DropDown Activity

Given each of the following scenarios, decide which type of application / report you should make to the ethics committee.

You have already received ethics approval for a molecular study using human breast tissue samples sourced from the pathology department. While you are carrying out your experiments, you discovered very interesting findings which gave you a brand new research idea. You want to change track and test your new research question on the tissue samples that you currently hold.
Answer: Cloze (1):
As part of your research study, subjects are required to run on a treadmill. One subject reported feeling chest tightness while she was on the treadmill. You stopped her exercise immediately as per the ‘stopping rule’ that was stated in the research protocol.
Answer: Cloze (2):
During a follow-up visit, you discovered that a subject has been taking two tablets of his trial drug every morning. He is supposed to take one tablet in the morning and one in the evening. He says that he does not remember being told to do so. He feels well and there are no abnormalities when you examine him. His blood test results are yet to come back.
Answer: Cloze (3):
You are the Principle Investigator of a qualitative study. You received a complaint that your research assistant (RA) has been rude and pushy when conducting interviews with elderly patients on the wards. On one occasion, your RA was reported to have pressed on with his questioning even though the patient had said repeatedly that she was tired and wanted to stop. You question your RA. He admits that he had done so because the patient was about to be discharged home.
Answer: Cloze (4):
As part of your research study, children who are about to undergo a surgical procedure are shown an educational video to help them understand how it feels like to be put to sleep for an operation. The study aims to find out whether this will reduce children’s anxiety levels during induction of anaesthesia. Unfortunately, one of your subjects died during his operation. The primary cause was deemed as uncontrolled blood loss.
Answer: Cloze (5):
You are conducting an online survey. You have already collected responses from a few subjects when you realised that one of the questions in your survey is confusing. You want to change that question and clarify it a bit more.
Answer: Cloze (6):

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A protocol amendment may suffice if you are just adding one or two extra outcome measures to an existing study. However, changing research directions will result in substantial differences to the way a study is currently conducted, thus deserve the full scrutiny of a new ethics application. ^(1,26)
No reporting is required because what you did was in accordance with the research protocol that has been approved by the ethics committee.
Errors in the administration of drugs are considered as non-compliance to the research protocol, regardless of who is at fault.
Subjects have the right to withdraw from a study at any point they want and be respected for their choice. Conducting a research procedure against the wishes of a subject is clearly inappropriate and violates ethical standards.
Because the death of your subject is related to your research in terms of its timing of occurrence, it is regarded as an adverse event, regardless of the causality. This should be reported and investigated further to ensure that your research study has not contributed to the child’s death (for example, interfered with his anaesthetic administration).
You should request for a protocol amendment if you want to make any changes to your research procedures after you have received the initial ethics approval. Such changes should not take place until approval has been granted, unless it is deemed urgently necessary to protect subjects from harm, or it is a minor administrative change.

The Canadian Institutes of Health Research (CIHR) and Queen’s University at Kingston. Module 8: REB review. In: TCPS 2: CORE (Course on Research Ethics) [Internet]. Government of Canada; Available from: https://tcps2core.ca/welcome

Secretariat for National Committee for Clinical Research, Ministry of Health Malaysia. Malaysian Guideline on the use of Human Biological Samples for Research [Internet]. Ministry of Health Malaysia; 2015. Available from: http://www.crc.gov.my/wp-content/uploads/2016/07/Guideline_on_Human_Tissue_in_Clinical_Research.pdf