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Safeguards for Vulnerable Subjects

Schulman IRB - Information for InvestigatorsYou must provide appropriate safeguards if you plan to recruit subjects from the following vulnerable groups:

 

Children

Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. A child’s parent or legal guardian must accompany a child during the informed consent discussion and sign the IC. The Board will determine whether and how assent should be obtained. In general, Schulman requires written assent to be obtained for children 7 years or older. The child should be given an opportunity to decide, independently, whether or not to participate in the study.

Economically Disadvantaged

The site must ensure that the subject compensation for participation is not presented in a manner that may unduly influence a subject to participate or that is coercive. For details on Schulman’s requirements for compensation, please refer to Compensation and Reimbursement.

Educationally Disadvantaged

For a potential subject who may have trouble comprehending the written IC, the person conducting the consent discussion must present the information at a level and in a manner that will allow the potential subject to make an informed decision. In order to ensure that the participant understands the information presented, the person conducting the consent discussion may pose questions after each section to ensure an adequate understanding.  For an illiterate potential subject, an independent witness must be present during the presentation and signing of the IC.  An independent witness must not be an employee of the investigator or research site.

Employees/Family Members

When a study targets employees and/or employees’ family members for participation, the Board will review the protocol to ensure that there are sufficient precautions in place to avoid coercion, including additional language in the IC if necessary. Measures must be taken to ensure the confidentiality of study-related records. Additionally, no action can be taken against an employee based on information to which an employer would not otherwise be entitled but obtains because of an employee’s participation in a study.  An employee who participates in a research study must be treated as other subjects and must be able to decide not to participate or to discontinue study participation without any impact on his/her employment status.

Physically Impaired

An individual with a physical impairment(s) (e.g., visual, hearing, speech) that would prevent normal communication, and who is unable to read and/or sign the IC, must have an independent witness present during the presentation and signing of the IC.  The independent witness must also sign the IC. An independent witness must not be an employee of the investigator or research site.

Life Threatening Condition/Seriously Debilitating Illness

For a potential subject with a life-threatening condition, the Investigator must fully explain alternative treatments and that participation in a research study may not benefit his/her present medical condition. The Investigator must confirm that the potential subject understands this information.

Adults with Diminished Decision-Making Capacity

A potential adult subject who has diminished decision-making capacity, and thus lacks the capacity to consent, must have a legally authorized representative (LAR) sign the IC on behalf of the subject. An LAR may consent on behalf of an adult subject only if the Board has determined that an LAR is appropriate for the study. As part of the initial submission process, sites participating in studies using LARs must describe the plan to assess subject ability to provide consent. Who may serve as an LAR is determined by state or province. If uncertain, Schulman recommends the PI/QI seek legal/regulatory advice to determine their state or provincial requirement.

Non-English Speaking Subjects

If a site consents a non-English speaking subject, there must be someone who is capable of answering questions about the research in the language of the non-English speaking subject and who is available throughout the study (i.e., employee, member of the study staff, or impartial translator).

Nursing Home Residents

Each state has a “Nursing Home Bill of Rights” or other applicable regulations of which the PI, study staff, subject and LAR, if appropriate, must be fully aware.

Pregnant Women

A pregnant woman is to be fully informed regarding the foreseeable impact of the research on the fetus or resultant child. In addition, the individuals engaged in research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy and will have no part in determining the viability of the fetus. No inducements, monetary or otherwise, will be offered to terminate a pregnancy.

Prisoners

Research involving prisoners requires additional safeguards. This includes subjects who become incarcerated during their participation in a research study. Please contact Schulman for more information regarding IRB review of this type of research.

Wards of the State

Research targeting wards of the state requires additional safeguards. Please contact Schulman for more information regarding IRB review of this type of research.