IRC-LMC:- Glossary
Case Studies
In-depth explorations of a particular project, policy, institution, program or system in a ‘real life’ context.
Children
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under th applicable law of jurisdiction in which the research will be conducted.
Cognitive Impairment
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseased affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interes.
Human Subjects or Human Participants

‘Living individuals about whom an investigator (whether professional or student) conducting research obtains:

 

  1. Data through intervention or interaction with the individual or
  2. Identifiable private information.
Informed Consent
A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
Institutional Review Committee (IRC)
A specially constituted review body established to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
IRC approval
The determination of the IRC that the research has been reviewed and may be conducted in LMC.
Interaction
Includes communication or interpersonal contact between investigator and subject.
Intervention
Includes both physical procedures by which data are gathered and manipulations of the participant or the participant’s environment that are performed for research purposes. Intervention includes communication or interpersonal contact between investigator and participant.
Investigators
The individual(s) designated to have the appropriate level of authority and responsibility to direct the research project and/or activity.
Journalism
Includes activities focused on the collection, verification, and reporting of information or facts on current events, trends, newsworthy issues or stories about people or events, with no intent to develop or test a hypothesis.
Key Personnel
Individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries are requested on the corresponding grant application/contract proposal.
Minimal Risk
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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.
Principal Investigator (Protocol)
The scientist or scholar with primary responsibility for the design and conduct of a research project.
Prisoner
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trail, or sentencing; and (3) detained in other facilities (e.g. for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.
Private information
Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.
Protected Health Information ( Identifiable Private Information)
Name; Address, including city and zip code; Telephone number; Fax number; Email address; Citizenship Number; Passport Number; Date of birth; Medical record number; Health plan ID number; Dates of treatment; Account number; Certificate/license number; Device identifiers and serial number; Vehicle identifiers and serial number; Biometric identifiers, including fingerprints; Full face photo and other comparable image
Quorum
A quorum will be a majority (greater than 50 per cent) of the voting members of the IRC. For reasons other than conflict of interest, abstentions do not alter the quorum, or change the number of votes required.
Research
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.
Specimen
A sample, as of human tissue, blood or urine, used for diagnostic or pathological analyses.
Unanticipated problem

An unanticipated problem involving risk to human participants or others, is one that
(1) was unforeseen at the time of its occurrence, and
(2) indicates that participants or others are at an increased risk of harm.

Itemized budget
An itemized summary of estimated or intended expenditures for a given period along with the estimated income for that period.
Objectives - General

General objectives are broad goals to be achieved.
They are usually less in numbers.
It states exactly how one intends to address the problem.

Eg.
Research topic: “Is the level of knowledge on recommended nutritional practices related to the nutritional status of pregnant women attending ANC in LMC?”

General Objective would be:
“To analyse the association between nutritional knowledge and the nutritional status of pregnant women attending ANC in LMC”.

Objectives - specific

Specific objectives are short and may be multiple.
General objective(s) can be broken into small logically connected specific objectives.
General objective(s) is met through accomplishing all the specific objectives.

Eg.
Research topic: “Is the level of knowledge on recommended nutritional practices related to the nutritional status of pregnant women attending ANC in LMC?”

Specific Objectives would be:

  1. To assess the knowledge level among ANC attendees on the recommended nutritional practices during pregnancy
  2. To assess the nutritional status of pregnant women attending ANC
  3. To analyse the statistical association between nutritional knowledge level and nutritional status in pregnant women attending ANC