Documents to be submitted when requesting ethical review

Documents to be submitted when requesting ethical review

The request for ethical review must be one PDF document consisting of all the information listed below. This document must be submitted to the Ethics Committee’s secretary by e-mail. In addition, the cover note must be printed, signed and submitted to the secretary as a hard copy.

Please submit your request at least two weeks before the meeting at which you wish to have your study discussed.

Please ensure the language of the request is clear and understandable. The request must contain the following information (please number each item and present them in the following order):

Nb. The committee does noet grant research perimission for the study, but it should be obtained form the organisation in question before the reseach process has been launched. The ethicall committee gives a statement on the ethical aspects relating to the statement request/research plan.

 

1. Cover note, including the following:

  • Contact details for the person in charge of the research
  • Reasons for submitting the request
  • Possible grounds for confidentiality

The Ethics Committee wishes to promote openness in ethical reviews but allows concealment, for example, in cases where the sponsor's agreements so require. Confidentiality concerns the information published on the Ethics Committee’s website (i.e. reasons for submitting the request, applicant’s evaluation of the ethicality of the study, summary of the research plan and the Ethics Committee's decision); other information and documents submitted to the Ethics Committee are not public.

2. Research plan (paginated) and a summary. Please note that if the study is conducted in English, the summary must be submitted in Finnish. The summary must be written so that the researcher and possible partners agree to publish it on the Ethics Committee's website under 'Decisions' unless the summary is confidential (see section 24[1:21] of the Act on the Openness of Government Activities). The research plan must be clearly defined. NB: The research plan must clearly indicate if the study is part of a larger research programme or if it involves other research projects (e.g. doctoral dissertation work).

3. Evaluation of the ethicality of the study by the person in charge of research

4. Announcement to research subjects

a. If the study deviates from the principle of informed consent, please present reasons in the section where you evaluate the ethicality of study.

5 Notice of consent for research subjects to sign (form A). The notice of consent is required in addition to the announcement if data are analysed with identifiers and include sensitive information. Model notices of consent:

6. Other materials provided to research subjects (interview schedule, diaries, questionnaires, etc.)

7. Data management plan (i.e. plan for handling, storing and archiving data). Nb. Large research projects involving several parties should include a mention of how the parties have agreed on the use of the material and how copyrights have been defined. This would apply to requests for statement dealt with from the year 2017 onwards.

8. Description of the file from the Data Protection Ombudsman:  if the study involves collecting information with identifiers: description of scientific research data file

When seeking consent from a minor's parent or other guardian, consent forms must also be submitted with the request. If a research subject is unable to provide his/her consent, for example, for a reason related to mental health or intellectual or developmental disability, consent must be obtained from the subject's guardian or legal representative. This consent form must also be included in the request.

In addition, the applicant must ensure that the following information is clear from the request:

  • People and organisations participating
  • Summary of the study
  • Schedule
  • Funding
  • Data collection (target groups and methods)
  • Research permits and consents
  • Consent to use the data for some other use than research (e.g. in teaching)
  • Voluntary participation and the right to withdraw from the study
  • Risks and benefits
  • Safety of the equipment used in the study
  • Confidentiality of information
  • Recording and storing data
  • Insurance policies
  • Feedback provided to research subjects
  • Letters to research subjects (see models)
  • Consent forms (see models)
  • Questionnaire and evaluation forms and interview schedule

Please note that the request must include a table of contents with appropriate page numbers. The table of contents must comply with the guidelines and structure provided above in items one to eight. The information presented in the bulleted list above can be included in the research plan and letter to research subjects.

Model table of contents

Letter to research subjects

The letter to research subjects must include the information listed in items one to seven below. Please pay attention to the following:

  • The clarity and intelligibility of writing
  • The language of the study; in multinational studies, the letter to subjects and the consent form must be submitted to the Ethics Committee in Finnish
  • The logic and information value of the letter to subjects
  • The intelligibility of the letter provided to research subjects; subjects must be able to understand the letter and ethical questions related to the study.

 

Take a look at the guidelines on informing Research Participants 

Informing research participants, please see Content of information to participants and write the participant information sheet as instructed in points 1-8 in above link. The ethics committee emphasizes that the announcement to research objects should be clear and intelligible. Disciplinary jargon should be avoided. The announcement should clearly indicate what the participants of the study agree to.

1.Contact inormation

2.Subject and objectives of the study.  The description of the research should alsoo mention whether the research entails any benefits or drawbacks to the research subjects and give the reasons why that is.

3.Data collection

4.Voluntary nature of participation. There should be a mention in the information letter whether the research subjects are rewarded in some way (for example cinema ticket, fee etc.) or not.

5.Maintaining confidentiality

6.Combining register or record data to information supplied by subjects

7.Maintaining privacy in publications

8. Informing about archiving and further use of the data


Further information on informing research participants, for example on the voluntary nature of research participation.

N.b. The collected research material should be restored the minimun time of five (5) years, if not ordered otherwise (for instance by the financer of the research).

 

The Ethics Committee will provide the following information on each study on its website unless the researcher prohibits this:

  • The applicant’s reasons for requesting an ethical review and his/her evaluation of the ethicality of the research
  • The researcher’s summary of the research plan
  • The Ethics Committee’s decision