Consent Process Plan
The investigator will develop and maintain a detailed consent process plan in the research application submitted to the IRB. The following factors should be considered:
- Type of research being conducted, for example, biomedical research, behavioural/social science research, health services etc.
- Risk to subjects, including procedures, devices, drugs, or
- Vulnerable categories of subjects, for example children; adults lacking decision- making capacity; prisoners; persons who are non-English speaking, economically or educationally disadvantaged, terminally ill, or students or employees of the organization.
- Characteristics of subjects such as age or health status that may influence health literacy and the consenting.
- Need for informing subjects of significant or incidental findings resulting from the research.
Waiver of Documentation of Consent
The IRB will review the research proposal to determine if waiver of documentation of informed consent is appropriate. The IRB may waive the requirement for an investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
- 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. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
- 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; Or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk or harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was
- When the IRB considers waiving the requirement to obtain written documentation of consent, the IRB reviews a written description of the information that will be provided to subjects via an oral consent script, contact letter, phone script or similar
- If a waiver of written consent is granted by the IRB, the IRB will determine whether the investigator must document the oral consent in research study files and/or the subject’s medical file.
The plan must include a description of the following:
- The method(s) for obtaining informed consent, including the location or methods of communicating and the related privacy needs for the initial and on-going discussions (e.g. in-person, mail, telephone).
- The amount of time planned for the consent
- Method(s) for assessment of a subject’s capacity to consent, as
- The protections that are planned to reduce potential subjects’ vulnerability to coercion or undue influence during the consenting
- Additional safeguards for the specific population, e.g. individuals with diminished capacity, language differences, inability to read, limited vision and/or hearing, or other physical
- The need to include a medical interpreter, Legally Authorized Representative, witness, or advocate to be present and observe the discussions within the informed consent
- The waiting period between discussion, decision, and
- Study team members who will meet with the prospective subject and obtain informed consent. These individuals must be sufficiently trained, knowledgeable about the research project in order to answer questions posed by the subject, and must have IRB approval.
Use of Social Media for Recruitment
- Investigators using social media (e.g. Twitter, Facebook, YouTube, etc.) as a recruitment method must have the research reviewed and approved by the Maroof IRB For questions please contact at email@example.com
- New projects proposing the use of social media as a recruitment method will contain a statement from the PI in either the IRBe application or the research project proposal that the use of social media for recruitment of research subjects has been reviewed and approved by the Mayo Clinic Public Affairs/Centre for Social Media.
- Investigators at institutions for which the Mayo Clinic IRB is the IRB of record will include within the IRB application documentation of review and approval by the relying organization for the use of social media, or documentation that such review and approval is not required by the institution.
IRB Submission and Review
The IRB reviews the application and attached documents including (but not limited to) the research protocol, consent forms, scripts and recruitment and advertising materials, and payment arrangements. The IRB:
- Determines whether the consent process is appropriate for the proposed research activities and if revisions to the consent process or document are necessary.
- Determines the amount of payment and the proposed method and timing of disbursement is neither coercive nor presents undue.
- Reviews the proposed research project and determines that the consent document accurately reflects the purpose, risks, benefits and procedures, and payments as outlined in the research protocol and contains all the required elements of consent
- Determines whether documentation of informed consent is appropriate for the proposed research activities, the subject population and the level of
The IRB will ensure that:
- The research application and related materials (i.e. recruitment/advertisement materials, payments, consent documents, scripts) as submitted to the IRB are acceptable and approvable.
- Recruitment locations, recruitment methods, advertising materials and payment arrangements do not place subjects at risk of coercion, undue influence or cause inequityzs.
- The consent process minimizes the possibility of coercion or undue influence and maximizes continued legally effective informed consent. When prospective subjects are vulnerable to coercion or undue influence due to their status, condition or situational vulnerability, the IRB will ensure that the informed consent process is appropriate.
- The consent document has the requisite regulatory and institutional information and is written in language that is understandable to the research project population.
- The consent documents accurately describe the risks and benefits initially approved by the IRB and at the time of research project modifications, continuing review, submission of reportable events or other safety-related.
- Significant new findings or alterations to the risks and benefits that may relate to the subject’s willingness to continue participation will be provided to the subject.