Institutional Research Committee Code Of Ethics

The IRC is headed by the Chairperson, principal of the college with a member secretary who will be the senior faculty of the college and members.

All research involving human participants should be conducted in accordance with the basic and general ethical principles as outlined in section 1. The researcher and the team are responsible for protecting the dignity, rights, safety and well-being of the participants enrolled in the study. They should have the appropriate qualifications and competence in research methodology and should be aware of and comply with the scientific, medical, ethical, legal and social requirements of the research proposal. The IRC is responsible for ensuring that the research is conducted in accordance with the mentioned principles.

Benefitstotheindividual,community or society refer to any sort of favourable outcome of the research, whether direct or indirect. The social and scientific value of research shouldjustifytherisk,whichistheprobabilityofcausingdiscomfortorharmanticipated as physical, psychological, social, economic or legal.

There searcher, sponsorand IRC will attempt to maximize benefits and minimize risks to participants so that risks are balanced to lead to potential benefits at individual, societal and/or community levels.

The IRC will assess the inherent benefits and risks, ensure a favourable balance of benefitsandrisks,evaluateplansforminimizingtheriskanddiscomfortanddecideon the merit of the research before approvingit.

The IRC also assess any altered risks in the study at the time of continuing review.

Informed consent protects the individual’s autonomy to freely choose whether or not to participate in the research.The process involves three components–providing relevant information to potential participants, ensuring the information is comprehended bythem and assuring voluntariness of participation. Informed consent should explain medical terminology in simple terms and be in a language that the participant understands

The informed consent document(ICD), which includes patient / participant information sheet(PIS)and informed consent form(ICF) should have the required elements

1. Statement mentioning that it isresearch
2. Purposeandmethodsoftheresearchinsimple language
3. Expected duration of the participation and frequency of contact with estimated number of participants to be enrolled, types of data collection andmethods
4. Benefits to the participant, community or others that might reasonably be expected as an outcome ofresearch
5. Any foreseeable risks, discomfort or inconvenience to the participant resulting from participation in thestudy
6. Extent to which confidentiality of records could be maintained, such as the limits to which the researcher would be able to safeguard confidentiality and the anticipated consequences of breach ofconfidentiality
7. Payment/reimbursement for participation and incidentalexpensesdependingonthetypeof study
8. Free treatment and/or compensation of participants for research-related injury and/ orharm
9. Freedom of the individual to participate and/or withdraw from research at any time without penalty or loss of benefits to which theparticipantwouldotherwisebeentitled
10. Theidentityoftheresearchteamandcontact persons with addresses and phone numbers (forexample,PI/CoPIforqueriesrelatedtothe researchandChairperson/MemberSecretary/ or helpline for appeal against violations of ethicalprinciplesandhumanrightsandshouldbereviewedandapprovedbytheIRC beforeenrolment ofparticipants.

For all bio medical and health research involving human participants,it is the primary responsibility of the researcher to obtain the written,informed consent of the prospective participant or legally acceptable/authorized representative(LAR).In case of an individual who is not capable of giving informed consent,the consent of the LAR should be obtained. If a participant or LAR is illiterate,a literate impartial witness should also be present during the informed consent process

In certain circumstances audio/audio-visual recording of the informed consent process maybe required,for example in certain clinical trials as notified by CDSCO.

Privacy is the right of an individual to control or influence the information that can be collected and stored and by who mand to whom that information may be disclosed or shared. Confidentiality is the obligation of the researcher/research team/organization to the participant to safeguard the entrusted information.It includes the obligation to protect information from unauthorized access,use,disclosure,modification,loss or theft

The researcher should safeguard the confidentiality of research related data of participants and the community

Potential limitations to ensure strict confidentiality must be explained to the participant. Researchers must inform prospective participants that although every effort will be made to protect privacy and ensure confidentiality,it may not be possible to do so under certain circumstances

Efforts must be made to ensure that individuals or communities invited for research are selected in such away that the benefits and burdens of research are equitably distributed

Conflict of interest(COI) is aset 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 orpolitical).COI can be at the level of researchers,IRC members,institutions or sponsors. If COI is inherent in the research,it is important to declare this at the out set and establish appropriate mechanisms to manage it.

Vulnerable groups and individuals may have an increased likelihood of incurring additional harm as they may be relatively(or absolutely)in capable of protecting their own interests.

Characteristics that make individuals vulnerable are legal status – children; clinical conditions–cognitive impairment,unconsciousness;or situational conditions including but not limited to being economically or socially disadvantaged,(for example, certain ethnic or religious groups,individuals/communities which have hierarchical relationships,institutionalized persons,humanitarian emergencies,language barriers and cultural differences)

In general, such participants should be included in research only when the research is directly answering the health needs or requirements of the group. On the other hand, vulnerablepopulationsalsohaveanequalrighttobeincludedinresearchsothatbenefits accruing from the research apply to them as well. This needs careful consideration by researchers as well as the EC

Community can be defined as a social group of people of any size sharing the same geographical location, beliefs, culture, age, gender, profession, lifestyle, disease, etc. The community should be meaningfully engaged before, during and after the research to mitigate culturally sensitive issues and ensure greater responsiveness to their health needs and requirements.

The community can be engaged in many ways and can provide valuable opinions.The degree of community engagement should depend on the type of research that is being conducted

Community advisory board/group (CAB/CAG) can act as an interface between the community(from which participants are to be drawn),there searchers and the concerned IRC.MembersoftheCABshouldbesuchthattheydonotcoercethemembersofthe community to participate in the research and also protect the rights and serve the requirements of the group.

The benefits accruing from research should be made accessible to individuals, communities and populations whenever relevant. Sometimes more than the benefit to the individual participant, the community may be given benefit in an indirect way by improving their living conditions, establishing counselling centers, clinics or schools, and providing education on good health practices.

Efforts should be made to communicate the findings of the research study to the individuals/communities wherever relevant

There search team should make plans wherever applicable for post-research access and sharing of academic or intervention benefits with the participants, including those in the control group.

The institutional review committee will do the internal check of all the research proposals. Members of IRC will correct the proposal, thesis or synopsis according to the checklist. Members have to tag after correction and send the corrections to the researcher’s via mail.. Final approval will be sent by secretary and chairperson later it will be submitted to the EC, JSS Academy of Higher education and Research which is CDSO certified ethical committee.