HREB 101 … a few other things you may want to know about ethics applications…

1. HREB 101… a few other things you may want to know about ethics applications… Charmaine Kabatoff, Senior REB Coordinator HREB Panel B February 9, 2012

2. By the end of the presentation you should be… • Familiar with HREB and the new REB structure at the U of A. • Understand the application process, including a brief introduction to HERO. • Understand common application pitfalls. • Understand where to go for HELP.

3. Health Research Ethics Board (HREB) • administers and reviews all research where the researcher will access health information (as defined in the Health Information Act of Alberta) OR conduct the research at Alberta Health Services or Covenant Health facilities.

4. HREB – two review panels • Biomedical Panel • This REB deals with health research applications that involve invasive interventions and invasive measures, regardless of how significant a part the intervention or measure has in the overall project, for example: - administration of drugs, vaccines, natural health products. - use of a device in a research study. - surgical procedures. - collection of blood or other specimens. - genetic research. - any research funded by a US federal funding source (i.e., NIH)

5. HREB - two review panels • Health Panel • This REB reviews applications for health research that primarily involves non-invasive interventions (behavioural, educational, psychological and training) or concerns privacy, confidentiality and survey methods. For example: • interviews • chart reviews • surveys • questionnaires • educational strategies • observational or descriptive research

6. HREB Review • Each panel meets monthly; schedule posted on the website (www.hreb.ualberta.ca) • Two types of Review Streams – Full Board or Delegated. • Type of review is related to the level of risk and whether the study is classified as above or below “minimal risk” • Full board (deadline 2 weeks prior to meeting), delegated review NO deadlines. • Online submission via HERO. • Researchers should expect the following timelines from submission to final approval: • Delegated Review – Approximately 1 month • Full Board Review – Approximately 6 weeks

7. HREB Work Flow PI – Submit Ethics Application Pre-REB/Departmental Approvals Changes Requested REB Administrator Full Board Review Delegated Review

8. Standards and Policy • Tri-Council Policy Statement2: Ethical Conduct for Research Involving Humans - current national standard for all research involving human subjects. • University of Alberta GFC policy – Protection of Human Research Participants – GFC Section 66

9. Guiding Ethical Principles – TCPS2 • Respect for Persons • Concern for Welfare • Justice

10. Your Application: what you need to consider • Scientific validity • Risk/benefit ratio • Sample size (can you find the number of subjects required) • Can the project be completed in the allotted time • Access to patients – can you? • How are you recruiting participants? • Who is obtaining consent? How?

11. Risk/Benefit Ratio • One of the more important and challenging aspects of review • no greater than what they would experience under similar circumstances in their everyday life then the study may be of minimal risk. • greater than they would encounter in their everyday lives, the protocol is subject to a higher degree of scrutiny and must make more provisions for the potential participants The REB must consider whether the potential benefits of a study justify the exposure of people to the potential risks

12. Privacy and Confidentiality • Access to health information is considered within an ethics review of a research proposal • Section 50 and 55 of Health Information Act guide research • Which hat are you wearing: researcher or custodian, will determine whether you have access to potential participants records • If you do not have access the “custodian”/treating clinician, must obtain WRITTEN consent for disclosure to release participant’s name

13. Privacy and Confidentiality • Access to records/data • Participants identified as a “code” • Who will have the link? • Security of records (during the study) • Who will have access? • Paper records, kept in a locked office • Electronic Records – password protected, encrypted • Storage of Data • 5 years per University policy • 25 years if conducted under Division 5

14. Informed Consent • According to the TCPS Tri-Council Policy Statement 2(article 2) research may only begin if prospective participants, or authorized third parties, have been given the opportunity to give free and informed consent to participate. • There are, however, circumstances under which the informed consent procedure can be altered or waived.

15. Informed Consent…written or …? The consent process may be altered (waived, delayed, presented in a different format) with REB approval under the following conditions: • The research involves no more than minimal risk • The waiver or alteration is unlikely to have a negative effect on the rights and welfare of the participants • The research could not practicably be carried out without the waiver or alteration • Whenever possible and appropriate additional pertinent information will be provided after participation • The waived or altered consent does not involve a therapeutic intervention.

16. Informed Consent – some examples • retrospective chart reviews – can request a WAIVER • secondary data analysis (no direct contact with subjects) - depends on how it was collected in the first place • completion and return of surveys and questionnaires implies consent to use the data, and does not require signed consent although subjects in such research should be provided with an information letter • Observation of people in a public environment

17. Assent For research involving participants not competent to consent on their own an authorized third party may be able to consent on their behalf (i.e. children, people with diminished capacity for judgement and self direction, people in emergency situations). Once consent has been obtained from an authorized 3rd party, the individual must still be asked for their agreement (assent). TCPS Article 2.7. Those who may be capable of assent or dissent include: • children, whose capacity for judgement and self-direction is maturing • adults whose competence has become diminished, (e.g. people with early Alzheimer's disease) • those whose competence remains only partially developed (e.g. adults and children with permanent cognitive impairment)

18. Quality Assurance TCPS and GFC 66 • Quality assurance studies, performance reviews of an organization, or its employees or students within the mandate of the organization, or testing within normal educational requirements, are not subject to REB review unless they contain an element of research in addition to assessment.  • Researchers should seek the advice of their REBs whenever there is any ambiguity or doubt about the applicability of the UA Standards to a particular project.

19. Approval!! Now what? • Approval is normally granted for one year. • Renewal reminders are sent via UA e-mail directly to the PI and named members of the study team starting at 45 days prior to expiration. • All changes to the research project must be submitted to and approved by the REB before implementation. • Submission of a closing report upon completion of study.

20. HERO(Human Ethics Research Online) • Complete application management system, from initial submission to study closure and beyond. • Permits collaboration during application development. • Monitor approval status online. • Incorporate material from various sources. • Save, copy and link applications.

21. Access to HERO • Active relationship in PeopleSoft HR system (employee, student, guest) • CCID and password – used for authentication purposes. • All UA employees have a CCID and password. If unsure, contact AICT. • Guests may apply for a CCID through their unit of affiliation (dept or faculty) • HERO role is used to define permissions.

22. Getting Started • Faculty Members & Clinicians • HERO investigator role auto-generated. • Proceed to logon • Study Coordinators, students & outside applicants • Self register first. • Proceed to logon • First Time Logon • Researcher must identify department for approval routing. • Researcher may add authorized study coordinators at this time.

23. Researcher Profile • First time logon will prompt you to complete your profile. • Basic information extracted from PeopleSoft • Name study coordinators in Authorization List in Researcher Profile.

24. Study Access • Who can access a study? • During preparation – the PI, study coordinator (SC) and all co-investigators (Co-I) can read and edit the application. ONLY the PI can submit the study for initial review. • Post submission, the PI, SC and Co-Is can respond to requests for changes and submit renewals/amendments. • To give view only access to someone you can add them to the Guest List for the study, all HERO users are available in the list. • To allow someone to receive all HERO notifications about the study, add them to the Study Email List.

25. Email Notifications • Initial submission • Change requests from reviewers • REB decision/approval • Renewal reminders – except when an amendment is pending. • Notifications automatically go to the PI and SC. Co-I’s must be added to the email list to receive notices. • HERO only sends to @ualberta.ca email addresses.

26. HERO Website https://HERO.ualberta.ca/HERO link from UofA and Research Ethics Office (www.reo.ualberta.ca) websites • Mac users must use Firefox or Internet Explorer as web browser – Safari is not compatible with HERO. • The first time you use HERO, disengage your pop-up blocker and make HERO a trusted site.

27. Important Links • www.hreb.ualberta.ca (for up to date information about HREB and HERO applications) • http://pre.ethics.gc.ca/eng/policy-politique/tcps-eptc/readtcps-lireeptc (for Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans); includes link to tutorial • http://www.uofaweb.ualberta.ca/gfcpolicymanual (see section 66 for up-to-date University of Alberta policies on research involving humans)

28. Points to Remember (tips for a successful application) • Answering only the red asterisk questions does not constitute a complete application. • The more detail the better! • N/A should be used sparingly. • Ensure all relevant documentation is attached. • If the study is in your inbox – its waiting on an action from you! • Be able to provide the Pro number when contacting your REB Administrator.

29. WHEN IN DOUBT…. check it out….

30. Where to find us Health Research Ethics Board 308 Campus Tower University of Alberta Charmaine Kabatoff (Health Panel) 492-0302 Patricia Lo (Biomedical Panel) 492-9724 Alice Fritch HERO Helpdesk 492-0839 REO Office 492-0459 website: www.hreb.ualberta.ca