Someone you know is alive today because of medical

research.

Gene therapy

• Teenager dies after receiving experimental therapy

• FDA halts all human gene therapy at the Univ of Pennsylvania

• Another family fights to have trials resumed because without therapy their son will die

What kind of research requires ethics review?

• All research that involves living human subjects

What is meant by human research?

• A systematic investigation to establish facts, principles or generalizable knowledge in which humans take part as research subjects.

•R esearch

•E thics

•B oard

When is REB approval required?

• research is funded or not

• funding is external or internal

• subjects from inside or outside of institution

• subjects are paid or unpaid

• conducted inside or outside of Canada

• conducted inside or outside of institution

• conducted by staff or students

• conducted in person or remotely

• collected from subjects or existing records

• to be published or not

• observational, experimental, or descriptive

• pilot or full developed study

What can REB’s do?

• Approve

• Reject

• Propose modifications

• Terminate

Regulatory Bodies

• Three granting councils – NSERC, SSHRC, CIHR (Tri-council)

• NCEHR – National Council on Bioethics in Human Research

• Office for Human Research Protections/ Office for the Protection of Research Risks

Guidelines

• Declaration of Helsinki (1964)• Belmont Report (1979)• Tri-Council Policy Statement – Ethical Conduct

for Research Involving Human Subjects (1998)• Health Canada Therapeutic Products Directorate

– Good Clinical Practice: Consolidated Guidelines (1997)

• 45 US Code of Federal Regulations 46 Protection of Human Subjects

Mandate

• University policy on the Conduct of Research

• All research involving human subjects conducted by UWO faculty, staff or students must be approved by a UWO sanctioned board

• UWO board(s) review protocols for all UWO affiliated institutions (e.g. hospitals)

UWO Structure

Medical REB Nonmedical REB

Subcommittee onResearch Ethics Policy

UniversityResearch Board

UniversitySenate

Full & Expedited Reviews

• Full: default requirement for all research unless the institution decides to authorize expedited reviews

• Expedited: research involving no more than minimal risk

Committee Membership

• scholarly expertise

• ethics expertise

• legal expertise

• community representation

• experts as required

Guiding Principles

• human dignity

• free and informed consent

• vulnerable persons

• privacy and confidentiality

• justice and inclusiveness

• balance harms (minimize) and benefits (maximize)

Tuskegee, Alabama

• 399 men signed up for free medical care• never told they had syphilis• denied treatment even though penicillin

came into use in 1947• study ran from 1930’s to 1972• successful $10 million law suit and

apology from the President of the United States

Risk

• Minimal - the probability of possible harm is no greater than those encountered by the subject in every day life

• Assessed - the risk associated with the subject’s usual lifestyle

Child Obesity Study

• 200 children ages 6 to 10• 15 year study to try and identify children

at risk for obesity• annual testing most of which was benign• some of the testing posed more than an

acceptable risk• study suspended

Therapeutic & Non-therapeutic

• Therapeutic - arise from the actions undertaken for the purposes of therapy

• Non-therapeutic - arise from actions that go beyond the need of the subject as a patient and incur only for the needs of the research

Research Design

• The REB must ensure that the design of a project posing more than a minimal risk is capable of addressing the questions being asked in the research

Subject Recruitment

• Who

• How

Vulnerable Populations

• Children

• Mentally incompetent

• Institutionalize persons e.g. prisoners

• special protection against abuse, exploitation or discrimination

Coercion or Inducements to Participate

• obligation to participate

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

• overwhelmed by institutional approval

• financial gain

$$ Ultimate Slacker Job $$

• collecting fees for participation in medical tests

• testing new drugs, treatments or procedures

• side effects are numerous and often unknown

• as a career it can be dangerous to your health

Anonymity & ConfidentialityWhat is the difference?

• Anonymity - the data cannot be traced back to the subject

• Confidentiality - the subject’s data is not made public in a way that can identify them

Conflict of Interest

• Disclosure of conflict of interest– to the REB– to the study subject

Publication of Results

• researchers are expected to avoid signing agreements that unduly limit the freedom of investigators to collaborate and publish

• excessive publication delays, editorial control, withholding of data all undermine the credibility of research and are unacceptable

Informed Consent

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

• Subjects must agree to participate

• Letter of Information

• Consent Form

LSD

• 1943 Dr. Albert Hoffman self dosed himself with LSD and took the well known bicycle ride around Basel Switzerland

• tested as ‘truth serum’ by US government in the 1950’s as unwitting subjects were given LSD in the CIA funded Project MK-Ultra to test the effects of the drug.

Letter of Information

• the study involves research

• the purpose of the study

• treatments/procedures

• assignment to treatment regime

• identification of ‘experimental’ aspects

• alternative procedures that may be available to subject

Letter of Information (Cont’d)

• foreseeable risks or inconveniences to subject and when applicable to a fetus or nursing infant

• possible benefits

• compensation for participation

• compensation or treatment for study-related injury

Letter of Information (Cont’d)

• participation is voluntary

• subject may refuse to participate or may withdraw at any time

• who will have access to the data

• records kept confidential to the extent laws or regulations permit and subject’s identity will remain confidential

Letter of Information (Cont’d)

• contact persons and study sponsors• information to be provided to subject that

may affect their willingness to participate in the research

• total number of subjects expected in the study

• Why a subject’s participation may be terminated

Letter of Information (Cont’d)

• grammatically correct

• no spelling mistakes

• use of lay language

• grade 8 level

• easy to read - type, titles

Consent Form

• I have read the Letter of Information

• I have had an opportunity to ask questions and they have been answered to my satisfaction

• I agree to be in the study

• signatures

Monitoring

• REB’s responsibility does not end with ethics approval

• approval of revisions and changes

• ongoing monitoring of study progress

• processing and assessment of Adverse Events

These are people not just subjects.

The safety and well-being of research subjects and

research personnel comes first.