INVESTIGATOR GUIDANCE:

Transcription

1 INVESTIGATOR GUIDANCE: Investigator Obligations HRP Sep 2013 Page 1 of 2 1. PURPOSE 1.1. This guidance describes the obligations of investigators conducting <Human Research> overseen by CGIRB or WIRB For research overseen by an IRB other than CGIRB or WIRB, investigators should follow the requirements of that IRB. 2. GUIDANCE 2.1. Do not commence research until you have the IRB approval letter and obtained all other required approvals, such as radiation safety approval, biosafety approval, and approvals of departments or divisions that require approval of the use of their resources If there are any questions about whether you are conducting research involving human subjects, contact the IRB before commencing the study Comply with all requirements and determinations of the IRB Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space Ensure that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials, protocol requirements and, when relevant, privileges) to perform procedures and duties assigned to them during the study Personally conduct or supervise the research Conduct the research in accordance with the relevant current protocol approved by the IRB Protect the rights, safety, and welfare of subjects involved in the research Submit proposed modifications to the IRB prior to their implementation Do not make modifications to the research without prior IRB review and approval unless necessary to eliminate apparent immediate hazards to subjects Submit continuing reviews when requested by the IRB Submit a closure form to close research (end the IRB s oversight) when: The protocol is permanently closed to enrollment All subjects have completed all protocol related interventions and interactions For research subject to federal oversight other than FDA: No additional identifiable private information about the subjects is being obtained Your analysis of private identifiable information is completed If research approval expires, stop all research activities and immediately contact the IRB Promptly report to the IRB the information items listed in INVESTIGATOR GUIDANCE: Prompt Reporting Requirements (HRP-801) Do not accept or provide payments to professionals in exchange for referrals of potential subjects ( finder s fees. ) Do not accept payments designed to accelerate recruitment that were tied to the rate or timing of enrollment ( bonus payments ) without prior IRB approval For studies regulated by a federal department or agency, follow the additional obligations, as applicable:

2 INVESTIGATOR GUIDANCE: Investigator Obligations HRP Sep 2013 Page 2 of INVESTIGATOR GUIDANCE: Additional DOD Obligations (HRP-810) INVESTIGATOR GUIDANCE: Additional DOE Obligations (HRP-811) INVESTIGATOR GUIDANCE: Additional DOJ Obligations (HRP-812) INVESTIGATOR GUIDANCE: Additional EPA Obligations (HRP-813) INVESTIGATOR GUIDANCE: Additional ED Obligations (HRP-814) INVESTIGATOR GUIDANCE: Additional FDA Obligations (HRP-815) For studies where ICH-GCP compliance is required, follow additional the obligations in INVESTIGATOR GUIDANCE: Additional ICH-GCP Obligations (HRP-816) When required by the IRB ensure that consent, permission, and assent are obtained and documented in accordance with the relevant current protocol as approved by the IRB Retain research records (including signed consent documents) for the greater of: Three years after completion of the research For drug studies conducted under an IND, two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified For device studies conducted under an IDE or abbreviated IDE, two years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol The retention period required by the sponsor The retention period required by local, state, or international law HIPAA requires signed authorizations to be retained for six years from the date signed or the date when it last was in effect, whichever is later The retention period required by a site that is not part of this [Organization]. 3. REFERENCES CFR 50, 56

3 INVESTIGATOR GUIDANCE: Prompt Reporting Requirements HRP Sep 2013 Page 1 of 1 1. PURPOSE 1.1. This guidance describes the information to promptly report to CGIRB and WIRB when the research is subject to oversight by CGIRB or WIRB For research overseen by an IRB other than CGIRB or WIRB, investigators should follow the requirements of that IRB. 2. GUIDANCE 2.1. Report the following information items to the IRB within 5 days: New or increased risk Protocol deviation that harmed a subject or placed subject at risk of harm Protocol deviation made without prior IRB approval to eliminate an immediate hazard to a subject Audit, inspection, or inquiry by a federal agency Written reports of federal agencies (e.g., FDA Form 483) <Allegation Noncompliance> or <Finding of Noncompliance> Breach of confidentiality Unresolved subject complaint Suspension or premature termination by the sponsor, investigator, or institution Incarceration of a subject in a research study not approved to involve prisoners Adverse events or IND safety reports that require a change to the protocol or consent State medical board actions Unanticipated adverse device effect Information where the sponsor requires prompt reporting to the IRB 2.2. Information not listed above does not require prompt reporting to CGIRB and WIRB. 3. REFERENCES CFR (b) CFR (b)(5) 3 For example, publications indicating a new risk, new risk in an investigator brochure, FDA black box warning, new risk identified in a data safety monitoring report, information or change that adversely affects subject safety, or information or change that adversely affects the conduct of the research. 4 Unanticipated adverse device effect means any serious adverse effect on health or safety or any lifethreatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

4 INVESTIGATOR GUIDANCE: Informed Consent HRP Sep 2013 Page 1 of 3 1. PURPOSE 1.1. This guidance describes a process that in general is suitable to obtain informed consent Other procedures may be suitable when approved by the IRB. 2. BACKGROUND 2.1. Person providing consent means: In the case of a cognitive intact adult, the individual being asked to take part In the case of an adult unable to consent, that individual s LAR In the case of a child: One parent, if the other parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child One parent if the IRB determined that permission from one parent was sufficient An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care Both parents 2.2. Consent information means: Long form consent document (when the IRB requires the long form of consent documentation) Short form consent document and summary (when the IRB allows the short form of consent documentation) Script or information sheet (when the IRB has approved a waiver of documentation of consent) 2.3. Communicate in the preferred language of the person providing consent 2.4. Unless the IRB affirmatively approved a protocol to include the following populations, such subjects may not be enrolled: Adults unable to consent Children Neonates of uncertain viability Nonviable neonates Pregnant women Prisoners Individuals unable to speak English 2.5. The short form of consent documentation may be use only if affirmatively approved by the IRB For the short form of consent documentation: The short form is a standard template translated into the subject s language The summary is the English version of the long form For waiver of documentation of consent, the script is the long form without a signature block.

5 INVESTIGATOR GUIDANCE: Informed Consent HRP Sep 2013 Page 2 of Interpreters are to be conversant in both English and the language understood by the person providing consent. When allowed by institutional policy, the interpreter may be a member of the research team, or a family member or friend of the subject or person providing consent If the consent process requires an <Impartial Witness>: 3. GUIDANCE The <Impartial Witness> is to be present during the entire consent discussion and to attest that the information in the consent form and any other information provided was accurately explained to, and apparently understood by, the subject/lar, and that consent was freely given The <Impartial Witness> may not be a person involved in the research Obtain the IRB-approved consent document, short form consent document, or script, as applicable Verify that you are using the most current IRB-approved information Verify that the consent document, if any, is in language understandable to the person providing consent If the person providing consent cannot read or the short form of consent documentation is used, obtain an <Impartial Witness> If the person providing consent cannot speak English, obtain the services of an interpreter Go over the information in the consent document using language understandable to the person providing consent Do not provide any information to the person providing consent through which the person providing consent is made to waive or appear to waive any of the subject s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence When providing information about treatments or compensation for injury, provide factual information and avoid statements that imply that compensation or treatment is never available Invite and answer questions Evaluate whether the following is true for the person providing consent. If not, take steps to correct or determine that the person providing consent is incapable of providing consent: The person providing consent has been provided sufficient information The person providing consent understands the information If the person providing consent has a disease or condition that may affect cognition, assess whether the person providing consent has sufficient cognitive capacity to legally provide informed consent If the subject is pregnant, ensure the person providing consent is fully informed regarding the reasonably foreseeable effect of the research on the fetus or neonate The person providing consent does not feel coerced or unduly influenced Ensure there is no threat of harm or adverse consequences for a decision to not participate.

6 INVESTIGATOR GUIDANCE: Informed Consent HRP Sep 2013 Page 3 of Ensure that outside parties (family or caretakers) do not coerce or unduly influence the person providing consent, especially if that person is vulnerable to coercion or undue influence Ensure that the amount of payment does not coerce or unduly influence economically disadvantaged individuals For persons providing consent who are in a subordinate position to a member of the research team (e.g., employee or student), ensure that there is no threat of harm or adverse consequences to the subject s position for a decision to not participate The person providing consent has sufficient time to make a decision Provide the person providing consent with sufficient time to understand the information. Spend as much time as needed Provide the person providing consent with sufficient time to ask questions The individual providing consent understands the consequences of a decision The individual providing consent can communicate a choice Once a person providing consent indicates that he or she does not want to consent, stop If the subject is a child or adult unable to consent: Explain the research to the extent compatible with the subject s understanding Ensure that parents or guardians do not coerce or unduly influence children Ensure that outside parties (family or caretakers) do not coerce or unduly influence adults unable to consent If the IRB determined that assent was a requirement and the subject is capable of being consulted, request the assent (affirmative agreement) of the subject. 4. REFERENCES CFR 50.20, CFR If the subject indicates that he or she does not want to take part, stop.

7 INVESTIGATOR GUIDANCE: Documentation of Informed Consent HRP Sep 2013 Page 1 of 3 1. PURPOSE 1.1. This guidance describes a process that in general is suitable to document consent in writing Other procedures may be suitable when approved by the IRB. 2. BACKGROUND 2.1. Person providing consent means: In the case of a cognitive intact adult, the individual being asked to take part In the case of an adult unable to consent, that individual s LAR In the case of a child: One parent, if the other parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child One parent if the IRB determined that permission from one parent was sufficient An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care Both parents 2.2. The short form of consent documentation may be use only if affirmatively approved by the IRB For the short form of consent documentation: The short form is a standard template translated into the subject s language The summary is the English version of the long form If the consent process required an <Impartial Witness>: 3. GUIDANCE The <Impartial Witness> is to be present during the entire consent discussion and to attest that the information in the consent form and any other information provided was accurately explained to, and apparently understood by, the subject/lar, and that consent was freely given The <Impartial Witness> may not be a person involved in the research If the consent process will be documented with the long form: Verify that the document is in language understandable to the person providing consent If the IRB required written documentation of assent, note one of the following: Assent of the child was obtained Assent of the child was not obtained because the capability of the child is so limited that the child cannot reasonably be consulted Have the following individuals personally sign and date the consent document:

8 INVESTIGATOR GUIDANCE: Documentation of Informed Consent HRP Sep 2013 Page 2 of Person giving consent Person obtaining consent <Impartial Witness>, if any 3.2. If the consent process will be documented with the short form: Verify that the document is in language understandable to the person providing consent If the IRB required written documentation of assent, note one of the following: Assent of the child was obtained Assent of the child was not obtained because the capability of the child is so limited that the child cannot reasonably be consulted Have the following individuals personally sign and date the consent document: Person giving consent Person obtaining consent <Impartial Witness> Have the following individuals personally sign and date the summary: Person giving consent Person obtaining consent <Impartial Witness> 3.3. Provide the person providing consent with copies of the signed and dated documents This may be accomplished either by making a photocopy or by having individuals sign and date two copies File a copy of the consent document with the medical record when required by local policy Retain the signed and dated documents in the study records for the greater of: Three years after completion of the research For drug studies conducted under an IND, two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified For device studies conducted under an IDE or abbreviated IDE, two years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol The retention period requested by the sponsor The retention period required by local, state, or international law The retention period required by a site that is not part of this [Organization]. 4. REFERENCES CFR 50.27, (b), (c), (d)

9 INVESTIGATOR GUIDANCE: Documentation of Informed Consent HRP Sep 2013 Page 3 of CFR (b),

10 DOD Obligations HRP Sep 2013 Page 1 of 6 1. PURPOSE 1.1. This guidance outlines the additional obligations of investigators conducting DOD research. 2. GUIDANCE 2.1. Training and education All personnel who conduct, review, approve, oversee, support, or manage human subjects research are required to undergo initial and continuing research ethics education There may be specific DOD educational requirements or certification required DOD may evaluate the organization s education policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research As the investigator, you must be aware of the specific requirements contained in DOD regulations and requirements and educated about these requirements when appropriate Scientific Review The IRB must consider the scientific merit of the research The IRB may rely on outside experts to provide an evaluation of the scientific merit International Research You or the organization must obtain permission to conduct research in that country by certification or local ethics review You must follow all local laws, regulations, customs, and practices Reporting: The following findings in DOD-supported research must be reported to the DOD human research protection officer within 30 days: Determinations of <Serious Noncompliance> or <Continuing Noncompliance> Significant changes to the research protocol that are approved by the IRB The results of the IRB continuing review Change of reviewing IRB When the organization is notified by any Federal department, agency or national organization that any part of an HRPP is under investigation for cause requirements <Unanticipated Problems Involving Risk to Subjects or Others> <Suspension of IRB approval> <Termination of IRB approval> 2.5. Survey Approval Surveys performed on DOD personnel must be submitted, reviewed, and approved by the DOD after the research protocol is approved by the IRB Multisite Research When conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party.

11 DOD Obligations HRP Sep 2013 Page 2 of Definition of <Minimal Risk> The definition of the minimal risk based on the phrase ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests must 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) The organization applies this definition to all research regardless of funding Appointment of a Research Monitor: This is required for research involving greater than minimal risk The IRB or institutional official can require a research monitor for a portion of the research or studies involving no more than minimal risk, if appropriate The research monitor is appointed by name and must be independent of the team conducting the research There may be more than one research monitor (e.g. if different skills or experience are needed) The monitor may be an ombudsman or a member of the data safety monitoring board. The IRB must approve a written summary of the monitors duties, authorities, and responsibilities The IRB or institutional official must 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 The research monitor may perform oversight functions (e.g., observe recruitment, enrollment procedures, and the consent process, oversee study interventions and interactions, review monitoring plans and <Unanticipated Problems Involving Risk to Subjects or Others>, oversee data matching, data collection and analysis) The research monitor may discuss the research protocol with investigators, interview human subjects, and consult with others outside of the study Report observations and findings to the IRB or a designated official The research monitor has the authority to: Stop a research study in progress Remove individuals from study Take any steps to protect the safety and well-being of subjects until the IRB can assess Recruitment of Service Members Officers are not permitted to influence the decision of their subordinates.

12 DOD Obligations HRP Sep 2013 Page 3 of Officers and senior 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 is present Compensation of Service Members: 2.9. Consent Service member may not receive pay or compensation for research during duty hours A service member may be compensated for research if the subject is involved in the research when not on duty Federal employees while on duty and non-federal persons may be compensated for blood draws for research up to $50 for each blood draw Non-Federal persons may be compensated for participating in research involving 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 disclosure for research-related injury must follow the requirements of the DOD component If the subject undergoes interactions or interventions for research purposes, the subject is considered an experimental subject. For experimental subjects: A waiver of the consent process is prohibited unless a waiver is obtained from the Assistant Secretary of DOD for Research and Engineering The Assistant Secretary for DOD for Research and Engineering may waive the requirements for 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 may 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 for subjects who are not experimental subjects If consent is to be obtained from the experimental subjects legal representative, the research must intend to benefit the individual subject The determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB Waivers of consent are prohibited for classified research Research on Pregnant Women

13 DOD Obligations HRP Sep 2013 Page 4 of Research involving pregnant women and fetuses as subjects is subject to HHS Subpart B except: Research on Prisoners The phrase biomedical knowledge is replaced with generalizable knowledge The applicability of Subpart B is limited to research involving pregnant women as subjects in research that is more than minimal risk and included interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as subjects Research involving prisoners is subject to HHS Subparts C Research involving prisoners cannot be reviewed by the expedited procedure 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 allowable 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 subject When a subject becomes a prisoner, if the investigator asserts to the IRB that it is in the best interest of the prisoner-subject to continue to participate in the research while a prisoner, the IRB chair may determine that the prisoner-subject may continue to participate until the convened IRB can review this request to approve a change in the research protocol and until the institutional official and DOD Component office review the IRB s approval to change the research protocol. Otherwise, the IRB chair must require that all research interactions and interventions with the prisoner-subject (including obtaining identifiable private information) cease until the convened IRB can review this request to approve a change in the research protocol. The convened IRB, upon receipt of notification that a previously enrolled human subject has become a prisoner, must promptly re-review the research protocol to ensure that the rights and wellbeing of the human subject, 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-subject can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the prisoner-subject s confinement does not inhibit the ethical conduct of the research, and there are no other significant issues preventing the research involving human subjects from continuing as approved, the convened IRB may approve a change in the study to allow this prisoner-subject to continue to participate in the research. This approval is limited to the individual prisoner-subject and does not allow recruitment of prisoners as subjects Research involving a detainee as a human subjects is prohibited.

14 DOD Obligations HRP Sep 2013 Page 5 of 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 prisoners of war is prohibited Research on Children Prisoner of war includes any person captured, detained, held, or otherwise under the control of DOD personnel (military, civilian, or contractor employee). Such persons include: Enemy Combatant, Lawful Enemy Combatant, Unlawful Enemy Combatant, Enemy Prisoner of War, Retained Person, and Civilian Internee. Such persons do not include personnel of the DOD being held for law enforcement purposes. It does not include persons being held primarily for law enforcement purposes, except where the United States is the occupying power This prohibition does not apply to activities covered by investigational new drug or investigational device provisions for the purpose of diagnosis or treatment of a medical condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the detainees informed consent when the medical products are subject to FDA regulations for investigational new drugs or investigational medical devices, and only when the same product would be offered to members of the U.S. Military Services in the same location for the same medical condition and only when consistent with established medical practice involving investigational drugs and devices Research involving children is subject to the HHS Subpart D The exemption for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed Research on Fetal Tissue Fetal research must comply with US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g Waiver of Informed consent for Planned Emergency Research An exception from consent in emergency medicine research is prohibited unless a waiver is obtained from the Secretary of DOD Records Records maintained that document compliance or <Noncompliance> with DOD regulations must be made accessible for inspection and copying by representatives of the DOD at reasonable times and in a reasonable manner as determined by the supporting DOD component Non-exempt Classified Research

15 DOD Obligations HRP Sep 2013 Page 6 of The involvement of classified information may be limited to information needed for IRB approval and oversight of the research; information needed to inform the human subjects during the consent process and Information provided by the subjects during the course of the research Secretary of DOD approval is required for all classified non-exempt research involving subjects Submission for approval must be from the Head of the OSD or DOD Component conducting or supporting the non-exempt research involving human subjects. The request must be coordinated with the ASD(R&E) and General Counsel of the Department of DOD after the IRB has approved the research Waivers of informed consent are prohibited Informed consent procedures must include: Identification of the DOD as the supporting institution of the research, unless the research involves no more than minimal risk. The Secretary of DOD may grant an exception to this requirement on the grounds that providing this information could compromise intelligence sources or methods A statement that the research involving human subjects is classified and an explanation of the impact of the classification IRB approval process must meet the following requirements: IRB review must be conducted using a full board review. Use of an expedited review procedure is prohibited At least one non-affiliated member must be a non-federal employee (other than as an individual appointed as an expert or consultant for purposes of service on the IRB) Any IRB member who disagrees with a majority decision approving a project may appeal the decision to the Secretary of DOD. The appeal must be included in the DOD Component s submission to the Secretary of DOD The IRB must determine whether potential subjects need access to classified information to make a valid, informed consent decision Disclosure or use of classified information must comply with DOD requirements for access to and protection of classified information. 3. REFERENCES USC DOD Instruction DOD Instruction OPNAVINST B 3.5. SECNAVINST D

16 DOE Obligations HRP Dec2014 Page 1 of 3 4. PURPOSE 4.1. This guidance outlines the additional obligations of investigators conducting DOE research. 5. GUIDANCE 5.1. DOE-funded or DOE laboratory-managed or conducted projects involving intentional modification of an individual s or a group of individuals environment must be managed as human subjects research and subject to the requirements of DOE Order 443.1B Where generalizable should be viewed in terms of contribution to knowledge within the specific field of study, this includes: Studies in human environments (e.g., occupied homes and offices, classrooms, and transit centers like subway systems and airports) that use tracer chemicals, particles, and/or other materials, such as perfluorocarbons, to characterize airflow Studies in occupied homes and/or offices that: Manipulate the environment to achieve research aims, e.g., increasing humidity and/or reducing influx of outside air through new energy-saving ventilation systems Test new materials (e.g., sequentially changing the filter materials in the HVAC system while monitoring the effects on air quality and energy use) Involve collecting information on occupants views of appliances, materials, or devices installed in their homes or their energy saving behaviors through surveys and focus groups. Some surveys may be online surveys administered through providers such as Amazon Mechanical Turk and Survey Monkey Even if the IRB does not view a project as meeting the literal definition of human subjects research as defined in 45 CFR Part 46, DOE requires initial review by the IRB of the application and supporting materials to determine whether the individuals included in the research will be properly informed and protected. Adherence to each specific requirement of 45 CFR Part 46 is not required in such a case, but DOE does require that: An application and supporting materials be submitted to the IRB; The Chair decide the level of review; During the review, the IRB assess risks associated with the research and whether the individuals to be included in such research will be properly informed and protected. SMEs should be used, as needed, in assessing risks and in determining whether risks have been mitigated to the extent practicable (to minimal risk) After the review, the Chair send a letter to the PI indicating that the project has been reviewed in accordance with DOE

17 DOE Obligations HRP Dec2014 Page 2 of 3 expectations and will be monitored and tracked by the IRB, which means that the PI will: Implement any IRB recommendations before the project begins; Notify the IRB of any proposed changes to the protocol in the future and ensure IRB review and authorization to proceed before implementing these changes; Provide an annual update to the IRB; and Follow the notification and reporting requirements in DOE O 443.1B for reporting adverse events, annual update of the DOE HSRD, etc Within 48 hours of the following (or within 24 hours if private identifiable information is involved), provide a description of corrective actions taken immediately following the incident, as well as corrective actions to be taken for concurrence by the appropriate DOE HRPP Manager: Any significant adverse events, unanticipated problems, and complaints about the research, Any <Suspension of IRB Approval> <Termination of IRB Approval>; Any significant <Noncompliance> with HRPP procedures or other requirements, which shall be reported to the IRB for evaluation for further action with the appropriate DOE Human Subject Protection Program Manager 5.3. In accordance with the DOE Checklist for IRBs to Use in Verifying that HS Research Protocols are In Compliance with DOE Requirements, your research protocol must include description of processes for: Keeping private identifiable information confidential Releasing private identifiable information only under a procedure approved by the responsible IRB(s) and DOE, where required Using private identifiable information only for purposes of the DOEapproved research Handling and marking documents containing private identifiable information as containing private identifiable information or containing protected health information Establishing reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of private identifiable information Making no further use or disclosure of the private identifiable information except when approved by the responsible IRB and DOE, where applicable, and then only: In an emergency affecting the health or 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 or when required by law Protecting private identifiable information data stored on removable media using encryption products that are Federal Information Processing Standards (FIPS) certified

18 DOE Obligations HRP Dec2014 Page 3 of Using FIPS certified encryption that meet the current DOE password requirements cited in DOE Guide Shipping 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 with FIPS certified encryption products Sending passwords that are used to encrypt data files containing PII separately from the encrypted data file, i.e. separate , telephone call, separate letter Using FIPS 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 Version found at: In addition to other reporting requirements, reporting the loss or suspected loss of PII immediately (within 5 business days) upon discovery to: 1) the DOE Project Officer and 2) the applicable IRBs. 6. REFERENCES CFR DOE Order B 6.3. Checklist for IRBs to Use in Verifying That HS Research Protocols Are in Compliance with DOE Requirements

19 DOJ Obligations HRP Sep 2013 Page 1 of 4 1. PURPOSE 1.1. This guidance outlines the additional obligations of investigators conducting DOJ research. 2. GUIDANCE 2.1. National Institute of Justice (NIJ)-funded research Investigators must have a privacy certificate approved by the NIJ human subjects protection officer Investigators and research staff must sign employee confidentiality statements, and investigators must maintain these statements Investigators must obtain written informed consent and disclose The names of the funding agencies A statement describing the extent to which confidentiality of records identifying the subject will be maintained Private, identifiable information will be kept confidential and will only be used for research and statistical purposes or if, due to sample size or some unique feature, the identity of the individual cannot be maintained, a statement to that effect What information will be disclosed, under what circumstances, and to whom Any risks that might result from this disclosure The research team does not have to report child abuse unless the subject signs another consent document to allow child abuse reporting Investigators must send to the National Archive of Criminal Justice Data a de-identified copy of all data with copies of the informed consent document, data collection instruments, surveys, or other relevant research materials Research conducted within the Bureau of Prisons The Department of Justice does not consider implementation of Bureau of Prisons programmatic or operational initiatives made through pilot projects to be research Investigators must follow the requirements of 28 CFR 512, including: The research must not involve medical experimentation, cosmetic research, or pharmaceutical testing The research design must be compatible with both the operation of prison facilities and protection of human subjects The investigator must observe the rules of the institution or office in which the research is conducted Any investigator who is not an employee of the Bureau of Prisons must sign a statement in which the investigator agrees to adhere to the requirements of 28 CFR The Bureau of Prisons IRB must approve the research The research must have an adequate research design and contribute to the advancement of knowledge about corrections.

20 DOJ Obligations HRP Sep 2013 Page 2 of The selection of subjects within any one organization must be equitable Incentives may not be offered to help persuade inmate subjects to participate. Soft drinks and snacks to be consumed at the test setting may be offered Reasonable accommodations such as nominal monetary recompense for time and effort may be offered to nonconfined research subjects who are both: No longer in Bureau of Prisons custody Participating in authorized research being conducted by Bureau of Prisons employees or contractors A non-employee of the Bureau of Prisons may receive records in a form not individually identifiable when advance adequate written assurance that the record will be used solely as a statistical research or reporting record is provided to the agency Except as noted in the consent statement to the subject, the investigator must not provide research information that identifies a subject to any person without that subject s prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertain Except for computerized data records maintained at an official Department of Justice site, records that contain nondisclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system If the investigator is conducting a study of special interest to the Office of Research and Evaluation (ORE) but the study is not a joint research involving ORE, the investigator may be asked to provide ORE with the computerized research data, not identifiable to individual subjects, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the research Consent documents must disclose: Identification of the investigators Anticipated uses of the results of the research A statement that participation is completely voluntary and that the subject may withdraw consent and end participation in the research 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

21 DOJ Obligations HRP Sep 2013 Page 3 of 4 federal or state law. For example, an investigator may not guarantee confidentiality when the subject indicates intent to commit future criminal conduct or harm himself or 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 will have no effect on the inmate subject's release date or parole eligibility Investigators must have academic preparation or experience in the area of study of the proposed research When submitting a research protocol, investigators must provide the following information: A summary statement, which includes: Names and current affiliations of the investigators Title of the study Purpose of the study Location of the study Methods to be employed Anticipated results Duration of the study Number of subjects (staff or 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 of Prisons 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 or administrative procedures to be followed to: Ensure the security of any individually identifiable data that are being collected for the study.

22 DOJ Obligations HRP Sep 2013 Page 4 of 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 materials such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules A statement regarding assurances and certification required by federal regulations, if applicable Investigators must assume responsibility for actions of any person engaged to participate in the research as an associate, assistant, or subcontractor to the investigator At least once a year, investigators must provide the Chief, Office of Research and Evaluation, with a report on the progress of the research At least 12 working days before any report of findings is to be released, investigators must distribute one copy of the report with an abstract in the report of findings to each of the following: The chairperson of the Bureau Research Review Board The regional director The warden of each institution that provided data or assistance In any publication of results, investigators must acknowledge the Bureau's participation in the research Investigators expressly disclaim approval or endorsement of the published material as an expression of the policies or views of the Bureau Prior to submitting for publication the results of research conducted under this subpart, investigators must provide two copies of the material, for informational purposes only, to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons. 3. REFERENCES CFR 22, CFR 512

23 ED Obligations HRP Sep 2013 Page 1 of 4 1. PURPOSE 1.1. This guidance outlines the additional obligations of investigators conducting ED research. 2. GUIDANCE 2.1. For research funded by the National Institute on Disability and Rehabilitation Research, when the IRB reviews research that purposefully requires inclusion of children with disabilities or individuals with mental disabilities as research subjects, the IRB includes at least one person primarily concerned with the welfare of these research subjects The Family Educational Rights and Privacy Act (FERPA) applies when investigators obtain student records or personal education information from an education program as defined as any program principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education, and adult education. FERPA requirements include: An educational agency or institution may disclose personally identifiable information from an education record of a student without consent if the disclosure is part of an agreement between organizations or subjects conducting studies for, or on behalf of, educational agencies or institutions to: Develop, validate, or administer predictive tests Administer student aid programs Improve instruction A school district or postsecondary institution that uses this exception is required to enter into a written agreement with the organization 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 Department of Education regulations on redisclosure 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 Organization with legitimate interests That the Organization 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 Organization 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:

24 ED Obligations HRP Sep 2013 Page 2 of 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; and 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 For certain types of research directly funded by ED the Protection of Pupil Rights Amendment (PPRA) applies PPRA prohibits students from being required, as part of any research project, to submit without prior consent to surveys, psychiatric examination, testing, or treatment, or psychological examination, testing, or treatment, in which the primary purpose is to reveal information concerning one or more of the following: Political affiliations or beliefs of the student or the student s parent Mental or psychological problems of the student or the student s family Sex behavior or attitudes Illegal, anti-social, self-incriminating, or demeaning behavior Critical appraisals of other individuals with whom respondents have close family relationships Legally recognized privileged or 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 such program For certain types of research projects not directly funded by ED and conducted in a school that receives funding from ED: Policies and procedures include a process to verify compliance with ED regulations that schools are required to develop and adopt policies in conjunction with parents regarding the following: The right of a parent of a student to inspect, upon the request of the parent, a survey created by a third party before the survey is administered or distributed by a school to a student Any applicable procedures for granting a request by a parent for reasonable access to such

25 ED Obligations HRP Sep 2013 Page 3 of 4 survey within a reasonable period of time after the request is received Arrangements to protect student privacy that are provided by the agency in the event of the administration or distribution of a survey to a student containing one or more of the following items (including the right of a parent of a student to inspect, upon the request of the parent, any survey containing one or more of such items): Political affiliations or beliefs of the student or the student s parent Mental or psychological problems of the student or the student s family Sex behavior or attitudes Illegal, anti-social, self-incriminating, or demeaning behavior Critical appraisals of other individuals with whom respondents have close family relationships Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers Religious practices, affiliations, or beliefs of the student or the student s parent Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program) The right of a parent of a student to inspect, upon the request of the parent, any instructional material used as part of the educational curriculum for the student Any applicable procedures for granting a request by a parent for reasonable access to instructional material received The administration of physical examinations or screenings that the school or agency may administer to a student 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 the 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

26 ED Obligations HRP Sep 2013 Page 4 of 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 must be available for inspection by the parents or guardians of the children engaged in such research Definitions: Prior consent means: Prior consent of the student, if the student is an adult or emancipated minor Prior written consent of the parent or guardian, if the student is not an emancipated minor Research or experimentation program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques Children are persons enrolled in research not above the elementary or secondary education level, who have not reached the age of majority as determined under state law "Psychiatric or psychological examination or test" means a method of obtaining information, including a group activity, that is not directly related to academic instruction and that is designed to elicit information about attitudes, habits, traits, opinions, beliefs or feelings (34 CFR 98.4) "Psychiatric or psychological treatment" means an activity involving the planned, systematic use of methods or techniques that are not directly related to academic instruction and that is designed to affect behavioral, emotional, or attitudinal characteristics of an individual or group (34 CFR 98.4) 3. REFERENCES CFR CFR CFR 356

27 EPA Obligations HRP Sep 2013 Page 1 of 1 1. PURPOSE 1.1. This guidance outlines the additional obligations of investigators conducting EPA research. 2. GUIDANCE 2.1. EPA regulates research that is conducted or supported by EPA EPA regulates research whose results are intended to be submitted to EPA, regardless of whether the research is conducted or supported by EPA or any federal agency Research involving intentional exposure of a human subject means 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 means any human research that is not research involving intentional exposure of a human subject Research involving the intentional exposure of pregnant women, nursing women, or children to any substance is prohibited Observational research involving children must meet the criteria in category (1) or (2) of CHECKLIST: Research Involving Children (HRP-310) 2.7. Observational research involving pregnant women must meet the criteria in CHECKLIST: Pregnant Women (HRP-305) Research approved by the IRB must be submitted to the EPA human subjects research review official for final review and approval before the research can begin. 3. REFERENCES CFR EPA Order Change A1