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BHBIA

FAQ - Legal & Ethical Guidelines

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 BHBIA Legal and Ethical Guidelines.

For FAQs related to Adverse Event Reporting please see our separate Adverse Event Reporting FAQ 

The FAQs below are grouped into the following areas:

  • ABPI Disclosure Requirements
  • Fieldwork
  • Incentives
  • Record Storage
  • Recruitment
  • 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 online Guidelines Query 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

Q. If a pharma company commissions MR through an agency, and therefore does not know the identities of participants, is the client company is required to disclose payment details?

A.

When MR is commissioned and the identity of HCP/HCO participants is unknown to the sponsoring pharma’ company e.g. blinded MR, there is no requirement to disclose the Transfer of Value (ToV) (honoraria/incentives, expenses, etc.) under the ABPI code. 

Q. What about the use of client lists - does this mean the pharma company is aware of the participants’ details, even if they don’t know who was recruited from the list?

A.

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.

Q. Is disclosure required if the HCP/HCO is aware of the sponsoring pharmaceutical company’s identity (but the company is not aware of the HCP/HCO’s identity)?

A.

No, disclosure of a Transfer of Value (ToV) is only required if the sponsoring pharmaceutical company is aware of the identity of the HCP/HCO i.e. 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 to a clearly identifiable recipient (HCP or HCO).

Q. Does it matter who makes the Transfer of Value (ToV) payment, –i.e. if a third party and NOT the pharmaceutical company makes the payment?

A.

ToV are either direct or indirect.  

Direct ToV are those made by the pharmaceutical company to a HCP or HCO and indirect ToV are those made by third parties e.g. a MR agency, on behalf of the pharmaceutical company to a HCP or HCO.  Where a direct ToV has been made then disclosure will always be required as the recipient is known to the pharmaceutical company.  

For indirect ToV disclosure is only required when the identity of the HCP or HCO participating in the activity is intentionally known or disclosed to sponsoring company for the purpose of the activity and a transfer of value (honoraria/incentives, expenses, etc.) has been made to a clearly identifiable recipient (HCP or HCO).

Q. If the respondent is at a conference (for example) and does not know who the commissioning company is, do we still need to disclose?

A.

If a HCP attending a conference is engaged in a MR activity and the identity of the respondent is intentionally disclosed to the commissioning pharma’ company and a transfer of value (ToV) (honoraria/incentives, expenses, etc.)  has been made then disclosure is required.  It is irrelevant whether or not the HCP knows the identity of the pharma’ company, it is only relevant whether the company knows the HCP/HCO’s identity.

Q. The BHBIA says in its guidance that “if the HCP’s/HCO’s identity is not known to the commissioning pharmaceutical company disclosure is not necessarily required” what exactly does necessarily mean?

A.

There is no explicit exemption within the ABPI disclosure requirements for market research (MR), only the general rule that if a Transfer of Value (ToV) (honoraria/incentives, expenses, etc.) is made and the identity of HCP/HCO participants is unknown to the sponsoring pharma’ company there is no requirement to disclose the ToV.  Consequently the BHIA has had to explore with the ABPI what would happen in some specific MR scenarios.  

a) It has been made clear by EFPIA that if a HCP provides personal data as part of an AE report this does not necessitate disclosure.  

However, other scenarios are subject to interpretation, including what happens if:

b) when viewing fieldwork a pharma’ company observer happens to recognise and can identify what should have been an unknown HCP respondent. The same principle as the AE situation has been adopted – that the revelation of identity is a consequence (a by-product) of the MR and not a direct (designed) outcome.

c) the commissioning pharma’ company provides a list of potential HCP/HCO respondents for interview. If the identity of those actually interviewed cannot be known for sure so we believe disclosure is not required (unless everyone on the list is interviewed (a census). 

There have not been any complaints to the PMCPA (e.g. by a HCP who had expected to disclose and wasn’t required to) to test the guidance yet. In the absence of further guidance from EFPIA or cases that test the guidance we have adopted (as advised by the PMCPA) guidance that is not absolute i.e. ‘not necessarily required’ rather than ‘not required’ and we advise companies when in doubt to disclose.  It is the responsibility of the individual pharmaceutical company to interpret the Disclosure of ToV and apply their own guidance if there is uncertainty.

Q. If we (a pharma company) are doing patient research in which we know the identity of the respondents do we need to disclose that?

A.

Disclosure of transfer of value (ToV) to patients is not required. However if the patient is also a HCP or other relevant decision maker as defined in the ABPI code then disclosure could potentially be required if they are participating in their capacity as a HCP as well as a patient.  

Q. When an HCP helps to recruit patients for a MR study and the details of that HCP is provided by the pharma company (i.e. is known to the company), however they are not paid any incentive for this recruitment role, do their details have to be disclosed?

A.

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.

Q. Is disclosure required when a respondent declines receiving an incentive but requests that a donation for the amount is made to a charity?

A.

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.

Q. Does the requirement for disclosure apply if the identity of the HCP is revealed during the course of the project (e.g. an observer recognises and can identify the HCP from the backroom of a viewing facility)?

A.

The PMCPA have informally advised us that if the intention was never to identify HCPs but an HCP respondent becomes known to the pharma’ company as a result of another process, then disclosure is not likely to be required.  The ‘other process’ being an indirect consequence of the MR rather than a direct outcome.  This means that disclosure is not likely to be required if:

  • an adverse event is forwarded  and it contains HCP reporter details – EFPIA have confirmed this within their FAQs

or

  • when viewing fieldwork a pharma’ company observer can identify what should have been an unknown HCP respondent

For the full text of the PMCPA’s advice please click here to see the ‘Update on the Implementation of the ABPI Disclosure Requirements’ on the BHBIA website.

If an observer from the member company becomes aware of a participants identity they should excuse themselves from the MR and make no further observations.  In situations like these where an observer from the pharma’ company has become unintentionally aware of the identity of the respondent, the observer has removed themselves from observation and the observer has made no use of their unintentional knowledge of the participant then clearly there has been no intent on the part of the company to know the identity of the respondent, therefore a requirement to disclose is not required.  

Q. For a recent blinded study, a client raised concerns about viewing anonymised fieldwork in case they came across the study participant at a future date, e.g. at a congress, and were then made aware of their identity. What should the researcher advise?

A.

The PMCPA have informally advised us that if the intention was never to identify HCPs but an HCP respondent becomes known to the pharma’ company as a result of another process, then disclosure is not likely to be required.  The ‘other process’ being an indirect consequence of the MR rather than a direct outcome.  This means that disclosure is not likely to be required if:

  • an adverse event is forwarded  and it contains HCP reporter details – EFPIA have confirmed this within their FAQs

or

  • when viewing fieldwork a pharma’ company observer can identify what should have been an unknown HCP respondent

For the full text of the PMCPA’s advice please click here to see the ‘Update on the Implementation of the ABPI Disclosure Requirements’ on the BHBIA website.

If an observer from the member company becomes aware of a participants identity they should excuse themselves from the MR and make no further observations.  In situations like these where an observer from the pharma’ company has become unintentionally aware of the identity of the respondent, the observer has removed themselves from observation and the observer has made no use of their unintentional knowledge of the participant then clearly there has been no intent on the part of the company to know the identity of the respondent, therefore a requirement to disclose is not required.  

Q. In a non-research project where named respondents are only made aware to the company at the end of the project is disclosure required?

A.

Non-research projects are not covered by the BHBIA’s legal & Ethical Guidelines but would be subject to ABPI Code if commissioned by an ABPI member company.  Consequently if the names of individuals HCP respondents in a database building exercise are intentionally made known to the sponsoring company and a clearly identifiable transfer of value (ToV) (honoraria/incentives, expenses, etc.) has been made to the HCP respondents then disclosure is required irrespective of when in the process the identities are made known.  If the intent of the activity is disclose the identity of the HCP respondents to the sponsoring company either prior or post the activity then this would require disclosure under the ABPI code. 

(If the identity of the sponsoring company is disclosed to the respondents after the MR but the identity of the HCP respondents are not intentionally disclosed to the sponsoring pharma’ company then no disclosure is required.  Disclosure is only required when the respondents are intentionally known to the sponsoring company).

Q. For KOL Mapping, it is usually nomination of names by other physicians - would that need to be reported? The names of the physicians taking the survey are not the ones necessarily named in the survey.

A.

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.

Q. Are these changes going to be covered in future BHBIA online tests and slides? If so, will we need to re-train and re-do the tests for an updated certificate?

A.

Yes, the changes will feature in future tests and slides, however your current Legal & Ethical Guidelines competency test certificate will remain valid until it is due for renewal. 

Q. We are currently carrying out a study which falls under the disclosure criteria but have not informed the respondents nor the client (pharmaceutical company) about the new requirements. Are we now to retrospectively seek consent from the respondents?

A.

The code required disclosure for all transfers of value (ToV) made for the 2015; therefore the study mentioned would require ToV disclosure and provision should have been made for disclosure.  In this case the agency should contact the sponsoring company, make them aware of the potential issue and discuss relevant actions for mitigation and appropriate disclosure.  

Q. I hear that the BHBIA will be providing wording, but will a reporting template be provided?

A.

We are drafting a template for consent to pass on personal data for disclosure for use at recruitment and this will be available to members as soon as it is finalised.  

The BHBIA does not however supply contract/MSA wording for MR agreements and won’t be doing so for the new disclosure requirements.  It is expected that members will use their legal advisors for this.

As far as reporting of transfers of value (ToV) to the ABPI is concerned, the ABPI does provide a template and this can be found on the PMCPA website

Q. What if the pharma company is not a member of the ABPI?

A.

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.

Q. Will the pharma company be responsible for providing the disclosure requirements in each market they are conducting the research, or will it be the responsible of the MR agency to find this out from local market bodies?

A.

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.

Q. Are EphMRA going to be publishing wider European guidelines, and if so are they different from these requirements and how are they different?

A.

EphMRA currently provides general guidance on disclosure requirements - see details.The BHBIA advises that members use the EphMRA website to look for non-UK country specific information and EphMRA member companies can contact EphMRA for up to date information.

Fieldwork

Q. We are planning to conduct some market research using patient records, asking HCPs to take information from them. No information which could identify the patient will be collected. In the UK, our medical and compliance team are concerned as they feel this approach could be seen as a form of clinical research and not market research - therefore requiring local ethics committee approval etc. Is this the case?

A.

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.

Q. Is it acceptable / permitted to recruit an interviewee, conduct the interview and only reveal the name of the sponsor at the end of the interview, even if they ask at the beginning?

A.

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 E (4.3):

If you use a list of named individuals for sample selection, you must reveal the source of the list to potential respondents during the interview if they ask. This applies even when it means identifying the client company (i.e. if they have provided the list).

However there are some differences to the above guidance when clients view non-anonymised fieldwork via video-relay (even if the sponsor has not provided the list):

The Data Protection Act 1998 requires you to disclose client names, so far as practicable, prior to live or delayed viewing of non-anonymised fieldwork via video-relay (with or without recording).

However, if revealing a client’s identity would be detrimental to a research project, and is unlikely to be detrimental to respondents, you can withhold their identity until the end of the interview. If revealing it poses a genuine threat of disguised promotion you can, withhold it indefinitely, as long as certain specific conditions are met.

See Guidelines section E: (6.3) for more details.

Q. We will be conducting a study which involves HCPs bringing along the records of patients they have recently seen for a particular therapy intervention (a completion sheet with pre-defined fields will be defined by the MR agency with our input). Is there any guidance on fields that would be inappropriate to collect? And is patient consent required?

A.

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.

Q. We have been asked by a pharmaceutical client whether they are able to have a representative participating in the market research discussion. This would be a member of the brand team who would be able to explain the scientific information discussed if required. Is this permissible?

A.

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.

Q. Is it a requirement of the BHBIA that any of the moderators we use have a valid Criminal Records Bureau certificate?

A.

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.

Incentives

Q. Does paying a market research incentive contravene the Bribery Act 2010?

A.

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: 4.8) 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)

Q. Is it permitted to give physicians a fee or an incentive for recruiting patients into a market research study on behalf of an agency?

A.

There is nothing in the guidelines or any regulations that prohibits payment of a fee/incentive for physician recruitment however the BHBIA recommends that the incentive is carefully structured to ensure that it does not appear to put any undue pressure on the physician to recruit or a patient to agree to participate. 

Q. Is there anywhere in the BHBIA Guidelines where I can find the range of incentives that should be paid for taking part in any market research project.

A.

The BHBIA does not provide either precise figures or ranges for appropriate incentives.

The Guidelines (Section E: 4.8) 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.

Q. We wish to commission a very short 3 minutes survey to help understand who initiates treatment for a series of products. The agency are proposing "prize draw" as the incentive (4 prizes of £150). Can this be done?

A.

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.

Q. I have recently been asked by a client company, for whom I recruit, to obtain bank details from respondents so that payment may be made by BACS transfer. Is asking for such information ethical under the guidelines?

A.

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).

Record Storage

Q. Could you please advise me as to how long pharmaceutical market research records must be stored?

A.

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.

Recruitment

Q. Are there any BHBIA guidelines regarding the recruitment of respondents by email?

A.

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.

Q. We are looking to recruit people with a certain condition via an advert on Facebook which would be tagged to show up on people's landing page if they have expressed an interest in discussion about their condition. We are not planning to capture any contact details other than the IP address. Can you please advise us on the validity of this recruitment methodology?

A.

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. 

Q. Our client has generated a list of KOLs using secondary data (online searches etc). They would like us (the MR agency) to contact the KOLs and, amongst other questions, ask them who they consider to be experts in the field. What are the regulations regarding providing names of KOLs mentioned during market research that are not already on the client list?

A.

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.

Q. Does Clause 20 of the ABPI Code mean that we must receive written confirmation from the respondent BEFORE a telephone interview can take place?

A.

Section E (4.2) of the Guidelines relates to Clause 20. 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.

Q. A number of individuals on a client target list used in a recent study have stated that they do not do market research. Our client has asked for this information to be flagged in the target list. Is this acceptable, even if the respondent was not told of this at the beginning? And is there a risk that the client could abuse this information?

A.

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.

Q. Can you please clarify whether or not customer details we have on our [pharma] company system can be passed on to a third party agency (MR agency) with whom we have a confidentiality agreement in place and who are acting on our behalf?

A.

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’.

Q. Is it acceptable for healthcare professionals to recruit patients into MR studies in the absence of Research Ethics Committee approval?

A.

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.

Research Findings

Q. I have been asked by a client to present the findings of a recent piece of research to a wider audience that is external to the client company and whose interest in the results was not anticipated when the respondents were recruited. Is this an issue as their identities have been kept completely confidential and the client intends to ask the audience to sign a non-disclosure agreement so that the results cannot be quoted out of context?

A.

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

Q. If a business consultancy commissions market research from a market research agency on behalf of a pharmaceutical company, who is the ‘client’?

A.

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.

Q. Do the BHBIA guidelines cover OTC research - specifically with reference to AE reporting?

A.

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.”

Q. We have been asked to collect basic awareness and usage data from specialists and present it back in anonymised aggregate format. The information would be available to us on a named basis in spreadsheet format, and may be used later on down the line for marketing purposes. Is this type of a project 'using research techniques for a non-research purpose’?

A.

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.

Q. Can we use interviews for sales training purposes if we pixilate the faces of the participating doctors so their identity is disguised even if they have not given informed consent for use of their interviews for training purposes?

A.

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.

Q. As a fieldwork agency we need to inform our client at proposal stage if we are going to use any sub-contractors. Often we do not know whether sub-contractors will be needed until later in the project. Do we have to always pro-actively tell a client that we have decided to use a sub-contractor at the point where this becomes necessary or just if the question is raised by the client?

A.

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.

Stimulus Materials

Q. What are the BHBIA’s guidelines on including product profiles of a competitor’s drugs in a survey? If the survey is being sponsored by company A, can I include a profile for company B’s product?

A.

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.

Q. We are trying to ascertain usage of certain drugs from patients. Our client has suggested that we cannot show a list of brand names to prompt the patients to select those they use, as this could be considered as direct to consumer promotion. Can you please advise us?

A.

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.

Q. We have been asked to conduct an online quantitative study to test reactions to two versions of a new detail aid and also to compare reactions to the new detail aids with the current version with a subset of respondents. Could such a study be construed as being promotional? And can we show a current detail aid online?

A.

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.

Keeping you informed about changes in the legal and ethical environment that may affect your work

Keeping you informed about changes in the legal and ethical environment that may affect your work

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