study.

IRB-Member Update

IRB-Member Update

Any relevant updates/ guidelines in the processes of the IRB shall be brought to the immediate attention of all members. Members shall be encouraged to attend national and international training programs in research ethics for maintaining quality in ethical review by being updated with the latest development in this milieu.

Remuneration

IRB-Remuneration

All members shall be paid remuneration of Rs 500 per proposal as well as the cost of travel for participation in the meetings where relevant.