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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. A written assent should be prepared for children 7 years or older unless assent is waived by the Board. The child should be given an opportunity to decide, independently, whether or not to participate in the study. If the child agrees, his/her signature (or printed name) indicates assent. Schulman does not review studies that target wards of the state/province.

Economically Disadvantaged

The site must ensure that the subject compensation for participation compensation is not presented in a manner that may unduly influence a subject to participate or that is coercive. Subject compensation for participation must not be contingent upon completion of the entire study.  There must be a plan to pro-rate payments. Any compensation or bonus for completion must be reasonable (not to exceed more than 15% of the Schulman approved compensation).

Educationally Disadvantaged

For a potential subject who may have trouble comprehending the written IC, the person conducting the consent discussion must review each section of the IC with the potential subject and pose questions after each section to ensure an adequate understanding.  For an illiterate potential subject, an independent witness must also 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 employees and/or employees’ family members participate in a research study, measures must be taken to ensure the confidentiality of their study-related medical 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.
The Board requires that each employee and/or family member sign a Non-Coercion Statement prior to participation in the study. The Board will send a Non-Coercion Statement with the initial approval documents if you indicate on the Research Site Submission Form that you plan to recruit employees/family members, and if doing so is consistent with the study’s inclusion/exclusion criteria. If, after receiving your initial approval documents, your site decides to enroll employees/family members, please send a written request to Schulman by completing the Non-Coercion Statement Request Form before enrolling employees/family members in the study.

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/assent and identify which individuals will be allowed to provide consent/permission. 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 at the site 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). This person cannot be a family member or friend of the subject.

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

Schulman does not review studies in which prisoners are the targeted population.

Wards of the State

Schulman does not review studies in which wards of the state are the targeted population.