McNair / ROP Research Scholar Program

Dr. Teddy Warner(twarner@salud.unm.edu )Dept. of Psychology and

Dept. Family & Community MedicineUniversity of New Mexico

February 22, 2014

© Teddy Warner, all rights reserved, 2014Note: Material in this presentation may be printed or modified by students only for their personal use in this course or program

and it may not be modified, shared or duplicated for any other purpose without written permission.

Ethics in Research

Because ethical issues are often rather complex & subtle,

we need to carefully consider the many ethical decisions

that researchers need to make in conducting research

Many ethical issues arise because of the involvement of Humans as research participantsAnimal subjects as research participants Human interactions in a wide variety of other domains

Table 1. Some Important Ethical Questions for Investigators to Consider and Answer

1. What are the guiding ethical principles of research?

2. What regulations for research are investigators required to follow?

3. Does the study have sufficient scientific merit?

4. Is the design of the study scientifically sound?

5. Do the investigators have sufficient expertise and experience to conduct the study?

6. Is the study population justified and selection from it equitable?

7. Are participants recruited fairly and without coercion?

8. Do vulnerable research participants require additional protections?

9. Are the risks of harm of the research for participants minimized?

10. Are the benefits of the research for participants and society maximized?

11. Are risks of harm reasonable in proportion to benefits?

12. Are informed consent processes for participants adequate?

13. Are the confidentiality and privacy of participants adequately protected?

14. Do potential study participants have sufficient capacity to make an informed decision?

15. Is the compensation for participating in the study appropriate?

16. Does the Data and Safety Monitoring Plan adequately protect study participants?

17. Do study researchers have potential conflicts of interest or conflicts of role?

Ethical Principles in Research (Belmont Report, 1979)

1. Respect for persons safeguard rights & welfare of people involved in research

a. obtain informed consent of research participants b. protect people from harm, especially vulnerable peoplec. protect participants’ privacy and confidentiality

2. Beneficence conduct research to maximize benefits & minimize risks

Risk e.g., physical harms, psycho-social harms (privacy or confidentiality violations; stigma, discrimination)

3. Justice distribute research benefits & burdens equitably

a. Vulnerable people should not be targeted or excludedb. Vulnerable people may require special protections to safeguard

their welfare and rights

More on Ethical Principles

Ethicists have proposed additional ethical research principles

Those interested in a more in-depth knowledge of ethical principles and issues involved in research should consult other resources (e.g., Beauchamp and Childress, 2008)

Alternate terms for research ethics:

“responsible conduct of research” & “research integrity”

Excellent overview of RCR issues can be found in a widely disseminated booklet, On Being a Scientist: A Guide to Responsible Conduct of Research, 3rd ed. (2009) [published by the National Academies of Science; http://www.nap.edu ]

Responsible Conduct of ResearchResponsible conduct of research (RCR). A consensus of expert opinion indicates that the training of researchers for responsible conduct of research should include issues related to (but not limited to):

1. Conflict of interest – personal, professional, and financial

2. Policies related to involvement of human and animal subjects

3. Policies related to safe laboratory practices

4. Mentor/mentee responsibilities and relationships

5. Collaborative research, including collaborations with industry

6. Peer review of manuscripts submitted for publication issues

7. Data acquisition & laboratory tools, including management, sharing, & data ownership

8. Research misconduct and policies for handling misconduct

9. Responsible authorship and publication

10. The scientist as a responsible member of society, including contemporary issues in biomedical research, and environmental and societal impact of scientific research

Scientific Integrity (research integrity)

Scientific integrity refers to:

a. commitment to truthfulness,

b. personal accountability for actions, and

c. vigorous adherence to standards of appropriate professional conduct (e.g., accuracy, fairness, collegiality, transparency)

Teaching Research Ethics / RCR

Case-based / Problem-based learning (CBL / PBL) approaches

used instead of only reading about ethical principles & rules – a. Students read case descriptions, systematically analyze them

b. Discuss cases with experienced facilitator

c. Focus on dilemmas with plus/minuses for various solutions

d. Helps teach learners to think more objectively on their own

e. Used now in medical, legal, graduate & other training too

f. Now required of all trainees funded by NIH and NSF

g. Expect CBL RCR training for all researchers in future

National Institute of Health & National Science Foundation

a. now require all funded trainees to have RCR training

b. expect requirement to be extended to all researchers in future

Regulated ResearchFederal & state laws and regulations are designed to assure research involving human or animal subjects is conducted in an

ethically acceptable manner that safeguards welfare of all subjects

Federal regulations apply to all research:

a. that is federally funded

b. conducted at institutions receiving any type of federal funding

c. to be submitted to the FDA to support drug or device approval

Most states also have laws that regulate research

Universities & research institutions require research conducted

by their faculty or staff to comply with federal and state research rules

Other types of research may or may not be regulated

Regulated Research Key Definitions

Research is defined in federal regulations as (45 CFR 56):

“Any systematic investigation designed to

develop or contribute to generalizable knowledge.”

Thus, activities collecting data only for internal use of an organization are not research

( = quality assurance data)

Human subjects = living people about whom researcher obtains data through intervention or interaction, or obtains identifiable private information

Private information = information person can reasonably expect will not be observed or recorded, or information that has been provided for specific purposes and person reasonably expects will not be made public (thus, observations of public behavior do not collect private information)

Identifiable Data & Research ProtectionsIdentifiable data = any information from which identity of a person

may be ascertained

Data with all of the following are not considered identifiable data:

a. identified only by code

b. not associated with individuals’ identities

c. there is no accessible link between data & individuals’ identities

Federal regulations provide 2 main protections for human subjects:

a. Institutional Review Board (IRB) review & ongoing oversight

b. Informed consent of human subjects to participate in research

Animal subjects research is overseen by

Institutional Animal Care & Use Committees (IACUC)

Institutional Review Boards

Federal regs require research involving human subjects (or animal subjects)

a. be approved by an IRB (or IACUC)

b. IRB (IACUC) reviews, approves & monitors all human (animal) subject research

IRBs

a. main responsibility is to protect welfare & rights of human participants

b. ensure that research is ethically acceptable

c. minimize possible study risks for harms,

d. maximize possible individual and societal benefits

e. ensure that relative balance of risks to benefits is maximized

f. must include 5 (usually more) or more members

g. must have at least 1 nonscientific and 1 community member

h. must have member representing any vulnerable population studied

INSTITUTIONAL REVIEW BOARDS

IRB impact on research:Requires researchers to explicitly describe their study

procedures, risks, benefits, etc. and to justify them scientifically and ethically

Takes time for approval of study (1-3 months is typical)Submissions often need to be revised or clarifiedVery cautious around approval, but few are disapprovedSometimes contentious issues between IRB & researcherIs IRB review effective in actually safeguarding subjects?

Data on IRB effectiveness is very difficult to obtain Process presumably motivates researchers to be more careful

Table 1. Key IRB Questions Asked About Each Study Protocol

1. Is the selection of subjects equitable, taking into account the purposes and setting of the research?

2. Is the informed consent process and documentation adequate?

3. Are financial obligations of the study sponsor, the institution where the research will be

conducted, and the study participants clearly described and appropriate?

4. Have specific study risks been adequately identified and justified?

5. Are the investigators qualified to conduct the research and safeguard the welfare and safety of participants?

6. Is the design and analysis of the study likely to yield interpretable results that will inform the

field?

7. Is there a prospect of direct benefit to individual subjects in the study and/or is there a prospect of potential benefit to society for study results?

8. Is individually identifiable protected health information (PHI) being collected in the study?

9. Does the study include provisions for monitoring data collected to insure the safety of

subjects during the course of the study?

10. Is an investigational device or investigational drug to be used in the study?

11. Is tissue banking or genetic testing being conducted in the study?

Conflicts of Interest in Research (COI)

Another important ethical issue in research is COI :

a. Financial COI (FCOI):

e.g., research is funded by company which makes drug being tested – studies show such studies are more likely to show positive findings in support of drug than

if researchers do not have FCOI

e.g., researcher is paid consulting fee by drug company

b. Role COI (conflict of commitment):

e.g., researcher enrolls his/her own patients in study

Universities have COI Committees & policies to:

examine, manage or eliminate COI’s of researchers

Scientific Merit & Study Design

If study does not have sufficient scientific merit, it is unethical because

a. it unnecessarily places a burden upon study participants

b. it places participants at risk without increasing understanding

c. it does not benefit participants or society

d. it uses resources that could be used in other meritorious studies

A study involving humans or animals should have reasonable prospect

of providing information that may provide

increased scientific understanding to justify use of subjects

Some scientists do not accept this premise and believe

they should be the final authorities for deciding

which studies are conducted regardless of ethical qualities

Scientific Merit & Study Design cont’dIRB review assesses basic scientific merit of a study

IRBs recognize limits & often seek outside experts as consultants

Whether study has sufficient scientific merit & sound study design:

a. involves professional judgment

b. no formula for making this decision

c. but decision is not purely subjective

d. although reasonable experts may disagree

Researchers must describe how their studies have scientific merit

a. at UNM, dept. chairs or their designees assess scientific merit too

b. grant funded studies are presumed to have sufficient merit

c. sometimes IRBs judge insufficient merit

(e.g., lack of a control group; too few subjects; knowledge gained is trivial)

BELMONT REPORTHenry Beecher NEJM 1966 article

exposed numerous medical studies of questionable ethics

The Belmont Report (1979):

Ethical Principles and Guidelines for the

Protection of Human Subjects of Research

Basic human subjects research principles: Beneficence (benefit for individuals and/or society & lack of harm) Autonomy (respect for persons) Justice (fairness by involving & benefiting diverse people & groups)

Led to oversight & regulation of human subjects research Federal & state laws beginning in early 1980’s Institutional Review Boards (IRBs) mandated

Practical Research Ethics Principles

Key principles of ethical research to address whenever applicable:

1. Design & conduct research to ensure integrity, quality & transparency

2. Participants must (normally) be informed fully about purpose, methods & possible uses of research results

3. Participants should be informed what their participation involves

4. Participants should be informed of all risks of harm and any benefits

5. Research risks must always be minimized

6. Confidentiality of information about research participants, including identity

7. Research participants must take part voluntarily, free from any coercion

8. Harm to research participants must be minimized in all instances

9. Any conflicts of interest or partiality of researchers or research sponsors

must be explicitly communicated to participants & research consumers

ASSESSMENT OF RESEARCH RISKS

Common risks in human subjects research Physical harm Psychological Stress

(emotional reactions, embarrassment, stigma . . . .) Loss of privacy (about people)

(participants are observed or measured) Loss of confidentiality (about data or information)

(identifiable data on participants might be compromised) Economic harm

(time and effort in participating; harm to reputation that may impact . . . .)

TYPES OF RESEARCH & IRB REVIEW

Exempt Research Research in which there is minimal risk of harm Routine procedures in life or anonymous data collected – After IRB classifies study as exempt, it is not subject to ongoing

monitoring or review unless study is changed IRB must determine exempt status, not researchers

Minimal Risk Research When the risk of harm is no greater than risk encountered in daily

life or routine physical or psychological tests Review conducted by IRB by individual experienced reviewer

Greater Than Minimal Risk Research Thorough review conducted by the full IRB

ASSESSMENT OF RESEARCH BENEFITS

Potential benefits of human subjects research:

Educational benefits – learning about research

New treatments for medical & psychiatric conditions

Subjects personally might benefit from treatments received

Material benefits such as testing, care, and feedback

Personal satisfaction from contributing to science

Altruism – helping others who might benefit

Monetary compensation is NOT considered a benefit!

INFORMED CONSENT

Informed consent form vs. IC process . . . .The ICF is NOT “informed consent” . . . .

Autonomy issuesObservational issues and concerns via Internet

Information issues:

withholding information and deception -What is the harm versus the benefit?

Is deception a major ethical problem

in human subjects research?

IMPORTANCE OF DEBRIEFING

Debriefing: Explains why deception was necessary Occurs after completion of the study Opportunity for the researcher to discuss issues

of withholding information, deception, and

potential harmful effects, if any, of participation Provides additional resources, if necessary Provides educational opportunity to explain study Most participants report debriefing is a positive experience Research indicates it is effective in achieving these goals Makes sure participant leaves study without

ill feelings towards field of psychology or science

ALTERNATIVES TO DECEPTIONRole-Playing

Asks participants how they would respond to a certain situation or to predict how others would respond (surveys)

Not considered a satisfactory alternative to deception

Simulation Studies Variation on role-playing that involves simulation of a real-

world situation Has a high degree of involvement from participants

Honest Experiments Participants are made aware of the purpose of the research

(e.g., speed dating studies; study skills improvement program); limited applications

JUSTICE & PARTICIPANT SELECTION

Tuskegee Syphilis Study (1932 - 1972)

and many other unethical studies in 1940’s and later

(also recall Nazi human research studies of 1930’s)

Justice principle requires researchers to address issues of equity Any decisions to include or exclude certain groups of people from

study must be well justified on scientific grounds

NIH & NSF require inclusion of all groups (races, ages, genders) unless well justified

New evidence found of other unethical studies of syphilis

(Reverby, 2011)

Questions?Main campus IRB: http://irb.unm.edu/

Health Sciences IRB (HRRC):http://hsc.unm.edu/som/research/hrrc/

DHHS Office of Human Research Protections: http://www.hhs.gov/ohrp/index.html

Consult your mentor and/or call the IRB

To conduct human subjects research, you will need CITI training:

https://www.citiprogram.org/