ERB Submission Guidance

Transcription

1 ERB Submission Guidance Dr. Nina Kupper, chair ERB Dr. Annemiek Karreman, vice-chair ERB Table of Contents Which research needs to be reviewed... 2 Level of review... 2 Exempt:... 2 Expedited:... 5 What to prepare?... 5 How to submit?... 6 Full review:... 6 What to prepare?... 6 How to submit?... 6 Urgency exception... 7 Ethical clearance and the educational program... 7 Bachelor... 7 PPO/research practicals Bachelor thesis Master... 8 Master thesis Documents required for each of the levels of review... 9 Exempt:... 9 Expedited & full review:... 9 Flow chart of the ethical clearance procedure... 10

2 Which research needs to be reviewed All research in which research participants are taking part, is subject to review of the ethical aspects of the research. The ethical review follows the guidelines as stated in the national code of ethics for research in the social and behavioral sciences (2016), which can be downloaded from the ERB website. Level of review The ERB will use three levels of review: exempt, expedited, and full review. Exempt: Some minimal risk research is exempt from full ERB review. Exemption waives only the need for an expedited or full review, but does not negate the need for the consent of research participants. Exempt categories 1. Research involving the collection or study of existing data, documents or records, if these sources are publicly available, or if the information is retrieved in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. Procedure: This research can be carried out without ERB oversight. Nevertheless, these studies need to be recorded administratively. This means that you fill out the exemption checklist for category 1 at [choose Exemption checklist] and submit the form. What will the ERB do: the ERB will review the submitted responses. If a study is not compliant with the checklist, the ERB will notify the researcher that a higher level of review is necessary. If the study is compliant, the ERB will not send a response. CATEGORY 1: Existing data Does your study exclusively concern the analysis of existing data, document or records? Are the sources of the existing data, documents or records are publicly available OR is the information will be recorded by the investigator in such a manner that participants cannot be readily identified either directly or through identifiers (such as a code) linked to them If the study uses de-identified data, does the investigator or study staff have access to the key to the code permitting re-identification of the person whose data are being studied? If any of the grey boxes are checked, the study is not qualified for exemption and will require the submission of a full protocol. YES NO 2. Research involving the collection of data through anonymous surveys or interviews, or the observation of public behavior, provided that the obtained information a) cannot be traced back directly or indirectly to the individual and b) does not harm or discomfort the individual in any

3 way. Whenever possible, individuals should be informed using an introductory script to inform the participant about the research and its requirements and about the rights associated with being a participant (not obligated to participate, free to quit at any time during the research). Procedure: The researcher needs to fill out a short checklist (including the proposed introductory script), which needs to be submitted to the ERB. After exempt status has been confirmed, the research may be carried out. Thus, fill out the exemption checklist for category 2 at [choose Exemption checklist and scroll down] and submit the form and requested other documents. What will the ERB do: the ERB will review the submitted responses. If a study is not compliant with the checklist, the ERB will notify the researcher that a higher level of review is necessary. If the study is compliant, the ERB will send an exemption accepted letter, or some changes to the introductory script are requested before clearance can be granted. CATEGORY 2: ANONYMOUS DATA COLLECTION WITH MINIMAL RISK YES NO The research will involve only the use of anonymous survey procedures, interview procedures or the observation of public behavior Will participants be asked to report their own or others' sexual experiences, alcohol or drug use, or suicidal thoughts, and will their identities be known to you? Are any participants confined in a correctional or detention facility? The research procedure does not harm or discomfort the individual in any way (e.g., research topic, or study activities) Please state your research question: Please describe your sample: Please shortly describe recruitment procedure: Please describe the methods of data collection briefly: If any of the grey boxes are checked, the study is not qualified for exemption and will require the submission of a full protocol. Submit: introductory script and informed consent form AN INTRODUCTORY SCRIPT IS A WRITTEN OUT DESCRIPTION OF WHAT YOU WILL TELL A POTENTIAL (ELIGIBLE) RESEARCH PARTICIPANT BEFORE STARTING A RESEARCH ACTIVITY (INTERVIEW, SURVEY, EXPERIMENT).

4 3. Classroom projects (e.g. PPO, research practicals) that are designed solely to instruct students about research methods and data collection procedures do not require ERB oversight. These projects (supervised by a faculty member) are for practice only, and do not generate generalizable knowledge. Individuals asked to participate in such projects need to be informed that it is a student project with the aim to practice research methods, and that the individual is not obligated to participate. Not applicable for topics requiring full review. Procedure: The supervisor (together with the students) needs to fill out a short checklist (including the proposed introductory script/information letter & consent), which needs to be submitted to the ERB. After exempt status has been confirmed, the research may be carried out. Thus, fill out the exemption checklist for category 3 at [choose Exemption checklist and scroll down] and submit the form and requested other documents. What will the ERB do: the ERB will review the submitted responses and attached documents. If a study is not compliant with the checklist, the ERB will notify the researcher that a higher level of review is necessary. If the study is compliant, the ERB will send an exemption accepted letter, or some changes to the introductory script and attached documents are requested before clearance can be granted. CATEGORY 3 The research is a Bachelor or Master level classroom project (PPO, research practical) or thesis, solely executed to learn about data collection and research methods If all goes well and good data comes out, the data might be used for scientific publication. Generalizable knowledge will be created The topic of research, research methods, and/or the research population concern patients, a vulnerable population (e.g., incapacitated, children, mentally challenged, traumatized, pregnant), an intervention, or a taboo subject (e.g., own or others sexual activity, hard drug use, suicide thoughts) If any of the grey boxes are checked, the study is not qualified for exemption and will require the submission of a full protocol. List of students involved in the research (please provide full name and ANR). YES NO Submit: introductory script and informed consent form and fill out statement of use

5 Statement of use I, [name supervisor, ANR].., declare that the current research for which exemption category 3 is requested, will be used for educational purposes only. Data collected in this research will not add or create generalizable knowledge, and will not be used for scientific publication. I certify that the participant will be informed that the research concerns a student project, with the aim to practice research methods. I certify that the information provided in this application, and in all attachments, is complete and correct. I understand that I have ultimate responsibility for the protection of the rights and welfare of human participants, the conduct of this study, and the ethical performance of this research. Expedited: Minimal risk research, of which the probability and magnitude of anticipated discomfort are not greater than those ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations or tests. Examples of research falling under the expedited category include (but are not limited to) research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Procedure: The expedited procedure includes the submission of a research proposal and accompanying documents, which are sent out for review to one committee member and one reviewer (TSB faculty member). Reviewer comments are sent to the researcher within approx. 2 weeks after submission, who then is either invited to submit a revision or receives ethics clearance. In case of a revision, ethics clearance is obtained most of the time within 1-2 weeks after its submission, depending on the pervasiveness of the revision. What to prepare? The investigator fills out a research proposal form and submits it to the committee with accompanying relevant documents, e.g., information letter, informed consent, advertisement, and written debriefing. The research proposal form contains a summary of the proposed study or research line, including background, research question(s), study design (written out for each experiment in case of a research line), procedure & materials (written out for each experiment in case of a research line), calculation and argumentation of effect and sample size(s), proposed statistical analyses, and scientific and/or societal relevance. Investigators are requested to give sufficient information on the data collection procedures (manipulations, stimuli, questionnaires, certainly when they may be ethically sensitive). Researchers may be asked to provide the entire survey, depending on familiarity. Moreover, the research proposal form contains sections on subject information (e.g., study population, recruitment, burden, potential negative

6 consequences of participation, and measures that have been taken to protect study participants), data archiving and privacy, and data use and publication. How to submit? The investigator first downloads the research proposal form from the online submission site of Ethics Research Boards and fills it out. The investigator then completes a web-form with submission information, for example title of research proposal, principal and other investigators, grant supplying funding organization, nature of the study, starting date and planned duration, and indicates whether the WMO law applies (NB. If MWO law applies, the proposal needs to be submitted to METC Brabant). Next step is to upload the research proposal form and all other relevant documents to the form and to submit the proposal. Full review: In case there is doubt whether or not the research is subject to the WMO (Medical research), when a vulnerable population (e.g., incapacitated, children, mentally challenged, traumatized, pregnant) is studied, when researchers propose to use passive consent, when the research involves an intervention or when the research involves a taboo subject, the submitted research proposal and accompanying documents receive a full review. This means that the proposal is discussed by the entire committee in the monthly committee meeting, which takes place on the first Thursday of the month. What to prepare? The investigator fills out a research proposal form and submits it to the committee with accompanying relevant documents, e.g., information letter, informed consent, advertisement, and written debriefing. The research proposal form contains a summary of the proposed study or research line, including background, research question(s), study design (written out for each experiment in case of a research line), procedure & materials (written out for each experiment in case of a research line), calculation and argumentation of effect and sample size(s), proposed statistical analyses, and scientific and/or societal relevance. Investigators are requested to give sufficient information on the data collection procedures (manipulations, stimuli, questionnaires, certainly when they may be ethically sensitive). Researchers may be asked to provide the entire survey, depending on familiarity. Moreover, the research proposal form contains sections on subject information (e.g., study population, recruitment, burden, potential negative consequences of participation, and measures that have been taken to protect study participants), data archiving and privacy, and data use and publication. How to submit? The investigator first downloads the research proposal form from the online submission site of Ethics Research Boards and fills it out. The investigator then completes a web-form with submission information, for example title of research proposal, principal and other investigators, grant supplying funding organization, nature of the study, starting date and planned duration, and indicates whether the WMO law applies (NB. If MWO law applies, the proposal needs to be submitted to METC Brabant). Next step is to upload the research proposal form and all other relevant documents to the form and to submit the proposal.

7 Urgency exception Most unusually, post-hoc review can take place in case research needs to happen right then and there because of a disaster or unexpected news event. Scheduled lab time is not a reason for exception. Procedure: Investigator s the ERB with Urgency exception in the message subject. In the body of the , the researcher needs to shortly describe the following: Research question Research method Population Measures taken to protect the participant Then, the researcher may commence the study, without ERB confirmation or review. The review will be completed while the study proceeding. This means that the researcher will submit the research proposal as soon as possible, but no later than 7 days after the urgency exception request was made. Ethical clearance and the educational program Bachelor PPO/research practicals - As long as projects or assignments are for practice only, and no generalizable knowledge would be created, these projects fall under exemption category 3. One would need to fill out a short checklist of important ethical aspects that need to be endorsed before a project can start. The checklist is submitted to the ERB for confirmation of exempt status and to validate that data will not be used for publication (except student presentations in the context of the course). In a limited number of cases (vulnerable populations, deception, risky methodology), the ERB will want to review the proposal itself, and a regular submission is necessary. Bachelor thesis - The majority of bachelor theses will be executed on based on an existing dataset. This means that the majority of bachelor theses will fall under exemption category 1. If a student is required to collect data, there are 2 options: 1. Expedited or full review is required when it is expected that generalizable knowledge will be created, and data will be used for scientific publication or when study characteristics require full review. To reduce the burden, it is strongly recommended to combine data collection thesis projects such that multiple theses can be written based on the same data collection and only one proposal needs to be reviewed. 2. Bachelor theses with data collection will fall under exemption category 3 when data is used for the purpose of the thesis only, no generalizable knowledge is created, and data will not be used

8 for publication. Also, the research design characteristics are such that they do not require full review. The supervisor signs an agreement on the checklist confirming this. Master Master thesis - If students collect data in the context of an existing research line that has already obtained ethical clearance, no ethical review is necessary. In any other case, the following decision should be made: 1. Expedited or full review is required when it is expected that generalizable knowledge will be created, and data will be used for scientific publication or when study characteristics require full review. To reduce the burden, it is strongly recommended to combine thesis projects such that multiple theses can be written based on the same data collection (e.g., in consecutive years) and only one proposal needs to be reviewed. 2. A master thesis project will fall under exemption category 3 when data is used for the purpose of the thesis only, no generalizable knowledge is created, and data will not be used for publication. The supervisor signs an agreement on the checklist agreeing to this. If, during the course of the experiment, the supervisor changes of opinion, the ERB chair should be contacted to discuss options.

9 Documents required for each of the levels of review Exempt: 1. Filled out checklist 2. Statement of use 3. Introductory script & informed consent (if applicable) Expedited & full review: 1. Filled out webform (admin) 2. Research proposal 3. (survey, research materials) 4. Information letter 5. Informed consent 6. Agreement external location (e.g. school, institution) 7. Advertisement

10 Exempt Expedited Full review Flow chart of the ethical clearance procedure Staff research: Choose level of review (exempt vs. expedited/full) based on above criteria Student research: Determine use and aim of research (education only vs. scientific publication) Then, choose level of review (exempt vs. expedited/full) Fill out checklist and submit introductory script/ic Submit full research proposal and additional requested documents WMO ERB reviewer concludes study meets exempt criteria Research does not qualify as exempt, or more information is needed Protocol is reviewed by committee member and reviewer Protocol is reviewed by committee member and reviewer and discussed in monthly committee meeting ERB approval Information is provided by the investigator Expedited review Revision is requested or more information is needed Revision is submitted/ Information is provided by the investigator ERB approval Research not suitable for expedited review Full review Minor concerns: Revision is requested or more information is needed Revision is submitted/ Information is provided by the investigator ERB committee member reviews revision, additional info Major concerns: Revision is requested Revision is submitted by the investigator ERB committee member and chair review revision Full review ERB approval ERB approval 2nd revision