Table 3

Summary of main findings

Experts	Citations	Patients and representative	Citations
Informed consent and patient understanding
True informed consent can be challenging		Patients and representative can have misunderstandings
Risk and uncertainty are the nature of the research; risks may not be clearly known at the time of research	24 27 30 32–34	Lack the understanding or misunderstanding of risk; or believe in minimal or no risk; believe risks should have been known already	41 42 44 45
Patients or representatives may not fully understand or misunderstand the research/risk; not pay attention or quickly forget the information	25 28 31 35	Lack the understanding or misunderstanding of research design	39–43
Patients may have impairment or do not have the capacity of decision-making	26 27 29 35	Inaccurate/overoptimistic/overestimate of benefit	41
Cultural and language barriers in developing countries may negatively impact comprehension	28
(Elderly) Participants may quickly forget the purpose of the study	35
How much information should be given is not clear cut	37	Knowing information about the research and trial is important for patients and representatives	25 38–40
Improving patient understanding, and patient education are recommended	28 29 36 37
Doctors/research staff are critical
Doctors/research staff have the responsibility to explain risks, including antimicrobial-resistant risk in antibiotic trials	24 27 33 37	Patients and representatives are influenced by:
Doctors/staff’s own preference and understanding may result in biased explanation or wording when communicating with patients	25 43	Doctors' attitudes and opinion, and how doctors frame risks	39 40 42 43 46
Doctors/staff should provide counselling to patients; discussion with patients such as exploration of options	24 27 28 37 43 47	Counselling and discussion with doctors and staff	39 43
Coercive decisions during informed consent may happen	27 28	Trust in/preferences of staff or doctors; believe that staff or doctors have their best interest	39 41 42 44 46
Staff/doctor training and improve communication/language of risk communication are recommended	29 36 43	Friendliness and empathy of staff	39 40 42
Senior/more experienced staff have better consent rate	35
Information leaflets and consent forms
Staff indicated that representatives may want simple explanations and can be put off by the lengthy information sheet	35	Participants may not interpret the information in consent forms as what is intended to be convened	44
Consent forms should provide balanced information about alternatives	25	Framing and format of consent form may influence risk perception when participants have sufficient time to read information; but may not influence consent	45 48 49
		Some patient information leaflets poorly inform people about risk	45
Patients’ considerations in consenting
Factors specific to trial properties and outcomes
Altruism	32 34	Benefit other patients like them and benefit science and research	35 40–42 44 50
Risk–benefit considerations including long-term ones; uncertainty around the treatment	31 32 36	Patient benefits from the treatment, hope	35 39 41 42 44
	31 32 36	Safety/minimal risk, side effects and health risk to patients and/or their unborn child	35 39 40 42 44 49
Logistics/time/convenience/ transport	27 32 36	Logistics/time/convenience/transport	39 46 50
Financial incentives/barriers	32	Reimbursement/incentives; costs related to the treatment	39 40 49
Social interaction with others during trial participation	32	Disruption to social life	39
		Interest	35 49
		Believe to have better medical care via trial participation	41
		Concerned about blinding	42
		Privacy and confidentiality	49
Other key factors/concerns
Trust in medicine	28 36	Trust in regulation, system or authorities	39 40 42 44
Partnership, patients’ knowledge and contribution are acknowledged	32	Trust in research and researchers (eg, researchers will aim for more benefits and less risks for patients)	40 44
Reliable information and source of information	34 36	Family or friends’ recommendations	41
		Having preferences on treatment options	40 46 49 50
		Autonomy	40 49
		Having the right to withdraw	38 40
		Sociodemographic factors (eg, education, age of patients, language spoken at home)	40 46
Consent procedure
Issues related to time
Time constraint in regular doctor consult session and variation in patient background	31	Time pressure; limited processing of information, rely on common sense/heuristics	42–44
Should allow sufficient time for patients to understand information and make decisions	27 28	Some may make decisions with little consideration or straightway	43 44
		Timing of approaching for recruitment is important	39
Health professionals and staff may be concerned about worrying families about treatment risks	43	Emotional distress, anxiety, fear, worry	38–40 42–44 49
Consent procedures especially complex ones take time and increase workload	29 31 33 35 38
IRB complications and issues impose challenges	29 31
Consent mode
Consider advanced consent and early enrolment	29 35 38	No concerns over advanced consent and early enrolment	35 38
Waiver or deferred consent	26 31	Retrospective consent may increase consent rate	67
The usual prior consent can be impractical or difficult, especially in urgent situations	26 27 29 51
The legally authorised representative should be communicated in any trial participation conversations	29 38
Opt-in/opt-out recruitment	31 33
Use eConsent	32
Not all situations can omit consent process	47