A Guide to the Preparation of Research Ethics Applications

1 A Guide to the Preparation of Research Ethics Applications Prepared by Bernd Kurz, PhD Professor Emeritus and Chair of UNBF Research Ethics Board Presented at Kinesiology Colloquium University of New Brunswick Fredericton, N.B. 31 October 2008

2 REB review required for: All research involving human subjects, human remains or secondary use of data about humans. UG course based research (except Honors theses) may be reviewed by Departments/Faculties.. Excluded from REB review are studies related directly to assessing the performance of an organization or its employees or students, within the mandate of the organization or according to terms and conditions of employment or training; Quality assurance studies, performance reviews or testing within normal educational requirements, all with no research component. Excluded from REB review is research involving public material, and a limited REB review is conducted for research involving individuals in the public arena on public matters. Non-research projects involving humans are reviewed by the UNB Human Ethics office. Definition of Research: A systematic investigation to establish facts, principles and generalizable knowledge. Some Statistics: Applications by Departments in 2007 Psych Educ Kines Nurs Socio Busin Biomed CompS IntDiscp Other 26.7% 20.0% 12.0% 9.3% 6.0% 3.3% 2.7% 2.7% 2.7% 14.6% Applications by Principal Investigators in 2007 Faculty Graduate UG students 46.7% 40.7% 12.6% if F&G/UG use F, if UG&G use G TCP - Eight Guiding Principles: Respect for human dignity Respect for free and informed consent Respect for vulnerable persons Respect for privacy and confidentiality Respect for justice and inclusiveness Balancing harms and benefits Minimizing harm Maximizing benefits The adherence to the above principles is reflected in the Q&A sections of the REB application. Resources: Tri-Council Policy Statement (TCP), http://www.pre.ethics.gc.ca/english/pdf/tcps%20october%202005_e.pdf Panel on Research Ethics (PRE) Interpretations, http://www.pre.ethics.gc.ca/english/policyinitiatives/interpretations/index.cfm UNB Policy (UNBP), http://www.unb.ca/research/ors/forms/ethicpol.pdf UNB Requirement for Informed Consent (part of UNB REB Application) Queens University Informed Consent form, http://www.queensu.ca/vpr/greb/instruct.htm UNBF Guidelines UNBF Checklist

3 University of New Brunswick Application for Review of Research Involving Humans Principal Investigator(s): Name(s); Academic Status (Faculty, Undergraduate Student or Graduate Student); Academic Unit, e-mail Address, Office Telephone, Home Telephone: UNB REB has review jurisdiction over UNB personnel and students, regardless whether research is carried out at UNB or at other sites. PI is ultimately responsible for actions of those acting with delegated authority. It is prudent to include all co-investigators and supervisors in the application. Title of Proposed Research: Concise but descriptive title, with no danger of misrepresenting research Commencement Date: Completion Date: Co-Investigator(s): Academic Unit, e-mail address, Office Telephone Include co-investigators both at UNB and other at other institutions/sites. If multi-centered research, then independent ethics review by other institution/site authorities is necessary. If UNB research is carried out at other sites, permissions and/or independent ethics review by other institution/site is necessary. Aboriginal research requires participation and ethics review by native communities. Supervisor(s) (if Principal Investigator is a student); Academic Unit, e-mail address, Office Telephone: Always include all supervisors. The undersigned parties certify that they have read, and undertake to comply fully with, the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans. Signers are fully responsible for their actions. This includes the implementation of ethics protocols within the framework approved by the REB, and for adherence to the laws at the home site or other sites where the research is carried out. Principal Investigator(s): Co-Investigator(s):

4 Supervisor(s): The undersigned certifies that the proposed research has been reviewed by, and is acceptable in all respects to, the academic unit(s) responsible. The Signer confirms that the research is approved by the academic unit. This implies much more than ethics, such as support for research, availability of resources, fit within research programs. Normally signed by Department Chair/Dean or delegated person. Dean/Director/Chair(s) Typed Name Signature Date submitted to the REB: 1. Summary: Provide here, in approximately 300 words, a summary of the proposed research, indicating clearly the role of the research subjects and any procedures to which they will be subjected. This summary should be a concise and balanced outline of the research and how human subjects are involved, focusing on the ethics related protocols. This summary is circulated among the members of the REB for review, and needs to have all relevant aspects to judge the appropriateness of the procedures. The REB members do not see the full application in case of an expedited review. 2. Risk: In your opinion, does this research pose more than minimal risk (Tri-Council Policy, Section 1.C1) to participating subjects? Yes No If yes, provide here a statement that describes in detail the aspects of the research procedure that pose a risk to subjects, and provide your assessment of the risk of harm (probability and severity). Note that not only physical injury but also anxiety or embarrassments are included in the concept of harm. Describe means adopted to minimize risk, and means (such as provision of counseling) to deal with harms, which subjects may experience. Describe as well the potential benefit, which will result from this research, which justifies the above risk of harm. Definition of Risk: Participants reasonably expect to participate in research activities in which the potential risk of harm is no greater than that which they experience in aspects of their everyday lives related to the research. Risk of harm can be physical, mental, emotional, and also depends on sensitive and controversial research topics, possible stigmatization.

5 The REB review includes an assessment of the balance between risk and benefits. If there is an elevated risk of harm, there must be benefits to the subjects or to research. Type of review: If risk is not greater than minimal risk and no deception or partial disclosure, expedited review is allowed. If risk is greater than or equal to minimal risk, full REB review is required. 3. Deception: Does this research involve deception or partial disclosure? Yes No If yes, refer to the Tri-Council Policy, Section 2, specifically Article 2.1(c) and subsequent commentary, and provide here an explanation of how you plan to comply with the requirements of that Section for debriefing. Describe as well the potential benefit, which will result from this research, which justifies waiving the normal requirements for full disclosure. Deception or partial disclosure of procedures is sometimes necessary for research in order to obtain unbiased and valid results. Deception may be permissible by including evidence that a set of conditions is met: (a) no more than minimal risk; (b) is unlikely to adversely affect the rights and welfare of subjects; (c) is necessary for the practical conduct of the research; (d) debriefing of subjects about the research after participation; (e) consent does not involve therapeutic intervention. Type of Review: If risk is not greater than minimal risk and research involves deception or partial disclosure, and all conditions above are satisfied, expedited review is allowed. If research involves deception or partial disclosure, and conditions above are not satisfied, full REB review is required. 4. Funding: Has funding been received for this research? Yes No If yes, from what agency and for what period? REB review requires a basic scientific assessment of research for scientific merit. For not more than minimal risk the following is acceptable: Peer review, e.g. approval of research proposal, funding approval, Department/Faculty/GAU approval for student projects acceptable, Excluded from scientific review is research in Humanities and Social Sciences.

6 For more than minimal risk: A more rigorous scientific review with external reviewers is required If yes, from what agency and for what period? 5. Research Subjects: 5.1 Number of Subjects: How many subjects will participate in this research? 5.2 Recruitment: How will they be recruited, and from what population? Sufficient information needed to assess voluntariness of participation with no coercion (active) and undue influence (passive) Outline recruitment in detail, by whom and how potential subjects are approached No position of authority or trust (professor/student, doctor/patient, employer/employee) rd If needed, involve independent 3 party (e.g. RA instead of professor) Sufficient time to contemplate participation Protection of subject identity (anonymity), where possible (e.g. surveys vs. lab experiments) Justify inclusion/exclusion criteria applied to population Public posters/ads to include REB approval # 6. Informed Consent: 6.1 Informing Subjects: How will the nature of the research be explained to potential subjects, in compliance with Section 2D of the Tri-Council Policy? Attach a copy of any document(s), such as an explanatory letter, to be used for this purpose. Informed Consent is central in research ethics and crucial to meet the TCP Guiding Principles Full, but concise, disclosure of all aspects of research objectives, procedures and expectations, and privacy considerations to allow for a fully informed consent If e-mail or web based surveys, full information must be included in lead-in page See Requirements for Informed Consent Forms for details:

7 Researcher name(s), UNB affiliation, contact info, supervisor if student PI Independent contact person and contact information Invitation to voluntary participation Free to withdraw at any time (including data) Free not to answer any question, with consequences (for interviews, surveys) Clear purpose of research in understandable language of target subjects (no scientific jargon, abbreviation) Full procedures and expectation disclosure Time period needed, any other expenses incurred Feedback on research results indication how result summary can be requested debriefing if needed (e.g. if deception or partial disclosure is involved) Potential risks, and benefit to subjects benefits needed if risk of harm exists mitigation of risk of harm (physical or emotional) Inducements and consequences on withdrawal Recording mechanisms (paper, audio, video, telephone) Permission, secure storage, access and destruction of data Compensation for injury Privacy protection no blanket statement - indicate context (e.g. public reports) of identity of individuals (anonymity) of identifiable personal data for discussion group need subjects agreement to privacy and confidentiality of others possible breach of confidentiality (e.g. reportable child abuse) must be noted If Internet is used, state risks of compromising privacy by unsecured E-mail and web 6.2 Consent: If written evidence of informed consent will be obtained, attach a copy of the consent form. (See Requirements for Informed Consent Forms.) If written evidence of informed consent will not be used, explain here, in detail, how you intend to comply with the requirements of Section 2A of the Tri-Council Policy: see particularly Article 2.1(b) and subsequent commentary.

8 Fully informed consent must be possible If verbal consent, then justify its use, add a list of items and justify that subjects understand, and make note of consent in researcher s journal If implied consent, e.g. by returning survey, this must be stated on survey, preferably by Submit button or Agree - Disagree buttons on web page Special case: Secondary Use of Data secondary use of data is often hidden and ignored use of data in research collected for other purposes (e.g. records, info from coaches) permission of owner must be obtained access is normally not an issue if the data is truly anonymous if identifying information is accessed, evidence is needed that conditions are met: (a) identifying data is essential for research; (b) privacy of individuals and confidentiality of data is endured; (c) individuals identified by the data have not objected to its use. Special case: Naturalistic Observations naturalistic observations require REB review unless public activities are observed to ensure privacy of subjects, whether they are aware of observation or not 6.3 Children as Research Subjects: If the proposed research involves children as subjects, provide here a statement indicating how compliance with Section 2E, and specifically with Articles 2.5, 2.6 and 2.7 of the Tri-Council Policy, will be achieved. Age of children and sensitivity of research topic determines type of consent criteria are competence of children to provide informed consent in the research context, and the right of parents/guardians Parental/guardian consent normally needed for minors The method proposed for parental active/passive consent must be justified: active parental/guardian consent passive parental/guardian consent child consent with information to parents/guardians Children involved in consent/dissent if mature enough Children s dissent overrides parental/guardian consent

9 6.4 Incompetent Adults as Research Subjects: If the research involves adults of diminished competence as subjects, provide a statement indicating how compliance with Section 2E, and specifically with Articles 2.5, 2.6 and 2.7 of the Tri-Council Policy, will be achieved. Competence of subjects and sensitivity of research topic determines type of consent criterion is competence of subjects to provide informed consent Authorized third party consent normally needed for incompetent adults Subject involved in consent/dissent if able to understand Subject s dissent overrides third party consent Any consent method must be justified 7. Inducements: Will any inducements (money, grade points, etc.) be offered to encourage participation? Yes No If yes, indicate here how compliance with Section 2B of the Tri-Council Policy (concerning voluntariness) will be achieved. If academic rewards are to be used, give details of alternative means of achieving equivalent rewards. Any inducement must not affect the voluntariness of participation in research. Reasonable in context (type of subjects and effort), normally not exceeding $50 In-kind inducement treated as above Lottery to max $100, include chance to win, clear terms If multiple inducement options offered, give a choice to all subjects Academic points and equivalent for non-subjects 8. Private Information: Does the proposed research involve accessing identifiable personal information about subjects by means of surveys, questionnaires, etc.? Yes No If yes, indicate here, in detail, how you propose to meet the requirements of the Tri-Council Policy, Section 3, specifically Article 3.2. A copy of any questionnaire, survey document or interview schedule to be used should be attached as well. Protection of identity of subjects and confidentiality of identifying personal data within research environment in public reports

10 Not using names, or using ID codes, does not imply anonymity or confidentiality of data Unintended breach of anonymity and confidentiality of information through published research results a concern if research topic is general in nature ( factual ) critical if topic is sensitive or controversial or about individuals Type and details of collected data might allow identification of subjects uniqueness in demographic information uniqueness in research data Few subjects (~<5...15) might allow identification of subjects Reports must use sufficiently aggregated data to avoid identification Audio/video recording hired transcriber/translator needs to sign NDA E-mail and web based surveys - are they secure, if not include statement of risk 9. Feedback: Describe the measures, which you propose for providing feedback to research subjects concerning the outcome of the research. Valuable benefit to subjects for volunteering in research Pro-active offering preferred 10. Data Security: Describe the measures, which you propose for ensuring the security of any identifiable personal data, which will be retained after completion of the research. Outline the safekeeping and security of documents, including identifying research data, consent forms, linkage forms for long-term storage Secure location at UNB site Access control, state individual who destroys data and alternative (student/professor) Duration of long-term storage (requirements vary with disciplines and funding sources) For waiver of privacy need storage of consent forms as long as data exists 11. Continuing Review: All research requires brief annual reports and a brief report upon completion of the research. Suitable report forms are included at the end of this file. Research

11 involving more than minimal risk may require additional measures for continuing review. If your research involves more than minimal risk, describe here the measures you propose for facilitating continuing review of this research, in compliance with Article 1.13 of the Tri-Council Policy. Annual Reports: Due on 15 January of each year, provided that this date is at least six months after the date of project approval. To be submitted on a standard form included with the UNB REB Application Final Reports: Due after the completion of the approved research project (not immediately after the completion of activities involving human subjects). To be submitted on a standard form included with the UNB REB Application. Any adverse events must be reported on all forms. Modifications: Any modification request must be submitted for another REB approval. To be submitted in free-form text or on a tentative standard form. Extensions: Any extension request must be submitted before or upon expiry of a REB approval (no backdating is possible). To be submitted in free-form text or on a tentative standard form. 12. Additional Information: Please feel free to append any additional information, which you feel may be helpful to the REB in evaluating this application. A REB approval is normally valid for 3 years.

12 Checklist for Attachments to Application for Review of Research Involving Humans For items that are attached, indicate X; for items that are not applicable, indicate N/A. Provide the following attachments where applicable: X or N/A Where the academic unit responsible for the research has a process of formal ethics review, a copy of the approval notice from that process, together with any substantive comments provided by the reviewers. If external funding has been sought or obtained for this research, one copy only of the complete application form as well as two copies of any reviewers comments which have been received. For student research, one copy of the full research proposal if one has been submitted to the relevant academic unit. A copy of any proposed information letter and/or informed consent form. (Do not duplicate if already included in above material.) A copy of any questionnaire(s), survey documents or interview schedules to be used in the research. (Do not duplicate if already included in above material.) A copy of any debriefing material to be provided to subjects. For research under the jurisdiction of more than one institution, an indication of which other REBs will review the research, and the results of such review if available (see Tri- Council Policy Section 1G). For all research (including student research) that exceeds minimal risk, which has not been approved by a sanctioned peer review process, the applicant must recommend two reviewers competent to undertake a scholarly review of the proposed research. Scholarly review in this context refers to the process of determining whether the design of the research project is capable of addressing the questions being asked in the research. In all cases, a full description of the proposed research, if this is not already contained in the material listed above. In all cases, an electronic text version of the Summary (Item 1 on the application form), via e-mail to ethics@unb.ca on the UNBF campus or to flagel@unbsj.ca on the UNBSJ campus. Please append this checklist to the application form. Missing documents even if item is checked by X

13 REQUIREMENTS FOR INFORMED CONSENT FORMS p.½ DO NOT ATTACH THIS DOCUMENT TO YOUR APPLICATION The purpose of an Informed Consent Form is to help to inform the potential research subject about the research and to document the subject s informed agreement to participate. One copy should be given to the research subject, and a copy signed by the subject should be retained in the researcher s files. An Informed Consent Form must be written in language that the potential subject can understand. It must contain at least the following information: A statement identifying the researcher(s). This statement should indicate their affiliation with the University of New Brunswick, and how they may be contacted. For student research, the name, affiliation and telephone number of the student's supervisor(s). A statement identifying a person not directly involved in the research, for example the Department Chair or Faculty Dean, who may be contacted should the subject have concerns about the research. A statement that the reader is being invited to participate in research. A clear statement of the purpose of the research. A full description of the procedures to be followed in the research (e.g. what is expected of participants, what they will be asked to do, what data will be collected). The period of time required for subject participation. A statement indicating that participation is voluntary, and that subjects are free to withdraw from the research, and to withdraw any data pertaining to themselves, at any time, without penalty. A statement indicating how subjects may receive information as to the outcome of the research. Where applicable, a clear description of any potential discomforts and/or risks associated with participation in the research. Where applicable, a clear description of the potential benefits of the research, whether to the subject or to others.

14 Where applicable, a statement concerning recording of subject participation (audio tape, video tape, photographic records, electronic data recordings, etc.); who will have access to the records, security provisions in storage, possible use in publication, and when they will be erased or destroyed. Where applicable, a statement concerning compensation for any injury incurred while participating in the research. Where applicable, (for any research involving questionnaires or interviews), a statement informing subjects that they may decline to answer specific questions. Where applicable, a statement indicating how confidentiality will be protected. Where applicable, a clear explanation of any inducements offered for participation, and of the consequences (if any) on those inducements if the subject withdraws before the research is completed. Children as Research Subjects: A parent or legal guardian must provide signed written consent for the participation of children in research. As well, assent of the child is normally required where the child is old enough to understand, and evident dissent is always an indication that the child s participation in the research should be terminated. When teenaged subjects are considered by the applicant to be competent to consent without parental involvement, the applicant must provide justification for this conclusion. Incompetent Adults as Research Subjects: For research involving adults of limited competence, signed written consent must be provided by an authorized third party. As well, assent of the subject is normally required, and evident dissent is always an indication that participation in the research should be terminated. (A sample consent form consistent with the requirements of the Tri-Council Policy exists on the web site of the National Council for Ethics in Human Research (NCEHR), at www.ncehr-cnerh.org)

15 University of New Brunswick Application for Modification of Research Project Involving Humans REB File Number: Project Title: Application Date: Principal Investigator Name(s): Supervisor Name(s): PI Signature(s): Signature(s): Summary of Requested Modifications: Will the risk of harm or deception/partial disclosure change? Yes No Will the nature or the objectives of the research change? Yes No Will the changes to the research design be major minor none Will the changes to the ethics protocol be major minor none Which sections of the approved REB application will be affected by the modification(s)? List all affected Sections (e.g. Recruitment, Consent,..., Data Security) below. Detailed Description of the Requested Modifications: Outline the planned changes to the research design and/or ethics protocol (status before the changes and after the changes) along with justifications and implications. If more pages are needed, please attach them and check here: Please append the approval from your ERC with respect to these changes if relevant.

16 University of New Brunswick Application for Extension of Research Ethics Approval REB File Number: Project Title: Application Date: Principal Investigator Name(s): Supervisor Name(s): PI Signature(s): Signature(s): Extension Request and History: What is the expiry date of the current REB approval? Number of previous extensions given: Date of 1st extension request approved? Date of 2nd extension request approved? Date to which this extension is requested? What is the date of expiry of funds used for this research? Annual Report: To which date? To which date? No funding Date of the last Annual Report? None due yet Note: Annual Reports are due on 15 January of each year, provided that this date is at least six months after the date of project approval. If an Annual Report is overdue, please attach it to this application form. Has there been any incidents causing harm to subjects in this project since the start of the project or the submission of the last Annual Report? Yes No Detailed Justification for the Extension Requested (reason, time period): If more pages are needed, please attach them and check here: Please append the ERC Approval to this document if relevant.

17 University of New Brunswick Annual Report on Ongoing Research Project Involving Humans REB File Number: Project Title: Report Date Principal Investigator(s): Signature(s): Signature(s): Is this Project still ongoing? Yes No If yes, what is the estimated completion date? How many research subjects have participated in this project to date? Have there been any incidents causing harm to subjects in this project? (If yes, provide full details for REB consideration).

18 University of New Brunswick Final Report on Research Project Involving Humans REB File Number Project Title: Report Date Principal Investigator(s): Signature(s): Signature(s): What was the (approximate) completion date? How many research subjects participated in this project? Have there been any incidents causing harm to subjects in this project? Yes (If yes, provide full details for REB consideration). No Is it intended that the results be published? Yes (If yes, the REB would appreciate receiving bibliographic data when available). No Attach a brief summary of the project. The abstract of a resulting paper, or of a student thesis or report, is acceptable.

19 Guidelines for Use of Email for Surveys and Consent Forms Prepared by B. Kurz, 5 November 2007, Rev 1 Email communication is normally insecure between an email client and its server, unless secure email (e.g. TSL) is used. Web based email is normally secure between a web browser and its server if a login is required. However, email communication is normally insecure across the Internet from server to server. Users of secure email have no control over how email is accessed (secure or insecure) by recipients at the remote server. When using email for the return of survey responses and return of consent forms, the inherent risks associated with email communication must be clearly stated in the information document for potential research subjects. The following statements need to be added to the information document (adapted from USC Patient Email Consent Form): The use of email carries risks that can lead to breach of confidentiality in several ways. email addresses can be mistyped and email can reach unintended recipients; email to group addresses (e.g. office@companyxyz.ca) can reach unintended recipients; email can be intercepted, read, altered and can be circulated to unintended recipients; employers have the right to inspect email; email is not anonymous and can be traced back to the sending computer and individuals able to use it; email clients normally store a copy of the sent email. The following recommendations should be added to the information document (adapted from USC Patient Email Consent Form): take precaution when using email, particularly insecure email; keep email listing sites up to date with your email address; avoid the use of employer s computer; avoid email for anonymous response submissions; erase any copies made by the email client. It is recommended that alternate means of submissions of survey responses and consent letters are offered to potential research subjects who feel uncomfortable using email. Reference: USC Patient Email Consent Form, www.usc.edu/admin/compliance/infosec/onlineresources/hipaa/forms/emailconsentform.pdf

20 Guidelines for Use of Parental Passive Consent Prepared by B. Kurz, 10 November 2007, Rev 1 Parental passive consent may be used in research scenarios where low participation rates and poor representative samples are expected if active parental consent would used (e.g. with groups of high-risk substance abuse and other problem behaviors). In all other research scenarios active parental consent should be used first. Another benefit of passive consent is the need for less cost and labor in administering the information and consent procedure. Parental passive consent may be used under the following conditions (adapted from CHKS Guidelines for Passive Consent): potential research subjects are in the age range 13 through 18 years (grades 7 through 12); the research data is anonymous, confidential and cannot be linked to individuals; a parental information letter is sent to parents/guardians by means that reasonably guarantee delivery (e.g. mail, school portfolio, notification by voice message); the parental information letter must state that the parent/guardian can decline participation of their child, and must indicate a convenient way for parents/guardians to do so; if the research protocol changes substantially after the initial notification, the parents/ guardians must be informed; the child must be included in the decision to consent to or decline participation; all other research ethics requirements are adhered to. Reference: California Healthy Kids Survey (CHKS) Guidelines for Passive Consent, http://www.wested.org/chks/pdf/passive_consent.pdf REB talk Kinesiology_V4.wpd