Informed Consent

The IRB may approve an informed consent process that waives the requirement to obtain informed consent,  alters some or all of the elements of informed consent, or waives the requirement to document informed consent (i.e., to obtain a signature).

• Waiver of the Consent Process

  The IRB may approve an informed consent process that:

  • Waives the requirement to obtain informed consent [CHECKLIST: Waiver or Alteration of the Consent Process (HRP-410)]

  To waive informed consent, the IRB must determine that:

  • The research involves no more than minimal risk to subjects
    • Minimal risk means that the probability and magnitude of harm or discomfort anticipated during the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
      
      
    • The waiver request should identify all risks associated with the research and justify why it is no more than minimal risk.
      
      
    • A breach of confidentiality is the primary risk associated with medical record review and with the use of existing identifiable data or specimens. Specifically, discuss the sensitivity of the data and the confidentiality protections in place to protect the data and minimize a breach of confidentiality.
  • The research could not be carried out practicably without the waiver. NOTE:  Practicability should not be determined solely by considerations of convenience, cost, or speed. There are situations where the investigator has access to the prospective subject but getting consent would make it impossible to actually conduct the study or would threaten the scientific validity of the research results
     
    • There must be a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained.
      
    • Examples of this might include the following:
      • The sample size required is so large (e.g., population-based studies, epidemiology trials) that including only those samples/records/data for which consent can be obtained would prohibit conclusions to be drawn or bias the sample such that conclusions would be skewed.
      • The subjects for whom records would be reviewed are no longer followed and may be lost to follow-up. For example the proportion of individuals likely to have relocated or died may be a significant percentage of the subject population and the research results may not be meaningful and lose statistical power.
      • The disclosure of the study purpose as part of the consent process would bias the research subjects so that the results will not be meaningful.
      • Example where it would be practicable: records will be reviewed and then subjects will be asked to complete a questionnaire. Consent should be obtained prior to records review and not just prior to the questionnaire.

  • The waiver will not adversely affect the rights and welfare of the subjects
    • Explain why the waiver will not adversely affect subjects’ rights. Patients have a right to privacy regarding their medical records. The impact of the research on this right must be minimized to the extent possible.

   

  • Where appropriate, the subjects will be provided with additional information about their participation (for an alternation of consent – debriefing)
    • The intent of this criterion is to require debriefing for participants in research that involves deception, misinformation, etc.

   

  • If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form.
    • It must be explained why the study itself would be infeasible to conduct without using identifiable information / biospecimens.

  The most important discussion should target why it is not practicable (not possible) to conduct the research without the waiver. The justification must provide a reasonable rationale for why the research would not be possible without the waiver.

  Studies that are entirely retrospective (use existing data, specimens and medical records that are available as of the date of IRB submission) represent a large percentage of the studies submitted to the IRB. These studies generally request and obtain a waiver of consent. However, if there are additional prospective components to the research, e.g. some subjects will be telephoned and asked to complete a questionnaire, it then becomes entirely practicable to obtain consent for the entire study, not just the questionnaire portion. If the data will be collected prospectively (after the date of IRB approval), a thorough justification is needed since it would be (or would have been) practicable to obtain consent.

  Waiving Parental Permission for Children

  The IRB may approve a waiver of parental permission only for research involving retrospective or prospective record review studies when the regulatory requirements are met.

   

  Waiver of Consent Process for Emergency Research

  This waiver is for IRB approved research that is done in emergency situations when there is no time to obtain informed consent. [CHECKLIST: Waiver of Consent for Emergency Research (HRP-419)]

   

  Things to Consider

  • Do you have access to the potential subjects in real-time or can you contact them to obtain consent?
    
    
  • Did you consider the psychological, physical, social, economic, and legal implications of a breach that would result if the private information placed in the research record became known outside the research team?
    
    
  • Did you consider how a subject may feel about their data being used for research purposes?
    
    
  • For secondary research, did you consider whether the research purpose is consistent with the original intent of the individual who provided the data?

• Alteration of the Consent Process

  The IRB may approve an informed consent process that:

  • Alters some or all of the elements of informed consent [CHECKLIST: Waiver or Alteration of the Consent Process (HRP-410)]

  Alteration of the Requirements for Informed Consent

  When the IRB approves a waiver of one or more of the elements of consent (this is called alteration), the information provided to the subject does not have to include information related to the waived element during the consent discussion or in the written consent document. This is often found in studies involving Deception or Incomplete Disclosure.

  To alter informed consent elements, the IRB must determine that:

  • The research involves no more than minimal risk to subjects
    • Minimal risk means that the probability and magnitude of harm or discomfort anticipated during the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
      
      
    • The waiver request should identify all risks associated with the research and justify why it is no more than minimal risk.
      
      
    • A breach of confidentiality is the primary risk associated with medical record review and with the use of existing identifiable data or specimens. Specifically, discuss the sensitivity of the data and the confidentiality protections in place to protect the data and minimize a breach of confidentiality.
  • The research could not be carried out practicably without the  alteration. NOTE:  Practicability should not be determined solely by considerations of convenience, cost, or speed. There are situations where the investigator has access to the prospective subject but getting consent would make it impossible to actually conduct the study or would threaten the scientific validity of the research results
     
    • There must be a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained.
      
    • Examples of this might include the following:
      • The sample size required is so large (e.g., population-based studies, epidemiology trials) that including only those samples/records/data for which consent can be obtained would prohibit conclusions to be drawn or bias the sample such that conclusions would be skewed.
      • The subjects for whom records would be reviewed are no longer followed and may be lost to follow-up. For example the proportion of individuals likely to have relocated or died may be a significant percentage of the subject population and the research results may not be meaningful and lose statistical power.
      • The disclosure of the study purpose as part of the consent process would bias the research subjects so that the results will not be meaningful.
      • Example where it would be practicable: records will be reviewed and then subjects will be asked to complete a questionnaire. Consent should be obtained prior to records review and not just prior to the questionnaire.

  • The alteration will not adversely affect the rights and welfare of the subjects
    • Explain why the waiver will not adversely affect subjects’ rights. Patients have a right to privacy regarding their medical records. The impact of the research on this right must be minimized to the extent possible.

   

  • Where appropriate, the subjects will be provided with additional information about their participation (for an alternation of consent – debriefing)
    • The intent of this criterion is to require debriefing for participants in research that involves deception, misinformation, etc.

   

  • If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form.
    • It must be explained why the study itself would be infeasible to conduct without using identifiable information / biospecimens.

   

• Waiver of Written Documentation of the Consent Process (Verbal consent)

  A waiver of documentation of informed consent (waiver of the requirement for a signature on a consent form) can be obtained under certain circumstances by the Investigator:

   

  • The study involves only minimal risk and the research does not include any procedures for which written consent is required.
  • The IRB may also waive the requirement of documentation of consent when the only record linking the subject and the research would be the informed consent form AND the principal risk would be potential harm resulting from a breach of confidentiality.

   

  The investigator must obtain consent following the same requirements as written consent, but the subject does not sign a consent form. It may still be appropriate to document that the consent process took place.

HIPAA

• Full Waiver of Authorization

  A waiver of authorization may be granted in situations where an individual’s authorization to access their PHI will not be obtained. In this case, the IRB can waive authorization for an entire conduct of the study . The most frequent situation where the IRB approves a full waiver of HIPAA is when the research also qualifies for a waiver of the requirements for consent for studies such as retrospective chart reviews.

  The waiver may only be approved by the IRB when specific regulatory requirements are met.

  • The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
    1. an adequate plan to protect the identifiers from improper use and disclosure;
       
       
    2. an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
       
       
    3. adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;
       
       
  • The research could not practicably be conducted without the waiver or alteration; and
    
    
  • The research could not practicably be conducted without access to and use of the protected health information.

  The IRB will also expect the PI to provide an attestation in the protocol that:

  • The PI will destroy the Protected Health Information (PHI) he/she and/or the Study Team acquires or receives from JHS and/or UHealth at the earliest opportunity.
    
    
  • The PI will confirm that the Protected Health Inform (PHI) he/ she acquired from JHS and/or UHealth will not be re-used or disclosed to any other person or entity, except as required by law or for authorized oversight of the research study or for other research for which the use or disclosure of PHI is permissible.

• Waiver of Authorization for Recruitment (Partial waiver)

  A waiver of authorization for recruitment may be granted to review information in the medical record, record the minimum necessary information needed to contact a potential subject and to make that contact.
  
  It is vital to scientifically justify in the research protocol why research could NOT practicably be conducted without access to and use of the protected health information. Practicable means possible; it does not mean convenient. For example, if a subject is available to provide then it is usually practicable to obtain their authorization.

   

  The IRB will also expect the PI to provide an attestation in the protocol that:

  • The PI will destroy the Protected Health Information (PHI) he/she and/or the Study Team acquires or receives from JHS and/or UHealth at the earliest opportunity.
    
    
  • The PI will confirm that the Protected Health Inform (PHI) he/ she acquired from JHS and/or UHealth will not be re-used or disclosed to any other person or entity, except as required by law or for authorized oversight of the research study or for other research for which the use or disclosure of PHI is permissible.

• Alteration of HIPAA Authorization

  The most frequent alteration is for verbal HIPAA Authorization when the IRB has also waived the requirement for written consent. Demonstrating that the "research could not practicably be conducted without the waiver or alteration" is the main obstacle to approving an alteration. If the subject is physically present, it is usually practicable to obtain written HIPAA Authorization.