Ratified by UFN and UFL 2009-04-02
Instructions for completing an application for review by the
Research Ethics Committee at Högskolan Dalarna
When you apply to the Research Ethics Committee you have to complete an
application form. To make it possible for the Committee to examine the application a
project plan must be attached, and when informed consent is needed you will also
have to attach an information letter. You find instructions below for filling in the
application form, and what should be included in the project plan and in the letter of
information.
Please note that the application as well as any enclosed documents should be typed.
The application
Remember that application must be signed by the manager (if applicable), applicant
and supervisor.
The numbers here refer to the corresponding numbers on the form.
1. Most studies on human beings involve some sort of ethical problem. This
might mean that individuals are subjected to some kind of discomfort or risk,
that there exists some kind of dependent relationship between applicants and
participants, that research is planned to involve a vulnerable group, or that
respect for the personal integrity of the individual is threatened by collecting
sensitive information. All such potential problems must be discussed here.
2. Under this point, further details are to be given regarding the measures taken
and any considerations for handling the ethical problems discussed in the
above paragraph. Such measures may, for instance, involve treating all
information confidentially, or not approaching individuals belonging to
especially vulnerable or exposed groups.
3. This is where you explain whether participants, or any group that they may
represent, will benefit from the investigation. Will the expected gain be of a
short or of a long-term nature for those who participate in the study?
4. The basic principle is that participants in a study should be fully informed
about the investigation before being asked to participate. In these cases a letter
of information must be attached to the application.
The project plan
To make it possible for the Committee to review the application, a project plan must
be attached. The project plan may consist of a maximum of 10 pages and shall
include:

information on the student’s research problem in a wider context

earlier accounts of results in this area/field

the purpose and problem/question

a detailed description of the method (selection of the group of subject, their
possible degree of vulnerability and the handling of data about individuals;
where appropriate, attach an inquiry or interview guide)

a preliminary timetable

forms for distribution of results

a list of references
The information letter
As part of the essay you may need to ask people if they want to take part in your
study. Then, what you must consider is that participants should be fully informed
about the investigation as well as what participation entails before being asked to
participate. The template for the information letter below is to be used. Words that are
mandatory are given in italics. However, in certain situations - for example, if the
letter is directed at children – it may be appropriate to reformulate these italicized
phrases to suit the target group.
The information is to be given in a neutral voice, be written in a clear, lucid language
and possibly form the basis of a question on informed consent. That is, it is to be
given in lay language and is not to contain any compelling or urgent request for
participation. Another important aspect of writing an information letter is to attempt
to put yourself in the place of the addressee. What would you want to know if you
received a similar request? Finally, do not forget to read through the letter very
carefully to be sure that the language is correct and easily read.
1. Heading and introductory information
It should be clear from the heading what the research is about and that the letter
provides information about the research in question. Following the header, it should
clearly state that the purpose of the letter is to request participation in the study.
Therefore, the following wording is obligatory:
a) In the heading: Information on …… (Describe the content of the study in a heading)
b) You are hereby asked to participate in this study.
2. Additional contents of the information letter
Begin the text itself with information about the objectives and content of the study.
Do not forget to explain why it is important that the study be conducted. Keep in mind
that it is the study itself that is to be presented, not those who are conducting it. In
some situations it may be appropriate to introduce yourself, but in such a situation this
should be done in the final paragraph (see point 3 below). After the objectives and
content have been presented, the practical issues should be explained, that is, which
methods for data collection will be used:
a) Begin with information about how many people are included in the study and how
the selection was made. Keep in mind that the participant would like to know why
s/he was asked to take part in the study.
b) Then, provide information about what is expected of the participant and what it
means in terms of possible pros, cons, and risks for the participants. Here is it
important to answer questions such as: How much time will participation require?
Might there be any inconvenience/discomfort? Will it be possible to examine the
results and/or the completed study?
c) Provide information about how the recorded information will be processed and
handled. The information should answer questions such as: With what degree of
confidentiality/secrecy (standard medical confidentiality or other agreements about
professional secrecy, coding, etc.) will any sensitive information be handled? Who
will have access to this information? Will material/tests containing sensitive
information be saved? If so, how, where, and for how long? How will the information
be disposed of?
In this part of the letter the following wording is obligatory:
a) Your participation in the study is completely voluntary. You may at any time end
your participation without stating your reasons.
Sometimes it may be appropriate to add that if the participant chooses not to
participate or discontinues participation it will not affect any future care (for medical
patients) or grades (for pupils/students). In this case, you should write “Your care will
be the same regardless of whether or not you participate in the study” or “Your
education will be the same regardless of whether or not you participate in the study”.
b) The study will be presented in the form of an essay at Högskolan Dalarna.
c) The study is reviewed by the Research Ethics Committee at Högskolan Dalarna.
Naturally, this is valid only when the university’s Research Ethics Committee has
reviewed the study.
3. Concluding information
In the conclusion, the place and date, as well as the names, titles, and contact
information of those responsible for the study are listed. The letter should be
personally signed. The following italicized wording and information is obligatory:
a) Further information supplied by responsible parties below
b) Place and date
c) Name, telephone number, and e-mail (of student/s and supervisor)
d) The students’ and supervisors’ signatures