These questions are based on queries that members have sent to our ethics advisor and a summary of the responses.
Please note that this resource is simply a selection of actual queries. It does not provide comprehensive coverage of all guidelines issues - your first port of call should always be to check the main Legal and Ethical Guidelines document.
The FAQs below are grouped into the following areas:
- ABPI Disclosure Requirements
- Record Storage
- Research Findings
- Scope of the Guidelines
- Stimulus Materials
If you cannot find the answer to your question in the BHBIA Legal and Ethical Guidelines or below, you can submit a new query to our Ethics Advisor. Please use the guidelines and legislation Online Enquiries Form. (This service is only available to full BHBIA members only and you will need to log in).
Responses given are not legal advice and if a legal opinion is required this should be sought separately. The information given in the response is for information purposes only. Whilst every reasonable effort is made to ensure the information is accurate, no responsibility for its accuracy or for any consequences of relying on it is assumed by the authors.
ABPI Disclosure Requirements
The use of sponsoring company client lists supplied to a market research company for the purposes of recruitment would be unlikely to constitute a requirement to disclose unless the sponsoring company was intentionally made aware of the identity of the individual respondents sampled from the list that participated in the MR activity and a Transfer of Value (ToV) (honoraria/incentives, expenses, etc.) was made to the participants. So in most market research scenarios, where a sample is drawn from a list of HCPs and the HCPs’ identity is not known to the pharma company, then disclosure is not necessarily required. But if the goal is to interview all HCPs on the list (i.e. complete a census), then their identity will be known and disclosure will be required.
If no transfer of value (ToV) (honoraria/incentives, expenses, etc.) has been made to the HCP directly or indirectly then there is no requirement to disclose the name of the HCP/HCO.
Yes. A disclosure of transfer of value (ToV) would be required if the identity of the HCP or HCO participating in the activity is intentionally known or disclosed to the sponsoring company for the purpose of the activity and a ToV (honoraria/incentives, expenses, etc.) has been made in respect of services provided by a clearly identifiable recipient (HCP or HCO). This applies whether or not the MR payment was made directly to the HCP/HCO themselves or to a third party – e.g. a charity.
Remember, disclosure is not required if the respondent is not a HCP e.g. if they are a patient or carer.
KOL Mapping and other associated ‘network science’ activities may require disclosure under the ABPI code depending upon the methodology. Where the identity of the respondent is known to the pharma’ company and a transfer of value (ToV) (honoraria/incentives, expenses, etc.) has been made then disclosure is required. Some pharma’ companies now perform network science type activities directly with HCP / HCO, in these cases the identity of the respondents will be known and if a ToV has been made then disclosure will be required. It is expected that the Member Company will secure the consent to disclosure through the company/HCP contract.
The ABPI Code of Practice‘s disclosure requirements apply to ABPI member companies and non-members that have agreed to adhere to the ABPI Code of Practice.
The pharmaceutical company is directly responsible for ensuring that they have made adequate provision for the disclosure of transfers of value (ToV) made to HCP / HCO either directly or indirectly in countries covered by the EFPIA Code. However it is important for agencies to understand the laws, regulations and codes of practice that apply in the markets that they conduct MR activities in. It is recommended that companies and agencies discuss and agree disclosure requirements and reporting processes likely to impact their MR study. The BHBIA suggests that disclosure data is provided on completion of every MR project for which it is relevant.
MR does not require the approval of the Research Ethics Committee (REC) because it falls outside the remit of the Research Governance Framework (RGF). Governance arrangements for research ethics committees: A harmonised edition published by the Department of Health in May 2011 says that: 2.3.14 Healthcare market research may be undertaken by professional market researchers on behalf of pharmaceutical or medical device companies. Where such research is conducted by professional market researchers in accordance with the Legal and Ethical Guidelines issued by the British Healthcare Business Intelligence Association (BHBIA), it does not require REC review except where otherwise required by law, e.g. if it requires approval under the Mental Capacity Act. The BHBIA guidelines require that informed consent is obtained from patients for provision of any personal data or to undertake additional procedures such as questionnaires or interviews. 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.
Please see the BHBIA Guidelines section E (4.2) and E (6.3) for the latest guidance under GDPR/UK Data Protection Act 2018:
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:
a. The data collected is not excessive and is ‘fit for purpose’ i.e. is designed to meet reasonable market research objectives
b. Personal data collected is relevant and not excessive
c. The patient's explicit consent is secured if personal data is collected. (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 say 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.
As long as it is made clear to individuals participating in longitudinal market research (e.g. in a tracker project) in advance of wave one that over time their input could or will be linked and they understand and give permission for this, then this is fine.
Principles 1 and 7 of the BHBIA’s Legal and Ethical Guidelines (reproduced below) require that researchers are transparent with regard to their use of data (not just personal data). The BHBIA Guidelines define ‘transparency’ as follows - ensuring individuals have a very clear and unambiguous understanding of why the data is being collected and how it will be used. Providing information and seeking permission after the event does not qualify as informed consent, individuals must be informed ‘up front’ of how their data will be used.
i. You must obtain informed consent from MR respondents, willingly given, to collect and use their data. Before you do this, you must make sure they clearly understand the specified and lawful purposes for which you’re collecting the data and how it will be used. In cases where you are collecting and using special category personal data, you must obtain explicit consent. Special category personal data was formerly referred to as sensitive personal data and includes information about a person’s health.
vii. You must ensure that data is processed fairly, lawfully and transparently. And that you only use it for the specific, explicit and legitimate purposes that you originally obtained it. You must ensure that personal data is accurate and kept up to date. You must ensure that personal data is processed in accordance with the rights of individuals under the Data Protection Act 2018.
Bona fide market research does not contravene the Bribery Act 2010. “The Act is concerned with bribery. Very generally, this is defined as giving someone a financial or other advantage to encourage that person to perform their functions or activities improperly or to reward that person for having already done so. So this could cover seeking to influence a decision-maker by giving some kind of extra benefit to that decision maker rather than by what can legitimately be offered as part of a tender process.” See more information Market research studies that meet the BHBIA’s definition of market research and are run in accordance with the BHBIA’s Legal & Ethical Guidelines (including those on incentives) do not encourage respondents to “perform their functions or activities improperly or to reward that person for having already done so”. The Guidelines (Section E: 4.9) say: You must never offer a reimbursement that: – could influence opinion or behaviour (e.g. excessive payments that look like an attempt to buy good opinion or reward buying behaviour)
The BHBIA does not provide either precise figures or ranges for appropriate incentives. The Guidelines (Section E: 4.9) say that incentives should be kept: - to a minimum amount - proportionate to the amount of the respondent’s time involved - appropriate to the type of respondent and the nature of the task There’s currently no MR industry guideline or central source for standard rates of reimbursement. However, you should not reimburse more than the fair market value for professional consultancy or advice. Please see the BHBIA Guidelines (Section E4.9) for additional detail, including new guidance on paying incentives and reimbursing respondents’ costs.
Prize draws are a reasonable form of incentive provided that they are conducted appropriately. The Guidelines (Section E: 4.8) say: You must not ask respondents to do anything other than agree to take part in a MR exercise or return a questionnaire, to be eligible to enter a free prize draw. ‘Free’ includes any method of communication (post, telephone or other) at a ‘normal rate’. For further information see the MRS regulations for administering free prize draws. The BHBIA 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, the Guidelines (Section E:4.8) say: You must keep the personal details of reimbursed respondents confidential: – If you’re in an agency, you must not pass these personal details to the client without explicit permission. This permission must not be a condition of being reimbursed. You must ensure that respondents’ personal data is not accessible to anyone outside the agency, research team or company personnel involved in processing the reimbursement. – If you’re in an in-house MR department, you must ensure these personal details are inaccessible to anyone outside the research team or company personnel involved in processing the reimbursement. For more details of the requirements when storing and processing personal data see Section H: 4 of the Guidelines (Personal data and data protection), Section I (Data Protection legislation) and Section E: 4.4 (Handling data).
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.
Email contact for bona fide market research is not prohibited in the UK. Market research e-mails aren’t defined as commercial communications within the 2003 Privacy and Electronic Communications Regulations. However if individuals have joined opt-out lists this must be respected.
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.
Section E (4.4) of the Guidelines says: When you’re developing a list (and then a sample) by asking people to supply other people’s names, you must tell the person being recruited how you obtained their name. This fits with our principle of being transparent. This technique, or ‘snowballing’, is often used to identify opinion leaders. When trying to recruit an opinion leader, you must tell the e.g. the doctor that another one suggested them, but there is no need to provide the name.
Section E (4.2) of the Guidelines relates to Clause 23. BHBIA guidance is as follows: Telephone recruitment – respondents can agree verbally but must then follow up by email, post or fax. They must actively accept the terms proposed 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.
When personal data is not obtained directly from the individual, the individual must be informed of the source of their personal data. Consequently this means identifying the end client company if they provided the names even if the names are supplied via a third party. So the end client must be named as the source even when the names were supplied by a third party directly – as the end client initiated the supply. The list supplier should also be named as well to be as transparent as possible.
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 Section E 7.2 ‘Reporting’ and 7.3 ‘Publishing’ 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.
Scope of the Guidelines
In terms of our guidelines, the client is the commissioning party and the agency is a sub-contractor executing the study on their behalf. 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 healthcare market research including 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 (Section E: 4.1) say that: If you’re doing market research alongside a non-research activity, you must get the respondents’ agreement for the non-research activity when you recruit them. You should separate and clearly distinguish market research from any other activity. When approaching anyone for non-research purposes, you mustn’t confuse or mislead them, or make them believe you’re asking them 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 12 underpinning the BHBIA’s Legal & Ethical Guidelines says “We must conduct our MR accurately, transparently and objectively”. 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.
Health research is a very broad
‘school’ and includes biomedical research including clinical trials and
non-interventional studies, epidemiological studies, health services research,
public health research, studies of behavioural, social, and economic factors
that affect health, evaluation of health care interventions and services and
drug safety surveillance. The BHBIA’s definition of market research makes
it clear that market research (MR) attempts to generate understanding and
knowledge of a market place and its consumers’ behaviour through the collection,
use, or analysis of information, this is very similar to the definitions used
by the MRS, ESOMAR and EphMRA.
Confusion between market
research and health research can arise because they sometimes address the same
audience, may use a similar tool – a questionnaire or discussion guide, and can
ask similar questions. In particular, non-interventional studies (or
post-marketing authorisation studies as they may also be called) are confused
with market research. However, key distinctions between MR and HR
|| ||Healthcare market research||Health research|
||Purpose||Commercial focus/purpose (market behaviour and opportunities) – designed to inform business decision making||Clinical or medical focus/purpose (safety, efficacy, pharmacokinetics, quality of life) – designed to advance science, the treatment of disease and improve patient outcomes|
||Endpoints||Clinical endpoints not required. No requirement to generate scientifically sound evidence||Clinical endpoints required. |
Goal is to generate scientifically sound evidence
||Protocol||Written protocol not essential||Written protocol essential|
||Method||Epidemiological methods not required||Epidemiological methods must be used to design the study and analyse the data|
||Incentives||Participants are generally financially incentivised||Participants are not incentivised|
||Management||Managed by company’s commercial teams generally marketing||Managed by company’s scientific/medical service or individual’s medical/academic supervisor|
||Approval||Does not require REC approval**||Normally requires REC approval |
| ** The following acknowledgement
appears within the ‘Governance arrangements for research ethics committees A
harmonised edition’ published by the Department of Health, May 2011:|
2.3.14 Healthcare market research7 may be undertaken by professional market researchers on behalf of pharmaceutical or medical device companies. Where such research is conducted by professional market researchers in accordance with the Legal and Ethical Guidelines issued by the British Healthcare Business Intelligence Association (BHBIA), it does not require REC review except where otherwise required by law, e.g. if it requires approval under the Mental Capacity Act. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213753/dh_133993.pdf
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 - Section E (5.4); 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 - Section E (5.2) say that: Avoid brand names as much as possible. Using them unnecessarily or repeatedly could make your MR look like promotion. Use ‘Product X’ unless: – reaction to the name or its visual representation is an objective – using a name is essential to the interpretation of the stimulus, and this is in turn essential to the study objectives – you need to refer to a specific product e.g. in brand tracking. If possible compare with other brands to reduce the product’s standout and so reduce the risk of the MR being considered promotion Don’t use the brand name of an unlicensed product (unless you’re testing the brand name alongside a range of options). 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 - see Section G7. 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.
It is important to be clear that the content that may be included in market research (MR) stimulus material (e.g. product concepts). is not bound by the same regulations as the content of promotional material that is to be published. The ABPI Code of Practice makes it clear that promotional materials must meet tightly defined requirements (Clause 7 Information, claims and comparisons).
Market research stimulus materials must be fit for purpose and the reasons for its use clearly and directly linked to the MR objectives. In addition, respondents must also be made aware when they are providing feedback on draft materials, hypothetical scenarios, assumptions, a product in development or an unlicensed indication. However the BHBIA’s guidance for reviewing/approving MR materials developed in conjunction with the ABPI makes it clear that on occasion it may be appropriate to test material that would not be suitable for publication but is nonetheless a valid proposition for MR testing and provides the following example:
- “Drug X truly understands the everyday feelings and emotions associated with condition Y and its treatment” - This is a concept statement. It is intended to encapsulate the underlying emotional benefit that could support the brand’s positioning – to test whether this feeling could resonate with an audience would be reasonable. This wording would not however appear in any promotional pieces but the market research could help define the tone of promotional literature.
The BHBIA’s Guidance for reviewing/approving market research materials was developed in conjunction with the ABPI specifically for non-market researchers involved in reviewing and approving MR and is available in the Online Training section of the website.
Furthermore, the ABPI Code of Practice states that MR stimulus material should be examined by the commissioning client company to ensure that it does not contravene the ABPI Code (Clause 12 Supplementary Information). Promotional material requires certification (Clause 14.1), certification is not required for MR stimulus material.