The Institutional Research code of ethics falls in line with the ICMR, National ethical guideline for Biomedical and health research involving human participation.
The guidelines are applicable to all projects involved in the college, by staff, students or any other persons who are doing the projects under JSSCPT , involving human participants, their biological material and data
The Purpose of the research should be
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
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.
Electronic media can be used to provide information as in the written informed consent document, which can be administered and documented using electronic informed consent systems.These are electronic processes that use various,and possibly multiple, electronic formats such as text,graphics,audio,video,podcasts or interactive websites to explain information related to a study and to document informed assent/consent from a participant or LAR.
The electronic consent must contain all elements of informed consent in a language understandable bythe participant. In addition to electronic consent, if required a paper/soft copy of the document is needed for archiving and a paper/soft copy is also given to theparticipant. Electronic methods should not be used if participants, for any reason, indicate a lack of comfort with electronicmedia.
There searcher can apply to the EC for a waiver of consent if there search involves less than minimal risk to participants and the waiver will not adversely affect the rights and welfare of the participants.
Re-consent is required in the following situations when:
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.