APPENDIX A

DEFINITIONS

  1. Child- A person who has not attained the legal age for consent to treatments or procedures involved in the research
     
  2. Coercion- Persuasion (i.e., of an unwilling person) to do or agree to something by using obvious or implied force or threats.
    • Court-appointed guardians
       
  3. Diminished Autonomy- a person who does not have the ability to deliberate choices and fully act on those choices due to current circumstances, i.e. imprisonment, mental defect, illness, language barrier, or impregnation.
     
  4. Exculpatory Language- Language that makes or appears to make a research participant waive their legal rights, or the general effect of freeing or appearing to free the researcher or an entity from malpractice, negligence, blame, fault or guilt.
     
  5. Human Subject- a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information.
     
  6. Informed Consent- The knowing, legally effective consent of any individual or the individual's legally authorized representative; such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
     
  7. Institutional Review Board (IRB)- An independent administrative body established to protect the rights and welfare of human research subjects. It consists of at least five members from varied disciplinary backgrounds who are qualified to review research.
     
  8. Legally Authorized Representative- An individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
     
  9. Minimal Risk- the risks of harm anticipated the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”.
    • Next of kin in the following order: spouse, adult child, parent, and adult sibling.
    • Persons appointed as health care agents under an Ohio Durable Power of Attorney for Health Care
       
  10. Research- systematic investigation designed to develop or contribute to generalizable knowledge.
     
  11. Risk- the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study.
     
  12. Vulnerable Subjects- Human subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Vulnerable subjects must be afforded special safeguards in a study to protect their rights and welfare.
     
  13. Undue Influence- Excessive or inappropriate reward or other incentive in which a person is induced to act otherwise than by his/her own free will or without adequate consideration of the consequences.