Key Research Stages - Before Fieldwork
Screening Questions and Questionnaires4.14
Screening questions MUST only be used pre-screen potential MR subjects for participation in the research, they MUST NOT be used to collect additional data.
Physician Recruitment of Patients4.15
Physicians may act as intermediaries to recruit patients by inviting patients to take part or passing on questionnaires on behalf of the agency, they MUST however:
–Ensure that patients understand that their participation is voluntary
–Not disclose the patient’s identity to the agency until the patient has consented to this.
Reimbursement should not be dependent on the number of patients successfully recruited. Agencies should beware of placing pressure upon patients and try to minimise this e.g. by issuing a written rather than a face to face invitation.
If the patients reply directly to the agency, which is preferable, the doctor should not be told which patients are going to/have participated.
Snowballing – MR subject supply of Potential MR subjects' Names4.18
When asking people to supply other people's names for the purposes of developing a list from which to draw a sample (a technique commonly referred to as 'snowballing' and used to identify opinion leaders) to meet the obligation to be transparent, the person being recruited MUST be told how their name was obtained. This means for example that when trying to recruit an opinion leader the recruiter MUST tell the doctor that they were suggested by another physician but there is no need to name the source of the nomination.
Recruitment – Information that MUST be Communicated4.19
At recruitment MR subjects MUST be told:
- Type of organisation sponsoring the market research e.g. a pharmaceutical company
- Subject and the purpose of the market research
- Approach/methodology to be taken/used
- If there is to be observation and/or recording, what sort and types of observers
- Contact details - Name of the researcher, recruiter or research or fieldwork agency conducting the discussion, telephone number or email address as appropriate
- Location, date, start time and length of the interview (as appropriate to the methodology)
- Of their rights – confidentiality, anonymity, that they can withdraw or withhold information at any time
- What will happen to their data (including personal data) and how it will be used
- Incentive offered – both the nature and the rate of remuneration.
- If the individual healthcare professionals will become known to the commissioning client company the need for disclosure should be explained and consent to pass on their personal data for this purpose requested (see section 4.25 for further detail)
- Healthcare professionals MUST be informed of the need to report adverse events uncovered during the study where this need exists. Templates for a standard text are available in Germany (http://www.akdae.de/Arzneimittelsicherheit/UAW-Meldung/index.html and http://www.akdae.de/Arzneimittelsicherheit/UAW-Meldung/UAW-Berichtsbogen.pdf) and the UK (http://www.bhbia.org.uk/guidelines/abpiadverseeventguidelines.aspx). Furthermore in the UK non-healthcare professionals MUST be informed that if adverse events are discussed during the research, then the details will be collected and forwarded to the commissioning pharmaceutical company.
- In Mexico, the privacy disclaimer (aviso de privacidad) has to be provided (in writing or read) to the MR subject, or a source for it given (i.e. hyperlink). MR subjects must consent to the terms of the privacy disclaimer.
If the potential MR subject/MR subject requests the name of the sponsoring client it is not necessary to provide this information unless the sponsoring client company provided the list from which the potential MR subject/MR subject’s name/contact details have been drawn. The requirements for naming the client when observation and recording are taking place are detailed at 11.4.
In Germany, the FSA Code recommends to members that employer permission (Dienstherrengenehmigung DHG) is sought and granted for healthcare professionals to participate in market research. There is no over-arching legal requirement for a DHG, however if you have to include healthcare professionals and/or federal civil servants e.g. payers (Bundesbeamte) within the market research sample and are committed to adhering to the FSA Codex, you have to check that a DHG is in place. You may do this by including suitable questions within the recruitment screener and ensuring potential MR subjects only participate if they have their employers’ permission. The DKG have also stated that employer permission is required unless participation in market research is a one-off or rare and the incentive does not exceed 100 euros. German market research associations have no such requirements.
- Physicians employed by public entities should have the permission of their employers before they participate in market research if they are paid an incentive. If no incentive is paid (even if expenses e.g. for travel, are reimbursed), employer permission is not required but the employer should be informed. It is the responsibility of the physician to gain their employer’s permission (not the market research agency).
- Market research should take place outside public entities office/clinic hours and not on a public employer’s premises unless the premises are used for private practice too.
Data Collected at Recruitment4.22
Data collected at recruitment MUST NOT be used for any purpose other than the purpose for which consent was granted. Seeking consent for other uses retrospectively is not allowed.
Scheduling of Fieldwork Appointments4.23
Recruitment Agreements and Disclosure4.24
EFPIA members and members of EFPIA-affiliated associations MUST document an agreement between agency or client company and the healthcare professional MR subject in advance of fieldwork (i.e. at recruitment) for all market research carried out face to face. Longitudinal studies and panels MUST also be covered by a written agreement irrespective of methodology. Single stage market research studies conducted online, by telephone or by post that involve only minimal remuneration do not require a written agreement in advance of fieldwork. EFPIA member associations provide guidance on the meaning of minimal. This ruling is based upon Article 14 of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals.
- Subject and purpose of the market research discussion
- Methodology and approach
- Location, duration of fieldwork
- Date and time of fieldwork
- Incentive offered – both the nature and the rate of remuneration.
Disclosure Code requirements apply to EFPIA and EFPIA affiliated association members and all those that have agreed to adhere to EFPIA or national associations’ code of practice. The Disclosure Code applies to prescription only medicines and only to over the counter medicines if they are dispensed on prescription.
Consequently pharmaceutical companies will need to disclose payments made to healthcare professionals (HCPs) for a range of activities including participation in market research (MR) when (and only when) the pharmaceutical company is aware of the identity of the HCP. These payments are referred to in the Disclosure Code as Transfers of Value (ToV).
For the full EFPIA Disclosure Code go to http://transparency.efpia.eu/the-efpia-code-2
- For each individual HCP that gives consent for their personal data to be used in this way:
- Full name and address of principal practice
- Fee for service and consultancy – MR incentive
- MR-related expenses
- Where only aggregate data can be given (where consent has not been given for personal data to be used in this way):
- Aggregate amount attributable to transfers of value to recipients i.e. the incentives and expenses (separate totals) for MR
- Number of recipients in the aggregate disclosure
- % of recipients included in the aggregate disclosure as a proportion of the total number of recipients disclosed (individual and aggregate)
- The purpose for which the individual’s personal data will be used – why it is requested
- The consequences of giving (how their personal data will be used) or not giving consent
- MR subjects’ agreement or refusal must be recorded.
- The agreed market research incentive should not be disclosed- The sponsoring company (and product) should not be named- HCP MR subjects MUST be informed of the processing of their personal data- This applies whether or not the client company is aware of MR subject identity.
In the USA generally speaking the federal Sunshine Act does not include mandatory disclosure of survey incentives made by drugs companies or their agents to doctors. While survey payments were included in initial versions of the law and have been the subject of ongoing debate in Congress, the law generally excludes thank you payments for taking part in surveys provided the company sponsoring the research is unaware of the MR subjects’ identity. However some state laws are different. The CASRO, PMRG and the MRA Association have advised that to their knowledge the Sunshine Act does not require agencies to identify to client companies the names of healthcare professionals who report adverse events. For further information see: http://www.casro.org/news/137727/Physician-Payment-Sunshine-Act-Alert.htm
For further details upon US state Sunshine laws see:
Re-contacting MR Subjects4.29
Informed consent requires that if it is necessary to contact a MR subject again to ask further questions (other than for quality control purposes), consent for re-contact MUST be sought at the time of the recruitment interview or during the interview; even if only simple clarification is needed. When children are researched consent for re-contact should be sought from the responsible adult and the child separately.
MR subjects agreeing to re-contact MUST be fully informed of the purpose of re-contact and who will make it. Re-contact questions should reflect the possible reasons for the re-contact, such as for a second stage of the study, to ask a question missed or further explore a particular issue. The question "May we contact you for future research?” is not sufficient to allow re-contact, this type of standard question is really panel building question as it asks about any other projects occurring at an unspecified future time.
Transferring Personal Data outside the European Economic Area (EEA)4.32
- Using other legal grounds, such as unambiguous and explicit consent from individuals for the transfer of their personal data for processing
- Using Model Contract Clauses (as approved by the European Commission)
- Implementing binding corporate rules (BCR’s) for transfers within a corporate Group.