BHBIA

When the BHBIA’s Legal & Ethical Guidelines refer to the ‘client’ they refer to “Any individual, organisation, department or division (including one belonging to the same organisation as the researcher) which requests, commissions or subscribes to all or part of a MR project.” The client is generally but not always a pharmaceutical company.  When a ‘middle man’ e.g. a business consultancy acts on behalf of a pharma’ company the ultimate client is the pharmaceutical company.

The BHBIA Guidelines cover primary healthcare market research. Primary healthcare market research includes ad hoc and syndicated work upon pharmaceutical products, biologics, medical devices and diagnostics – available with or without prescription.

Reporting of adverse events may or may not be required for OTC products depending upon whether the product is a medicinal product or not. Article 1 of Directive 2001/83/EC as amended defines a 'medicinal product' as:

“Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”

The project described above has two purposes – one of which (involving the use of anonymised aggregated data) is a market research purpose and the other is a non-research purpose (using the named data for a marketing purpose). Independent and explicit consents for participation in a) the research purpose and b) the non-research purpose must be sought i.e. two separate consents are required from participants.

The BHBIA Guidelines state that:

4.6 Researchers must ensure that MR information will not be used for any non-research purpose. BHBIA members must be honest and not mislead respondents when they are being asked to participate in a non-research project.

4.7 If market research is to be carried out alongside a non-research purpose explicit consent for this must be obtained at recruitment.

4.8 There must be no danger that respondents or the public generally could be confused or misled, when being approached for non-research purposes, that they are being asked to take part in a MR project.

Respondents data cannot be used for a purpose(s) other than that/those which they originally gave consent for. Informed consent requires that respondents are told what will happen to their data and how it will be used, at recruitment, and undertakings made to respondents must be honoured. So no, market research data in the form of anonymised patient interviews cannot be used for training purposes if explicit permission for this was not sought and given.

There is no specific guideline that addresses this point directly however the over-arching principle is that of transparency. Principle IIIX underpinning the BHBIA’s Legal & Ethical Guidelines requires researchers to “conduct MR accurately, transparently, objectively and of appropriate quality”. The requirement to be transparent clearly suggests that the use of sub-contractors should be acknowledged as and when they are brought into a study even if their use was not anticipated at the planning stage.

The BHBIA does not provide either precise figures or ranges for appropriate incentives but does provide general guidelines. These are available within the Ethical & Legal Guidelines.

Prize draws are a reasonable form of incentive provided that they are conducted appropriately –see section Reimbursement of the BHBIA’s Legal and Ethical Guidelines, within which states that:

“With regard to free prize draws, respondents must not be required to do anything other than agree to participate in a market research exercise or return a questionnaire to be eligible for entry to a free prize draw. ‘Free’ includes any method of communication (post, telephone or other) at a “normal rate”. The MRS has also issued a series of regulations for administering free prize draws.”

The Market Research Society provides comprehensive guidelines for the use of prize draws as an incentive to participate in market research surveys. These guidelines are available online: www.mrs.org.uk/standards/downloads

The BHBIA would recommend that the agency abides by these.

It is permitted under the BHBIA’s Legal and Ethical Guidelines to obtain and hold bank details for the purpose of paying an incentive by bank transfer. However there are guidelines that should be borne in mind and stored when processing sensitive personal data, these are as follows:

1. Personal data must be processed in accordance with the Data Protection Act. The ‘processing’ of personal data includes the collection, recording, organisation, storage, alteration, retrieval, use, disclosure, dissemination, alignment or combination, blocking, erasure or destruction, of personal data.
   
   
2. Those companies (client companies, recruiters or agencies) that supply personal details to be used as a basis for sampling for a MR study must have notified the Information Commissioner’s Office (ICO) in accordance with the Data Protection Act. Notification is a statutory requirement and every organization that processes personal information must notify the ICO, unless they are exempt. Failure to notify is a criminal offence. Notification is the process by which a Data Controller gives the ICO details about their processing of personal information.
   
   
3. Researchers must keep copies of e-mails and other documents received from respondents agreeing to, or restricting, the use of or access to their personal information. This is a legal requirement in all European Union member states.

There are no market research guidelines that prohibit online recruiting via an advertisement on a social media site however the content and tone should be designed such that it cannot be misconstrued as disguised promotion.  We would also recommend that the online service provider’s (i.e. Facebook’s) terms and conditions are reviewed to ensure that this approach does not breach them.  A respondent’s email address or other personal identifiers (e.g. screen or user name or device identifier) is personal data where it refers to an individual and therefore needs to be protected in the same way as other identifiers.  An IP address might constitute personal data in combination with other identifiable data but there is no international consensus about the status of IP addresses (which can generally identify a unique computer, but may or may not identify a unique user).  If national law/regulations classifies IP addresses as personal data and it is not possible to differentiate between those IP addresses which are linked to an individual and those that are not, all the information collected should be treated as if it were personal data.  In Germany an IP address is considered by law to be personally identifiable information. 

When asking people to supply other people's names for the purposes of developing a list from which to draw a sample, the person being recruited must be told how their name was obtained to meet the obligation to be transparent (this technique is commonly referred to as 'snowballing' and used to identify opinion leaders).  This means that for instance 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.  This advice rests on the assumption that the physician’s status as an opinion leader does not constitute a piece of identifiable personal data and so would not contravene the Data Protection Act.  

Section 8 of the Legal & Ethical framework relates to Clause 20. An agency had been interpreting this as an instruction not to telephone interview unless they had received written confirmation from the respondent BEFORE the interview took place. However, the BHBIA guidance is as follows:

In the case of telephone interviews when recruitment and interview are conducted within the same telephone call, the BHBIA requires verbal acceptance of the terms of the recruitment agreement before the interview starts, this must then be followed up after the interview with written confirmation (by email, post or fax) of acceptance of the recruitment agreement. So written confirmation is not required to undertake a telephone interview when recruitment and interview take place within the same telephone call, verbal confirmation (given before the interview starts) that will be confirmed in writing after the interview, is required.

Prior permission is not required to flag a listed individual as ‘do not contact for MR’ as long as this flagging is not used for any other purpose. You cannot guarantee that the client will not abuse this information (e.g. contacting the respondents to ask why they would not take part) but as long as you are clear about the terms under which you can supply this information (i.e. it cannot be used for any other purpose) you have fulfilled your responsibility. You may wish to ask the client to acknowledge their understanding and agreement to this in writing for additional security and peace of mind.

Customer details held upon a company system may be passed to a third party agent. However the client must ensure that the data and use to which it will be put are adequately registered with the Data Protection authority and the sub-contractor is bound by appropriate confidentiality agreements.

Assuming that the potential respondent’s personal details are held with the appropriate original consent it is not necessary to seek their consent to pass these details on to a sub-contractor. Respondents must have originally agreed to their personal data being held on file – this is required by the Data Protection Act.

Personal data can be added to a database only if the respondent is told of this intention at the time of data collection. Respondents must also be told why and for what purposes the data will be used, and that under no circumstances will it be released or used for any unauthorised purpose.

When a database containing personal data is purchased or created by a client company, or a market research agency, they become the ‘data controller’. When recruiters or interviewers incorporate names of respondents issued to them for one project into a list or database for recruiting on future projects, they will become data controllers. Data controllers are obliged under the Data Protection Act to comply with the notification procedures and register as data controllers with the Office of the Information Commissioner. A notification register exists and can be checked by clients (www.informationcommissioner.gov.uk).

Data Controllers must also enter into a written agreement with any subcontractor who is to process data on the controller's behalf, confirming the subcontractor's agreement to process personal data in accordance with the controller's instructions and to implement technical and organisational measures equivalent to those required of the controller. Sub-contractors must be bound by the same confidentiality requirements as the main researcher. This must be clearly specified in any contract with the sub-contractor in order to establish an unbreakable ‘chain of confidentiality’.

There is no national regulatory requirement for ethics approval for healthcare professionals to recruit patients into market research studies but it is possible that local bodies may put such a requirement in place. In the absence of this requirement it is acceptable for healthcare professionals to recruit patients into market research studies.

Market research does not require Clinical Research Ethics Committee or Independent Review Board approval.  The purpose of ethics committees is to put in place arrangements for research that relates to health and social care and so do not extend to research relating to markets or consumer behaviour.  Occasionally there is confusion between market research (MR) and non-interventional studies (NIS).  NIS involve the collection of scientifically valuable information to answer clinical questions for medicines.  NIS are carried out for clinical purposes and MR for commercial purposes.  EFPIA draw a clear distinction between participation in MR and NIS, requiring NIS to meet specific criteria not required of MR.  Patient information may be obtained for MR from patient records without patient consent only if the data are fully anonymised or if the patient has given explicit written consent.  Patient MR does not require ethics approval.

Revelation of the sponsor’s company name is only required if a respondent asks and the respondent's name was supplied by the sponsor, and even then this information can be revealed at an appropriate point in the interview (e.g. at the end of the interview so as not to bias the responses).

(Guidelines section 7.2: When lists of named individuals are used for sample selection the source of the list must be revealed to potential respondent(s) at an appropriate point in the interview, if requested).

However there are some differences to the above guidance if observation takes place (even if the sponsor has not provided the list):

Live via a one-way mirror or sitting in:

• Respondents must be told and must give their prior consent to observation and the fact that the observer is the client must be disclosed.

Live viewing of non-anonymised fieldwork via video-relay/streaming with and without recording:

• Client names must be revealed prior to live viewing of non-anonymised fieldwork via video-streaming with or without recording 

Delayed via video-relay (including video-streaming and taping):

• The client company name must be given prior to transfer of data to the client company but if respondents agree, the company name can be withheld until the end

(See Guidelines section 10.74 for more details).

Inappropriate data fields - The BHBIA Legal and Ethical Guidelines do not include any guidance upon specific types of information it is inappropriate, unethical or illegal to collect. At present, there are no known specific data types that cannot be collected. However it is essential that researchers take reasonable steps to ensure that:

• The data collected is not excessive and is ‘fit for purpose’ i.e. is designed to meet reasonable market research objectives
• Personal data collected is relevant and not excessive

Patient consent & GP ability to use patient data for MR - It is not necessary to inform the patient or seek consent from the patient if only anonymous details are used from their records.

The situation described is permissible in the UK; client personnel may be involved directly with respondents in the capacity you describe as long as the following conditions are met:

• Their role is transparent and non-promotional
• Their company identity is made clear, not hidden or disguised in any way
• They are not familiar with/known to the respondents
• They must respect the confidentiality of all information exchanged in the market research discussion

A written agreement detailing the terms above should be provided and signed.

The BHBIA Guidelines state that criminal record checks should be conducted for those who will have contact with children. This is a recommendation not a requirement. There is no general recommendation that all market research professionals should be have criminal record checks.

It is acceptable to profile a competitor product, the same guidelines would apply to the competitor product’s profile as they would to the sponsor’s own product profile – these are detailed within the section on Stimulus Material in the Guidelines, in addition it essential that a competitor is not misrepresented in any way.

The use of brand names as stimulus is not prohibited but it does have to be handled with care in order to avoid being misinterpreted as disguised promotion.

The BHBIA’s Guidelines state that:

9.4 In order to ensure that MR is not mistaken for promotion:

9.4.1 Avoid unnecessary or repeated use of brand names, use ‘Product X’ unless:

• Reaction to the name or its’ visual representation is an objective.
• Use of a name is essential to the interpretation of the stimulus and this is in turn essential to the study objectives.
• A specific product needs to be referenced e.g. in brand tracking, if possible include other brand names as comparators to blind the subject’s identity and so reduce the risk.

So it should be clear within the research objectives that showing the brand names is essential to meeting the information needs of the study – so that their use is justifiable. The BHBIA would also strongly advise that a series of competitor brand names are included to obscure the focus of the study.

Detail aid pre and post testing is both legitimate and reasonable, and there are no guidelines which directly or indirectly suggest that it cannot or should not be done online. There are a range of guidelines within the BHBIA’s Legal & Ethical Guidelines that stipulate the way in which it should be done to ensure that it is carried out ethically.

Whether a study is vulnerable to the accusation of disguised promotion depends upon a variety of factors, it is therefore essential to ensure that:

• Objectives reflect genuine and reasonable information needs
• Sample size is not excessive and is justifiable in the light of the information needs
• Questions and questionnaire design is not leading
• Stimulus material is fit for purpose and approved internally
• Inappropriate expectations are not raised
• Respondents know when they are providing feedback on drafts, hypothetical scenarios, assumptions, unlicensed products
• Unnecessary or repeated use of product names is avoided – again, it must be justified in the light of reasonable information objectives

If these ‘conditions’ (alone or together) are not met, it could suggest promotion disguised as market research.

No, researchers are not required to probe for missing information and can only report AEs based on information volunteered that meets the minimum reporting requirements.

If an interview is conducted in a foreign language, the local interviewer/moderator should be AE trained and so should report the AE as soon as they are aware, it should not wait till the English translation is available.  Where translation is needed before analysis (e.g. from self-completion open questions in an online survey completed in local languages in several countries but analysed in English in the UK), it is not expected that translators would be AE trained or aware; in this instance awareness would begin with the analyst. 

Adverse event reporting (AER) is required for potential events that have already occurred (i.e. prior to the market research fieldwork).  AER is not required for hypothetical events that are highlighted in market research i.e. events that could occur in the future outside of the market research setting.

The new ABPI/BHBIA Guidance notes on the collection of adverse events and product complaints from market research programmes (April 2013) lists unapproved/off-label usage as a ‘special reporting situation’ associated with the use of a company product, that should be reported, whether or not there is an associated AE.

The ABPI’s Guidelines for Collecting Adverse Events and Product Quality Complaints from Market Research Programmes clearly state that reporting is out of scope i.e. not required, if the marketing authorisation holder is not the commissioning company (i.e. the company sponsoring the market research).

In addition, the BHBIA would advise against collecting and forwarding adverse events associated with the products of other companies. Given this is not required by the ABPI, the MHRA or the EMA, this could make the commissioning company vulnerable to an accusation of using inappropriate means to collect competitive intelligence and consequently their agencies of unethical non-research activity.

Reporting of adverse events is a legal requirement irrespective of the source. The ABPI has just published ‘Guidance Notes on the Management of Adverse events and Product Complaints from Pharmaceutical Company Sponsored Websites’. These are available on the ABPI’s website.

The Guidelines state that “If a company chooses to “listen” at non-company sponsored sites, it is recommended that the listened to pages should be monitored for AEs/PCs for the period of the listening activity only.”

The BHBIA would also advise that the sponsoring company’s pharmaco-vigilance department is consulted and that company policy is clear and taken into account.

For syndicated studies e.g. patient diary studies, there is no legal responsibility for the supplier to forward AEs as the supplier is not the legal agent at the time of data collection. The legal responsibility to collect AEs lies with the pharma company that purchases the syndicated data. However, as on this occasion, the supplier may be requested to prepare patient record data in the appropriate format for the pharma company client. This is not a regulatory requirement though.

As long as the confidentiality and anonymity of respondents is not in any way compromised by the dissemination of the market research findings outside of the commissioning company and guidelines with regard to reporting and publication of data are adhered to, there is no ‘market research’ issue with release of the findings. This has been confirmed with the UK Market Research society. See also the BHBIA Guidelines ‘Reporting’ and ‘Publication’ sections for reference.

Upon consulting the PMCPA (ABPI), their advice was that the information must be considered “appropriate” information to disseminate and that safeguards should be put in to place to try to ensure that the information is appropriately disseminated and used. These safeguards would include the disclaimer referred to in your original enquiry and careful adherence by all parties to the BHBIA guidelines.

Research records must be destroyed when the purpose of the study is redundant. The researcher/agency should store research records for an appropriate length of time - there are no absolute guidelines on how long this should be. This period will vary according to the nature of the data, the type of project and the need for future research or follow up analysis. Personal or identifiable data (e.g. recruitment questionnaires) may well be destroyed before non-personal data (such as tabulations). The period of storage should be agreed with the client in advance.