Section 25: Additional Requirements for Federal Agency Funded Research
25.1 Department of Defense (DoD)
When following DoD regulations, the definition of minimal risk based on the phrase, “ordinarily encountered in daily life of during the performance of routine physical or physiological examination or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).
Also, as a practice, the University of Texas at Austin does not currently conduct non-exempt, classified, human subject research. However, if practice changes, the University will follow the requirements of DoD Directive 3216.02 when conducting such research.
Research involving pregnant women, prisoners and children is subject to DHHS Subparts B, C and D.
- For purposes of applying Subpart B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge”.
- The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and includes interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants.
- Research involving prisoners cannot be reviewed by the expedited review process.
- When the IRB reviews research involving prisoners, at least one prisoner representative must be present for quorum.
- In addition to allowable categories of research on prisoners in Subpart C, epidemiological research is also allowed when:
- The research describes the prevalence or incidence of a disease by identifying all cases or studies potential risk factor association for a disease.
- The research presents no more than minimal risk.
- The research presents no more than an inconvenience to the participant.
If a participant becomes a prisoner and if the researcher asserts to the IRB that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, the IRB chair may determine that the prisoner-participant may continue to participate until the convened IRB can review the request to approve a change in the research protocol and until the organizational official and DoD Component office review the IRB’s approval to change the research protocol. Otherwise, the IRB chair shall require that all research interactions and interventions with the prisoner-participant (including obtaining identifiable private information) cease until the convened IRB can review the request to approve a change in the research protocol. The convened IRB, upon receipt of notification that a previously enrolled human participant has become a prisoner, shall promptly re-review the research protocol to ensure that the rights and well-being of the human participant, now a prisoner, are not in jeopardy. The IRB should consult with a subject matter expert, having the expertise of a prisoner representative, if the IRB reviewing the research protocol does not have a prisoner representative. If the prisoner-participant can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the prisoner-participant’s confinement does not inhibit the ethical conduct of the research and there are no other significant issues preventing the research involving human participants from continuing as approved, the convened IRB may approve a change in the study to allow this prisoner-participant to continue to participate in the research. This approval is limited to the individual prisoner-participant and does not allow recruitment of prisoners as participants.
- Research involving a detainee as a human participant is prohibited.
- This prohibition does not apply to research involving investigational drugs and devices when the same products would be offered to US military personnel in the same location for the same condition.
Research involving children cannot be exempt.
If consent is to be obtained from the experimental subject’s legal representative, the research must intend to benefit the individual participant.
- The determination that research is intended to be beneficial to the individual experimental subject must be made by the IRB.
25.1.1 Scientific Review
DoD requires scientific review prior to IRB review for all new DoD supported human research. Review by Departmental Review Committees (DRC) meets this requirement. The IRB will accomplish the scientific review. DoD also requires that all substantive amendments to approved DoD research involving human subjects receive scientific review prior to IRB review. The IRB will complete the scientific review. In the event that the IRB lacks adequate expertise to conduct scientific or scholarly review, the IRB may rely on outside experts to conduct this review (See Section 5.2.3).
25.1.2 Education Requirements
DoD requires that all individuals involved in the “design, conduct, or approval of human subjects research” complete human subjects research training. The University’s requirements for mandatory and continuing education meet the requirements. The DoD component may evaluate the University’s education policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research.
25.1.3 Research Monitor Required: More than Minimal Risk Studies
For DoD funded research involving greater than minimal risk to subjects, appointment of an independent research monitor is required, although the IRB or Institutional Official can require this for a portion of the research or studies involving no more than minimal risk, if appropriate. The following are additional IRB considerations:
- There may be more than one research monitor if different skills or experience are needed.
- The monitor may be an ombudsman or a member of the data and safety monitoring board.
- The IRB must approve a written summary of the monitors’ duties, authorities and responsibilities and the IRB or HRPP official shall communicate with research monitors to confirm their duties, authorities and responsibilities.
- The duties of the research monitor are determined on the basis of specific risks or concerns about the research, such as:
- Perform oversight functions such as observing recruitment and enrollment procedures, observing the consent process, observing study interventions and interactions, reviewing monitoring plans and reports of unanticipated problems involving risks to participants or others, reviewing aspects of data matching, collection and analysis.
- Discuss the research protocol with researchers, interview participants and consult with others outside the study.
- Report observations and findings to the IRB or designated official.
The research monitor has the authority to:
- Stop a research study in progress.
- Remove individuals from the study.
- Take any steps to protect the safety and well–being of subjects until the IRB can assess the research monitor’s report.
The PI may identify a candidate for the position of research monitor, taking into account the nature and disciplinary focus of the study and the likely type of expertise required. The IRB will consider the nomination along with ensuring that the research monitor has the appropriate experience and expertise, and is independent of the research team. The monitor should be named in the research protocol and the informed consent document in the Privacy and Confidential section (the monitor will have access to individually identifiable data).
25.1.4 Research Involving International Citizen Populations
For research conducted internationally, refer to Section 14: Transnational Research. This section must meet the DoD requirements. This includes taking into consideration subject populations, the cultural context, the languages understood by the human subjects, identifying and considering local laws, regulations, customs, and practices. In addition, determinations are made as to whether the sponsoring DoD Component requires an additional ethics review by the host country or a local DoD IRB with host country representation.
25.1.5 Waiver of Consent and Exception from Informed Consent in Emergency Medicine
If a research subject meets the definition of “experimental subject,” (An activity, for research purposes where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction.), DoD regulations prohibit a waiver of consent unless the PI obtains a waiver from the Assistant Secretary of Defense for Research and Engineering. The Assistant Secretary of Defense for Research and Engineering may waive the requirements for obtaining informed consent when all of the following are met:
- The research is necessary to advance the development of a medical product for the military services;
- The research might directly benefit the individual experimental subject;
- The research is conducted in compliance with all other applicable laws and regulations;
The IRB may waive the consent process if the research does not meet the definition of “experimental subject.” DoD regulations prohibit an exception from informed consent in emergency medicine research unless the PI obtains a waiver from the Assistant Secretary of Defense for Research and Engineering.
25.1.6 Multi-site or Collaborative Research Requirements
Any investigator developing a proposal for DoD funding or other support that involves collaborating institutions needs to consult the sponsoring DoD component to identify additional requirements for multi-site research. When conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party.
25.1.7 Provisions for Research Related Injury
The PI is responsible for informing the IRB if there are any additional requirements from the DoD Component regarding the provision of care in the case of a research-related injury. If the DoD Component has stricter requirements than the Common Rule or the University’s policies, the verbiage will need to be discussed with the University’s Legal Affairs Office and the Associate Vice President for Research (ORS Director). These requirements will also need to be disclosed in the informed consent document.
25.1.8 Research Involving US Military Personnel as Research Subjects
If any research includes U.S. military personnel as subjects:
- Officers are not permitted to influence the decision of their subordinates;
- Officers and non-commissioned officers may not be present at the time of recruitment;
- Officers and senior non-commissioned officers have a separate opportunity to participate;
- When recruitment involves a percentage of a unit, an independent ombudsman must be present;
- Federal employees while on duty and non-federal persons may be compensated for blood draws for research up to $50 for each blood collection;
- Unless military personnel who are research subjects are on leave status during their participation, they may not receive compensation for their participation.
- Non-Federal personnel may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.
The research protocol must include a plan for subject recruitment that incorporates additional safeguards to minimize undue influence from individuals within a potential subject’s chain of command. The PI is required to consult with the sponsoring DoD component to determine appropriate recruitment plans.
25.1.9 Research Involving Prisoners of War
Under no circumstances shall the IRB approve research involving prisoners of war, as defined by the specific DoD Component.
25.1.10 Additional DoD Review Prior to Initiation of the Study
After the IRB completes its review and issues approval, the PI will need to submit documentation of IRB approval, the risk level, and the expiration date of the research to the DoD component funding or otherwise supporting the study. The DoD may also request additional documentation to verify compliance with federal and DoD policies, including minutes related to the research.
Surveys performed on DoD personnel must be submitted reviewed and approved by the DoD after the research protocol is reviewed and approved by the IRB.
Investigators may not initiate the study until the human research protection officer within the sponsoring DoD Component reviews and approves the study.
25.1.11 Reporting Requirements
The following must be promptly reported to the DoD-specific component’s human research protection official or office (30 days or less):
- When significant changes to the research are approved by the IRB.
- Results of continuing IRB review.
- Change(s) in reviewing IRB.
- Notification by any federal department, agency, or national organization that any part of the HRPP is under a “for-cause” investigation involving DoD-supported research.
- Serious and/or continuing noncompliance.
- Any unanticipated problem involving risks to subjects or others for DoD-supported research.
- Any suspension or termination of DoD-supported research.
25.1.12 Records Accessibility
Records documenting compliance (or noncompliance) with DoD regulations will be made accessible for inspection and copying by DoD representatives at reasonable times and in a reasonable manner.
25.2 Department of Education (ED)
25.2.1 Family Educational Rights and Privacy Act (FERPA) 34 CFR Part 99
The Family Educational Rights and Privacy Act is a Federal law that protects the privacy of student education records. In general, schools must have written permission from the parent or eligible student in order to release any information from a student's education record. However, FERPA allows schools to disclose personally identifiable information from an education record of a student without consent if the disclosure is to organizations conducting studies for, or on behalf of, educational agencies or institutions to:
- Develop, validate, or administer predictive tests.
- Administer student aid programs.
- Improve instruction.
The IRB must verify compliance with US Department of Education regulations that schools are required to develop and adopt policies in conjunction with parents regarding the following:
- Any applicable procedures for granting a request by a parent for reasonable access to a survey within a reasonable period of time after the request is received.
- Any applicable procedures for granting a request by a parent for reasonable access to instructional material received.
- The collection, disclosure or use of personal information collected from students for the purpose of marketing or for selling that information (or otherwise providing that information to others for that purpose), including arrangements to protect student privacy that are provided by the agency in the event of such collection, disclosure or use.
- The right of a parent of a student to inspect, upon request of the parent, any instrument used in the collection of personal information, before the instrument is administered or distributed to a student.
- Any applicable procedures for granting a request by a parent for reasonable access to such instrument within a reasonable period of time after the request is received.
25.2.2 Exception to Written Permission for Records Release under FERPA
Requests for exception (waiver) to written permission from parents or assent of students for records release are reviewed by IRB Program Coordinators with recommendations to the IRB reviewer for protocols undergoing expedited review or for protocols requiring review by a convened IRB. A school district or postsecondary institution that uses this exception is required to enter into a written agreement with the University or with the investigator conducting the research that specifies:
- The determination of the exception.
- The purpose, scope, and duration of the study.
- The information to be disclosed.
- That information from education records may only be used to meet the purposes of the study stated in the written agreement and must contain the current requirements in 34 CFR 99.31(a) (6) on re-disclosure and destruction of information.
- That the study will be conducted in a manner that does not permit personal identification of parents and students by anyone other than representatives of the university with legitimate interests.
- That the University is required to destroy or return all personally identifiable information when no longer needed for the purposes of the study.
- The time period during which the university must either destroy or return the information.
- Education records may be released without consent under FERPA if all personally identifiable information has been removed including:
- Student’s name and other direct personal identifiers, such as the student’s social security number or student number.
- Indirect identifiers, such as the name of the student’s parent or other family members; the student’s or family’s address, and personal characteristics or other information that would make the student’s identity easily traceable, date and place of birth, and mother’s maiden name.
- Biometric records, including one or more measurable biological or behavioral characteristics that can be used for automated recognition of an individual, including fingerprints, retina and iris patterns, voiceprints, DNA sequence, facial characteristics, and handwriting.
- Other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty.
25.2.3 Protection of Pupil Rights Amendment PRPA (34 CFR Part 98)
126.96.36.199 Informed Consent/Parental Permission Requirements
Research funded by the Department of Education must comply with additional protections under PRPA, 34 CFR Part 98. No student shall be required, as part of any research project, to submit without prior consent to surveys, psychiatric examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following:
- Political affiliations.
- Mental and psychological problems potentially embarrassing to the student or his or her family.
- Sex behavior and attitudes.
- Illegal, anti-social, self-incriminating, and demeaning behavior.
- Critical appraisals of other individuals with whom the student has close family relationships.
- Legally recognized privileged and analogous relationships, such as those of lawyers, physicians, and ministers.
- Religious practices, affiliations, or beliefs of the student or student’s parent.
- Income, other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under a program.
As used above, prior consent means prior consent of the student, if the student is an adult or emancipated minor; or prior written consent of the parent or guardian, if the student is an un-emancipated minor. Schools and contractors must obtain prior written parental consent before minor students are required to participate in any ED-funded survey, analysis, or evaluation.
188.8.131.52 Parental Access to Instructional Material Used in a Research or Experimentation Program
All instructional material—including teachers' manuals, films, tapes, or other supplementary instructional material—which will be used in connection with any research or experimentation program or project shall be available for inspection by the parents or guardians of the children engaged in such program or project. As used above:
Research or experimentation program or project means any program or project in any program under in any research that is designed to explore or develop new or unproven teaching methods or techniques.
Children means persons not above age 21 who are enrolled in research not above the elementary or secondary education level, as determined under state law where the research is taking place.
25.2.4 Additional Requirements for School Research Not Funded by the ED
Even if the research is not funded by the ED, the IRB will verify compliance with ED regulations regarding the following:
- The right of parents to inspect, upon request, a survey created by a third party before the survey is administered or distributed by a school to students.
- Arrangements to protect student privacy in the event of the administration of a survey to students, including the right of parents to inspect, upon request, the survey, if the survey contains one or more of the same eight items of information noted above.
- The right of parents to inspect, upon request, any instructional material used as part of the educational curriculum for students.
- The administration of physical examinations or screenings that the school may administer to students.
25.2.5 Other Conditions Pertaining to Waivers of Parent Permission or Informed Consent
The IRB may waive the requirement for obtaining consent from a parent or legal guardian if:
- The research meets the provisions for waiver in Section 6.7 of the IRB Policies and Procedures Manual [45 CFR 46.116(d)(1-4)] and if the IRB determines that the research protocol is designed for conditions or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children).
- An appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
25.3 Department of Energy (DoE)
The IRB reviews and approves the “Checklist for IRBs to Use in Verifying That HHS Protocols are in Compliance with DOE Requirements” submitted by the researchers to verify compliance with the DOE requirements for the protection of Personally Identifiable Information.
25.3.1 Personally Identifiable Information
In accordance with the Privacy Act, the DoE has established requirements for the protection of Personally Identifiable Information (PII) with the DoE Privacy Program (DoE Order 206.1), DoE Manual (M) for Identifying and Protecting Official Use Only Information (DoE M 471.3-1), and DoE Cyber Security Incident Management Manual (DoE M 205.1-8).
25.3.2 Description of Processes
Research protocols must include description of processes for:
- Keeping PII confidential.
- Releasing of PII, where required, only under a procedure approved by the IRB and DoE.
- Using PII only for purposes of the DoE approved research.
- Handling and marking documents containing PII as “containing PII” or “containing PHI.”
- Establishing reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of PII.
- Making no further use or disclosure of the PII except when approved by the responsible IRB and DoE, where applicable, and then only:
- In an emergency affecting the health and safety of any individual.
- For use in another research project under these same conditions and with DoE written authorization.
- For disclosure to a person authorized by the DoE program office for the purpose of an audit related to the project.
- When required by law.
- Protecting PII data stored on removable media (CD, DVD, USB Flash Drives, etc.) using encryption products that are Federal Information Processing Standards (FIPS) 140-2 certified.
- Using passwords to protect PII in conjunction with FIPS 140-2 certified encryption that meet the current DoE password requirements cited in DoE Guide 205.3.1.
- Sending removable media containing PII, as required, by express overnight service with signature and tracking capability, and shipping hard copy documents double wrapped via express overnight service.
- Encrypting data files containing PII that are being sent by e-mail with FIPS 140-2 certified encryption products.
- Sending passwords that are used to encrypt data files containing PII separately from the encrypted data file, i.e. separate e-mail, telephone call, separate letter.
- Using FIPS 140-2 certified encryption methods for websites established for the submission of information that includes PII.
- Using two-factor authentication for logon access control for remote access to systems and databases that contain PII. Two-factor authentication is contained in the National Institute of Standards and Technology (NIST) Special Publication 800-63 Version 1.0.2 found at: http://csrc.nist.gov/publications/nistpubs/800-63/SP800-63V1_0_2.pdf
- In addition to other reporting requirements, reporting the loss or suspected loss of PII immediately upon discovery to:
- DoE Project Officer
- Classified projects that use PII must also comply with all the requirements for conducting classified research.
25.3.3 Researcher Reporting Requirements
Researchers must report, as soon as possible but always within 30 days, the following to the human subject research program manager:
- Any significant adverse events, unanticipated risks and complaints about research, with a description of any corrective actions taken or to be taken.
- Any suspension or termination of IRB approval of research.
- Any significant non-compliance with HRPP procedures or other requirements.
Any compromise of personally identifiable information must be reported within 2 days of determining that there was a compromise.
25.4 Department of Justice (DoJ)
25.4.1 Principal Investigator Responsibilities
Principal Investigators (PIs) who are recipients of funds from the NIJ are required to comply with the DoJ regulations at 28 CFR 46 (Protection of Human Subjects) which include the following additional requirements:
- Obtain a privacy certificate approved by the NIJ Human Subjects Protection Officer. Information about Privacy Certificates may be found at the NIJ website at www.ojp.usdoj.gov/nij/funding/humansubjects/welcome.htm.
- Include a statement in the informed consent document under the section dealing with confidentiality that confidentiality can only be broken if the subject reports the probability of immediate harm to self or others.
- Submit a copy of the IRB approval as well as supporting documentation of the IRB’s institutional affiliation, assurance, etc. to the NIJ prior to initiation of any research activities that are not exempt from the requirements of 28 CFR 46.
- Submit supporting documentation of the IRB’s approval of the research meeting the criteria for exemption under 28 CFR 46.101(b).
- Sign and maintain an Employee Confidentiality Statement for themselves and their research staff. A model employee confidentiality statement can be found at www.ojp.usdoj.gov/nij/funding/humansubjects/employee-confidentiality.htm.
- Send a copy of all de-identified data, including copies of the informed consent document, data collection instruments, surveys and other relevant research materials to the National Archive of Criminal Justice Data.
25.4.2 Bureau of Prisons
Additional requirements for prospective researchers to obtain approval to conduct research within the Bureau are described at 28 CFR Part 512. Although some research may be exempt from 28 CFR part 46 under 46.101(b)(5), as determined by the Office of Research and Evaluation (ORE) of the Bureau, no research is exempt from 28 CFR Part 512. However, implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research. The following additional requirements are included in 28 CFR Part 512:
- Obtain review of the research proposal by the Bureau of Research Review Board.
- Sign an agreement to adhere to the provisions of the Bureau under 28 CFR 512.
- Respect the rights, health, and human dignity of individuals involved in the research.
- Adhere to applicable provisions of the Privacy Act of 1974 and regulations pursuant to this act.
- Provide a research project design that contributes to the advancement of knowledge about corrections.
- Provide a research project design that is compatible with both the operation of the prison facilities and protection of human subjects.
- Observe the rules of the institution in which the research is conducted;
- Provide a research project design that does not involve medical experimentation, cosmetic research, or pharmaceutical testing.
- Provides documentation that:
- Risks to participants are minimized and risks are reasonable in relation to the anticipated benefits;
- Selection of participants within any one organization is equitable; and
- Incentives may not be offered to help persuade inmates to participant, unless snacks or soft drinks are consumed at the test setting.
- Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to non-confined research subjects who are both:
- No longer in the Bureau custody, and
- Participating in authorized research being conducted by Bureau employees or contractors.
- Provide documentation of experience in the area of study of the proposed research.
- Provide documentation of review of related literature.
- Provide documentation that research records will be destroyed or individual identifiers will be removed from the records after the research is completed;
- Assume responsibility as the investigator for actions of any research staff engaged to participate in the project.
- Provide 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.
- Advance written assurance has been provided to the Bureau that the records will be used solely for statistical research or reporting.
- Agree not to provide research information that identifies a subject to any person (i.e. cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding) without the subject’s prior written consent to release the information.
- Agree not to maintain records electronically that contain non-disclosable information directly traceable to a specific person at the institution (NOTE: Computerized data records may only be maintained at an official DoJ site).
- 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 ORE if requested.
- Obtain informed consent of subjects prior to initiating the research activity (See Section 6).
- Submit planned methodological changes in the research to the IRB for review and approval prior to initiation and revise study procedures in accordance with the new methodology, if required.
- Provide, at least yearly, a report on the progress of the research and at least one report of findings to the ORE Chief.
- Acknowledge the Bureau participation in any publication of the results.
- 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.
- Provide, at least 12 working days before any report of findings to be released, one (1) copy of the report, which shall include an abstract of the findings, to each of the following:
- Chairperson of the BRRB.
- The regional Bureau Director.
- The warden of each institution which provided data or assistance.
- Submit two (2) copies of the results of the research project for informational purposes only to the ORE Chief prior to submission for publication.
25.4.3 Research Proposals
When submitting a research proposal to the Bureau, the PI shall provide the following information in the proposal:
- A summary statement which includes:
- Name(s) and current affiliation(s) of the researcher(s).
- Title of the study.
- Purpose of the project.
- Location of the project
- Methods to be employed.
- Anticipated results.
- Duration of the study.
- Number of subjects (staff/inmates) required and amount of time required from each
- Indication of risk or discomfort involved as a result of participation.
- A comprehensive statement which includes:
- Review of related literature.
- Detailed description of the research method.
- Significance of anticipated results and their contribution to the advancement of knowledge;
- Specific resources required from the Bureau;
- Description of all possible risks, discomforts, and benefits to individual subjects or a class of subjects, and a discussion of the likelihood that the risks and discomforts will actually occur;
- Description of steps taken to minimize any risks.
- Description of physical and/or administrative procedures to be followed to:
- Ensure the security of any individually identifiable data that are being collected for the project, and
- Destroy research records or remove individual identifiers from those records when the research has been completed.
- Description of any anticipated effects of the research project on institutional programs and operations; and
- Relevant research materials such as vitae, endorsements, sample informed consent statements, questionnaires, and interview schedules.
- A statement regarding assurances and certification required by 28 CFR part 46, if applicable.
25.4.4 Informed Consent
Before commencing a research project requiring participation by staff or inmates, the researcher shall give each participant a written informed consent statement containing the following information (The researcher may not be required to obtain the signature if the researcher can demonstrate that the only link to the subject's identity is the signed statement of informed consent or that there is significantly more risk to the subject if the statement is signed.):
- Identification of the PI(s);
- Objectives of the research project;
- Procedures to be followed in the conduct of research;
- Purpose of each procedure;
- Anticipated uses of the results of the research;
- A statement of benefits reasonably to be expected;
- A declaration concerning discomfort and risk, including a description of anticipated discomfort and risk;
- A statement that participation is completely voluntary and that the participant may withdraw consent and end participation in the project at any time without penalty or prejudice (the inmate will be returned to regular assignment or activity by staff as soon as practicable);
- A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law. For example, a researcher 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. Under the privacy certificate investigators and research staff do not have to report child abuse unless the participant signs another consent form to allow child abuse reporting.
- A statement that participation in the research project will have no effect on the inmate participant's release date or parole eligibility;
- An offer to answer questions about the research project; and
- Appropriate additional information as needed to describe adequately the nature and risks of the research.
25.5 Environmental Protection Agency (EPA)
25.5.1 Research Involving Intentional Exposure of Any Human Subjects
The EPA does not conduct or support research involving intentional exposure of any human subjects who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. Other adults who voluntarily choose to participate are protected under the EPA’s rule, “Protections for Subjects in Human Research”, which requires proposed protocols describing intentional exposures be reviewed by EPA and its Human Studies Review Board.
25.5.2 Observational Research Involving Pregnant Women and Fetuses
The EPA requires application of 40 CFR 26 Subpart B to provide additional protections to pregnant women as subjects in observational research, i.e., research that does not involve intentional exposure to any substance.
25.5.3 Observational Research of Children Not Involving Greater Than Minimal Risk
The EPA requires application of 40 CFR 26 Subpart D to provide additional protections to children as subjects in observational research, i.e., research that does not involve intentional exposure to any substance.
25.5.4 Observational Research of Children Involving Greater Than Minimal Risk
Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects is allowable only if the IRB finds that (See Section 12.4):
- The intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject's well-being;
- The risk is justified by the anticipated benefit to the subjects;
- The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
- Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.
25.5.5 Final Review by EPA
EPA policy requires submission of IRB determinations and approval to the EPA Human Subjects Research Review official for final review and approval before the research can begin.
25.5.6 Research Not Conducted or Supported By Any Federal Agency
For research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:
- EPA extends the provisions of the 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance.
- EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.