major milestones in the history of ethical issues in research

P A R T 1 : E T H I C A L I S S U E S

6310-WEEK 2

LEARNING OBJECTIVES

• Identify ways to address ethical issues in human subjects research

• Define evidence-based practice • Identify and apply the steps in the evidence-based

practice process • Identify resources that support evidence-based

practice

OUTLINE OF WEEK 2

• Ethical issues • Evidence-based practice

ETHICAL ISSUES IN RESEARCH

RESEARCH ETHICS

• Research priorities versus subjects’ rights • Ethical Principles • History • Human subjects protection • Institutional Review Board (IRB) • Informed consent

RESEARCH PRIORITIES VERSUS SUBJECTS’ RIGHTS

• Primary ethical responsibility is to research subjects • Other responsibilities to:

• Colleagues: provide feedback on research • Sponsoring body: final report • Profession: publication of findings

• Moral responsibility to publicize results, even if negative findings or inconclusive findings

ETHICAL PRINCIPLES

Three ethical principles guide research with human subjects: • Respect: requires investigators to obtain informed and

voluntary consent from research participants, to allow them to discontinue participation in research at any time, and to protect participants with impaired decision- making capacity.

• Beneficence: requires that the scientific knowledge to be gained from a study must outweigh the risk and inconvenience experienced by research participants, and that risks be minimized.

• Justice: requires that the benefits and burdens of research be distributed fairly . It also requires equitable access to the benefits of research.

HISTORY

• The history of research involving human subjects includes instances of unethical practices and, consequently, the advent of guidelines and regulations to ensure the protection of human subjects’ participation in research.

INSTITUTIONAL REVIEW BOARD (IRB) (1)

• An IRB is a review committee established to ensure that the research is ethically acceptable and that the welfare and rights of research participants are protected.

• Members: Researchers, community members, legal and ethical experts.

• While federal regulations use the term IRB, institutions may choose other names for the review committee, such as: • Research Ethics Board • Independent Ethics Committee • Human Subjects Committee

• UTRGV’s Institutional Review Board website link available here.

INSTITUTIONAL REVIEW BOARD (IRB) (2)

• IRB responsibilities include: reviewing protocols and consent forms, tracking progress annually, reviewing changes in protocol.

• Before approving a research study, the IRB must determine that: • Risks to participants are minimized • Risks are reasonable in relation to anticipated benefits and

the importance of the knowledge that is expected to be obtained

• Selection of participants is equitable • Informed consent will be obtained from participants or their

legally authorized representatives • Confidentiality is adequately maintained

HUMAN SUBJECT TRAINING

• To ensure human subjects protection, all research team members must complete a course on human subjects protection. Examples of such courses include: • National Institutes of Health (NIH) web course link • UTRGV requirement is to complete CITI (Collaborative

Institutional Training Initiative) course available at this link

INFORMED CONSENT

• Informed consent requires researchers to obtain the voluntary participation of subjects after informing them of possible risks and benefits.

• Informed consent also requires the researcher to ensure that the person understands the conditions of the study and the extent of their involvement.

• Informed consent is voluntary; persons have the right to refuse to participate in a study, not just at the beginning but at anytime.

INFORMED CONSENT COMPONENTS

• Nature of the research project, its title, its purpose, and who is being recruited as a participant.

• Researchers’ names, affiliations, funding agencies. • Procedures

• What participants are going to do • Time required • Type of data to be collected • If clinical trial, participants must understand the concepts of

randomization and blinding

INFORMED CONSENT COMPONENTS

• Potential risks • Medical, psychosocial, and economic • Frequency: risks that occur often • Severity: including rare adverse reactions

• Potential benefits • Example: having a physical exam or new test • In an experimental study: treatment group

• new medication, not yet available to others • new therapy (unknown side effects) • new educational program

INFORMED CONSENT COMPONENTS

• Right to refuse or withdraw • participation is voluntary

• Compensation, if any • monetary • gifts (books, toys, gift certificates)

INFORMED CONSENT COMPONENTS

• Confidentiality statement • study results do not identify names or personal

characteristics • records not accessible to outside persons • log of name and identification number is in locked file

cabinet with limited access • special statement for online surveys

• Contact information • UTRGV IRB ([email protected]; 956-665-2093) • Questions

• Signature of participant and investigator

INFORMED CONSENT: ISSUES

• Language of consent form • Comprehension and readability: avoidance of technical

jargon and complicated sentences; 6th grade reading level • Translation to other languages

• Participation of children requires parent/guardian consent and child’s assent if 7 years or older.

• Voluntary nature of consent: researchers must minimize the possibility of coercion or undue influence. Participants must understand that declining to participate in the study will not compromise their medical care/grades/ and that they may withdraw from the project at any time.

INFORMED CONSENT: ISSUES

• Confidentiality: Securing participant confidentiality is key. Breaches of confidentiality might cause stigma or discrimination, particularly if the research addresses sensitive topics.

• Strategies for protecting confidentiality include: • Coding research data • Protecting or destroying the key that identifies participants • Limiting personnel who have access to identifiers

RESEARCH PARTICIPANTS WHO REQUIRE ADDITIONAL PROTECTIONS

• Some participants might be vulnerable to being used in ethically inappropriate ways in research • Persons with cognition or communication impairments • Persons with unequal power relative to the investigators

(e.g., prisoners, students, patients of a treating physician/investigators)

• Persons with low socioeconomic status, poor access to health care, or low levels of educational attainment

HIPAA

• Health Insurance Portability and Accountability Act of 1996 (HIPAA) • HIPAA Privacy Rule: protects the privacy of individually

identifiable health information • HIPAA Security Rule: sets national standards for the security of

electronic protected health information • HIPAA Breach Notification Rule: requires covered entities and

business associates to provide notification following a breach of unsecured protected health information

• HIPAA and research: requires additional information on consent forms or additional signed authorization for the use of protected health information in a research project • Medical record transfer or sharing information • Review of medical records (archival, present) • Research including medical records