Requesting assistance for training
requesting assistance in organizing the training to be in accordance with the readiness of the Office of Human Research Standards
Doing “Case Study” work for promotion I didn't do research. Do I need to apply for EC?
It is likely that the case report must also be submitted for certification from the EC, and the EC will consider an “Exemption” or “Exemption” form and issue a certificate called “Certificate of Exemption” when published. Editors may request a certificate through EC review, if not submitted before the researcher cannot apply for retrospectively. Case report must not exceed 3 cases.
Web site of research ethics work, can I put the whole SOPs on the web?
must be put up on the web site for those involved in addition to the research ethics committee require the researcher research sponsor research volunteers and other institutions Acknowledge the transparent performance of the Ethics Committee
External researchers will be requested to conduct research in our institute/hospital. Research Project/Thesis It has been accredited by the parent institution, can our EC grant exemptions from ethical considerations?
Exemption If means “Exemption” does not meet the criteria or criteria of the “Exemption”, the Institute will authorize an external investigator to conduct research on its patients/staff. Research projects should be considered ethical. A quick review or a full board may be used. This is also written in the SOP, as we must protect the research subjects in our institutions.
External researchers will be requested to conduct research in our institute/hospital. Can I request permission from the management of the institution / the director of the hospital only?
Although the research project/thesis Has been certified by the affiliated institution In order to conduct research in our institute/hospital, there should be a requirement for the researcher to submit a research project/thesis to obtain approval from our ethics committee before requesting permission from the institute's executive/director. hospital Along with attaching a certificate from our EC institute's administrator / hospital director It should not be allowed before EC endorsement unless the institution/hospital has written otherwise in the SOP.
External researchers will be requested to conduct research in our institute/hospital. Must have personnel in the institute/hospital as a co-researcher. Or is it a co-adviser?
It depends on the policy of the institution/hospital and the research method if the patient is used as a research subject. Our physicians/healthcare workers should be co-investigators/co-advisors. to properly protect the volunteers If data were collected with questionnaires that were not too intrusive to the subject's privacy, Institution/Hospital then have personnel to coordinate with the researcher To provide appropriate access to volunteers
Can the researcher ask for the name of the ethics committee who reviewed the researcher's research project?
Ethics Committee must be willing to reveal himself Therefore, the researcher can request to know. but must inform the researcher that The result of the decision It is considered by the whole committee. It is not the result of consideration of the main directors who have been assigned. means to consider that research project
Ethical work in human research Should I collect a submission fee from the researcher?
highly deserved But the institution/hospital Should be defined as different types, may be defined as: 1) Institution/hospital personnel unfunded or receiving research funding from an institute/hospital will be exempt The institution/hospital should support the EC by allocating the EC annual expenditure budget. 2) Set a moderate submission fee rate (eg 2000 baht/project). Received research funding from external funding sources and is also funded in the submission fee section. 3) Set a high rate of submission fee if funded by Pharma for drug/medical device research. However, be wary of taking advantage of exclusions , such as finding a co-investigator. (co-investigator) who is affiliated with the institution/hospital Will this be an exception? set clearly
highly deserved But the institution/hospital Should be defined as different types, may be defined as: 1) Institution/hospital personnel unfunded or receiving research funding from an institute/hospital will be exempt The institution/hospital should support the EC by allocating the EC annual expenditure budget. 2) Set a moderate submission fee rate (eg 2000 baht/project). Received research funding from external funding sources and is also funded in the submission fee section. 3) Set a high rate of submission fee if funded by Pharma for drug/medical device research. However, be wary of taking advantage of exclusions , such as finding a co-investigator. (co-investigator) who is affiliated with the institution/hospital Will this be an exception? set clearly
In such a case, the researcher should submit the research project and the patient/participant information sheet to let them know even if the research project/thesis has its background, objectives, and method of conducting the research. Has it been certified by the affiliated institute or not so that the EC of the institute/hospital can consider certifying first? Institutional Executive/Hospital Director Therefore, it is allowed to collect information from the volunteers. If the researcher does not follow the research project the institution/hospital A complaint can be submitted to the EC of the researcher's parent institution that the investigator did not comply with the accredited research program. (non-compliance)
How does Verbal consent work?
verbal consent Similar to consent form (by action), the researcher can ask the EC for permission by specifying justify. There may be the following situations: 1. Collect data from large population groups. Research is low risk When submitting information documents along with the questionnaire If the recipient is willing to take the research answer the questionnaire sent back to the researcher directly Research recipients are a fragile group. There is a risk that if the confidentiality is disclosed it will seriously damage the subject, such as being a drug addict, drug dealer, being a special professional woman, being a prisoner, suffering from a serious disease, social distaste, etc. The researcher will ask. except for the signature of the research subject or the research recipient does not want to sign because it will be evidence or is it an acceptance of one's own status In these cases, if tracking and welding are required Link the information to the research subjects. Researchers should have volunteers use a pseudonym instead of their real name.
Using data/biological samples Secondary use of data/specimen collected from other research projects Which did not specify the objectives initially when requesting the EC, can it be done or not?
Yes, the researcher must submit a new research project for EC to approve by referring to the old research project. together with an explanatory data sheet or patient/participant information sheet to show that the consent of the research subjects has been requested and the data/biological samples match the actual requirements
The researcher has completed the research. While waiting for research to be published, the EC certificate (COA), usually valid for 1 year, has expired. Does the researcher have to request an ethics certificate?
The research project has been completed. no action with other research subjects Therefore, there is no need to request the COA.
Destruction of data collected in research projects after publication There are principles to consider how, such as video tape, voice record, image, should indicate when to destroy.
information collected In addition to the above There are also questionnaires and identifiers. The researcher has already entered the data in a data record or CRF (Case Report Form). If the tape is removed, it should be read by the research subject. for accuracy The subject may request the removal of certain information. If it is a photograph, it must be concealed from the identifiable person, e.g. a black band around the person's identifier. The researcher must specify in the information sheet. to destroy the picture When was the audio recorded video after it was published? And ask for consent if you want to keep it for future use. Specify the length of time requested to be kept, the place of storage, the concealment of persons, the destruction of the identifiers, as well as specifying that “Future research, the researcher will submit a research protocol for consideration by the EC.”
Signing consent to participate in the research Volunteers sign in signature only, or in succinct writing only. or both the signature and the embossed
Signing consent to participate in the research Volunteers should sign their signatures. and write