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Strict Distinction

The need for confidentiality and informed consent separates market research from most other marketing activities

As pharmaceutical companies gear up their emphasis on compliance across all areas of marketing activity, the Legal and Ethical Framework for Healthcare Market Research, produced by the British Healthcare Business Intelligence Association (BHBIA) will become an increasingly important source of reference.

The BHBIA's overall mission is: "To promote and enhance the professionalism and value of business intelligence within the healthcare industry." This commitment to promoting best practice is reflected in the support and advice on legal and ethical issues that is provided to the organisation's pharmaceutical industry and research agency members.

The framework, also commonly known as the BHBIA guidelines, aims to provide clear, comprehensive and explicit best practice guidelines on the design, execution and use of healthcare market research within an up to date legal and ethical framework. It is revised annually, incorporating changes and additions based on legislative changes, developments within the industry environment and changes to the professional standards of industry bodies.

The framework draws heavily on the Market Research Society (MRS) code of conduct, the International Chamber of Commerce/ European Society for Opinion and Market Research (ICC/ESOMAR) international code of marketing and social research practice, and the ABPI code of practice for the pharmaceutical industry. It complements (but is not designed to replace) these codes and importantly, also draws upon key legislation – most notably the 1998 Data Protection Act.

The executive committee and ethics lead of the BHBIA pro-actively works in partnership with both the MRS and the ABPI to ensure that the BHBIA guidelines reflect their guidance in relevant areas. Recent examples include interpretation of legislation regarding the collection of adverse events in market research, and guidance surrounding the ABPI's requirement for a written agreement with physicians for payment of fees or honoraria.

The 2008 edition of the framework provides enhanced guidance on how to deal with market research (MR) as a non-promotional marketing activity. If conducted properly, MR falls outside some of the restrictions of the ABPI code, but researchers need to be very careful not to fall into the trap of 'disguised promotion', which is discussed in more detail below.

Continuous monitoring
In addition to the annual revisions, the BHBIA provides a monthly Framework Update monitoring service that alerts members to relevant changes or developments in the legal and ethical environment.

For example, the recently released 2008 ABPI code of practice includes a revision that will impact on MR within clause 20 – the use of consultants. The use of health professionals within MR studies is now defined as a consultancy role and arrangements with consultants must meet specific criteria. Proposed revisions to the framework will provide clarification on how market researchers can meet the following criteria:

• A written contract must be agreed in advance of the commencement of the services that specifies the nature of the services to be provided and the basis for payment of those services
• The contracting company must maintain records concerning the services provided by consultants.

What differentiates MR?
Although MR is used to inform and direct marketing activities, a strict distinction exists between it and direct marketing activities. The ABPI code of practice states that MR activities must be such that the collection and analysis of information is kept quite separate from any promotional use to which that information might be put.

Two core principles underpin the detailed information contained in the framework:

1. The principle of confidentiality
The need for confidentiality is the most crucial point of distinction between MR and most other forms of marketing activity.

MR attempts to generate an understanding of a marketplace by systematically collecting the opinions, attitudes and behaviours of a specific sample of the population under study and extrapolating the results to a wider population. The individual respondent is of interest only in so far as their opinions are a reflection of this wider population. Their identity and personal data are kept fully confidential by the researcher and cannot be disclosed, or used, for any non-research purpose.

MR does not include data collection intended directly to create sales or to influence the opinions of participants, nor does it include data collection as a means of information gathering for use in future sales or marketing activities. In other words, no direct action can be taken in relation to named individuals or organisations as a result of MR in which they have participated.

2. The principle of informed consent
This means that the respondent must be given sufficient information about the true nature and purpose of the study (including what will happen to the information they provide) so that they can make an informed decision about whether they wish to take part or not. They must also be made aware of their right to withdraw or withhold information, details of any viewing, monitoring or recording and requirements for adverse event reporting. The framework provides detailed guidance on all the points that must be covered in order for informed consent to be obtained.

Informed consent can allow participants to waive their right to confidentiality in certain circumstances where specific permission has been sought and granted. The principle of not using the MR data to influence the respondent's opinion or prescribing would, however, still apply.

Avoiding disguised promotion
The legal principle of informed consent clearly suggests that there can be no attempt to sell within an exercise presented as market research. Therefore, MR must not be used as a means of promotion, selling or influencing the opinion or behaviour of respondents – referred to as 'selling under the guise of', 'disguised promotion' or 'sugging'.

We have all been on the receiving end of phone calls supposedly conducting a 'survey' on how many doors or windows we would like to replace, which transpires into a blatant attempt to sell double-glazing. But marketers must also be aware of far more subtle transgressions that could be considered as disguised promotion. Such errors could include unnecessary use of brand names or over-emphasis of product claims within a questionnaire, disparaging competitors or including questions that ask respondents to change their attitude or behaviour (as opposed to investigating whether such a change could hypothetically be possible).

Another important consideration is to ensure that the sample size for a market research study is limited to that necessary to achieve the objectives of the research – overly large samples could be viewed as an attempt to disseminate product information to a wide audience.

Preserving anonymity
The framework gives extensive guidance on how to safeguard respondent anonymity while enabling the client to gain maximum benefit from the research process.

Best practice guidance is provided for the direct observation of interviews or group discussions by client personnel. Respondents must give their consent to being observed and observers must agree to a set of guidelines designed to protect the respondent's right to anonymity and freedom from disguised promotion. Observers should withdraw if a respondent is known to them or recognised, unless the respondent gives explicit permission for observation to continue.

Use of stimulus materials
Although materials such as product profiles, advertising concepts or detail aids for use in MR are not strictly bound by the ABPI requirements for promotional materials, it is best practice to bear these in mind when preparing stimulus materials for MR. Product information or trial data must be accurate and not misrepresented and research material should be approved by the client company's medical department. In line with the principle of informed consent, it is vital that respondents are told whether their feedback will be on draft materials, hypothetical scenarios, products still in development or unlicensed indications.

Guidance on research scenarios
A number of research scenarios represent particular 'minefields' when seeking to abide by the legal and ethical principles of the framework; detailed guidance is provided on how to handle these areas. Examples include detail aid testing (where it is vital to clarify that a 'mock detail' is being staged for research purposes only), patient research (where particular sensitivity is needed) and internet research (where additional issues such as data security and use of cookies need to be considered).

In addition to its comprehensive advice on conducting MR fieldwork, the framework provides guidance on areas such as use of client databases by MR agencies, analysis, reporting, publication and data storage.

A number of proformas are provided, which companies can tailor to their specific needs, ensuring that all key requirements are covered – for example respondent consent forms, confidentiality agreements regarding the use of audio and video tapes, and a data collection form for adverse events/product complaints (see below).

Adverse event reporting
A new section added to the 2008 edition of the framework is a summary of the Guidelines for Collecting Adverse Events and Product Complaints from Market Research Programmes, which was produced by the BHBIA in conjunction with the ABPI in 2007.

In order to comply with recent European legislation on product safety, companies are obliged to collect adverse events identified by respondents in MR studies, for those products for which they are the marketing authorisation holder. An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a medicinal product, whether the AE is believed to have a casual relationship with the treatment or not. In addition to potential side effects, reportable events include any exposure during pregnancy or lactation, unexpected lack of efficacy, maladministration or dosage errors, and product complaints such as packaging and device defects.

An MR agency conducting research on behalf of a pharma company is acting as that company's agent and, as such, is required to report adverse events back to the company's product safety/pharmacovigilance department, regardless of whether the healthcare professional has already reported the event via the MHRA's 'yellow card' system or not. The BHBIA/ABPI guidelines give advice on the identification and reporting of AEs, including how to handle this within the confidentiality of the MR process. They were produced to encourage high standards and consistency across the industry. An online training programme is available and BHBIA members can obtain certification in this area following the successful completion of an online competency test.

Increasing compliance
To enhance compliance across the industry, acceptance of the framework is a condition of BHBIA membership and the BHBIA recommends that all researchers working within the pharmaceutical industry abide by it. Furthermore, the BHBIA recommends that a written contract be drawn up detailing the rights and responsibilities of both commissioning company and MR agency, including a clause committing each party to observing the rules laid down in the framework.

Any complaints regarding possible breaches of the framework are investigated by the BHBIA and, if necessary, referred to the MRS and/or ABPI.

An online module to assess knowledge and understanding across all key areas of the framework is in development and will further promote the legal and ethical best practice to which the BHBIA is committed.

The Legal and Ethical Framework for Healthcare Market Research is available online

The Author:
Heike Bäumlisberger is ethics lead on the BHBIA executive committee and market research manager at Bristol-Myers Squibb and Rachel Medcalf is acting chair of the BHBIA and managing director of Adelphi Research UK

20th October 2008

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