Denise Grafton, Ph.D. Consultant, SJHC London Contract Academic Staff, WLU Ethical Considerations in Research vs. Program Evaluation An Introduction to.

Denise Grafton, Ph.D.Consultant, SJHC London

Contract Academic Staff, WLU

Ethical Considerations in Research vs. Program Evaluation

An Introduction to Research Ethics

Research Ethics 101• Why?

– Why the REB is a part of the research process

• Who & Where? – What is the REB? What does it do?

• What & When? – What research requires Ethics Approval– Levels of Review (risk)– What to do if you are not certain?

• How– Specific Examples– Database studies– Chart review

Why Research Ethics?The REB process was

developed because of BAD research!

1. Tuskegee Syphilis Study• US Public Health Service • 1930s - natural history of untreated syphilis -

until 1972• 400 African American men with and 200 men

without syphilis• participants were recruited without informed

consent• 10 yrs later death rates 2X high

– 1940s - penicillin effective in the treatment of syphilis…the study continued and the men were neither informed nor treated

2. Nuremberg Trials: Doctors

Responses to “Bad” Research

• Nuremberg Code

• Helsinki Declaration

• Belmont Report

• TCPS, TCPS 2.

Nuremberg Code:Permissible Medical Experiments

• Voluntary consent is essential.• Study should yield fruitful results for the good of society,

unprocurable by other methods or means of study, and not random and unnecessary in nature

• Avoid all unnecessary physical and mental suffering and injury• The study should be conducted only by scientifically qualified

persons.• The experiment should be so designed and based on the results of

animal experimentation and a knowledge of the natural history of the disease or other problem under study

"Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.]

Helsinki Declaration

• World Medical Association• 1964 – expands on principles of the Nuremberg

Code– Research combined with clinical care OR non-therapeutic/non-

clinical– Informed consent– IRB– Relation to Declaration of Geneva (1948)

Belmont Report (1974)• Respect for Persons

– Respects the autonomy of people and provides protection for those with diminished autonomy

• Beneficence– Do no harm; maximize benefits & minimize risks

• Justice– Fair, equal – balance of the burdens and benefits of

research

http://phrp.nihtraining.com/users/login.php

What is the TCPS 2 (2010)?• Tri-Council Policy Statement: Ethical Conduct

for Research Involving Humans• Based on ethical principles and norms from the

previous 3 documents• Adopted by Federal Granting Agencies –

SSHRC; CIHR; NSERC in 1998; TCPS unveiled 2010

• standard for ethical conduct for research involving human subjects

• condition of funding for researchers and their institutions

Who Ensures That Ethical Principals and Norms are Met?

• REB – Research Ethics Board– e.g. Canadian University Boards

• IRB – Institutional Review Board– e.g. American University Boards

• ERB – Ethics Review Board– e.g. Public Health Ontario

Who Sits On a REB?

• scholarly expertise

• research expertise

• ethics expertise

• privacy expertise

• community representation

• experts as required

• legal expertise (biomedical)

When is the REB involved in research review?

Canada

Use of the TCPS 2

Article 2.1

•research involving living human participants;•research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

Application

The scope of this Policy is restricted to the review of the ethical conduct of research involving humans. The scope of REB review is limited to those activities defined in this Policy as “research” involving “human participants.”

Ergo, this means…

• You must have BOTH of the following to require an ethics review under the TCPS 2– Research (process): undertaking intended to extend

knowledge through a disciplined inquiry or systematic investigation

– Human subject: is a human (or parts thereof) the subject of the research? You may have humans participating actively, but they are not the subject (e.g. a hospital program, results of a testing program in a school).

Are there any exceptions?

– Tissues, cadavers, remains, discarded, etc. (e.g. bequeathal programs, waste) – so long as it was either ‘wanted’ or there is no linkage to a person

– Secondary Use of de-identified information– Living individual - public arena– Publicly available information, documents– Performance or quality assurance studies (organization,

employees or students), pedagogical processes - always check first!

Evaluation vs. Research

For the purposes of the TCPS, “research” is defined as “an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.A determination that research is the intended purpose of the undertaking is key fordifferentiating activities that require ethics review by an REB and those that do not” (TCPS 2, 2012, p.15)

Article 2.5

• QA & QI studies, program evaluation activities, performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research

• If data are collected for the purposes of such activities but later proposed for research purposes, it would be considered secondary use of information not originally intended for research, and at that time may require REB review in accordance with this Policy.

For Example:

• You wish to conduct a study of the ways in which space and resources are used in the Psychology Instrument Library– Goal #1: to improve service, see what areas

are used, how could physical space be improved?

– Goal #2: to interview psychology students to understand their perceptions of the library, how important access to materials is to their work, what their demographics are, etc.

• Systematic approach to review practices/procedures to identify improvements & bring them about

• Raises questions that could be answered by research

• Are things being done as well as they could/should be?

• Compares current practice with standards or best practices

• Systematic approach to increase knowledge, often involving application of a hypothesis or theory

• Generates knowledge that might be applied in QA

• Finding the correct thing to do and most effective form of intervention

QUALITY ASSURANCE RESEARCH

QUALITY ASSURANCE

• Tests adherence to a treatment vs. considering a completely new treatment

• Results are local to the population/location/time – data is applicable to specific site or area

• Continuous and on-going process (PDSA)

• Results are disseminated at the local or internal level

RESEARCH• Involves a completely new

treatment (or new application of the treatment) and investigates areas where no best practice exists

• Results can be generalized• Requires the participation of

subjects – using a representative sample

• Results are usually published to share knowledge with a wider base of persons

What does the REB consider when it reviews research?

• Protection of human subjects• Assess risks (minimal/relative) and benefits• Assess research design to ensure minimal risk

and meet objectives• Review subject recruitment to ensure informed

consent• Protect vulnerable groups

Use of the TCPS 2

Review ConsiderationsProportionate

• Proposals that involve higher risks to participants will receive greater scrutiny over the life of the research project.

• Children, elderly, incarcerated, diminished capacity, deception, physiological

Relative

• How likely is it that any participant will suffer any harm (physical, social, economic & pysch.) as a result of the study

• How severe could the harm be? Severity? Temporal? Scope?

Probability

Magnitude

Levels of Review

• Full Board Review: default requirement for all research unless the institution decides to authorize delegated reviews

• Delegated Review: review of research involving no more than minimal risk - delegated by REB to smaller group of reviewers

What the REB Reviews

• Study submission form (varies by organization), Study protocol, Objectives, rationale, hypotheses– Methods, including surveys/instruments– Participants– Confidentiality

• Letter of Information & Consent

• Scripts & Advertisements

In general…

• Justification for study

• Qualifications of the investigators

• Methodology and data analysis

• Study budget

• Duration of study

• Dissemination

• Privacy, confidentiality & storage of data

• Informed Consent

Specific “Areas of Interest” on the Ethics Submission Form

John Tallon, CAEP Conference, 2012

Ethics & Clinical Equipoise

• “The ethics of clinical research requires equipoise‐‐a state of genuine uncertainty on the part of the clinical investigator [really, the expert medical community] regarding the comparative therapeutic merits of each arm in a trial. Should the investigator discover that one treatment is of superior therapeutic merit, he or she is ethically obliged to offer that treatment.”

Freedman B. N Engl J Med. 1987 Jul 16;317(3):141‐5

Coercion or Inducements to Participate

• overwhelmed by institutional approval

• fear of loss of health benefits, employment or educational status

• obligation to participate

• financial gain

Capacity

• The ability of potential/actual participants to understand information about a research project and to appreciate the potential consequences of their decision to participate/not participate.

• Does the participant (or prospective participant) sufficiently understand the nature of a particular research project, the risks, consequences and potential benefits associated with it?

• Also pertinent is idea of future incapacity and decisions to stay in a research project (e.g. Alzheimer’s patients)

Informed Consent

• Subjects must be told exactly what is going to happen to them

• Subjects must agree to participate

• Plain language

• Letter of Information

• Consent Form

• Assent Form

Rules of Wisdom - Consent

Article 3.1•Consent shall be given voluntarily.•Consent can be withdrawn at any time.•If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials.•There should be no undue influence, coercion, incentives•Consent is an on-going process

Privacy & Confidentiality Issues

• Privacy and confidentiality are recognized as fundamental human rights.

• What counts as loss of privacy may vary from individual to individual and society to society.

• CIHR Privacy Best Practices, PHIPA, FIPPA

http://www.cihr-irsc.gc.ca/e/29072.html

PHIPA• Consent based:

– Required when a HIC discloses to a non-HIC. – Required when a HIC discloses to another HIC for a

purpose other than providing health care to the individual

• Circle of care• IPC issues orders and investigation reports -

made public– http://www.ipc.on.ca/english/Home-Page/

• Waiver of Consent – risk of obtaining consent outweighs the benefits of obtaining consent

Obtaining access to Health Records

HIC may disclose PHI if the researcher submits to the HIC:– An application.– A research plan, and;– A copy of the decision of the REB that

approves the research plan, and;

Enters into an agreement with the HIC.

REB review is the ‘law’ when you do a retrospective chart review – section 44.

Ongoing Ethics Review

• REB’s responsibility does not end with initial ethics approval

• approve all revisions and changes

• ongoing monitoring of study progress (surveillance report)

• processing and assessment of unexpected adverse events