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Special Protections

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Last update
01.03.08

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RECRUITMENT PROCESS

The Campus Institutional Review Board (Campus IRB) requires prospective review of the full recruitment plan before any initiation of ANY PHASE of the research or interaction with subjects occurs, to assure that the methods comply with the regulatory requirements of Informed Consent. Informed Consent is a "process" not a document, so it is very important that the recruitment process for soliciting participants provides optimal opportunities for subject comprehension and voluntariness.

Investigators must provide the Campus IRB with the proposed recruitment method materials for review and approval. Throughout the recruitment process, investigators must ensure prospective human subjects receive the information necessary to help them understand the nature of the research so they can knowledgeably and voluntarily decide whether or not to participate. The recruitment process must not be modified without the prior approval of the Campus IRB.

Recruitment of Vulnerable Subjects (PDF, 176K)
Recruitment Process (PDF, 80K)

RECRUITING VULNERABLE SUBJECTS

The Campus Institutional Review Board (Campus IRB) requires research proposing to recruit vulnerable subject populations to provide special protection and adequate safeguards to protect their safety and welfare.

Federal regulations gives special consideration to protecting the welfare of certain vulnerable subject populations, and requires the investigator to take the necessary measures to ensure special protections are incorporated into the recruitment processes to assure optimal protection of research participants.

Federal regulations identify 3 subparts for vulnerable subject populations which will require additional safeguards be implemented by the researcher: (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

1. Subpart B (45 CFR 46.201): Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
2. Subpart C (45 CFR 46.301): Additional Protections Pertaining to Biomedical and Behavior Research Involving Prisoners as Subjects
3. Subpart D (45 CFR 46.401): Additional Protections for Children Involved as Subjects in Research

The Campus IRB recognizes that additional populations may be vulnerable in certain situations, thus providing the need for special protections. The following list includes subjects that are considered vulnerable, under certain conditions, and therefore subject to special protections:

1. Women of Childbearing Potential
2. Pregnant Women
3. Fetuses and Human in Vitro Fertilization
4. Children and Minors
5. Prisoners
6. Cognitively Impaired Persons
7. Students and Employees
8. Low-Income Persons
9. Minorities
10. Elderly Persons
11. International Subjects

NOTE: The Campus IRB has the unfettered discretion to determine if a particular subject group is considered vulnerable under certain conditions. If you have a question, please contact the IRB for guidance.

Recruitment of Vulnerable Subjects (PDF, 176K)
Recruitment Process (PDF, 80K)

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