Informed Consent Waiver Information

Under the Policy for the Protection of Human Participants, MREC may approve an informed consent process that:

• Waives the requirement to obtain informed consent, or
• 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 or Alteration of Informed Consent

For research that is no more than minimal risk the MREC may approve a request to waive of some or all of the required elements of informed consent under specific circumstances.  Waivers of informed consent are primarily requested for researches involving the secondary analysis of existing data or in researches involving deception.  However, in all circumstances the intent of this waiver criterion is to require debriefing for participants in deception research

• To waive in total or to alter informed consent elements, the MREC must determine that:
• The research involves no more than minimal risk to subjects;
• The research could not be carried out practicably without the waiver or alteration;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
• Whenever appropriate, the participants or legally authorized representatives will be provided with additional pertinent information after participation.
• Note: 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 is not appropriate to request a waiver of documentation of informed consent for human subject projects that collect biospecimens.

Waiver of Documentation of Informed Consent

For some researches, the MREC will approve a request to waive the documentation of informed consent. This means that the study team must provide the participant with the required consent information, but the study team is not required to obtain the participant’s signature on the informed consent document. Each participant (or legally authorized representative) will be asked whether the participant wants documentation linking the participant with the research, and the his/ her wishes will govern;

In all cases, even if MREC approves a waiver of documentation of consent, MREC will review a written description of the information provided to participants and should be offered a copy of the consent information for their records even when a signed document is not required for the study.

A waiver of documentation is permissible when:

• The signature on the informed consent document would be the only record linking the participant to the research and the principal risk of harm to the participant would be a breach of confidentiality. For example, for research on sensitive topics, such as domestic violence or illegal activities; OR
• The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context. OR
• Alternative mechanism for documenting that informed consent was obtained.

For example:

1. Surveys/interviews conducted via telephone or online and involves minimal risk.
2. Retrospective chart reviews
3. Studies of existing pathology specimens
4. Ethnographic research
5. Passive (opt-out) consent.
6. Public Demonstration Researches: MREC may waive or alter the requirements for informed consent in research involving public benefit and service programs if MREC finds and documents that:
7. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials; and
8. The research is designed to study, evaluate or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
9. The research could not practicably be carried out without the waiver or alteration.
10. Screening, Recruiting, and Determining Eligibility Researches: MREC may approve a research proposal in which a researcher will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective participants without the informed consent of the prospective participant or the participant’s legally authorized representative, if either of the following conditions are met:
11. The researcher will obtain information through oral communication with the prospective participant or legally authorized representative, or
12. The researcher will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
13. Waiver of Requirement for Parental Permission: For research involving children as participants, MREC may waive the requirement to obtain parental permission if it finds and documents that:
14. An appropriate mechanism for protecting the children who will participate as participants in the research is substituted.
15. The research involves no more than minimal risk to the participants;
16. The waiver or alteration does not adversely affect the rights and welfare of the participants;
17. The research cannot practicably be carried out without the waiver or alteration e.g., domestic violence or children abuse;
18. When appropriate, the participants will be provided with additional pertinent information after participation.

For emergency research, MREC may approve a waiver of consent or documentation in emergency research protocols in which participants are unable to give informed consent at the time of enrollment due to their medical condition. However, these studies require additional steps to ensure that potential participants in the communities where the study takes place have adequate opportunity to learn about the study at any time:

1. “Community Consultation” prior to MREC submission of the full study protocol
2. “Public Disclosure” (such as advertisements)

• Before study initiation, MREC will assess and evaluate the plans for the investigation and its risks and expected benefits
• After study completion, of study results and the demographics of the study population.

“Emergency Use of an Investigational Agent” prior to MREC Review and Approval: MREC may waive or alter the requirements for informed consent under the following requirements

1. • MREC receives a request to use an investigational agent without informed consent, MREC will assess whether or not the regulatory criteria apply.
   • Where MREC is informed after the use of an investigational agent without informed consent, MREC will assess whether or not regulatory criteria were followed according to Appendix A

APPENDIX A

Exception from informed consent requirements for emergency research

• MREC may approve the waiving of informed consent in emergency research if it finds anddocuments each of the following requirements and are met with the concurrence of a licensed physician who is a member of or consultant to MREC and who is not otherwise participating in the clinical investigation:

1. The human subjects are in a life-threatening situation, available treatments are unproven or
   unsatisfactory, and the collection of valid scientific evidence, which may include evidence
   obtained through randomized placebo-controlled investigations, is necessary to determine the
   safety and effectiveness of particular interventions.

1. Obtaining informed consent is not feasible because:

• The subjects will not be able to give their informed consent as a result of their medical condition;
• The intervention under investigation must be administered before consent from the subjects’ legally authorized representatives is feasible; and
• There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.

1. Participation in the research holds out the prospect of direct benefit to the subjects because:

• Subjects are facing a life-threatening situation that necessitates intervention;
• Appropriate animal and other preclinical studies have been conducted, and the
  information derived from those studies and related evidence support the potential for the
  intervention to provide a direct benefit to the individual subjects; and
• Risks associated with the investigation are reasonable in relation to what is known
  about the medical condition of the potential class of participants, the risks and benefits of
  standard therapy, if any, and what is known about the risks and benefits of the proposed
  intervention or activity.

1. The clinical investigation could not practicably be carried out without the waiver.

1. The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each participant within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to MREC at the time of continuing review.

1. MREC has reviewed and approved informed consent procedures and an informed consent document. These procedures and the informed consent document are to be used with participants or their legally authorized representatives in situations where use of such procedures and documents is feasible. MREC should have reviewed and approved the procedures and information to be used when providing an opportunity for a family member to object to a subject’s participation in the clinical investigation consistent with paragraph (A) (7) (v) of this appendix.

1. Additional protections of the rights and welfare of the subjects will be provided, including, at
   least:
2. Consultation (including, where appropriate, consultation carried out by MREC) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;
3. Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;

• Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;

1. Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and
2. If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject’s family member who is not a legally authorized representative, and asking whether he or she objects to the subject’s participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to MREC at the time of continuing review.

• MREC is responsible for ensuring that procedures are in place to inform, at the earliest feasible
  opportunity, each participant, or if the participant remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the participant’s inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document.

MREC shall also ensure that there is a procedure to inform the participant, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the participant’s participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

If a legally authorized representative or family member is told about the clinical investigation and the participant’s condition improves, the participant should also to be informed as soon as feasible.

If a participant is entered into a clinical investigation with waived consent and the participant dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the participant’s legally authorized representative or family member, if feasible.

• MREC determinations required by paragraph (a) of this section and the documentation required byparagraph (e) of this section are to be retained by MREC for at least 3 years after completion of the
  clinical investigation, and the records shall be accessible for inspection and copying by Supreme Council of Research Ethics.

• Protocols involving an exception to the informed consent requirement under this section must be
  performed under a separate investigational new drug application (IND) or investigational device
  exemption (IDE) that clearly identifies such protocols as protocols that may include participants who are
  unable to consent. The submission of those protocols in a separate IND/IDE is required even if an IND
  for the same drug product or an IDE for the same device already exists.

• If MREC determines that it cannot approve a clinical investigation because the investigation does notmeet the criteria in the exception provided under paragraph (a) of this section or because of other
  relevant ethical concerns, MREC will document its findings and provide these findings promptly in
  writing to the clinical investigator and to the sponsor of the clinical investigation. The sponsor of the
  clinical investigation must promptly disclose this information to the relevant authority and to the sponsor’s clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other research ethics committees that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.

APPENDIX B

DEFINITIONS

• Clinical investigation: The terms research, clinical research, biomedical research, clinical study,study, clinical trial, trial, and clinical investigation are deemed to be synonymous for purposes of this) The term means: For drugs (including biological drugs): Any experiment in which a drug/biologic is administered or dispensed to, or used involving, one or more human participants.

• For devices: Any investigation or research involving one or more participants to determine the safety oreffectiveness of a device.

• Clinical Investigator: An individual who actually conducts a clinical investigation (i.e., under whose
  immediate direction the test article is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of that team.

• Community: A community means a group or groups of people who live and work in a particular regionand who may be linked by common interests; an interacting population of different kinds of individualsconstituting a society or association; or, simply an aggregation of mutually related individuals in a given A community may also include persons who share common experiences or conditions.

• Community consultation: Community consultation means providing the opportunity for discussions
  with, and soliciting opinions from, the community or communities in which the study will take place and
  from which the study subjects will be drawn.

• Data Monitoring Committee (DMC): A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials.The DMC advises the sponsor regarding the continuing safety of current trial participants and those yetto be recruited to the trial, as well as the continuing validity and scientific merit of the trial.

• Emergency Research: A planned clinical investigation that requires prior written authorization toproceed and involves participant(s) who are in a life-threatening situation for which available treatments orin vitro diagnostic tests are unproven or unsatisfactory.

• Family member. Any one of the following legally competent persons: spouse, parents, children, brothers, sisters, and spouses of brothers and sisters, and any individualrelated by blood or affinity whose close association with the subject is the equivalent of a family
• Legally competent: may vary but generally includes an age of majority and an assessment of mental capacity.

• Medical Research Ethics Committee (MREC): The board committee formally designated by National Research Centre to review, to approve the initiation of, and to conduct periodic review of, biomedical researchinvolving human participants. The primary purpose of such a review is to ensure the protection of the rightsand welfare of the human subjects.

• Legally authorized representative (LAR): An individual or judicial or other body authorized under
  applicable law to give informed consent on behalf of a prospective subject to the participant’s participation in the procedure(s) involved in the research.

• Life-threatening: Diseases or conditions where the likelihood of death is high unless the course of thedisease or condition is interrupted.

• Public disclosure: dissemination of information about the emergency research sufficient to allow a reasonable assumption that the communities areaware of the plans for the investigation, its risks and expected benefits, and the fact that the study will beconducted without obtaining informed consent for most or even all subjects. Public disclosure alsoincludes dissemination of information after the investigation is completed so that the communities andscientific researchers are aware of the study’s results.

• Sponsor: A person who takes responsibility for and initiates a clinical investigation. A sponsor may be an individual, a company, a governmental agency, an academic institution,a private organization, etc.

• Therapeutic window:

The therapeutic window is the time period, based on available scientific evidence, during which administration of the test article might reasonably produce a demonstrable clinical effect.

For investigations of in vitro diagnostic devices that meet the criteria for emergency research, the therapeutic window is the time period, based on available scientific evidence, during which diagnosis must occur to allow administration of appropriate therapy.

Request for Waiver of Informed Consent

Request for Waiver of some Items of Informed Consent

Request for Waiver of Documentation of Informed Consent

Section 1: About the Waiver of Informed Consent

Use this form if none of the required elements of consent are given. A waiver of informed consent completely waives the requirement to obtain informed consent. The MREC may approve a consent procedure which does not include some or all of the required elements of informed consent provided all of the following are true:

• The research involves no more than minimal risk
• The waiver of informed consent will not adversely affect the rights and welfare of the subjects
• It is not practicable to conduct the research without the waiver or alteration

Whenever appropriate, participants will be provided with additional pertinent information after their participation.

PLEASE NOTE: MREC will take into consideration the risks and potential harms involved in the research before granting a waiver of informed consent. Additionally, there are restrictions for when MREC may waive the requirements for child assent and parental permission.

Section 2: Who Needs to Complete this Form

If you choose “waiver of informed consent / waiver of informed consent documentation or waiver of some items of informed consent box in the CONSENT FORM DOCUMENT, you will need to complete this form as part of your application.