Chapter 26 - Additional Requirments for Research Supported by Other Federal Agencies

Department of Defense

Overview

Research supported by the Department of Defense (DoD), including the separate components, the Army, Navy, Air Force and Marine Corps, or recruitment of DoD personnel requires compliance with additional federal regulations, Directives and Instructions. This procedure applies to human subject research that is funded by any DOD component or that recruits participants from the DoD.

Definitions

DoD Addendum: An application to the Department of Defense attesting that the University of Pittsburgh will comply with all relevant federal regulations, DoD Instructions and Directives and other relevant documents regarding the protection of human subjects in research.  The Addendum applies to research supported by the DoD, Air Force, Navy, and Marine Corps.  The Army does not use the mechanism of an Addendum.  Additional Army requirements are managed through the contracting process.

The University of Pittsburgh has a DoD Addendum in place for the Air Force and Navy. Copies of these documents are available on the HRPO website.

Continuing non-compliance: A pattern of noncompliance that suggests the likelihood that, without intervention, instances of noncompliance will recur. A repeated unwillingness to comply, or a persistent lack of knowledge of how to comply with the DoD Instructions 3216.02.

Minimal risk: When following Department of Defense regulations: The definition of minimal risk based on the phrase “ordinarily encountered in daily life or 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 everyday life.  For example the risks imposed in certain work environments (emergency responder, pilot soldier in a combat zone) or with certain medical conditions (frequent medical tests or constant pain).

Non compliance: Failure of a person, group, or institution to act in accordance with DoD Instruction 3216.02

Research Involving a Human Being as an 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 (32 CFR 219.103(f) reference (c)). Examples of interventions or interactions include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose. Research involving a human being as an experimental subject is a subset of research involving human subjects.  Further information surrounding this definition may be found at: http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf.

Educational Requirements

Initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support or manage human research supported by the DoD or its components. At the present time, the University of Pittsburgh IRB requires that individuals conducting human subjects research complete modules on Responsible Conduct of Research and Human Subjects Protection as described in Chapter 22.  Individual DoD components may have stricter or specific educational requirements, and may require re-certifications more frequently than currently mandated by the University of Pittsburgh IRB.  Researchers should contact their Program Officer at the DoD, or DoD component, to ensure adherence to any unique requirements.  It is the Principal Investigator’s responsibility to ensure that research staff has completed all appropriate educational requirements as mandated by DoD policy. Please refer to the following link outlining the minimum educational requirements:    http://www.onr.navy.mil/About-ONR/compliance-protections/Research-Protections/Research-Protection-Training-References.aspx

Scientific Review

New research and substantive modifications to approved research must undergo scientific review prior to or at the time of IRB review.  This requirement can be met by University departmental scientific review process. 

Research Monitor

For studies involving greater than minimal risk, appointment of an independent research monitor is required. If appropriate, the IRB or organizational official can also require this for research involving no more than minimal risk.

  • The Principal Investigator is responsible for providing the name, contact information and responsibilities of the monitor or to the IRB in Section 5.13 of the OSIRIS application.
  • There may be more than one research monitor for a study depending on the skillset required by the protocol.
  • The monitor may be an ombudsman or a member of the data safety monitoring board.
  • The IRB must approve a written summary of the monitor’s duties, authorities, and responsibilities.
  • The IRB or Institutional Official shall communicate with the research monitors to confirm their duties, authorities, and responsibilities.
  • Depending on the nature of the study, the research monitor may be assigned to assess one or more of the following functions of the research project: observation of subject recruitment, enrollment, or the consent process, oversight of study interactions or interventions, data collection, or data storage and analysis, and review of monitoring plans and unanticipated problems involving risk to participants or others.
  • The research monitor may discuss the research protocol with the investigators, interview subjects, and consult with others outside of the study about the research.
  • The research monitor has the authority to stop a research study in progress, remove individuals from a study, and/or take any steps to protect the safety and well-being of subjects until the IRB can make an assessment.
  • The research monitor has the responsibility to promptly report any discrepancies or problems to the IRB or designated official.
  • The Heads of the OSD and DoD Components may waive the requirement to have a research monitor on a case by case basis when the inclusion of a research monitor is not necessary to provide additional protections for human subjects.  

Consent Issues

Research Related Injury

The Department of Defense components may have stricter requirements regarding research-related injury than those outlined in the policies of the University of Pittsburgh and federal regulations.  Investigators should work with their Program Officer within the DoD component to identify such requirements.  Additional language regarding specific requirements by the DoD should be incorporated into the informed consent document as appropriate.

Waiver of Consent

If the research subject of a study funded by the DoD or its components meets the definition of “experimental subject” then a waiver of consent [including an exception from informed consent in emergency medicine research] by the IRB is prohibited unless a waiver is obtained from the Assistant Director of Defense for Research and Engineering. However, if the research subject does not meet the definition of an “experimental subject,” then the IRB may waive the consent process. Waivers are prohibited for classified research.

Consent from Legally Authorized Representative

Research involving consent by a legally authorized representative is only permissible if the research is intended to be beneficial to individual subjects. The determination that the research is intended to be beneficial to the experimental subject must be made by the IRB. The University of Pittsburgh has additional requirements for those who are decisionally impaired as outlined in Chapter 14. As a protocol at the University would need to meet both sets of requirements, the more restrictive policy would apply.

Archiving of Records

The Department of Defense may require submission of records to the Department of Defense for archiving.

Studies Involving Department of Defense Personnel

Undue Influence

For research involving more than minimal risk and also involving military personnel, the following additional protections must be in place and articulated in the OSIRIS application to minimize undue influence:

  • Officers cannot influence the decision of their subordinates to participate in the research.
  • Officers and senior non-commissioned officers cannot be present at the time of recruitment into the research.
  • Officers and senior non-commissioned officers must have a separate opportunity to participate in the research.
  • When recruitment involves a percentage of a unit, an ombudsman, who is independent of both the proposed research as well as the unit must be present to monitor that the voluntary nature of the individual participants is adequately stressed and that the information provided about the research is adequate and correct.  

Compensation

The following limitations on dual compensation for U.S. military personnel apply for DoD funded research: 

  • An individual may not receive pay from more than one position for more than 40 hours of work in one calendar week. This limitation on dual compensation includes temporary, part-time and intermittent appointments.
  • Individuals may receive compensation for research activities if the research activities take place outside of scheduled work hours.
  • 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 research participation other than blood draws in a reasonable amount approved by the IRB according to local prevailing rates and the nature of the research.  

Vulnerable Populations

Research supported or conducted by the Department of Defense that affects vulnerable classes of subjects must meet the additional protections of 45 CFR Part 46, Subparts B, C, and D.  Determinations authorizing or requiring any action by an official of DHHS is under the authority of the Director, Defense Research and Engineering.

Research with Minors

The exemption at 45 CFR 46.101 (b) (2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed (See 32 CFR 219.101.  

Service Members and Their Status as Adults  For purposes of legal capacity to participate in DoD-conducted or supported research involving human subjects, all active duty Service members and all Reserve Component members in a Federal duty status are considered for the purpose of DoD Instruction 3216.02 to be adults.   When Service members are under 18 years of age, students at Service Academies, or trainees, the IRB shall carefully consider the recruitment process and the necessity to include such members as human subjects. 

Research with Prisoners

Captured or detained personnel: -The DOD Directive 3216.02 (section 4.4.2) prohibits research involving prisoners of war.    This includes any person captured, detained, held, or otherwise under the control of DOD personnel (military and civilian or contractor employees).  Such persons include enemy prisoners of war, civilian internees, detained persons, lawful and unlawful enemy combatants.  Such persons do not include DOD personnel being held for law enforcement purposes.   

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.  

DOD funded research involving prisoners cannot be expedited.  

In addition to the allowable categories of research on prisoners in 45 CFR Part 46, Subpart C, epidemiological research is allowable when:

  • The research describes the prevalence or incidence of a disease by identifying all cases or studies the potential risk factor associations for a disease.
  • The research presents no more than minimal risk.
  • The research presents no more than an inconvenience to the participant.
  • Prisoners are not a particular focus of the research.  

If a participant becomes a prisoner, 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 it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, until the convened IRB can review this 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. 

Pregnant Women

For the purposes of applying 45 CFR Part 46, Subpart B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge.”

The applicability of Subpart B is limited to research involving pregnant women 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.

Fetal Research

Fetal research funded by the DOD must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.   Please refer to Chapter 14 of the IRB Policies and Procedures Manual, Considerations for Special Subject Populations, Research Involving Pregnant Women, Neonates, and Fetuses.   

Additional DoD Review Requirements
 

Formal Agreements

When conducting multi-site research, investigators should contact the University of Pittsburgh Office of Research to ensure that a formal agreement between organizations is implemented. The purpose of the agreement is to specify the roles and responsibilities of each party.

Surveys

Surveys involving Department of Defense personnel must be submitted, reviewed, and approved by the Department of Defense after the research protocol is reviewed and approved by the IRB. Any requested DoD changes must subsequently be submitted to the IRB for review.

International Research

When DoD-sponsored research involves human subjects who are not U.S. citizens or DoD personnel and the research is conducted outside the United States, and its territories, the Principal Investigator must obtain permission from the host country.  The laws, customs, regulations and practices of the host country and those required by the University of Pittsburgh IRB will be followed.  An ethics review by the host country, or local DoD IRB with host country representation is required.  Evidence of permission to conduct the research in the host country by certification or local ethics review must be submitted to the University of Pittsburgh IRB prior to initiation of the project.

Additional Reporting Requirements for Investigators and the IRB

Investigators

Investigators conducting DOD funded research must promptly report (within 30 days)to the DoD research protection officer:

  • When Significant changes to the research protocol are approved by the IRB
  • The results of the IRB continuing review
  • Change of reviewing IRB

The IRB

The IRB must promptly report (within 30 days) to the DoD research protection officer when they are notified by any Federal department, agency or national organization that any part of the human research protection program is under for cause investigation of a research protocol involving a DoD support.   

References

  • 32 CFR 219
  • 10 USC 980
  • DoD Directive 3216.2
  • SECNAVINST 3900.39D
  • OPNAVINST 5300.8B
  • DoD Dual Compensation Act, 24 U.S.C 301 

Department of Justice

The University of Pittsburgh IRB will review submissions supported by the Department of Justice (DOJ) or conducted within the federal Bureau of Prisons with respect to the following additional requirements.

Research funded through the National Institute of Justice (NIJ) must comply with the provisions of 28 CFR Part 46, related to human subject protections, and also 28 CFR Part 22, related to privacy and confidentiality of research data.  Specific requirements for such research are outlined below.

The research must have a privacy certificate approved by the NIJ Human Subjects Protection Officer. The NIJ requirements for privacy certificates are very specific and are available at: http://www.nij.gov/nij/funding/humansubjects/privacy-certificate-guidance.htm.  A model form for a privacy certificate can be found at: http://www.nij.gov/nij/funding/humansubjects/model-privacy-certificate.htm

  1. A statement must be included in the consent document that confidentiality may only be broken if the participant reports immediate harm to participants or others.
  2. All Researchers and Research Staff are required to acknowledge in writing the confidentiality protections of the study, and copies of that acknowledgement must be maintained by the responsible Researcher.
  3. Identifiable portions of the data must be destroyed after the three year data retention period has expired and a copy of all de-identified data must be sent to the National Archive of Criminal Justice Data including de-identified informed consent documents, data collection instruments, surveys or other relevant research materials.

Research Involving the Bureau of Prisons

Research within the federal Bureau of Prisons is subject to the additional requirements of 28 CFR 512.
The regulations apply to any research involving inmates in the custody of the Attorney General, and assigned to the Bureau of Prisons, regardless of the institution in which the inmate is incarcerated (e.g., even if the inmate is resident in a state institution). 

Research Application

In order for the IRB to review projects being conducted in the Bureau of Prisons, the Investigator must provide the following information through the OSIRIS system:

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
  • Durations of the study
  • Number of subjects (staff or inmates) required and the 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 the individual subjects or a class of subjects, and a discussion of the likelihood that the risks and discomforts will actually occur
  • Description of the steps taken to minimize risks
  • 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
    • Destroy research records or remove individual identifiers from those records when the research has been completed
  • Description of any anticipated effects of the research study on organizational programs and operations
  • Relevant research material such as vitae, endorsements, sample consent statements, questionnaires, and interview schedules
  • A statement regarding assurances and certification required by 28 CFR 46, if applicable.

Approval Process

  1. Research protocols within the Bureau of Prisons must be approved in advance by the federal Bureau Research Review Board (“BRRB”), and by the warden of the individual facility in which the research is to be conducted.
  2. No medical experimentation, cosmetic research or pharmaceutical testing is permitted.  Only research studies that advance knowledge about corrections will be considered.
  3. Research protocols may not offer incentives to inmate subjects, except for soft drinks and snacks to be consumed at the test site.  Non-confined research subjects may be offered nominal monetary recompense for time and effort provided that such subjects are 1) no longer in Bureau of Prisons custody, and 2) participating in approved research being conducted by Bureau of Prisons employees or contractors.
  4. The investigator must assume responsibility for actions of any research staff engaged to participate in the project, and all researchers must agree to abide by the rules of the institution where the research will be conducted.  Researchers must sign an acknowledgement to adhere to the regulations of the Bureau of Prisons at 28 CFR Part 512.
  5. The investigator must agree not to provide research information that identifies a subject to any person without the subject’s prior written consent to release the information.

Research Design

Projects conducted within the Bureau of Prisons must have an adequate research design and contribute to the advancement of knowledge about corrections.

The IRB will determine that the research design is compatible with both the operations of the prison facilities and the protection of human subjects.

Informed Consent

The informed consent document for a study to be conducted in the Bureau of Prisons must include the following elements, in addition to the elements required under the Common Rule:

  • Identification of the investigators;
  • 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 project at any time without penalty or prejudice (e.g. the inmate will be returned to regular assignment or activity by staff as soon as possible);
  • A statement regarding the confidentiality of the research information and exceptions to any guarantees of confidentiality required by federal or state law (i.e. an investigator may not guarantee confidentiality when the subject indicates intent to commit future criminal conduct or harm himself/herself or someone else, or if the subject is an inmate, indicates intent to leave the facility without authorization);  
  • A statement that participation in the research project will have no effect on the inmate subject’s release date or parole eligibility.

Storage of Data and Confidentiality

Research protocols must include documentation for maintaining confidentiality of data preliminary to the research, during and after the conclusion of the research by assuring:

  • Records are not in an individually identifiable form; and,
  • Advance written assurance has been provided to the Bureau of Prisons that the records will be used solely for statistical research or reporting
  • Research data may not be maintained electronically at the University that contain non-disclosable information directly traceable to a specific person (NOTE: Computerized data records may only be maintained at an official DOJ site)
  • The principal investigator must negotiate arrangements, prior to the beginning of the data collection of the project, to provide non-identifiable computerized data on individual subjects along with documentation to the Office of Research and Evaluation (ORE) if requested
  • At the conclusion of the research, the investigator must document that research records will be destroyed or individual identifiers will be removed from the records.

Post Study Obligations

Research conducted in the Bureau of Prisons must acknowledge the Bureau of Prisons participation in any publication of the results and include a disclaimer in the results for publication that the approval or endorsement of the published material is an expression of the policies or view of the Bureau of Prisons;

Researchers must provide, at least 12 working days before any report of findings to be released, one (1) copy of the report, which includes an abstract of the findings, to each of the following:

  • The Chairperson of the BRRB;
  • The Regional Bureau of Prisons Director; and
  • The Warden of each institution which provided data or assistance.

Researchers must submit two (2) copies of the results of the research project for informational purposes only to the Chief, Office of Research and Evaluation, Central Office, Bureau of Prisons prior to submission for publication.

References

  • 28 CFR 22
  • 28 CFR 512

Environmental Protection Agency

Overview

Research that is either: 1) conducted by the EPA, 2) supported by the EPA or 3) conducted by any party with the intent that the results will be submitted to the EPA for consideration under the Federal Insecticide, Fungicide, and Rodenticide Act, or under Section 408 of the Food, Drug and Cosmetic Act.  40 C.F.R. § 26.1203, is subject to additional regulations specific to the Environmental Protection Agency (EPA)found at 40 CFR 26.  These regulations outline additional protections and prohibitions for children, pregnant women and fetuses, and nursing women. 

Definitions

Research involving intentional exposure of a human subject: a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study.  

Observational Research: any human research that does not meet the definition of research involving intentional exposure of a human subject.

Specific EPA Requirements and Restrictions

EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children.

While intentional exposure is prohibited in pregnant women and fetuses, in EPA sponsored studies, observational research is permitted provided all of the conditions outlined in 45 CFR 46.204 and 45 CFR 46.206 are met.  

Children may also be enrolled in observational studies provided that the study either presents minimal risk, or the study presents greater than minimal risk, but holds out the prospect of direct benefit to the child or “is likely to contribute to the subject’s well being.” 40 C.F.R. § 26.405(a).  In reviewing studies of this nature, the IRB must determine that the risk is justified by the anticipated benefit, and that the relation of the anticipated benefit to the risk is at least as favorable as the available alternative approaches.  40 C.F.R. § 26.405.  Appropriate mechanisms must be employed for soliciting the permission of the parents and the assent of the children in such observational studies.  40 C.F.R. § 26.406. 

Prior Submission of Proposed Human Subject Research for EPA 

All human subject research studies supported by the EPA must either be approved or be determined to be exempt research by the EPA Human Subjects Research Review Official before any contract, grant, or formal agreement involving EPA support is awarded or entered into.

To obtain approval by the EPA Human Subjects Research Review Official (Review Official), the following documents must be submitted by the investigator to the EPA:

  • The Primary Awardees Federalwide Assurance (FWA) number
  • Copies of:
    • the IRB approval (or exemption) letter
    • the study protocol(s) as submitted to the IRB (the pre-award document is not sufficient)
    • the IRB approved consent forms and subject recruitment materials if applicable
    • all supplementary IRB correspondence

The materials should be submitted to
By E-mail Attachment:
lux.warren@epa.gov

By Regular Mail or EPA Pouch Mail:
Warren Lux, M.D.
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Mail Code 8105R
Washington, DC 20460

By Private Carrier (FedEx, UPS, etc.):
Warren Lux, M.D.
U.S. Environmental Protection Agency
1300 Pennsylvania Avenue

References 

 

Department of Education

Research funded through the Department of Education must comply with additional regulatory requirements under 34 CFR 98.3, 34 CFR 98.4, 34 CFR 99, 34 CFR 356.3

Protection of Pupil Rights Amendment (PPRA)

The Protection of Pupil Rights Amendment (PPRA) (20 U.S.C. § 1232h; 34 CFR Part 98) applies to programs that receive funding from the U.S. Department of Education (ED). PPRA is intended to protect the rights of parents and students.

Research Funded by the Department of Education

No student shall be required, as part of any research project, to submit without prior consent (parental permission and assent) 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
  • Mental and psychological problems potentially embarrassing to the student or his or her family
  • Sex behaviors 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 & analogous relationships, such as those of lawyers, physicians & 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

Unless consent is waived, prior consent means:

  • Prior consent of the student, if the student is an adult (age 18 or older) or emancipated through a court order
  • Prior written consent (permission) of the parent or legal guardian, if the student is an un-emancipated minor

Research Not Funded by the Department of Education

It is the responsibility of the IRB to verify, by acceptance of the school official’s letter of agreement or School IRB approval (when applicable), that compliance with US Department of Education regulations will be maintained. Specifically, schools are required to develop and adopt policies in conjunction with parents 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 the 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
  • The collection, disclosure, or use of personal information collected from students for the purpose of marketing or for seeing 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.

When accessing 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
  • 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.

Family Education Rights and Privacy Act (FERPA)

The Family Educational Rights and Privacy Act (FERPA) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the U.S. Department of Education.

FERPA gives parents certain rights with respect to their children's education records. These rights transfer to the student when he or she reaches the age of 18 or attends a school beyond the high school level. Students to whom the rights have transferred are "eligible students.”

Parents or eligible students have the right to inspect and review the student's education records maintained by the school. Schools are not required to provide copies of records unless, for reasons such as great distance, it is impossible for parents or eligible students to review the records. Schools may charge a fee for copies.

Parents or eligible students have the right to request that a school correct records which they believe to be inaccurate or misleading. If the school decides not to amend the record, the parent or eligible student then has the right to a formal hearing. After the hearing, if the school still decides not to amend the record, the parent or eligible student has the right to place a statement with the record setting forth his or her view about the contested information.

Generally, schools must have written permission from the parent or eligible student in order to release identifiable information from a student's education record.

Conditions for Which Student Records Can Be Disclosed without Consent for Research Purposes

For research purposes, FERPA allows schools to disclose students’ educational records, without consent, to the following parties or under the following conditions (34 CFR § 99.31),

  • The Researcher will receive a completely de-identified data set from the educational institution.
  • The organization is conducting certain studies for or on behalf of the school to develop, validate, or administer predictive tests.

Schools may disclose, without consent, "directory" information such as a student's name, address, telephone number, date and place of birth, honors and awards, and dates of attendance. However, schools must tell parents and eligible students about directory information and allow parents and eligible students a reasonable amount of time to request that the school not disclose directory information about them. Schools must notify parents and eligible students annually of their rights under FERPA. The actual means of notification (special letter, inclusion in a PTA bulletin, student handbook, or newspaper article) is left to the discretion of each school.

View full FERPA regulations 524 http://www2.ed.gov/policy/gen/reg/ferpa/index.html.

Requests for Waivers of Consent

It is important that researchers apply FERPA and human subject protection regulations when accessing educational records. Generally FERPA and IRB requirements are met if a student or parent signs a consent form to participate in a study and authorizes release of his/her educational records for research purposes.  In instances where a researcher requests to waive the informed consent process, the following conditions must be met:

Research on University of Pittsburgh Student Records

  • If records are being requested from the University of Pittsburgh, the IRB will forward any requests to access information without written consent to Pitt’s Office of General Counsel and the University Registrar. The University Registrar, with the advice of the Office of General Counsel, will make the final determination if the study meets the FERPA criteria to release educational information without a signed consent form.  The written approval from the University Registrar must be uploaded into the OSIRIS application.

Research on Student Records at Institutions other than the University of Pittsburgh

Where researchers are conducting a study on behalf of the school district to improve instruction or to develop or validate a predictive test, the school district may provide FERPA protected records without consent under specific conditions and pursuant to a written agreement between the school district and the researcher.  If researchers are proposing to access student records at institutions other than Pitt, utilizing a waiver of consent then the researchers should contact that institution and follow that institution’s FERPA policy.    

Even if a school district makes the determination that it will provide records under a waiver of consent under FERPA, the IRB will also have to approve a waiver of consent under its policies.  Researchers will have to provide a copy of the waiver from the school district and the written agreement with the school district when requesting this waiver.  

  • Researchers should upload the waiver and the written agreement that meets the requirements of FERPA for permitting the release of the educational records from the school district into the Other Documents section of the OSIRIS application.
  • The investigator should describe the procedures they will undertake to be compliant with the external institution’s FERPA policies within Item 2.6 of the OSIRIS application.
  • In accordance with FERPA, an educational institution has the authority to determine what information may be accessed from an educational record. If an institution denies an investigator access to information in an educational record, the IRB cannot overrule the decision.
  • According to the IRB federal regulations, for non-exempt studies, an IRB cannot waive informed consent or documentation of informed consent unless specific conditions are met. Consequently, researchers should include rationale for waiver requests in the IRB application even in circumstances where FERPA allows access without prior consent.
  • FERPA and the Health Insurance Portability and Accountability Act (HIPAA) regulations provide conflicting requirements for medical records. In some situations FERPA is more restrictive than HIPAA for researchers. Researchers should contact each educational institution and follow that institution’s applicable policies, whether FERPA and/or HIPAA policy when accessing student medical records.

Those involved in the review and conduct of research involving students records and / or research
funded by the Department of Education should refer to the following:

Policy 09-08-01 http://www.cfo.pitt.edu/policies/policy/09/09-08-01.html

34 CFR 98.3 and 34 CFR 98.4 http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title34/34cfr98_main_02.tpl

34 CFR 99 http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title34/34cfr99_main_02.tpl    

34 CFR 356.3 http://www.ecfr.gov/cgi-bin/text-idx?SID=21c075cfd469ef1b7f8d7591a7861f74&node=pt34.2.356&rgn=div5    
 

version 7.17.2015