Source: http://www.irb.pitt.edu/book/export/html/366
Timestamp: 2018-02-21 18:55:44
Document Index: 86167239

Matched Legal Cases: ['art 46', 'art 22', 'art 512', '§ 26', '§ 26', '§ 26', '§ 26', 'art 26']

Chapter 26 - Additional Requirments for Research Supported by Other Federal Agencies
The University of Pittsburgh IRB will review submissions supported by the Department of Justice (DOJ) or conducted within the federal Bureau of Prisons with respect to the following additional requirements.
Research funded through the National Institute of Justice (NIJ) must comply with the provisions of 28 CFR Part 46, related to human subject protections, and also 28 CFR Part 22, related to privacy and confidentiality of research data. Specific requirements for such research are outlined below.
The research must have a privacy certificate approved by the NIJ Human Subjects Protection Officer. The NIJ requirements for privacy certificates are very specific and are available at: http://www.nij.gov/nij/funding/humansubjects/privacy-certificate-guidance.htm. A model form for a privacy certificate can be found at: http://www.nij.gov/nij/funding/humansubjects/model-privacy-certificate.htm
A statement must be included in the consent document that confidentiality may only be broken if the participant reports immediate harm to participants or others.
All Researchers and Research Staff are required to acknowledge in writing the confidentiality protections of the study, and copies of that acknowledgement must be maintained by the responsible Researcher.
Identifiable portions of the data must be destroyed after the three year data retention period has expired and a copy of all de-identified data must be sent to the National Archive of Criminal Justice Data including de-identified informed consent documents, data collection instruments, surveys or other relevant research materials.
Research Involving the Bureau of Prisons
Research within the federal Bureau of Prisons is subject to the additional requirements of 28 CFR 512.
The regulations apply to any research involving inmates in the custody of the Attorney General, and assigned to the Bureau of Prisons, regardless of the institution in which the inmate is incarcerated (e.g., even if the inmate is resident in a state institution).
In order for the IRB to review projects being conducted in the Bureau of Prisons, the Investigator must provide the following information through the OSIRIS system:
Names and current affiliations of the investigators
Durations of the study
Number of subjects (staff or inmates) required and the amount of time required from each
A comprehensive statement, which includes:
Detailed description of the research method
Significance of anticipated results and their contribution to the advancement of knowledge
Specific resources required from the Bureau of Prisons
Description of all possible risks, discomforts, and benefits to the individual subjects or a class of subjects, and a discussion of the likelihood that the risks and discomforts will actually occur
Description of the steps taken to minimize risks
Ensure the security of any individually identifiable data that are being collected for the study
Destroy research records or remove individual identifiers from those records when the research has been completed
Description of any anticipated effects of the research study on organizational programs and operations
Relevant research material such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules
Research protocols within the Bureau of Prisons must be approved in advance by the federal Bureau Research Review Board (“BRRB”), and by the warden of the individual facility in which the research is to be conducted.
No medical experimentation, cosmetic research or pharmaceutical testing is permitted. Only research studies that advance knowledge about corrections will be considered.
Research protocols may not offer incentives to inmate subjects, except for soft drinks and snacks to be consumed at the test site. Non-confined research subjects may be offered nominal monetary recompense for time and effort provided that such subjects are 1) no longer in Bureau of Prisons custody, and 2) participating in approved research being conducted by Bureau of Prisons employees or contractors.
The investigator must assume responsibility for actions of any research staff engaged to participate in the project, and all researchers must agree to abide by the rules of the institution where the research will be conducted. Researchers must sign an acknowledgement to adhere to the regulations of the Bureau of Prisons at 28 CFR Part 512.
The investigator must agree not to provide research information that identifies a subject to any person without the subject’s prior written consent to release the information.
Projects conducted within the Bureau of Prisons must have an adequate research design and contribute to the advancement of knowledge about corrections.
The IRB will determine that the research design is compatible with both the operations of the prison facilities and the protection of human subjects.
The informed consent document for a study to be conducted in the Bureau of Prisons must include the following elements, in addition to the elements required under the Common Rule:
Identification of the investigators;
A statement that participation is completely voluntary and that the subject may withdraw consent and end participation in the project at any time without penalty or prejudice (e.g. the inmate will be returned to regular assignment or activity by staff as soon as possible);
A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law (i.e. an investigator may not guarantee confidentiality when the subject indicates intent to commit future criminal conduct or harm himself/herself or someone else, or if the subject is an inmate, indicates intent to leave the facility without authorization);
A statement that participation in the research project will have no effect on the inmate subject’s release date or parole eligibility.
Storage of Data and Confidentiality
Research protocols must include documentation for maintaining confidentiality of data preliminary to the research, during and after the conclusion of the research by assuring:
Records are not in an individually identifiable form; and,
Advance written assurance has been provided to the Bureau of Prisons that the records will be used solely for statistical research or reporting
Research data may not be maintained electronically at the University that contain non-disclosable information directly traceable to a specific person (NOTE: Computerized data records may only be maintained at an official DOJ site)
The principal investigator must negotiate arrangements, prior to the beginning of the data collection of the project, to provide non-identifiable computerized data on individual subjects along with documentation to the Office of Research and Evaluation (ORE) if requested
At the conclusion of the research, the investigator must document that research records will be destroyed or individual identifiers will be removed from the records.
Post Study Obligations
Research conducted in the Bureau of Prisons must acknowledge the Bureau of Prisons participation in any publication of the results and include a disclaimer in the results for publication that the approval or endorsement of the published material is an expression of the policies or view of the Bureau of Prisons;
Researchers must provide, at least 12 working days before any report of findings to be released, one (1) copy of the report, which includes an abstract of the findings, to each of the following:
The Chairperson of the BRRB;
The Regional Bureau of Prisons Director; and
Researchers must submit two (2) copies of the results of the research project for informational purposes only to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons prior to submission for publication.
Research that is either: 1) conducted by the EPA, 2) supported by the EPA or 3) conducted by any party with the intent that the results will be submitted to the EPA for consideration under the Federal Insecticide, Fungicide, and Rodenticide Act, or under Section 408 of the Food, Drug and Cosmetic Act. 40 C.F.R. § 26.1203, is subject to additional regulations specific to the Environmental Protection Agency (EPA)found at 40 CFR 26. These regulations outline additional protections and prohibitions for children, pregnant women and fetuses, and nursing women.
Research involving intentional exposure of a human subject: a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study.
Observational Research: any human research that does not meet the definition of research involving intentional exposure of a human subject.
Specific EPA Requirements and Restrictions
EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children.
While intentional exposure is prohibited in pregnant women and fetuses, in EPA sponsored studies, observational research is permitted provided all of the conditions outlined in 45 CFR 46.204 and 45 CFR 46.206 are met.
Children may also be enrolled in observational studies provided that the study either presents minimal risk, or the study presents greater than minimal risk, but holds out the prospect of direct benefit to the child or “is likely to contribute to the subject’s well being.” 40 C.F.R. § 26.405(a). In reviewing studies of this nature, the IRB must determine that the risk is justified by the anticipated benefit, and that the relation of the anticipated benefit to the risk is at least as favorable as the available alternative approaches. 40 C.F.R. § 26.405. Appropriate mechanisms must be employed for soliciting the permission of the parents and the assent of the children in such observational studies. 40 C.F.R. § 26.406.
Prior Submission of Proposed Human Subject Research for EPA
All human subject research studies supported by the EPA must either be approved or be determined to be exempt research by the EPA Human Subjects Research Review Official before any contract, grant, or formal agreement involving EPA support is awarded or entered into.
To obtain approval by the EPA Human Subjects Research Review Official (Review Official), the following documents must be submitted by the investigator to the EPA:
The Primary Awardees Federalwide Assurance (FWA) number
the IRB approval (or exemption) letter
the study protocol(s) as submitted to the IRB (the pre-award document is not sufficient)
the IRB approved consent forms and subject recruitment materials if applicable
all supplementary IRB correspondence
The materials should be submitted to
By E-mail Attachment:
lux.warren@epa.gov
By Regular Mail or EPA Pouch Mail:
Mail Code 8105R
By Private Carrier (FedEx, UPS, etc.):
CFR 40 Part 26
Project Review by the Human Subjects Research Review Official (www.epa.gov/phre/project.htm)