A key aspect of the design and execution of any research study involving human participants is research ethics.
Question 4
A key aspect of the design and execution of any research study involving human participants is research ethics. As you know, research studies involving the collection of data from human participants require review and approval by an independent ethics panel before they can begin. For the purposes of this question, you should consider yourself a member of a human research ethics review committee at the S290 Clinical Research Institute.
An excerpt of a protocol from a research study considered and approved by your human research ethics review committee is provided below. Review this protocol and answer the questions that follow.
An investigation of the impact of a new medication to promote tissue regrowth in Achilles tendon injuries
Recruitment and participant details
The participants for this study are:
all volunteers with clinician-diagnosed Achilles tendon injuries who responded to adverts placed in hospital emergency departments, doctors’ surgeries and pharmacies
required to give informed consent prior to study enrolment
advised that they can withdraw from the study at any time
permitted to request that any data collected from them can be withdrawn from the study up to the point at which the data collected from all the participants are combined together and analysed (after this point the data are fully anonymised so it becomes impossible to isolate the data collected from a specific individual).
Treatment details
All enrolled participants are:
provided with capsules of the same shape/colour/texture (so they do not know whether they are taking the new medication or an inactive placebo)
required to take two capsules each day with a glass of water at 8 a.m. and 8 p.m. for the 90-day treatment phase of the study.
Data collection schedule details
All enrolled participants are:
invited to the investigator’s laboratory to complete the data collection process on the 15th, 30th, 45th, 60th, 75th and 90th days of the study
invited back to the investigator’s laboratory on the 120th day of the study (i.e. after 30 days without any medication) for a post-treatment follow up.
Data collection process details
The data collection process requires each participant to undergo a gait analysis, including the recording of high-definition videos of them walking unaided along a runway of a fixed distance, under the supervision of a specially trained clinician (Dr G).
During this process, participants will also be asked to report their levels of pain using a pain scale where 0 = no pain and 10 = extreme, unbearable pain. Other physiological markers associated with pain, including heart rate, blood pressure and respiration rate, will be recorded, as will videos of the faces of the participants, as facial expression changes are also pain indicators. The participants are aware of these measurements being taken and facial recordings being made.
With regard to clinical aspects, if, on two consecutive visits to the laboratory, a participant rates their level of pain while walking as 6 or more, they are to be immediately excluded from the study on clinical grounds and will be admitted to their local hospital for further clinical investigation.
As this study involves a new medication, participants are asked to report any side effects they experience at any time during the study by telephoning the research team on a number that is staffed 24 hours a day, seven days a week.
Other participant-research team interactions
During their visits to the S290 Clinical Research Institute, participants are also accompanied by the clinician who enrolled them on the study (Dr P). Dr P led the development of the new medication so has the best knowledge about how it might affect the participants and so may recognise very subtle signs and descriptions of symptoms from the participants that Dr G may not consider potentially serious. Recognition of such effects is an important safeguard in ensuring participant safety. While Dr G is blind to the group assignments of the participants and so is unaware of whether a particular participant is taking the new medication or the inactive placebo, Dr P is aware of them.
At the S290 Clinical Research Institute it is routine for the researchers working on an approved study involving human participants to deliver a presentation to members of the human research ethics review committee to update the committee on progress. You attend the presentation by Drs G and P describing their studies of the new medication. The presentation is delivered just after the 75th day of the study and both members of the research team remain in the conference room throughout the presentation so they can answer any questions the committee raises that might require their specialist knowledge.
As part of the presentation Dr G plays some clips of the gait analysis videos recorded from randomly selected participants, obtained during the 30th, 45th and 60th days of the study. The videos indicate which laboratory visit they were recorded on but the videos and Dr G’s presentation do not provide any information as to whether the participants are receiving the placebo or the new medication. You notice that the gait analysis videos are cropped to only show the participants from the neck down.
After the videos have been played and Dr G has finished speaking, they hand over to Dr P. Dr P comments that there have been no side effects reported by any of the participants so far and that no one has been excluded from the study.
Dr P goes on to say that the data collected so far suggests that the new medication may decrease pain levels from Achilles tendon injuries. Dr P then plays some example videos showing the facial expressions of participants while completing their gait analysis walks. These videos also capture the participants saying what their pain level is.
You happen to notice that a video showing the same participant recorded on the 30th, 45th and 60th day of the study is included in the presentation and that on the 30th day they reported a pain level of 8, on the 45th day they reported a pain level of 7 and on the 60th day they reported a pain level of 6. Dr P comments that this is a good example of the pain relief caused by the new medication and that the data from this participant provides definitive evidence that it accelerates the healing of injured tendons. Dr P also notes that they have already shared this exciting finding with colleagues involved in the development of the medication but who are not part of the gait analysis research team. Dr P goes on to provide information from the clinical record of this participant, including their name, age and general levels of health and fitness, and specifies that they injured their Achilles tendon while at work as the manager of a nearby athletics club that many staff from the S290 Clinical Research Institute regularly use. Dr P says this information provides the audience with important context about the participant and their injury.
After the presentation, members of the committee such as yourself are asked to answer the following questions:
a.Give two examples of good practice that are apparent from the presentation given by the research team.
b.Give three examples of bad practice that are apparent from the presentation given by the research team.
c.Has there been a violation of the clinical aspects of the protocol for this study and, if so, what is the violation?
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