Informed consent
Do the participants have the intellectual and emotional abilities to give informed consent? Dementia is a syndrome that leads to loss of thinking, reasoning, and remembering skills and a severe disconnection from reality. Thus, how will dementia patients understand all the research-related information and voluntarily provide their willingness to participate in the clinical trial?
Avoidance of harm
I would like to know whether instruments and/or tools used for positive reinforcement in the clinical trial have contributed to harm in previous clinical studies. In behavioral psychology, positive reinforcement entails giving something to a subject when they perform desired actions and associating them with the reward. Going by this argument, I would ask the research two more questions: Which approach and/or tools will you use to reward the study participants for positive reinforcement? Are there constraints on the maximum allowable risks introduced to avoid participants from being harmed in the experimentation?
Privacy
As the researcher is going to use positive reinforcement to conduct the study for patients with dementia in a hospital unit, I would ask him/her these questions: Do the patients have the right to withdraw or refuse to participate in this research without providing any reason and without affecting their routine treatment at the hospital unit? Since the study is to be carried out in an open hospital unit, will you afford participants ample opportunity to protect their privacy?
Review by the academic ethics committee
How will you justify your research to academic ethics committees? How will the participants, hospital, and the healthcare system benefit from this research? My recommendation to the research is; ensure that you meet all ethical considerations related to psychiatric research, such as informed consent, therapeutic misconception, privacy, vulnerability, exploitation, and conflict of interest.
Question 2
Informed Consent
Should individuals exhibiting severe PPD symptoms be included in this study? How will you determine each participants’ ability to give informed consent? Do the study’s procedures align with the ethics declarations regarding consent for publication and participation?
Avoidance of Harm
Ideally, mothers who experience PPD exhibit signs of self-neglect and engage in risk-related behaviors. Thus, I will ask the psychologist the following questions: Which study procedures and measures are you going to use to assess the participants’ PPD symptoms and their ability to participate in this research without experiencing physical and psychological harm? Will you advise mothers identified as having PPD symptoms to turn to treatment? Will you provide specific details concerning where they can access treatment? Does the research puts some and/or all participants at s social disadvantage, psychological stress, or discomfort?
Privacy
How will you handle sensitive and/or confidential information provided by the study participants? Have you tested whether the data collection, storage, analysis, and publication methods and procedures are privacy-proof? Since the participant selection process is to occur in a hospital/healthcare facility, are you going to notify the staff responsible for treating the mothers and their newborns? Under which circumstances and to which person can you disclose confidential information provided?
Review by the academic ethics committee
The key question is: will the study participants and their communities receive fair benefits from the research modalities? Before giving you the green light to proceed with your research, the academic ethics committee must ascertain whether the proposed study procedures and methods minimize the risk of harm, protect confidentiality and anonymity, provides participants with the right to withdraw, and clearly elaborates the process of obtaining informed consent.
Question 3
Informed Consent
I would advise the psychologist to ascertain the participants’ age and whether the local laws and/or the jurisdiction disqualify them from giving valid informed consent. If the subjects are aged below 18 years, the psychologist needs to understand that teenagers have limited emotional and intellectual abilities to give valid informed consent. Thus, she should request the teenagers’ biological or adoptive parents or other persons with legal capacity and responsibility to valid consent on their behalf without any form of coercion. Thus, the psychologist needs to embrace voluntary participation based on valid informed consent.
Avoidance of Harm
The psychologist needs to carry out a risk assessment to consider any risk of harm to teenagers. After identifying potential risks, the research needs to devise risk avoidance and/or control measures based on the ethics committee’s guidelines. Ideally, the psychologist needs to consider the negative social anxiety-behavioral and emotional symptoms common in teenagers, such as excessive fear of being humiliated, embarrassed and judged in social settings before undertaking this research. Thus, she should ensure that the data collection, storage, and analysis procedures will not cause psychological harm and distress to the vulnerable participants. For instance, she needs to consider participants’ past experiences and their coping strategies during the selection process and be sensitive and empathetic to minimize distress.
Privacy
Discuss confidentiality and reporting concerns at the beginning of the process. Explain to the teenagers and their parents/guardians that you will not disclose information with anyone outside the research team and the legal remedies available in case of any breach.
Review by the academic ethics committee
The ethics committee represents the local population’s interests, making it important to explicitly explain that you have no competing interests that could directly or indirectly undermine the study’s objectivity, integrity, and publication value. The ethics committee will identify and weigh up the potential benefits and risks of the research. To do so, the committee will evaluate the process and materials to be used for seeking teenagers’ valid informed consent, assess the recruitment process and incentives given to participants, evaluate risks to participants’ confidentiality and adequacy of privacy controls.