1. 
RESEARCH PERMIT APPLICANT
	Name 
     	
	Address 
     	
	Telephone number and e-mail address 
     	
	Office, research institute, educational institution or other community 
     	
	Degrees earned and current profession or field of study
     
	
2. 
OTHER MEMBERS OF THE RESEARCH TEAM 
(use an appendix if necessary)
	Name 
     	Qualification and profession
     	Post 
     	
	E-mail address
     	Telephone 
     	
	Name 
     	Qualification and profession
      	Post 
     	
	E-mail address
     	Telephone 
     	
3. 
RESEARCH SUPERVISOR/
DIRECTOR
	Name 
     	
	Address 
     	
	Telephone number and e-mail address 
     	
	Office, research institute, educational institution or other community 
     	
	Qualification and profession
     	
	Date of approval of the research plan
at the educational institution

     	Director’s signature

     	
4. 
STUDY
	 4.1 Name, subject and short description of the study (objectives of the study, research questions, data collection, recruiting the subject persons)
     	
	4.2 Quality/level of research	
		Doctoral thesis		Licentiate thesis		Master’s thesis		Bachelor’s thesis	
		UAS Master’s thesis 		UAS Bachelor’s thesis 		Other, please specify
     	
	4.3 Contact person at the Social Services and Health Care Division, position, telephone number
     
 I have agreed on the implementation of the research (data collection, recruiting the subject persons) with the contact person.	
	4.4 Units/services of the Social Services and Health Care Division in which the study is to be carried out
     	

	4.5 Subject area of the research in the Social Services and Health Care Division 	
	1 Family and social services

 Well-being and health of families with children

 Child welfare services

 Services for young people and adult social work

 Services for the disabled
	2 Health and substance abuse services

 Health stations and Internal Medicine Outpatient Clinic

 Psychiatric and substance abuse services

 Oral health care
	3 Hospital, rehabilitation and care services

 Investigation, assessment and placement
 Southern service district
 Eastern service district
 Western service district
 Northern service district
 Helsinki City Hospital
	4 Administration services

 Administration services 
 Financial and planning services 
 Human resources and development services
 Information management services
 Support services 
 Communications
 Procurement services	
	4.6 Data collection method(s)	
		Survey 		Interviews		Documentary/statistical analysis 	
		Trial/experiment		Observation		Other, please specify      	
	4.7 Material related to data collection. Attached
  Information letter about the study 
  Consent document for research subjects
  Survey form	
   Interview outline
   Description of observation
   Other, please specify      	
	4.8 Planned period of data collection 	Estimated completion time of the study	
	Begins	Ends	Date	
	     	     	     	
5. 
PUBLICITY OF THE RESEARCH PLAN
	The general principle is that the research plan is a public document. A research plan may only be categorised as a confidential document based on justified grounds. The research permit applicant must check the following box if the research plan contains information categorised as confidential based on the Act on the Openness of Government Activities or other legislation. 	
	
 My research plan contains information that would, if disclosed, cause inconvenience to the researcher or the party commissioning the study or development project. Section 24(1)(21) of the Act on the Openness of Government Activities (621/1999)	
6. 
ETHICAL EVALUATION
OF THE STUDY
	6.1 How have the ethical perspectives of research been considered in this study?
     	
	6.2. Opinion from HUS’s Ethics Committee or the National Committee on Medical Research Ethics, if such an opinion is required by law (see the Medical Research Act 488/1999), and, if the study is a pharmaceutical study, opinion from the Finnish Medicines Agency Fimea.
 Attached opinion

7. 
COSTS INCURRED TO THE SOCIAL SERVICES AND HEALTH CARE DIVISION
	Estimate of the extra costs incurred to the Social Services and Health Care Division (a more detailed account may be attached as an appendix)	Hours	Euros	
	staff work contribution	     	     	
	IT services (such as collecting data from the client register)	     	     	
	material services, postal services, facilities and equipment	     	     	
	other
     	     	     	
	TOTAL	     	     	
	Sponsor(s)
     	
8. 
USER RIGHTS	Have or will you apply for user rights to the Social Services and Health Division’s information systems as part of the study?
  No -   Yes 	
	Which system and duration?
     	
9. 
DOCUMENT DATA FOR WHICH THIS PERMIT IS BEING SOUGHT	9.1 Required confidential social services and health care document data, what information and from where?
     	
	9.2 Other document data, which, from where and with what kind of permits?
     

  The statistics services' request for information is attached. (Form Te-027en)	
10. 
RESEARCH DATA FILE DATA CATEGORIES
	 The study does not include any personally identifiable information. No data file is formed.

  A detailed account of the personally identifiable information collected in the research data file (image or video material, recorded interviews, from which a person can be identified also requires the forming of a research data file).

 Attached privacy policy that the researcher must maintain for the entire duration of the study.	
	The processing of personal data means all operations that are performed on personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction. Viewing the data also constitutes use and thus processing of personal data, necessitating compliance with legislative requirements concerning the processing of personal data. 

The persons whose data is collected are data subjects. Every data controller must maintain records of their processing activities. 
(Articles 4 and 30 of the EU’s General Data Protection Regulation)	
11. RETENTION
AND DESTRUCTION/ARCHIVING OF THE RESEARCH DATA
	11.1 Description of the storing of the research data in a data-secure manner during the study.
     	
	11.2 Destruction or archiving of the research data after the study has ended. 
  The research data and all personally identifiable information will be destroyed in their entirety, how and when? 
           
  The research data will be retained without personally identifiable information, what is the destruction method of the personally identifiable information? 
           
  The research data will be archived along with personally identifiable information in accordance with the provisions of the Archival Act after the study has ended, where? 
           
  A permit will be sought from the National Archives for archiving the data without personally identifiable information.
          	
12. 
IMPACT
ASSESSMENT
	The impact assessment is based on the EU’s General Data Protection Regulation (2016/679). 
12.1 Grounds for why personal data is being requested
     	
	12.2 Grounds for why these particular categories of personal data are requested and to this particular extent 
(e.g. are all the categories of personal data requested justified from the perspective of the study).
     	
	12.3 Description of the risks concerning the research subjects’ rights and freedoms and of the measures for mitigating and eliminating said risks (e.g. protection and security measures for safeguarding the research subjects’ personal data).
     	
13. SECONDARY EMPLOYMENT PERMIT	Secondary employment permits are applied for the following members of the research team employed by the Social Service and Health Care Division for the purpose of carrying out the study.
     	

14. 
SECRECY OBLIGATION AND SIGNATURES OF THE RESEARCH PERMIT APPLICANT AND RESEARCH TEAM

	I agree not to disclose any confidential information used in connection with the study to third parties.
The abovementioned agreement is an obligation to maintain the professional secrecy of the information I gain during the study.
Every person who handles data contained in confidential documents or personal data files must sign a promissory note, either with this form or a separate appendix, with the same contents.

The promissory note must always be submitted as an original copy (not via e-mail).
 	
	Date                                Signature and name in block capitals

                         	
	Date                                Signature and name in block capitals

                         	
	Date                                Signature and name in block capitals

                         	
	Date                                Signature and name in block capitals

                         	
	Date                                Signature and name in block capitals

                         	
	Date                                Signature and name in block capitals

                         	

RESARCH PERMIT APPLICATION INSTRUCTIONS

Read these research permit application instructions thoroughly and be sure to follow them. Applications that are not filled out according to these instructions will not be processed. 

Research permit application
1.	Research permit applicant. Fill in the applicant’s current contact information. 
2.	Members of the research team. Fill in the required information.
3.	Research team supervisor/director. Fill in the required information. The director’s signature is mandatory.
4.	Study
4.1 Name, subject and short description of the study (objectives of the study, research questions, data collection). Fill in the required information.
4.2	Level of research. Check the applicable options.
4.3	Contact person at the Social Services and Health Care Division. Before applying for a research permit, the applicant must designate a contact person with whom they agree on the conducting of the study. 
4.4	Units/services of the Social Services and Health Care Division in which the study is to be carried out. The applicant must confirm the place where the study is to be carried out with their contact person.
4.5	Subject area of the research in the social services and health care sector. The applicant must confirm the place where the study is to be carried out with their contact person.
4.6	Data collection methods. Check the applicable options.
4.7	Material related to data collection. Check the applicable options and add the relevant appendices to the application.
4.8	Planned period of data collection and completion time of the study. Enter the estimated times.
5.	Publicity of the research plan. The research plan may be designated as confidential only if it contains information categorised as confidential based on the Act on the Openness of Government Activities or other legislation. 
6.	Ethical evaluation of the study. Specify how the ethical perspectives of the study have been considered and attach the opinion from HUS’s Ethics Committee or the National Committee on Medical Research Ethics.
7.	Costs incurred to the Social Services and Health Care Division. The applicant estimates the required personnel resources and other costs in collaboration with their contact person.
8.	User rights. The applicant must confirm the required user rights and systems with their contact person.
9.	Document data for which this permit is being sought.
9.1   Required confidential document data. Specify what data is being sought and the systems that it is being sought from in as much detail as possible. The applicant must confirm with their contact person whether the collection of the specified data is possible.
9.2   Other document data. Specify any other document data required that is not confidential.
10.	Research data file data categories. Check the applicable options in accordance with the research plan. For more information on data protection, see the EU’s General Data Protection Regulation 2016/679 and www.tietosuoja.fi. 
11.	Retention and destruction/archival of the research data. 
11.1   Description of the storing of the research data in a data-secure manner during the study. Add a brief description.
11.2   Destruction or archival of the research data after the study has ended. Check the relevant option and add a brief description.
12.	Impact assessment. The impact assessment is based on EU regulation 2016/679.  The purpose of the impact assessment is to describe the processing of personal data, evaluate the necessity and appropriate scope of the processing and assess the risks resulting from the processing of personal data and the necessary measures for addressing said risks. An impact assessment is mandatory when there are likely to be high risks associated with the processing of personal data. The purpose of the impact assessment is to help the data controller comply with the requirements of the General Data Protection Regulation and demonstrate compliance.
12.1-12.3   Enter the required information. Continue the description in an appendix, if necessary.
13.	Secondary employment permit. Fill in if necessary.
14.	Secrecy obligation and signatures of the research permit applicant and research team. Add the applicant’s signature and the signatures of every member of the research team, add an appendix if necessary.

Research permit application appendices
Required appendices to the research permit application:
1)	Research plan. If the text part of the research plan is over 10 pages long, add a summary that clearly describes the purpose of the study, data collection, research methods, data storage during the study and destruction of the research data after the study.  
2)	Consent document.
Voluntary consent must be requested from research subjects in writing before the start of the study. The consent document must include the following information:
-	A short description of the study, its purpose and how the client was selected for the study.
-	How the client’s contact information was acquired.
-	What data will be collected from the subject.
-	How the client’s data will be protected and an assurance that the data will be processed and presented in all stages of the study in such a way that individual client information is not disclosed.
-	Who will process the data.
-	Whether data is also collected from other sources, and if so, on what grounds.
-	Whether the data will be disclosed outside of the research team.
-	Whether the data will be transferred to a third country.
-	How the results will be reported and published.
-	The duration of the study (how long the collected data will be processed for).
-	What will happen to the research data file after the study.
-	The client’s right to refuse and withdraw from the study at any point of the study without negatively affecting their client relationship of the availability of services. The client must also be made aware of to whom they may submit their refusal.
-	The consent document must be dated and signed by the consent giver and receiver. A copy of the document must be given to the consent giver.
-	The notification, consent document and survey must also be available in Swedish, if needed.

The consent form, as referred to in section 6 of the Medical Research Act, must include:
1)	the name of the subject, their personal identity code or date of birth and address
2)	an account of the notification given to the subject and the giver of this information, in accordance with section 6(3) of the Medical Research Act
3)	an account of where else data related to the research subjects will be collected from
4)	an account of to whom data collected during the study may be disclosed to and how the confidentiality of the information will be secured
5)	the voluntary consent of the subject 
6)	mention of the right to withdraw consent without the withdrawal affecting the subject’s right to receive required treatment.
7)	mention of the fact that any data collected prior to withdrawal will be processed in accordance with Section 6a of the Medical Research Act.

3)	Information letter, which must include the following information in plain language that the target group can understand:
-	A short description of the study and its purpose.
-	How the results will be reported and published.
-	How the client’s data will be protected and an assurance that the data will be processed and presented in all stages of the study in such a way that individual client information is not disclosed.
-	The form must be written in plain language and in a way that the target group can understand.

4)	Opinion from HUS’s Ethics Committee or the National Committee on Medical Research Ethics, if such an opinion is required by law (see the Medical Research Act 488/1999).
5)	If the study is a pharmaceutical study, opinion from the Finnish Medicines Agency Fimea.
6)	Material related to data collection (such as a survey form).
7)	Privacy policy.

Requirements imposed on the author of the study by the EU’s General Data Protection Regulation

The City of Helsinki is the data controller, the researcher is a data processor as well the data controller of the research data file.

The researcher must notify the Social Services and Health Care Division’s development services without undue delay if they become aware of a personal data breach: tutkimusluvat.sote@hel.fi, tel. 09 310 5015. 

Regulations concerning processing:
1.	The parties agree to comply with currently valid legislation concerning the processing of personal data and the protection of privacy, such as the EU’s General Data Protection Regulation, in the processing of persona data.
2.	The data controller is responsible for ensuring that it has a lawful basis for transferring personal data [to the researcher] for processing. 
3.	The researcher is responsible for ensuring that they have a lawful basis for processing personal data.
4.	The researcher agrees to: 
-	process the personal data that they acquire only in accordance with the Data Controller’s instructions and the law, and as a joint controller also and only in accordance with the research plan 
-	notify the Data Controller without delay if they consider the Data Controller’s instructions to be unlawful
-	ensure that the persons who process or have access to personal data have agreed to comply with obligations to maintain secrecy
-	see to it that personal data is appropriately protected, in order to ensure the confidentiality, integrity and availability of the personal data 
-	[help the Data Controller fulfil the Data Controller’s obligation to respond to requests for exercising the data subject's rights by, for example, providing the Data Controller with the data subject’s personal data in machine-readable format upon request] 
-	delete or restore, depending on the Data Controller’s choice, after the end of [the study] all the personal data received from the Data Controller, unless otherwise required by compelling legislation
-	notify the Data Controller without undue delay after becoming aware of a personal data breach
-	assist the Data Controller in complying with its obligations by, for example, providing the Data Controller with necessary information
-	allow and participate in audits conducted by an auditor authorised by the Data Controller. The audit must not endanger scientific freedom.
-	notify the Data Controller of any information requests from the authorities concerning the processing of personal data, unless doing so would constitute a violation of compelling regulation.

The application must be sent to:

City of Helsinki
Registry, Department of Social Services and Health Care
PO Box 10, 00099 City of Helsinki