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  1. INFORMED CONSENT The Ethical Principle The Regulations The Document The Process What Should It All Mean To Me?

  2. The Ethical Principle • The Belmont Report outlines three basic ethical principles: • Respect for Persons • Beneficience • Justice Which principle supports informed consent?

  3. Respect For Persons Respect for Persons carries with it a number of responsibilities for a researcher.

  4. Respect for Persons Respect the person’s autonomy. The person has the right to make decisions for him/herself. The person has a right to information that will help them make that decision. The person has a right to enough time to make a decision without feeling coerced. The person has a right for information to be presented in a language and in words they can understand.

  5. What Information Does a Person Need in Deciding Whether to Participate in Your Study?

  6. Information For Potential Subjects • They need to know that it is research! • They need to be told what is the purpose of doing the research. • They need to know how long they will be expected to participate in the research. • They need to know what you plan to do and what are they going to be expected to do. • They need to know which of the procedures are experimental and if applicable how that might differ from anything they would undergo if they didn’t participate.

  7. Information For Potential Subjects • They need to know what potential risks or discomforts they may experience as a result of participating in your study. Need to address not only any physical risk to the participant but also any emotional or psychological risk or discomforts they may experience and any risks to a person’s ability to get or retain employment, get insurance, be arrested, or be sued.

  8. Information For Potential Subjects • They need to know what potential benefits they may receive by participating. BEWARE – do not overstate any potential benefits! And, acknowledge that they may not receive any benefits, if that is the case. • They need to know if there are any alternatives available to them should they choose not to participate. • They need to know whose going to see the information they provide. (You need to be comprehensive in describing individuals, agencies, etc that will have or may have access to the data. )

  9. Information For Potential Subjects • If the study involves greater than minimal risk, the potential subject needs to know whether there will be any compensation and medical/psychological/social services available to them. • They need to know that their participation is 100% voluntary. They won’t be forced to participate and they won’t be forced to stay in the study, should they want to withdraw at any time.

  10. Information For Potential Subjects • They need to know who they can call or contact to ask questions about: • Things that occur in the research • Their rights as participants in the research • Who to contact should they become distressed, physically or emotionally injured.

  11. Information For Potential Subjects • You might also want to tell potential subjects: • That there may be risks about which you are currently unaware; • That there may be certain circumstances that may cause you to terminate their participation; • That there may or may not be additional costs associated with their participation; • How many other people are participating in the study; • That if new findings become available during the research that would impact their willingness to continue participation, you will share that information with them.

  12. The Consent Process The consent process begins when you begin recruitment of subjects. Informed consent does not end with the signing of a document.

  13. The Consent Process How do you show respect for persons in each of these situations? • Information gathered to identify potential subjects? • Information provided in flyers? • Information provided in published ads? • Information provided when contacting the potential subject?

  14. The Consent Process The consent process is an on-going, dynamic “conversation” with your subject to ensure: the person understands what’s being asked of him/her; that the person has an opportunity to ask questions; and that the person truly wants to continue inthe study.

  15. The Consent Process Are there times when it is not appropriate to have a consent process? How do I inform the IRB that the process is not appropriate?

  16. Request for Waiver of Consent Process The IRB may waive the consent process if the following conditions exist: • the study involves no greater than minimal risk; • the rights and welfare of the subjects would not be adversely affected; • the research could not be practicably carried out without the waiver; • when appropriate, subjects will be provided pertinent information after participation is completed.

  17. Documentation of Informed Consent The consent form is one of the most important ways to document your respect for persons.

  18. Informed Consent Document Common problems found during IRB review include: Information is not presented in terms the average person understands (usually 8th grade level); Typographical or grammatical errors; All of the procedures are not included; The risks are not appropriately described; The benefits are overstated; and The person isn’t told that they are participating in research!!!

  19. Informed Consent Document Are there times when documentation of informed consent is not appropriate?

  20. Informed Consent Document There are times when signed consent is not absolutely required and documentation can be waived. Waiver of documentation requires a formal request to the IRB with justification that the study is: • The study poses no greater than minimal risk; • The only record linking the subject and the research would be the consent document; • The principal risk would be harm resulting from breach of confidentiality; and • Each subject is asked whether he/she wants documentation.

  21. Request for Waiver of Documentation of Consent Typically, whenever possible, the IRB will ask that you provide a letter to the participant that contains all of the elements of informed consent. This can serve as a cover memo for a survey, be provided at the beginning of an interview, or be sent subsequent to a telephone research procedure.

  22. What if my subject population is not fully autonomous? Certain “vulnerable” populations are not considered totally autonomous and therefore must have someone else sign informed consent for them. Examples of these populations include children, individuals with limited mental capacity, or individuals under acute stress or sedation.

  23. Parental Permission Children are not considered autonomous individuals (unless they meet the definition of emancipated). However, we want to respect them as individuals. To use children in research, you must first obtain the permission of the parent(s) and then obtain assent from the child. Minors (children) are defined as those individuals under the age of 18 years.

  24. Emancipated Minors • Individuals under 18 years of age that are considered emancipated (therefore able to give consent for themselves) include: – Minors declared emancipated by the courts – Minors who are married or have been married – Minors who are pregnant and are being asked to participate in research about pregnancy or impacts the well-being of the mother or her unborn baby

  25. Verbal and Documented Assent Children participating in research should be given the opportunity to agree to that participation. For children under 7 years of age, it is an informal process. Children 7 – 12 years of age, assent is verbally obtained and documented in the research records. Minors 12 – 17 years of age, should be given the opportunity to document their assent onan IRB approved assent form.

  26. Where do I go and What do I do?

  27. USF on-campus mailing: MDC35 Off-campus mailing: USF Division of Research Integrity and Compliance 12901 Bruce B. Downs Blvd. MDC35 Tampa, FL 33612 Hand delivery:USF Division of Research Integrity and Compliance University Technology Center 3702 Spectrum Avenue, Suite 155 Tampa, Florida  Fax number: (813) 974-5618  Call us at:(813) 974-9343 Visit our web site: