Guidelines For Researchers As Per ERB Requirements
- ERB is bound to review all research projects involving human subjects, whether as individuals or communities, even including the use of fetal material and embryos before the study begins.
- Some research that involves human subjects may be exempted from the regulations requiring ERB approval. Examples include educational research, testing and survey procedures.
- Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others.
- The human subjects in your project must participate willingly, having been informed about the research. Please provide all information that is likely to affect the person irrespective of age, sex, or literacy level of the subjects. If the human subjects in your project are part of a vulnerable population, such as prisoners, children or mentally handicapped then the researcher should clearly state why is it necessary to have such groups as their research subjects and how do they plan to administer the informed consent.
- The researcher should provide information regarding funding, sponsors, institutional affiliations, potential conflicts of interest and incentives for subjects.
- Specify the cost of management directly related to the study and indicate what portion of the cost would be incurred by the study participants.
- The researcher should also declare any personal and institutional benefits (monitory or otherwise including travel) accrued through study participation.
- The research protocol should indicate that there is compliance with the principles of Helsinki Declaration. In case of conflict kindly specify the particular clause, which is being contravened.
- A Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person.
- The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy and confidentiality of the patient’s information. Minimize the impact of the study on the subject’s physical, mental and social integrity.
- The personality, rights, wishes, beliefs, consent and freedom of the individual subject should be valued.
- Compensation should be given to volunteers and patients for travel and any out of pocket expenses.
Essentials of informed consent:
- Comprehension: Investigator must ensure that the informed consent is clearly comprehended by the subject / guardian
- Purpose of research must be clearly explained.
- Procedure: In simple word describe the procedure that the subjects would be expected to undergo. Identify any procedures that are experimental/ investigational/ non-therapeutic. Indicate type and frequency of monitoring during and after the study.
- Length of time: subject is expected to participate. If subject’s participation is expected to continue over a long period of time, please indicate that any new information that develops during the study and may affect the subjects’ willingness to continue participation will be communicated to them. This would apply even when the intervention/investigation phase of the study has ended but monitoring continues.
- Benefits of the research must be shared with/communicated to subjects, other study participants, society and funding agency (if any).
- Please specify financial burden to be incurred by the research subject while participating in the study.
- Explain all foreseeable risks or discomforts to the subjects. Note this not only includes physical injury, but also possible psychological, social, or economic harm, discomfort, or inconvenience. If risk is unknown, state so.|
- Treatment for adverse experiences Explain what therapeutic measures would be available to the subjects in case of adverse reactions or injury as a result of being a participant in the study. All research related adverse reactions are the financial responsibility of the researchers.
- Confidentiality: Describe the extent to which confidentiality of records identifying the subject will be maintained.
- Person to contact for answers to questions, or in event of research related injury or emergency.
- Statement that “participation is voluntary” and that refusal to participate will not result in any penalty or any loss of benefits that the person is otherwise entitled to receive.
- Subject’s right to withdraw from the study at any time.
- Explain process of sharing of results with subjects.
- No abbreviations will be used.
- The Principal Researcher should submit a typed application for review of the ethics of proposed biomedical research. The procedure is as follows:
- All information and application forms are available at ERC website Ethical Review Committee General Principles.
- ERC meets every second Friday of the month.
- The deadline for submission of the application is 2 weeks prior to the next meeting.
- Researchers shall be informed after acknowledging their applications. If incomplete, This will obviously delay the review process.
- The outcome of review shall be communicated to the researchers within a week after the ERB meeting.
- If ERB requests supplementary information or changes to documents from the applicant, it should be provided at least a week before the next meeting.
- In cases where clarification is sought and researchers fail to respond within 3 months, ERB will send a reminder and allow a further 3 months period for response. Beyond these 6 months, the file will be closed.
- Researcher may be asked to present the case in the meeting if required.
- Application to ERB along with research protocol must be submitted by e-mail at firstname.lastname@example.org and hard copy to HOD office Pharmacology.
- Questionnaire (if applicable) intended for research participants should be included.
- Flyer or document used for recruitment process of subjects.
- Informed consent form (clearly identified and dated) with translation in Urdu/local language.
- Official signed and stamped Permission letter from administrator of the institute.
- All significant previous decisions (those leading to a negative decision or modified protocol) by same or other ERBs. The reasons for previous negative decisions should be provided.
- Approval is given for a specified period. If the project takes longer, a request for an extension of the ethics clearance should be sought.
- Any alteration proposed to the approved protocol should be submitted to the ERB for approval prior to the alterations being effected.
- A copy of the research project final report is lodged with ERB for its information.
- Researchers should notify the ERB if and when a project is curtailed, terminated or completed.
- Approval is given for therapeutic trials subject to the principal investigator notifying the ERB within seven (7) days of any adverse event or occurrence that takes place during that trial.
- ERB can audit the research anytime to ensure compliance with guidelines.
World medical association declaration of Helsinki. Ethical principles for medical research involving human subjects. (1964)
WHO research ethics committee. Basic principles for capacity building. (2009)