Glossary

Accountability

The obligation of an individual or organization to account for its activities, accept responsibility for them and to disclose the results in a transparent manner.

Adverse Event

Any untoward medical occurrence in a patient or participant involved in a study which does not necessarily have a causal relationship with the intervention. The adverse event can, therefore, be any unfavourable or unintended sign or experience, whether or not related to the product under investigation.

Appellate Authority

It decides on the appeal filed against a decision of the lower authority. Its mandate is to ensure that due process of law is followed.

Assent

To agree or approve after thoughtful consideration an idea or suggestion to participate in research by a young person below the age of 18 years who is old enough to understand the implications of any proposed research but not legally eligible to give consent. The assent has to be corroborated with the informed consent of parent/LAR.

Audit

A systematic and independent examination of research activities and documents to determine whether the review and approval activities were conducted, data recorded and accurately reported as per applicable guidelines and regulatory requirements.

Autonomy

The ability and capacity of a rational individual to make an independently informed the decision to volunteer as a research participant.

AYUSH

Intervention Includes any existing/new intervention with drug, therapeutic or surgical procedure or device in the recognized traditional systems of India as per Ministry of AYUSH, GOI (including Ayurveda, Yoga, Naturopathy, Unani, Siddha, Homoeopathy, SOWARIGPA).

Biomedical and Health Research

Research including studies on basic, applied and operational research designed primarily to increase the scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation including clinical research.

Beneficence

To try to do good or an action which weighs the risks against benefits to prevent, reduce or remove harm for the welfare of the research participant(s) in any type of research.

Caregivers

A caregiver or carer is an unpaid or paid person who helps another individual with illness or impairment with daily activities/ performance.

Case Record/Report Form (CRF)

Case record form or case report form is a printed, optical or electronic document designed to record all the required information in the protocol on each study participant for reporting to the sponsor.

Clinical Research

Research that directly involves a particular person or group of people to study the effect of interventions, or uses materials/data from humans indirectly, such as their behaviour or samples of their tissue for prevention, treatment and diagnosis of a disease condition/health disorder.

Clinical Trial

As per amended Schedule Y (2005) of the Drugs and Cosmetics Rules, 1945, a clinical trial refers to a systematic study of new drugs in human subjects to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and /or adverse effect with the objectives determining the safety and/or efficacy of a new drug. The academic clinical trial as per GSR 313 (e) dated 16 March 2016 is a clinical trial intended for academic purposes in respect of approved drug formulations for any new indication or new route of administration or new dose or new dosage form.

Clinical Trial Registry

An official platform for registering a clinical trial, such as Clinical Trial Registry-India

Clinician

A person with recognized medical qualification and expertise/training.

Cognitive Impairment

When a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life.

Coercion

An overt or implicit threat of harm to a participant which is intentional to force compliance.

Collaborative Research

An umbrella term for methodologies that actively engage researchers, communities and/ or policymakers in the research the process from start to finish.

Compensation

Provision of financial payment to the research participants or their legal heirs when temporary or permanent injury or death occurs due to participation in biomedical and health research.

Confidentiality

Keeping information confidential which an individual has disclosed in a relationship of trust and with the expectation that it shall not be divulged to others without permission.

Confidentiality Agreement

Secrecy or non-disclosure agreements designed to protect trade secrets, information and expertise from being misused by those who has learned about them?

Contract Research Organization (CRO)

An institution or service organization which represents a sponsor in providing research support/services on a contractual basis nationally or internationally.

Custodian

A person who has the responsibility of taking care of or protecting entrusted assets, either biological samples or data.

Debriefing

A process of providing a summary update of a condition or situation to the affected or concerned parties. It is an important ethical consideration in studies involving deception. Such post-experimental follow-up is considered beneficial even if no deception is used or there is an only minimal risk to participants.

Deception

Occurs when investigators provide false or incomplete information to participants to misleading them to achieve the study objectives and for larger public good. Research employing any type of deception should undergo full committee review.

Distributive Justice

Fair distribution of burden, resources and benefits. In research, it means fair selection of participants.

Ethicist

One whose judgement on ethics and ethical codes is based on knowledge/experience through qualification or training.

Exploitation

The action or fact of treating someone unfairly in order to benefit from their participation.

Exploratory Research

Preliminary research conducted to gain insights into a problem that has not yet been clearly defined.

Impartial Witness

A literate person, who is independent of the research and would not be unfairly influenced by people involved with the study, who attends the informed consent process if the participant and/or their LAR cannot read, and understand the informed consent form and any other written information supplied to the participant.

Independent Consultant

An expert who gives advice, comments and suggestions to the EC and has no affiliation with the institute or researchers proposing the research protocols. This individual has no voting power for decision making.

Inducement

A motive or consideration that leads one to action or to additional or more effective actions without considering the harm that may occur.

Informed Consent Document (ICD)

Written signed and dated paper confirming a participant’s willingness to voluntarily participate in a particular research, after having been informed of all aspects of the research that is relevant for the participant’s decision to participate.

Justice

Pertains to fairness in the way people are dealt with, indicating fair selection and distribution of benefits and risks to participants who should be fully apprised of them.

Layperson

A literate person who has not pursued a medical science/health related a career in the last 5 years and is aware of the local language, cultural and moral values of the community. Legal expert A person with a basic degree in law from a recognized university, with experience.

Legally Acceptable Representative (LAR)

A person who will give consent on behalf of a prospective a participant who, for either legal or medical reason, is unable to give consent herself/himself to participate in research or to undergo a diagnostic, therapeutic or preventive procedure as per research protocol, duly approved by the EC.

Legally Authorized Representative (LAR)

A person who, under applicable law or judicial authority, can give consent on behalf of a prospective participant who, for either legal or medical reasons is unable to give consent herself/himself to participate in research or to undergo a diagnostic, therapeutic or the preventive procedure as per research protocol, duly approved by the ethics committee.

Maleficence

The act of committing harm or a harmful act.

Marginalized communities

A group of people actively separated or excluded from the rest of society.

Minimal Risk

Probability of harm or discomfort anticipated in the research is not greater than that ordinarily encountered in routine daily life activities of a healthy individual or general population or during the performance of routine physical or psychological examinations or tests. However, in some cases like surgery, chemotherapy or radiation therapy, great risk would be inherent in the treatment itself, but this may be within the range of minimal risk for the research participant since it would be undertaken as part of current everyday life.

Nontherapeutic Trial

A trial which is unlikely to produce any direct benefit to the participants involved. The aim of a non-therapeutic trial is to obtain knowledge which may contribute towards the future development of new forms of treatment or procedures.

Ostracization

To exclude, by general consent, from society, friendship, conversation, privileges, etc.

Particularly vulnerable tribal group (PVTG)

These are a special class of tribal groups, classified as such by the Government of India, due to their especially low development indices when compared to other local tribes. These were classified under the Dhebar Commission (1960–1961), so as to better facilitate their growth, at par with other scheduled tribes on a national scale, and help them to get included in the mainstream development while using their indigenous knowledge. They have a pre-agricultural system of existence as main hunters with zero or negative population growth, extremely low level of literacy and no written language.

Pilot Studies

A pilot study, project or experiment is a small-scale preliminary a study conducted in order to evaluate the feasibility, time, cost, adverse events and effect size (statistical variability) in an attempt to predict an appropriate sample size and improve upon the study design prior to performance of a full-scale research project.

Pivotal Trial

A clinical trial or study intended to provide evidence for drug marketing approval from the licensing authority; usually, a Phase III study which presents the data that the licensing authority uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind.

Post-marketing Surveillance

The practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market. This is an important part of the science of pharmacovigilance.

Professional Competence

The broad professional knowledge, attitude and skills required in order to work in a specialized area or profession.

Principal Investigator

An individual or the leader of a group of individuals who initiates and takes full responsibility for the conduct of biomedical health research; if there is more than one such individual, they may be called co-principal investigators/ co-investigators.

Psychosocial Harm

Research, particularly psychology studies, can put participants in situations that may make them feel uncomfortable while learning about their reaction to a situation. The result can be psychological the harm that can manifest itself through worry (warranted or unwarranted), feeling upset or depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence.

Quorum

Minimum number and/or kind of EC members required for decision making during a meeting.

Research Related Injury

Harm or loss that occurs to an individual as a result of participation in research, irrespective of the manner in which it has occurred, and includes both expected and unexpected adverse events and serious adverse events related to the intervention, whenever they occur, as well as any medical injury caused due to procedures.

Risk Probability of Harm or Discomfort to Research Participants

Acceptable risk differs depending on the conditions inherent in the conduct of research.

Serious Adverse Event (SAE)

An adverse event is serious when the research outcome for the participant is death, life-threatening injury requiring hospitalization, prolongation of hospitalization, significant disability/incapacity, congenital anomaly, or requirement of intervention to prevent permanent impairment or damage.

Sexual Minorities

A group whose sexual identity, orientation or practices differ from the majority of the surrounding society. It refers to lesbian, gay, bisexual and transgender (LGBT), queer (including the third gender) or intersex individuals.

Social Scientist

A person who is an expert on societal and social behavior with specialization/experience in the area.

Sociobehavioural Research

Refers to the socio-behavioral studies on the response of individuals, groups, organizations or societies to external or internal stimuli.

SOP (Standard Operating Procedure)

Detailed written instructions in a certain format describing all activities and actions to be undertaken by an organization to achieve uniformity in the performance of a specific function.

Sponsor

An individual, institution, private company, government or nongovernmental organization from within or outside the country who initiates the research and is responsible for its management and funding.

Stigmatization

Negative perceptions about an individual because of perceived differences from the population at large. It may occur on the basis of physical appearance, race or sex.

Surrogate

A substitute or deputy for another person in a specific role.

Theologian A person who is an expert in the study of religious faith(s), including the system of spirituality, practice and experience about the nature of the divine.

Test of Understanding

A simple oral or written test designed to identify if the participant has understood the details related to her/his voluntary participation in research before signing the ICD form. (Questions such as “If you decide not to take part in this research study, do you know what your options are?”, “Do you know that you do not have to take part in this research study if you do not wish to?”, “Do you have any questions?”, etc. will clarify the understanding of the participant.)

Transparency It implies intentional openness, communication, and accountability operating in such a way that it is easy for others to see what actions are performed.

Therapeutic Misconception

It is a misconception by participants believing that the purpose of clinical trials/research study is to administer treatment rather than to conduct research.