Initial Review of Submitted Protocol

4.1. Purpose

The purpose of this section is to describe how the IRB members will review a research proposal for initial review and approval using the application form for initial review. The form is an adaptation from ICMR to facilitate standardisation, reporting, recommendation and comments offered to each individual protocol.

All biomedical research involving human beings conducted in CIHSR must be first be approved before the research is initiated. The research proposal must be reviewed first by the scientific committee of IRB before being reviewed by EC.

4.2. Scope

The scope of this SOP is to describe the process of review and assessment of all protocols that are submitted for initial review and approval from the institute review committee IRB.

4.3. Types of review

• The member secretary shall screen the proposals for their completeness and depending on the risk (see table 3) involved categorised them as described below.

1. Exemption from review; Proposal with less than minimal risk where there are no linked identifiers.
2. Expedited review; Proposal that pose no more than minimal risk.
3. Full committee review; All research proposal presenting more than minimal risk that are not covered under exempt of expedited review.

• A researcher cannot decide that his/her proposal fall in the exempted, expedited or full review categories.

Table 2, showing the categories of risk is an adaptation of National Ethical Guidelines for Biomedical and Health Research Involving Human Participants by ICMR, 2017 ²

Initial Review of Submitted Protocol

While reviewing the research protocols, the following situations should 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 venepuncture from: –

• Healthy adults and non-pregnant women who weight normal for their age and not more than 500 ml blood is drawn in an 8week period and frequency of collection is not more than 2 times per week.
• 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 8week period and not more than 2 times per week
• 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.

b. Prospective collection of biological specimens for research purposes by non-invasive

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)
•  un-cannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum or by applying a dilute citric solution to the tongue.
• mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
• sputum collected after saline mist nebulization and bronchial lavages.

c. Collection of data through non-invasive procedures routinely employed in clinical practice. Where medical devices are employed, they must be cleared/ approved for marketing, for instance –

• 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\
• Weighing or Testing Sensory Acuity.
•  Magnetic Resonance Imaging.
• Electrocardiography, Echocardiography Electroencephalography, Thermography, detection of naturally occurring radioactivity, Electroretinography, Ultrasound, Diagnostic Infrared Imaging, Doppler Blood Flow and such alike.
• Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

d. Research involving clinical materials (data, documents, records, or specimens) that will be collected solely for non-research (clinical) purposes.

e. Collection of data from voice, video, digital, or image recordings made for research purposes.

f. Research on individual or group characteristics or behaviour not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behaviour or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

4.4 Components of review

The universal ethical principles guiding research involving human subjects are to be considered at all times while reviewing a research proposal.  The following are the considerations as applicable while reviewing a research protocol.

4.4.1 Social values

For any research to be ethically permissible the basic requirement is that it must have anticipated social value.  The Following are the considerations under this section.

• The stakeholders, including sponsors, researchers and the EC must ensure that the planned research has social value.
• The benefit accruing from research should be made accessible to individuals, communities and population whenever relevant.
• Post- research access arrangements or other care must be described in the study protocol for the EC for consideration during the meeting.
• In studies with restricted scope, post study benefit to the participants may not be feasible, but conscious effort must be made by the institute to take steps to continue to support and give better care to the participants.

4.4.2 Scientific design and conduct of the study.

The SC will evaluate all aspects of sciences with particular emphasis on the scientific methods as poor science can expose research participants or communities to risk without any possibility of benefit. The following areas are to be analysed:

• The appropriateness of the study design in relation to the objectives of the study.
• EC will evaluate the process of data collection with regard to the setting of the study.
• Publication of the research and authorship will be in accordance with ICJME¹⁰.
• The EC will evaluate the ethical compliance to the standards

4.4.3 Benefit-risk assessment

The principle of beneficence finds its expression in benefit-risk assessment. The benefits accruing from the planned research either to the participants or to the community or society in general must justify the risks inherent in the research. Risk is the probability that a certain harm will occur, it maybe physical, psychological, economic, social or legal and harm may occur either at an individual level or at the family, community or societal level.

• EC will review plans for risk management by assessing the adequacy of the site, supporting staff, available facilities and emergency procedures.
• EC will evaluate the adequacy for provisions made for monitoring and auditing the conduct of the research.
• EC should give advice regarding minimizing of risk/discomfort whenever applicable.

4.4.4 Selection of study population and recruitment of research participants.

The principle of justice finds its expression in the process of selection of research subjects which is voluntary and non-coercive.

• Appropriate criteria for inclusion and exclusion of research participants with particular consideration for distributive justice.
• EC should ensure that participants can opt anytime without their routine care being affected.
• Recruitment of vulnerable groups should be done only after provision of proper justification.
• No study participants or groups of persons must bear the burden of participation in research without accruing any direct or indirect benefits.
• The EC must review the process by which the researcher(s) plan for the conduct of initial contact and the means by which full information is to be conveyed to potential research participants or their representatives.

4.4.5 Payment for participation

• EC will review the plans for any payment for participation, reimbursement of incurred cost, such as travel or lost wages, incidental expenses and other inconveniences.
• EC will review any insurance and indemnity arrangements.

4.4.6 Protection of research participants’ privacy and confidentiality.

• No single individual or institution can provide complete protection for research participants. Therefore, it becomes important for the researches to evaluate all potential risk involved with the research and convey the same to the participants.
• EC will examine the process set in place for safeguarding participants’ privacy and confidentiality.
• Research records are to be filled separately than routine clinical records and access of such files are to be reviewed.

4.4.7 Community consideration

• EC should ensure that due respect is given to the community, their interest is provided and the research addresses the community’s need.
• Steps to consult with the concerned communities during the course of designing the research.
• Appropriate representation from community during committee review.
• Steps to ensure proposed research does not lead to any stigma or discrimination.
• Review the plans for communicating the study results to individuals or concerned community.

4.4.8 Qualifications of researchers and adequacy assessment of study site

EC will look at the suitability of qualification and experience of the PI to conduct the proposed research along with adequacy of site facilities for participants.

4.4.9 Disclosure or declaration of potential Conflict of interest

Conflict of interest (COI) is a set of conditions where professional judgement concerning a primary interest such as participants’ welfare or the validity of research tends to be unduly influenced by a secondary interest, financial or non-financial, personal, academic or political⁵

• The EC will review any declaration of COI by a researcher and suggest its management.
• Detailed description is provided in the SOP for Policy to monitor or prevent the conflict of interest.

4.4.10 Informed consent process

• The Belmont principle of autonomy or respect for persons is primarily applied by requiring that all human research participants provide voluntary informed consent to participate in research. The principle of autonomy finds its expression in the requirement of consent.
• The three fundamental aspects of informed consent are
  • Voluntariness
  • Comprehension
  • Disclosure
• The process used for obtaining informed consent, including identification of those responsible for obtaining consent and the procedures adopted for vulnerable populations.
• The EC will make a checklist for the required components necessary in the ICD⁹.
• Refer for detailed description of informed consent process in section 4 of national ethical guidelines for biomedical and health research involving human participants by ICMR, 2017².

4.4.10 Informed consent process

• The Belmont principle of autonomy or respect for persons is primarily applied by requiring that all human research participants provide voluntary informed consent to participate in research. The principle of autonomy finds its expression in the requirement of consent.
• The three fundamental aspects of informed consent are
  • Voluntariness
  • Comprehension
  • Disclosure
• The process used for obtaining informed consent, including identification of those responsible for obtaining consent and the procedures adopted for vulnerable populations.
• The EC will make a checklist for the required components necessary in the ICD⁹.
• Refer for detailed description of informed consent process in section 4 of national ethical guidelines for biomedical and health research involving human participants by ICMR, 2017².

4.5 Responsibility.

4.5.1 Responsibility of IRB secretariat:

• Responsible for the receiving, verifying and managing the final hard copies of the research protocol and its related documents.
• Responsible for record keeping, distributing the received protocols and agendas to the IRB members for review and communicating the results/decisions to the individual investigators.
• Assign lead discussant/s for each research proposal.

4.5.2 Responsibility of IRB members

• Verify and acknowledge research protocol received from IRB secretary.
• Check the meeting date to see if he/she is available to attend the meeting.
• Identify the project assigned for review.
• Notify IRB secretary 4 days prior to the convened IRB meeting for any missing documents, if any.

4.6 Detailed instructions

4.6.1 Distribution of the research proposals and related documents.

The chairman, secretariat and the lead discussant/s will get complete project proposal while all other members should be given only the duly filled IRB application form and informed consent forms.

4.6.2 Assigning lead discussants

• A lead discussant is someone in the IRB nominated by the IRB member secretary and he/she is assigned to one research proposal for detailed review. He/she has the responsibility for thoroughly reviewing the assigned proposal, offering their observations, comments and decision/s to the IRB during the meeting.
• The lead discussant should be informed at least 14 days prior to the convened IRB meeting. In case the lead discussant is unable to attend the meeting for various reasons, he/she should inform the IRB secretariat at the earliest so that such research proposals are duly assigned to another member.
• The lead discussant in his/her absence can still send written comments on the research proposals to the IRB members. However final decision on the research protocol will be done on a broad consensus at the end of the discussion among the attending members only.

4.6.3 Informed consent checklist and assessment form for research protocol.

IRB members should use informed consent checklist and assessment form while reviewing research proposal.

The assessment form is designed to standardised the review process. This is to ensure that every elements of the research protocol are reviewed and accordingly documented during the meeting.

The assessment forms are to be submitted to the IRB member secretary at the end of the meeting which will become part of official record.

4.6.5 IRB meeting and reporting comments.

The member secretary or secretariat will collect all comments from each reviewer.

The detailed procedure of IRB meeting and communication of decision is described in detail under section 12 of CIHSR IRB SOP.v