Certec Report No. 1, 1999

Tankar

What is right?

Everyday legal and ethical questions encountered by Certec
Annika Fält, Bodil Jönsson

Background

In our daily work at Certec, we often touch upon legal and ethical issues. This is mostly a good thing – it is important that an organization whose work is closely related to individuals carries on a discussion of ethics and constantly raises questions concerning issues that may be regulated by law. In our discussions, not only do we ask ourselves whether a particular action would be unlawful or unethical – just as often we are faced with the question of whether neglecting to do something would be unlawful or unethical.

This report has four parts:

  1. Liability in connection with testing of technical devices
  2. Confidentiality
  3. Documentation concerning individuals
  4. Certec’s Internet Code of Conduct

 

The bulk of the work on parts 1-3 was carried out by Annika Fält, doctoral student in the Faculty of the Sociology of Law, under the supervision of Professor Håkan Hydén. This work included interviews with Hans-Gunnar Axberger, associate professor of criminal law, Bertil Bengtsson, professor emeritus of civil law, and Jan Freese, professor of computer law. Part 4, the Internet Code of Conduct, was adopted unanimously by Certec on January 11, 1999. Parts 1-3 were revised by Bodil Jönsson who also drafted the Code of Conduct.


1. Liability in Connection with Testing

Summary

It is Certec’s responsibility to ensure that the technology we develop and test meets reasonable safety requirements. Certec is part of Lund University, i.e. it is part of a public organization, and it is not engaged in business activities. Consequently, neither the Product Liability Act, the Product Safety Act, nor the Consumer Sales Act is applicable to Certec.

As an employer, Certec (in reality, the state) is liable for "any harm caused by an employee as a result of fault or negligence in the course of employment." Project leaders/teachers are responsible for work carried out by their students, but since the former are employed by Certec, this means that the state is in fact also liable for torts committed by students.

When testing new technology, the user should be fully aware of any deficiencies known to Certec and should also be conscious of the fact that unexpected problems can arise. Effective communication between Certec and the user is thus essential and informed written consent must be obtained. A standard co-operation agreement, adapted to different types of testing, should always be used in order to inform the test user of the terms of our collaboration and to set out mutual responsibilities.

From a moral point of view, the employee involved is responsible for ensuring that such a co-operation agreement is signed, and that test users are informed of its terms. A standard co-operation agreement form is available as a shared file. The person responsible must consider whether any amendments should be made to the standard text. Signed agreements are to be kept in the secretary’s office at Certec.

 

Keywords: informed consent, testing, co-operation agreement, Product Liability Act, Product Safety Act, Consumer Sales Act

 

A. Normative Aspects

Liability

Liability arises when there is causation in the form of fault or negligence. Causation implies that the consequences of an act and the harm it caused should have been foreseen by the reasonable person. (Strict liability, which, for example, exists in the context of environmentally dangerous activities regardless of whether the person deemed to have caused the damage was at fault, is not applicable in this case.)

Liability in Contract and Liability in Tort

Within the law a distinction is made between liability in contract and liability in tort. Liability in contract must be relatable to an agreement between two parties, e.g. between a test user and Certec. Liability in tort can only arise if a third party (e.g. a personal assistant, other care staff, a friend, or a relative) suffers harm when using a device developed by Certec and it is established that the staff member who developed the device acted negligently. Accordingly, as a rule, any liability for damages on the part of Certec with respect to a user will be based on an agreement (a contractual relationship).

Liability Act

It is a special aspect of Certec’s liability that Certec can be acting either as an employer or in an official capacity. There are special regulations concerning the exercise of public authority. However, these are not applicable to Certec’s development work. Rather, the relationship between Certec and users of assistive technology must be considered to be an ordinary contractual relationship.

 

Vicarious Liability

Under section three of the Liability Act, the employer is liable for harm caused by the tortious acts of an employee when those acts arise in the course employment. Consequently, since Certec is part of a public organization, the state is liable for any harm caused by Certec’s products. In certain situations, the state, or Certec in this case, has the right to be indemnified by the employee who caused the harm. However, under section four, for this to occur there must be special reasons, such as gross negligence on the part of the employee: "An employee is responsible for harm caused through fault or negligence in the course of employment only if special reasons exist with respect to the nature of the act, the position of the employer, the interest of the injured party, and other circumstances."

Project leaders/teachers are responsible for work carried out by their students, but since the former are employed by Certec, the state is in fact also liable for torts committed by students. In some projects, students carry out the same type of work as employees do. In such cases, the same regulations apply to them as apply to other employees: "a person who, while attending an educational institution or receiving institutional care, carries out work similar in nature to that usually carried out by an employee" (s.6, ss.4 of the Liability Act). In such circumstances, students at Certec are equated with employees and the above-mentioned limited right to be indemnified by the employee/student applies.

 

Damages Claims

Damages claims against the state are governed by legislation. (SFS 1995:1301). According to s. 1 of the Statute in question, it is not applicable to liability resulting from a contractual relationship. On the other hand, the Statute is applicable to liability pertaining to the Liability Act (s. 7). It is not always easy to determine whether liability falls under the Law of Contracts or under the Liability Act because the Liability Act applies to both contractual relationships and to torts.

 

This means that the Statute could be applied in an action for damages. In such a case, the claim is handled by the central government authority within whose field of activity the injury occurred (s.5). If there is no central government authority for the activity in question, the claim is handled by the Office of the Chancellor of Justice. In Certec’s case, any claims would be handled by the National Agency for Higher Education.

 

With regard to personal injury, there are special provisions as to who should handle the claim for damages (s.9) Cases concerning claims for damages for personal injury, including injury suffered by a third party, should be submitted by the central government authority in question to the National Judicial Board for Public Lands and Funds, unless the claim is based on s. 2 of Ch. 3 of the Liability Act. This section of the Liability Act deals with the exercise of public authority and since Certec’s activities in the context discussed herein cannot be considered to fall in that category, s. 9 of the Statute applies. Claims for damages should thus be submitted to the National Judicial Board for Public Lands and Funds by the central government authority.

 

Product Liability and Product Safety

The Product Liability Act
Certec is not engaged in business activities. It forms part of Lund University, which is a public organization. If Certec were considered to be a business entity, engaged in the sale of products, the Product Liability Act as well as the Consumer Sales Act would apply. Limiting the scope of these Acts to business entities is sometimes seen as too restrictive since the state de facto is engaged in various types of manufacturing. However, there is no support in either the opinions accompanying these Acts or in precedent for equating public activity with business activity.

 

By analogy with the Product Liability Act, it is conceivable that the state could have broader liability. The Product Liability Act relates to liability for personal injury or material damage resulting from a lack of safety (s.1), which is defined as follows: "if the product is not as safe as can reasonably be expected." Furthermore, the Act provides that "the safety of a product shall be assessed based on how one would expect the product to be used, how it was marketed, the directions for use, the time the product was made generally available, and other circumstances" (s.3). However, the Product Liability Act only applies to products that are made generally available, i.e. some type of mass production and mass distribution must take place.

 

In sum, Certec is a public organization, which is not engaged in business activities and, consequently, the Product Liability Act is not applicable. However, as mentioned above, the possibility cannot be excluded that a court may apply the Act by analogy.

 

The Product Safety Act
The Product Safety Act applies to "goods and services supplied in the context of a business activity and to goods supplied in the context of a public activity" provided that the good or service is primarily used by consumers for private purposes. Furthermore, section 1 states that the provisions concerning manufacturers in this Act also apply to those who supply goods in the context of a public activity.

 

In Certec’s case, it is mainly the provisions concerning safety information and warnings of danger that are relevant (s. 1). Moreover, the Product Safety Act stresses the importance of providing information about the product in order to prevent personal injury or material damage (s. 5). In addition, there is a section concerning goods that carry a particular risk of injury (s. 7).

 

The Product Safety Act does not include any special provisions concerning liability. However, the fact that a good is supplied in contravention of the Product Safety Act may influence the assessment of what constitutes negligence should injury or damage result, even though the Act is not directly applicable.

 

Acts Which Are Not Applicable to Certec
It has been determined then that neither the Product Liability Act nor the Product Safety Act are directly applicable to Certec. The Product Liability Act does not apply because Certec is part of a public organization and, consequently, is not a business entity. The Product Safety Act is not applicable either unless Certec engages in more extensive manufacturing, for example in the form of a "Certec range" of assistive devices.

 

On the other hand, both these Acts can be said to be normative. The basic tenet of the Product Liability Act is that if a product is deficient in terms of safety, the manufacturer may be held liable. The provisions of the Product Safety Act establish the lowest acceptable level of safety and of information concerning dangers associated with a product.

 

b. Definition of Collaboration

In the case of an injury, there are several circumstances that must be taken into consideration in determining whether Certec was negligent in some way when developing or testing a prototype. One important question is to what extent the user was aware of any deficiencies of the prototype. There is a particular risk of unexpected problems when a new device is being developed; i.e. there may be teething problems.

 

Consequently, when testing new technology, it is important that the user is fully aware of any deficiencies known to Certec and that he is conscious of the fact that unexpected problems may arise. Effective communication between Certec and the user is thus essential. Certec must quickly inform the user of any new deficiencies and problems of which it becomes aware and the user must inform Certec of his observations when using the product. Certec and the user are thus in a position of mutual dependence.

 

This mutual dependence means that a contractual relationship exists between Certec and the user. It is very important that this is made clear and that the parties are aware of what is expected of them. The fact that the user is aware of any obligations he may have in connection with the testing and of any limitations in the use of the product may be of considerable importance to the determination of whether Certec has failed in its duty of care in the event of an injury.

 

The terms of the agreement must seem reasonable to the user. Certec is the stronger of the two parties and is in possession of expert knowledge. Consequently, Certec should inform the user both in writing and orally in a way that is easy to understand of the terms that apply to the testing of the assistive device. Subsequently, both Certec and the user should sign a written document. If the user is a minor, a parent or guardian should sign. It may also be advisable to inform, for example, the user’s personal assistant of the content of the document and perhaps ask him to sign the document to acknowledge receipt of the information. If information conveyed in writing or orally is not helpful to the user, the information must be conveyed in some other suitable manner.

It is essential that the intentions reflected in the agreement be in fact carried out. Should a situation arise where Certec might be held liable, it is important to be able to show that the terms of the agreement have been carried out, for example that the user really has understood its meaning, that the communication between the user and Certec has been effective, that necessary changes have been effected as promptly as possible, etc.

 

From a moral point of view, the employee involved is responsible for ensuring that such a co-operation agreement is signed and that test users are informed of its terms. A standard co-operation agreement form is available as a shared file. The person responsible must consider whether any amendments should be made to the standard text. Signed agreements are to be kept in the secretary’s office at Certec.

Standard Agreement:


Co-operation Agreement With Respect to the Testing of …

Certec is responsible for ensuring that the technical devices developed by us meet reasonable safety standards. Since we are primarily engaged in research rather than manufacturing of products, there is often no prior experience to rely on with respect to the technology which is to be tested.

Certec is willing to assist the user in every way during the testing. The test user is expected to have a strong interest in carrying out the testing and to provide information about/or document the results, including reporting any deficiencies in the technology, and to use the product with care.

Certec is only responsible for injury resulting from demonstrable fault or negligence in connection with the development of the device. The Product Liability Act, the Product Safety Act, and the Consumer Sales Act are not applicable.

Any claim for damages by the user should be made within five years of his beginning to use the device or within six months of an injury or of the effects of an injury becoming apparent.

 

The user is requested to inform all other users of the product of the content of this agreement.

 

The user should pay special attention to the following (any additional information concerning the product in question should be provided here)

…..

 

I have acquainted myself with the above information provided by Certec and I agree to the terms of this agreement.

 

 ………………..

Dated signature of test user


 

2. Confidentiality

Summary

According to the Secrecy Act, confidentiality should be observed for the benefit of the individual - not for the benefit of the public authority in question. First and foremost, the authorities must abide by the principle of public access to official records. The individual has the right to decide whether information concerning himself should be classified. If there is any uncertainty, an informed consent form should be signed.

 

Certec aims to make new knowledge available to all. Transparency is thus a general objective of this organization. Confidentiality agreements should be signed at the request of the person concerned or his representative.

Keywords: Confidentiality, Secrecy Act, principle of public access to official records, informed consent

 

a. Background

In 1996-97 Certec published the Free Freya series of reports. The reports deal with a woman called Stefania Weiss who has been in closed psychiatric care for about thirty years. Ms Weiss not only consented to publication of the reports but she also actively participated in the their coming into being. Her parents, in their capacity as guardians, also agreed to and participated in the writing of the reports. However, the clinic management requested that the reports not be written for reasons of confidentiality.

 

Questions regarding confidentiality have also been raised repeatedly in the context of Certec’s collaboration with the Pictorium, a day center in Lund. In this case, the issue has been raised by staff outside the Pictorium. The following analysis discusses the issue of confidentiality and a number of conclusions are presented.

 

b. Analysis

The information the clinic management wanted to classify falls within the category of medical information. The provisions concerning confidentiality in this area are set out in Chapter 7 of the Secrecy Act. This Chapter states that information concerning the health or other personal circumstances of the individual are classified unless it is clear that the information can be disclosed without harming the individual or those close to him (Ch. 7 s. 1).

 

Thus, the main rule is that the individual has the right to decide whether confidentiality should apply. However, there is one exception: The hospital may refuse to disclose information if the treatment in question may be jeopardized if the information is disclosed to the patient (Ch. 7 s. 3). On the other hand, in Chapter 14 or the Secrecy Act it is stated that "the rule of confidentiality for the purpose of protecting the individual does not apply with respect to the individual himself and can moreover be revoked in full or in part by the individual" (Ch. 14 s. 4).

 

Furthermore, the concept of informed consent should be considered in this context. The question of informed consent often arises when there is a certain imbalance in a relationship. Such a relationship could, for example, be a doctor-patient relationship or a layperson-expert relationship. In such cases, it is considered necessary to obtain informed consent with respect to issues concerning the patient. Ms Weiss not only consented to but also assisted in the publication of the reports. We can therefore conclude that informed consent was obtained from Ms Weiss as well as from her parents. Consequently, the rule of confidentiality for the protection of the individual does not apply and, therefore, only Ms Weiss herself could assert a right to confidentiality in connection with the publication of the Free Freya reports.

 

The reason why the provisions concerning confidentiality for the protection of the individual even exist is partly due to the fact that in the 1980s the Secrecy Act came to be applied to new sectors of society as result of the expansion of the welfare state. This means that the principle of public access to documents was extended to new areas. Transparency is recommended as long as there is no risk of adverse effects, while confidentiality should apply when necessary to protect the integrity of the individual. This trend from transparency to secrecy was a direct result of the fact that issues concerning secrecy were brought to the fore as government expanded into these new sectors of society.

 

It is both logical and humane to apply the principle of confidentiality in certain situations in order to protect the integrity of the individual. However, the development of new technology complicates the issue of who owns information about an individual. If people with developmental disabilities begin to take photographs and to communicate extensively through pictures, to whom do these pictures belong? Who has the right to publish them on the Internet? One way of handling this circumstance may be to apply the principle of informed consent. It is important to make clear that it is the individual who owns and has the right of disposition of information concerning himself and thus the right to agree to or forbid its publication.

 

A further dimension that can be introduced into this context is that "publication" is a very broad term. Documents such as the Free Freya reports are at one end of the spectrum as examples of non-commercial publications while the tabloids may be said to represent the other extreme. The publication of a picture in a commercial context may be problematic since there is a risk of the individual becoming the object of ridicule and an opportunity to profit from someone else’s appearance. Accordingly, in the case of commercial publication, it would most likely be necessary to obtain the informed consent of the individual concerned. When deciding whether it is reasonable to publish something one should always take into consideration the context in which it will be published.

 

c. Conclusion

It is the individual who has the right to set aside the principle of confidentiality. If an individual decides that information concerning himself should not be confidential, his wish should prevail. The only exception to this rule is when a care provider believes that this openness may be detrimental to the treatment the individual is undergoing. The principle of confidentiality exists for the benefit of the individual, not for the benefit of the public organization in question. The authorities should be guided by principle of public access to documents. The problems of confidentiality brought to the fore by the Free Freya reports concern the question of whether Certec violated the rules of confidentiality that apply to the hospital. It can be unequivocally stated that this was not the case.

 

3. Documentation Concerning Individuals

Summary

It is not ethically defensible to deny an individual access to and the right of disposition of her own history, e.g. in the form of pictures. However, the question of who has the right to decide whether a person should appear in a photo has not been addressed by the law. There is no special need for confidentiality in the case of photos of individuals within the care services. Nevertheless, documentation may be prohibited by agreements between each special school, day center or the like and their respective participants. The participants, or their guardians, are considered to be clients. Consequently, the issue of "documentation concerning individuals" is mainly a matter of policy, which Certec should discuss with the institution in question. Certec will strive for the highest possible level of transparency.

 

Keywords: ethics, principle of public access to official records, Health and Medical Care Services Act, Code relating to Parenthood and Guardianship.

 

a. Background

Today, thanks to technological progress, people with disabilities are able to make constructive use of various technical devices to assist them in their daily activities. Many of these devices facilitate communication and a new kind of openness. If a conflict arises between the individual’s wish to document and make his own history available to himself and others on the one hand and, on the other hand, the wish of certain individuals in his surroundings to maintain confidentiality – who is "in the right?" What is the legal position?

b. Analysis

A run-through of the legislation in the areas of healthcare, freedom of expression, and confidentiality reveals that there are no provisions in the public law that are applicable to the above-described situation.

 

The type of publication discussed here is not covered by the legislation concerning confidentiality. Photos of participants at a day center do not create a need for confidentiality. However, documentation may be prevented by agreements between the special school, the day center, or the like and the participants. The participants, or their parents in the case of minors, are considered to be clients. Accordingly, the issue is primarily a matter of policy, which should be developed in consultation with each unit.

 

The next step consists of investigating whether this area is covered by any other parts of the law. It is possible that aspects of the issue could be related to the criminal law. There is a remote possibility that the crime of libel, i.e. subjecting someone to disrespect (Ch. 5 s. 1 of the Criminal Code), could arise in connection with the situation described above. However, this seems rather far-fetched and would most likely not be applicable in practice.

 

Furthermore, the legal capacity of the participants must be taken into consideration. In other words, it must be established whether the individuals who appear in the photographs are legally competent. Today, there are generally very few cases where a person is deprived of his full legal capacity. Nevertheless, trusteeship and administratorship may apply in some cases in the present context. In addition, participants under the age of 18 are always considered to be minors.

 

These issues are dealt with in the Code relating to Parenthood and Guardianship. A person under the age of 18 is a minor (Ch. 9 s. 1) and is normally under the guardianship of his parents (Ch. 10 s. 2). Furthermore, administratorship or trusteeship may apply to individuals over the age of 18: "If necessary, the court should provide a guardian for an individual who because of illness, mental disturbance, failing health, or similar circumstances requires assistance in ensuring that his legal rights are observed, in managing his estate, or in providing for himself" (Ch. 11 s.4). If it is deemed that an administrator is not sufficient, the court should appoint a trustee. (Ch. 11 s.7). The code provides, as a general rule, that the individual should be allowed to perform legal acts on his own, with the consent of the trustee (Ch. 11 s. 10). If the individual enters into agreements without the consent of the trustee, the other party has the right to be released from the agreement, as long as it has not been approved or been discharged by performance (Ch. 9 s.6).

 

It is thus desirable that an administrator or trustee always be informed of circumstances affecting the individual under administratorship or trusteeship. If the person is under the age of 18, the parents, in their capacity as guardians, should be informed.

 

c. Conclusion

From an ethical point of view, it is never defensible to deny an individual the right to his own history. The question of who has the right to decide whether a person should appear in a photograph has not been clearly answered by the law. If the person in question is under the age of 18, it is reasonable to inform his parents of the publication of such a photograph. Moreover, there are situations involving trusteeship and administratorship that may be of importance in this context. If the individual is over the age of 18, he should be allowed to make his own decision as to whether he wishes to appear in a photograph that will be published. Nevertheless, the issue is very interesting in that it brings to the fore the need for the individual to have the right of disposition of information concerning himself.

 

The argument in favor of publishing is that the individual has the right to his own history. A possible argument against publishing is that there is a risk that relatives will see it some kind of violation of their own or the individual’s integrity. However, the latter interpretation would mean acting in accordance with an outlook on people which is inhumane and out-of–date.

 

If an individual wishes to protect himself against any photographs being published, he may choose to enter into an agreement to that effect. Suitably, this is done by means of a reservation clause in which the individual himself, or his guardian, trustee or administrator, expresses his standpoint. He must clearly state that he does not wish that a photograph of himself should appear, for instance, on the homepage of a special school. Without a reservation clause, there is no legal foundation for abstaining from publishing such a photograph. Furthermore, in this context, the obtaining of informed consent carries great weight.

 

If someone publishes such a photograph despite the existence of a reservation clause, it may constitute questionable conduct. However, it would not amount to a breach of confidentiality under the Secrecy Act, but rather a breach of contract.

 

4. Internet Code of Conduct

 

Certec’s Internet Code of Conduct

The code of conduct was adopted in January 1999 and is applicable to all material published on or after the 20 of January 1999. To the greatest extent possible, material published prior to that date should be revised if it does not comply with the Code of Conduct.

The Code is intended to facilitate decision-making concerning what should or should not be published and how it should be done. It forms the basis for a continuous internal discussion about the Code itself, its consequences, and any need for changes. It shall also serve to inform the public of our basic rules.

The Internet Code of Conduct primarily answers the question: "Should this information be made public at all?" As a general rule: YES. The availability of information from Certec should be characterized by the AHARA principle (As High As Reasonably Achievable) for two reasons. First of all, because article 27 of the Universal Declaration of Human Rights states that "Everyone has the right to (...) share in scientific advancement and its benefits". And secondly, because we have a special responsibility to make information accessible to people with disabilities.

 

The fact that Certec has an Internet Code of Conduct does relieve the individual staff member of his responsibility for the thoughts he chooses to make available as well as those he chooses to keep secret. This responsibility comprises spoken and written information, including information published on the Internet. Each staff member must decide, to the best of his ability, what information he wishes to disclose and what information he wishes to keep secret.

 

Internet Code of Conduct

Each time you consider publishing something on Certec’s website you should ask yourself the following questions:

 

1. Legal aspects

Are there any legal obstacles?

If you are uncertain: ask the webmaster! The answer to questions from people outside Certec as to whether they are permitted to quote from texts or reproduce pictures from our non-password-protected material should always be: "Absolutely, as long as you acknowledge the source."

 

2. Ethical aspects

What are the ethical arguments in favor of publishing?

Ethical questions can seldom be answered with a simple yes or no – and one must learn to live with this uncertainty. However, decisions must be taken. Follow the steps below in order to make such a decision easier:

a. Always ask the individuals concerned! Inform them of any consequences you can foresee in a worst case scenario as outlined below. Allow sufficient time for this dialogue.

b. Try to see the ethical problem in question from two points of view by painting a worst case scenario on the one hand, and by playing down any possible ethical implication on the other. Allow these perspectives to challenge one another in your mind.

c. If you still feel uncertain, discuss the matter with your colleagues at Certec. Call a meeting if necessary. Keep in mind that it may be as great an error not to publish as it would be to go ahead with the publication.

 

3. Practical Aspects

The following general rules apply to how the information should be made available in practice. Any deviation from these rules must be preceded by a submission in writing to the webmaster stating reasons.