Can I receive approval after start of study?
No. You must secure approval for your project before you begin any part of your research which involves human participants, an example including collecting blood sample, taking photographs or conducting interviews.
All health-related research, including surveys and interventional studies, must be reviewed and approved by an Ethics Committee (EC) prior to commencement.
What does an EC do?
The main role of an EC is to safeguard dignity, rights, safety and well-being of research participants and to ensure proper evaluation of all ethical aspects of research proposals.
It has authority to ask for research protocol modifications. EC can enforce and monitor conduct of research projects with respect to informed written consent as well as right of all research participants. Furthermore, EC can suspend or stop any health-related research that violates ethical issues.
It is said that well begun is half done. Ethical review scrutinizes research proposal so that any study can be carried out with smoothness. The elements of ethical review by EC include following aspects.
- Review of research proposals and supporting documents giving special attention to
- Informed consent process
- Documentation
- procedures
- Suitability and feasibility of study
- Consideration of scientific evidence
- Requirements of applicable laws and regulations.
- Appropriateness of study design in relation to objectives of study
- Methodology of study
- Specification of expected duration of research
- Prior approval needs to be given before implementation amendments
- Justification of predictable risks and anticipated benefits to research participants
- Potential risk to participants < anticipated benefits.
- Additional safeguards for research on vulnerable population
- Informed consent in an appropriate language understandable by participant.
- Criteria for withdrawal at any time by research participants: Participant should be allowed to withdraw from research at any time without explanation.
- Provisions for suspending or terminating research
- Monitoring and supervision of research
- Dissemination of research results through publication and other media are to be well defined.
- EC should receive periodic and final reports from researchers
Research Participants Recruitment
Before any potential research participant is recruited, a detailed description of the research has to be provided and explained to their full satisfaction in their own language and informed written consent form has to be signed.
Characteristics of study populations including gender, age, and economic status need to be considered. Further, especial precautions have to be taken for potential vulnerable populations. Full information is to be conveyed to potential research participants or their representatives.
Not all individuals can conduct scientific study. It can be done considering investigator(s)’ qualifications and experience. There should be explanations regarding any medical care to be provided during and after course of research; adequacy of medical supervision and psycho-social support for research participants; steps to be taken if research participants voluntarily withdraw from research; description of any financial costs to research participants; and compensation/reward for research participants (including money, services and/or gifts).
Moreover, detailed information needs to be noted for compensation/treatment in the case of the injury/disability/death of a research participant attributable to participation in research. Outline of any plans to make study product available to research participants following completion of research has to be well mentioned. And, any plans to withdraw or withhold information or standard therapies for purpose of research, and justification for such action need to be described in detail.
Adequate provisions are to be made for protection of privacy of participants; maintenance of confidentiality of data; monitoring during data collection to ensure safety of participants and compensation in case of injury.
Vulnerable population:
Pregnant women, children, elderly, disabled people, prisoners, mentally disabled, disaster affected populations, those with chronic conditions or anyone with diminished autonomy are considered to be vulnerable population.
Supervision and Monitoring
EC has the authority to supervise and monitor researches which have been given approval. Monitoring progress of research to observe whether it has followed specific approved research proposal.
During the supervision and monitoring process, the EC will review problems (if any) in implementation of research proposal and provide guidance to the study team to solve the problems. It can provide feedback to study team on problems like lacunae identified in ethical and scientific aspects; Methodology; and/or data analysis. Further, EC can advise on corrective steps to be taken.
Frequency as well as type of monitoring and supervision needs to be determined by EC.
Principal investigator needs to immediately report anything which might warrant additional ethical approval. For example,
- Serious/unexpected adverse effects on research participants/communities
- Proposed changes in the protocol
- Unforeseen events that might affect continual ethical acceptability of project
Suspension or Discontinuation
The EC has the authority to suspend or discontinue any research when EC notices research not being or cannot be conducted in accordance with approved protocol and when welfare as well as rights of research participants are violated or cannot be protected. EC may take following steps:
- Withdraw approval
- Inform principal investigator of such withdrawal
- Recommend suspension/discontinuation of research project or, any necessary steps to be undertaken
- Make sure that research activities are suspended, stopped or discontinued via process of withdrawal of ethical approval
Before any potential research participant is recruited, a detailed description of the research has to be provided and explained to their full satisfaction in their own language and informed written consent form has to be signed. The consent form should very explicitly explain nature and purpose of study. It should inform what the study is going to do with the participants. Even basic details have to be informed like the participants will have 5 times of vein puncture daily or daily 5 times of urine sample will be done.
There should be provisions made for receiving and responding to queries and complaints from research participants or their representatives. Assurances need to be made that research participants will receive information that becomes available during course of research relevant to their participation.
Studies involving participants below 7 years old require to submit a consent form from a parent or guardian. Assent form as well as parent/guardian consent is required for participants aged 7 to 18 years. A consent form only is required for participants above 18.
Deviations from standard research practice and ethical norms can be considered as research misconduct. It can be in different stages of conducting a study like proposing, performing, reviewing or reporting results.
Research misconduct is detrimental to scientific fraternity. It eventually leads to wasting of resources; damaging scientific record; poor patient care and setting a poor example for trainees.
It can range from less severe misconduct like excessive self-citations and inappropriate data storage to serious misconduct such as data fabrication and plagiarism.
Some of the facets of scientific misconduct are along the following lines
- Fabrication
- Falsification
- Plagiarism
- Violation of standard research practices
- Impropriety of authorship
- Incompliance to legislative requirements
Falsification
Falsification is alteration or manipulation of research data, protocols or results in an attempt to give a false impression.
Fabrication
Fabrication is making up or construction of data or observations that never existed. Alteration or manipulation of a value to show desirable change is also fabrication.
Plagiarism
It is a common form of research misconduct. Plagiarism is supposed to have occurred when an author takes credit of someone else’s work like idea, data, results, text as his/her own work without acknowledging or taking permission from the original person or source. It can be either in part or wholesome. Different software is available to check for plagiarism.
Violation of standard research practices
Any study needs to have adequate provisions to protect privacy of participants and maintain confidentiality of data. Monitoring during data collection to ensure safety of participants as well as compensation in case of injury are important component of research practice. Prior approval needs to be taken from ethics committee before implementation amendments.
Impropriety of authorship
Authorship is an important component of a scientific study. Granting honorary authorship or denying authorship to deserving individuals is regarded as impropriety of authorship. Following aspects are also considered as impropriety of authorship.
- Claiming undeserved authorship on your own behalf
- Excluding material contributors from co-authorship
- Including non-contributors as authors
- Submitting multi-author papers to journals without the consensus of all named authors
Incompliance to legislative requirements
Medical research has legislative boundary. Legal provisions are to be considered for any studies. Anticipated benefits to research participants must be always more than potential risk. At times, there can be some vulnerable populations for whom additional safeguards measures need to be adopted. Informed consent in an appropriate language understandable by participant is an integral part of clinical research. Further, participant should be allowed to withdraw from research at any time without explanation.
Be truthful in what you say and do in research.
A manuscript can be retracted or removed from journal if a serious degree of publication misconduct or gross error in reporting results is identified after its publication.
Prime cause of retraction is research misconduct because it leads to communication of wrong conclusions that ultimately affects patient care and outcome.
