14. What problems may arise during the research process?


Researchers at hospitals and other biomedical or health care research institutions do hopefully experience research as a source of intellectual and personal fulfillment. Although this chapter focuses on some of the problems which can and do arise, the pursuit of ideas is undoubtedly exciting, challenging and rewarding. In short - research is fun. The authors of this Handbook therefore wish readers the best of luck in their efforts to find effective solutions to the challenges arising from their research and also hope that the researcher will both find and generate satisfaction through research.

The research process often entails emotional ups and downs. At times research will be challenging, fun or even lead to a sense of euphoria, whilst at others it will be tiring, frustrating and heavy going. The attitude of the individual researcher to his/her work plays a significant role in determining the quality of their experiences.

Pessimists will maintain that there are endless possibilities for things to go wrong in any research project. As well as everything one can conceivably plan for in advance, things go wrong even after safeguarding. For example, the freezer (containing irreplaceable patient biological samples) and two separate alarms malfunction simultaneously, the result being destroyed samples and three years of research wasted. A piece of advice: put the samples in two separate freezers. That way only half the batch will be lost next time.

Optimists, on the other hand, will say that one can learn from one's mistakes and that skills improve with every project (not least with respect to backing up data compilations electronically; not doing so has led to many research crises).

Personal drive and enthusiasm, background knowledge and a willingness to implement new information and skills are important factors in spurring on research. Usually more than one person is required to carry out a research project, however (supervisors, other research collaborators etc.). The period during which data is collected is often (relatively) unproblematic, provided that everyone involved is basically polite and has reasonable social IQ. But then comes the time for analyses and publication. Experience dictates that this is the time when problems tend to arise.

1. Possible conflicts regarding authorship
Disagreement on the order of authorship in scientific publications is the most common cause of conflict within science. The reasons for, and consequences of this, may vary. However suffice to say, the guidelines given in Vancouver Convention should govern the order of authorship (see Chapter 8).

The Vancouver Convention ("Vancouver Rules") states that no one is to be listed as a co-author without having made a significant contribution to the research. Although the Vancouver Rules specify who satisfies authorship requirements for a scientific paper, they do not say anything about the order of authors. Usually the order reflects the contributions made by each individual to the research work and the publication. However, different traditions and unwritten rules apply in different countries and research settings.

The first author has usually formulated the problems, been responsible for the analyses/ data processing and has done most of the writing of the manuscript.

The second author has usually made the second largest contribution and any remaining authors are listed after this. Note that some research groups write authors subsequent to the first author in alphabetic order.

The last author is usually the person with the overall scientific responsibility. In some research institutions, leaders of research groups or heads of institutes are listed as last authors of the publication, whatever the nature of their contribution to the project. There is no support for this practice under the Vancouver Convention unless there has been real scientific contribution to the project concerned. A statement regarding the contribution of each author to the paper (required by some high-impact journals) will hopefully reduce any conflict surrounding authorship.

The pursuit of research engenders few financial benefits in Norway and academic recognition and publication of results are therefore of great significance. This is likely to be one of the reasons for conflict in this field, with damaging consequences for both research and research groups. Many researchers are concerned about their potential to obtain research grants and the chances of doing so are reduced if they are not in a key position in the order of authors (either number one, two or last).

How to reduce the potential for conflict regarding authorship:
· Come to an agreement about the order of authors before the study commences or as soon as the aim for a supplementary study has been formulated (the precondition being that the contribution actually qualifies the individual for authorship). It may seem awkward raising the matter at such an early stage, but experience has proved it to be even more awkward later. Doing so will also clarify each study participant's role in the project so that all parties have realistic expectations with respect to their own contribution and their "rewards" as an author.
· Be generous in offering co-authorship and equally generous in refusing any co-authorship offered. Remember that, as co-author, one must be able to justify the general thrust of the article (and some journals also ask authors to state whether they take responsibility for the entire paper or only part of the paper).
· If the premise for the research or the research activities themselves are altered in the course of the project, the question of authorship should be discussed again. It is quite common for new methods to be introduced and problems to arise and it is thus quite reasonable to review authorship.
· This is an area in which etiquette plays an important role and much is to be gained from playing with an open hand. The question of order of authors is, in essence, about "giving credit where credit is due". As long as collaborators/co-workers are in agreement about each individual researcher's contribution to a project, they should be able to reach agreement about the order of authors in any publication.

2. Potential conflicts with a supervisor
See Chapter 9 on supervision (including contracts, the option of institutional mediation where a conflict has arisen and supervisor courses).

Both an uninterested supervisor and an over-controlling supervisor can prove to be a challenge for doctoral candidates. There is no blueprint for how conflicts between supervisor and candidates can be avoided, nor for which types of relationship promote independence, are the most productive or the "best". Personal characteristics clearly affect any collaboration. Candidate and supervisor do not necessarily need to share personal characteristics; in fact it may be more fruitful for them to have complementary strengths.

The potential for conflict can be reduced by having clear agreements between and feedback from both parties. An agreed level of ambition is also important; what is the time frame of the project and do both candidate and supervisor(s) agree on the project progress? Clarify in advance how much time the supervisor has available for the candidate and whether the candidate is to have free access or access at fixed times. Schedule a set time for feedback on drafts of papers; stick to appointments to avoid wasting time and causing unnecessary irritation.

3. Access to research data and research biobanks after the PhD period
A number of factors determine whether the access to research data and biological material in a research biobank after the PhD period is over:
· the nature of the employment contract and whether the employer remains the same during and after the doctoral period
· the nature of the information to and consent by respondents who have provided data and/or biological samples for the project
· conditions for obtaining information from existing databases (such as a patients? medical charts and external registers), as well as conditions for use and collection of sample from existing bio-banks
· conditions determined by public authorities such as the Data Inspectorate, the Regional Committee for Medical and Health Research Ethics (REK) and the Directorate for Health Affairs.

It is difficult to provide a general answer to whether research data and biological samples will be accessible for candidates at the end of a PhD period if this has not been agreed in advance with both employer and respondents. Many research institutions have their own guidelines on access to data in health registers and biological samples. In principle, the ideal condition is that research data and biological samples should be accessible for future research by other parties. However, "protection against competitors" must also be considered. In practice the person/entity responsible for data processing and the person/entity responsible for scientific biobanks (in the case of large research institutions this is often at an administrative level above that of project manager) will determine whether continued access will be granted. Proposals for new use of existing research data and/or material from research biobanks must always be submitted to REK etc., as specified by the laws and regulations described in greater detail in Chapter 10. The Vancouver Convention also place restrictions on publications based on existing biobank material. Collection of biological samples alone is not considered to be a "substantial contribution", and is therefore not sufficient to satisfy criteria for authorship under these regulations.

4. What if papers are rejected for publication?
Why are the articles being rejected? Identify the key problem. Peer reviewers of the journal usually provide useful comments on why they reject a paper and sometimes the editor will add her/his own comments. Go through the phases outlined in Chapter 3 to identify where the research project went wrong. If the study has not been sufficiently well designed there is little chance of having papers published after the study is completed. If additional analyses are required, it is usual to follow the advice of reviewers or alternatively the article may be submitted to another journal. Researchers seeking publication in journals with the highest impact factor (The Lancet, Cell, Nature etc.) should check the profile of the journal before submitting a manuscript.

5. Insurance and research projects
It is usual to have insurance to cover biomedical and health care research projects involving human participants.

The Norwegian System of Compensation to Patients (Norsk Pasientskadeerstatning, NPE)
The Norwegian System of Compensation to Patients (www.npe.no) is an independent government agency under the Ministry of Health and Care Services. NPE processes compensation claims by patients /research project participants who believe they have suffered an injury after treatment within the public health care system. The NPE system also covers research projects.

Product Liability Act ("Lov om produktansvar")
The Product Liability Act of 23 December 1988 no. 104 safeguards the interests of patients/research subjects participating in pharmaceutical trials. The project manager is legally obliged to take out insurance through membership of the Drug Liability Association ("Legemiddelansvarsforeningen") if the project is not covered by the insurance policies of the pharmaceutical company concerned.

Separate insurance
It the research project is not covered by the Product Liability Act or the Norwegian System of Compensation to Patients (NPE), separate insurance must be taken out. The relevant insurance policy should cover liability and damages regardless of culpability.

Publiseringsdato: 04.07.2008.
Sist endret: 02.07.2010.
Informasjon fra Ullevål universitetssykehus, utskriftsdato : 10.09.2010 http://www.ullevaal.no
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