Institutional Review Board

Waiver of Documentation of ConsentGuidelines

Federal regulations (45 CFR 46.117) require written informed consent (meaning the use of an IRB-approved written consent form which is signed by the subject or the subject’s legal representative) unless the IRB has determined that the research meets the criteria for waiver of documentation of informed consent. In most cases for telephone, online, mailed or written surveys, the waiver would be granted under #2.

Criteria for Waiver of Documentation of Informed Consent may be granted if:

  1. The only record linking the subject and the research is the consent document, and the principal risk is potential harm resulting from breach of confidentiality.

OR

  1. The research involves no more than minimal risk of harm and involves no procedure for which written consent is normally required outside of the research context.

If obtaining only verbal consent, you must state that you are requesting a Waiver of Documentation in the Informed Consent portion of your protocol (see template), indicate Waiver of Documentation of Consent on the Initial Submission form (Section N.), and also check an Alteration of HIPAA Authorization.

The IRB encourages that whenever possible the informed consent process be done in person. However, when the research cannot reasonably be conducted in person, a telephone script**, written information page (primarily for surveys)or oral consent may be deemed appropriate. These documents should include your introductions, and how you plan to proceed when the potential participant responds. Survey cover letters can include a simple introduction, all the elements below and a statement to continue with the survey, including instructions for mailing or returning the survey. The consent portion of the script/cover letter must meet all elements of informed consent, as well as HIPAA information (see scripts for sample language) including:

  1. Statement that the study involves research
  2. Explanation of the purpose
  3. Duration of the subject’s participation
  4. Description of the procedures
  5. Description of risks/discomforts
  6. Description of benefits
  7. Confidentiality
  8. Whom (and how) to contact for questions regarding the actual study (researcher) and their rights as participants (IRB)
  9. The voluntary nature of participation in the research and her/his ability to withdraw without any penalty
  10. The approximate number of subjects.
  11. HIPAA Information

See Appendix A: Sample Script for Telephone Consent

See Appendix B: Sample Cover Letter for Emailed/Mailed/In person Survey

**Special Consideration for Telephone Consent:The Children’s IRB discourages investigators from recruiting participants with "cold calls" based on information derived from the medical records of another practitioner when the investigator has no prior relationship with the recruits. Instead, Children’s recognizes the ability of a practitioner to discuss with his or her own patient the possibility of participating in clinical research studies. When an investigator seeks a HIPAA waiver/partial waiver for recruitment activities that include "cold calls" to potential recruits, Children’s prefers that potential recruits be contacted only by individuals who have been actively involved in providing health care to the potential recruits.

Appendix A: Sample Script for Telephone Consent:

This is only an example and can/should be expanded to meet the needs of your study. The script should be followed by the actual survey/questions you will be asking, as well as the signature page (see below). Include Version Dates.

Study Title:

Principle Investigator:

Hello, my name is ______from ______. We are asking you to volunteer to take part in a phone interview/survey as part of a researchstudy about_ (briefly explain the study). This phone interview is being conducted to determine ______. The phone interview will consist of questions pertaining to your child's ______. The interview/survey will take approximately _____ minutes of your time. Your participation in this survey is completely voluntary. This means you do not have to participate if you don’t want to. If you agree to participate, you have the right to only answer the questions you choose to answer. The potential risks of this research are minimal and confidentiality of protectedhealth information that you share with us will be maintained to the highest level. You have the right to stop participation at any point during the interview if you so choose. We expect to enroll ___ participants in this study. If you have questions or concerns regarding this research, you can contact the PI ______at ______or the Children's Healthcare of Atlanta Institutional Review Board (IRB) at 404-785-7555.The IRB is a committee that works to protect your rights and welfare.

As a part of this study, I am asking you to give authorization to release some of your protectedhealth information (PHI). We will be collecting _(list whatever PHI is being collected- reference the HIPAA Authorization form, and simply list what you would have “checked”)___.

This information may be shared with other members of the research team, the Children’s IRB and ______. They will take special care to maintain confidentiality and privacy about you and your protected health information. It is your choice to let the researchers use and share your child’s health information. You can, at any time, change your mind.

If you change your mind and want to cancel your permission, you must contact the study team at: (insert study team contact information, including name and address). At that point, researchers would not collect any more PHI, but may use or disclose information already collected for safety reasons, to verify research data or if required by law. If you cancel your permission, you will not be able to stay in the study.

“Do you have any questions?”

"Do you agree to voluntarily participate in this survey process?"

[ ]YesIf Yes.....Continue

[ ]NoIf No... Good-bye.

Follow with list of specific questions you will be asking. You can only collect information provided in the IRB approved script, so be specific and thorough.

The last page is your record of your telephone/oral consent. This must be kept, just as a signed, written Informed Consent would be kept. See sample below.

(Title) Telephone/Oral Consent Study Documentation

ORAL CONSENT DOCUMENTATION FOR PARTICIPATION

Study ID#______

Subject: (Title of Study)

This consent serves as documentation that the required elements of informed consent have been presented orally to the participant or the participant’s legally authorized representative.

Verbal consent to participate in this (research/survey/discussion/focus group) has been obtained by the participant’s willingness to continue with (research/survey/discussion/focus group) by providing answers to a series of questions related to ______.

______

Surveyor’s Name (Printed)

______

Surveyor’s Signature

______

Date

NOTE: If you are collecting PHI on the survey, you can add a line for name/ or study number to link to PHI on the document for your documentation. However, if you are not collecting PHI and this information would be the only document linking the PHI/Name to the research, then please delete.

______

Participant NameParticipant Study Number/ ID

Appendix B: Sample Survey Cover Letter:

This is only an example and can/should be expanded to meet the needs of your study. The letter should be followed by the actual survey you will be asking. Include Version Dates. When not having direct contact with the participant, oral consent documentation is not required (as above). However, if you are handing the survey to the participant in person or in the office (vs. mail/email), you may choose to do a verbal consent and can document that process as is done with telephone consent (above).

Study Title:

Principle Investigator:

We are asking you to volunteer to take part in a survey as part of a researchstudy about_ (briefly explain the study). This survey is being conducted to determine ______. The survey will consist of questions pertaining to ______. The survey will take approximately _____ minutes of your time. Your participation in this survey is completely voluntary. This means you do not have to participate if you don’t want to. If you agree to participate, you have the right to only answer the questions you choose to answer. The potential risks of this research are minimal and confidentiality of protectedhealth information that you share with us will be maintained to the highest level. You have the right to stop participation at any point during the interview if you so choose. We expect to enroll ___ participants in this study.If you have questions or concerns regarding this research, you can contact the PI ______at ______or the Children's Healthcare of Atlanta Institutional Review Board (IRB) at 404-785-7555.The IRB is a committee that works to protect your rights and welfare. If you would like to participate- please continue with completing this survey and return it to ______or mail back to _(address)______.

As a part of this study, I am asking you to give authorization to release some of your protectedhealth information (PHI). We will be collecting _(list whatever PHI is being collected- reference the HIPAA Authorization form, and simply list what you would have “checked”)___.

This information may be shared with other members of the research team, the Children’s IRB and ______. They will take special care to maintain confidentiality and privacy about you and your protected health information. It is your choice to let the researchers use and share your child’s health information. You can, at any time, change your mind. If you change your mind and want to cancel your permission, you must contact the study team at: (insert study team contact information, including name and address). At that point, researchers would not collect any more PHI, but may use or disclose information already collected for safety reasons, to verify research data or if required by law. If you cancel your permission, you will not be able to stay in the study.

Version 8/2017