1. Informed Consent It’s a Process …not a form

2. Outline  Historical Background  Respect for Persons  Consent Process  Elements of Informed Consent  Waivers of Informed Consent and Documentation of Consent forms  General Reminders

3. Historical Background  The National Research Act of 1974 established the modern IRB system for regulating research involving human subjects  The National Commission for Protection of Human Subjects of Biomedical and Behavioral Research committee was formed to clarify the ethical guidelines applying to human subject research. The Commission conducted a series of meetings and issued the Belmont Report in 1978

4. Historical Background The requirement that researchers obtain informed consent from research subjects originates with Principal 1 of the Belmont Report: Respect for Persons

5. Respect for Persons  Individuals are treated as autonomous agents. This means that the subjects are not controlled by others and are able to make independent decisions  Persons with diminished autonomy are given protection (e.g. vulnerable subjects such as children, prisoners, mentally disabled)  Consent to participate in research is voluntary and informed

6. Informed Consent - Process Informed consent is a process that begins when you first approach the potential research subject and continues throughout the course of the study.

7. Informed Consent- Process The first contact with research subjects may be through any of the following:  direct advertising  medical record review to screen for eligible subjects  physician referral

8. Informed Consent - Process Obtaining Informed Consent involves:  Providing information to the subject in a language that is understandable to the subject or their representative  Ensuring that the subject understands what they are being asked to do  Answering any questions that the subject may have  Allowing enough time for the person to think about the research before consenting to participate  Obtaining voluntary agreement of the subject to participate in the study

9. Informed Consent - Process The consent process continues each time that an investigator has contact with a research subject. The consent dialogue is renewed every time that the study is revised, or if new information becomes available that would impact upon a subject’s decision to participate,

10. Informed Consent - Elements Federal Regulations 45CFR46.116(a) specify the elements that must be included for informed consent. The Lifespan IRB consent form template is designed to include all of the required elements of informed consent. Consent form templates are posted on the IRB webpage at www.lifespan.org/research/irb/irbformslist.asp

11. Informed Consent - Elements Elements of informed consent: 1. Information that the study involves research 2. Risks or discomforts 3. Benefits 4. Alternatives 5. Confidentiality 6. Compensation/treatment offered 7. Contact for additional information 8. Contact information for research subject rights 9. Statement that participation is voluntary

12. Informed Consent - Elements Element 1: Information that the study involves research  Explain the purpose of the research,  expected duration of the subject’s participation,  and identify any procedures that are experimental or done solely for research purposes. Element 2: Risks or discomforts  Include a clear description of the risks/discomforts  Review any risks related to procedures and tests relating solely to the research  Inform subjects about previously reported adverse events

13. Informed Consent - Elements Element 3: Benefits  Explain any benefits to the subjects or others Element 4: Alternative Procedures  Describe any alternative treatments that may be beneficial to the subject so that they can consider the full range of options. When appropriate, include a statement that supportive care with no additional treatment is an alternative

14. Informed Consent - Elements Element 5: Confidentiality  Explain how the researchers will maintain confidentiality of study records and include any agencies, institutions, or individuals who will have access to the records Element 6: Compensation and Available Treatment  Describe any compensation that will be offered  State whether any medical treatment will be offered in case of research related injury and describe the conditions and extent of the payment/treatment. Include contact information for questions.

15. Informed Consent - Elements Element 7: Subject Rights  Include contact information (name and phone number) for questions relating to subject rights and research related injury. Element 8: Participation is Voluntary  State that participation is voluntary, that refusal to participate will not incur a penalty or loss of benefits and that the subject may discontinue at any time

16. Informed Consent - Elements Additional Elements, if relevant:  Describe additional costs  Declare the approximate number of subjects to be enrolled  State that the procedure may involve unforseeable risks.  Describe any consequences for early withdrawal including instructions for discontinuing study participation safely  Describe the circumstances that might lead the researcher to terminate the subject’s participation early  State that subjects will be notified of significant findings which may impact their decision to continue to participate.

17. Informed Consent - Elements Consent forms cannot include any language that waives, or appears to waive the subject’s legal rights. The consent document must explain whether there is compensation available in case of injury but must not waive or appear to waive the rights of the subject or release or appear to release those conducting the study from liability for negligence. When no system has been set up to provide funds, the preferred wording is: "no funds have been set aside for“… "[the cost] will be billed to you or your insurance," or similar wording that explains the provisions or the process.

18. Informed Consent - Elements Telephone consent Federal regulations do not allow for telephone consent. However it is acceptable to send the consent form by fax to the legally authorized representative (LAR) and then to conduct the consent interview by telephone when the LAR can read the consent form as it is discussed. If the LAR agrees then he/she can sign the consent form and return it to the researcher by fax.

19. Informed Consent - Waivers Federal regulations allow for some types of research to be conducted without obtaining written informed consent from research subjects. Typically, waivers are only granted for studies that present no greater than minimal risk. The most frequent types of studies that are eligible for waivers are chart reviews and surveys.

20. Informed Consent- Waivers and Medical Record Review If researchers review private records to collect information or to pre-screen for potential subjects, then a waiver of consent is required because the subject/patient never gave permission for anyone to look at their records for research purposes. It does not matter if the researchers have access to the medical records for clinical/treatment purposes. Patients/subjects must either give explicit permission for review by researchers, or a waiver must be obtained from the IRB.

21. Informed Consent - Waivers Criteria for Waivers of Informed Consent 46CFR46.116 (d):  The research must present no greater than minimal risk to the subjects  The waiver or alteration will not adversely affect the rights and welfare of the subjects  The research could not practicably be carried out without the waiver or alteration (please note inconvenience, time and resources are not acceptable criteria).  Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

22. Informed Consent - Waivers When applying for a Waiver of Informed Consent 46CFR46.116 (d):  The researcher must describe the steps taken to assure privacy and confidentiality of subject data and to protect the identifiers/links to identifiers from improper use or disclosure.  Identifiers (or links) should be destroyed at the earliest possible time. However, for research plans that may be subject to future continuing and secondary data analysis, the IRB highly recommends that you consider providing a justification for not destroying the identifiers).

23. Informed Consent - Waivers Criteria for Waivers of Consent form Documentation 46CFR46.117 (c):  The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.  The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

24. Informed Consent - Waivers When applying for a Waiver of Consent form Documentation 46CFR46.117 (c):  Typically an information letter which contains all of the required elements of consent will be provided to subjects when a waiver of consent form is employed.  All material(s) must be submitted for IRB review and approval (e.g. a letter accompanying a questionnaire or survey).

25. General Reminders  Download the most recent consent form template from the ORA webpage every time that you submit a consent (new or revised)  Consent forms should be written in the second person (“you” and “your”)  Language in the consent form should be understandable to the subject population (about 6 th -8 th grade reading level)

26. General Reminders Advertising:  Cannot make false or exaggerated promises or claims  Cannot be coercive  The Lifespan IRBs do not allow specific dollar amounts to be included in advertisements.

27. Questions? For questions regarding informed consent or other IRB related issues please call:  Pat Houser, IRB Manager, 444-2099  Adrienne McParlin, Coordinator, 444-3527  Jacqui Poore, Coordinator, 444-2093  Dawn Roux, Coordinator, 444-7547