Miscellaneous and Other Regulatory Considerations
“Internet research” is a broad term that includes both the Internet as a tool for research and as a research location. Internet-based research may be used for surveys because it is a quick way to gain access to a large number of respondents. Observations, interventions, and analysis of existing data are also commonly used methods of internet-based research. Internet-based research brings up difficult issues concerning human subject protections in the application of federal regulations 45 CFR 46 and the ethical principles of the Belmont Report. Topics such as privacy, confidentiality, recruitment, and informed consent can become complicated when research is conducted online.
Special considerations for survey researchers:
- Informed consent materials / information sheets: Prospective research subjects must be informed about the nature, purpose, procedures, risks, and benefits associated with the research. When using anonymous surveys, include the information sheet content (i.e., informed consent) on the first page of the survey for prospective subjects to review. Subjects must "agree" to participate before being directed to the survey questions.
- Recruitment – examples of acceptable sites: Google, Amazon M Turk
- Survey providers – examples acceptable sites: ISBER (UCSB, LTSC), Qualtrics (External), SurveyMonkey (External)
- Survey question design: Online surveys must be designed to allow subjects to skip any question which they choose not to answer
What should be considered when using one’s own students or any participant who has a lower position of power, or personal relationship, with the PIs or senior members of the research team as subjects?
Particular care must be taken when UCSB students are used as research subjects, as there is an inherent power differential between the students and the faculty members who serve as Principal Investigators or members of research teams. No matter how well intentioned the Principal Investigator, students may feel compelled to participate, believing that failure to do so will negatively affect their grades, standing within the lab or course, or impact their relationships within a department, as well the attitude of the Principal Investigator (and perhaps other students and/or members of the research team) toward them. For this reason, the HSC will not, in general, permit a Principal Investigator to use his/her own students, lab members, or individuals with a personal relationship to the research team, as subjects in the research project. The HSC will review for risks to autonomy and if appropriate safeguards, such as collection of data by a third party or a student's consent to use his/her own data be obtained after grades are entered, as possible ways to mitigate risks regarding this type of research. However, consent should be obtained before research data is used.
For students being recruited from one’s own course, the Principal Investigator must ensure that procedures are not likely to adversely impact students’ opportunity to learn required educational content.
For participants (e.g., graduate, undergraduate students, etc.) who have a lower position of power or personal relationship with the research team, great care must be taken to ensure that a participant's autonomy is not unintentionally compromised. This includes privacy and confidentiality considerations as the participant’s personal or private information may become readily known to members of the research team.
Although students often provide a ready source of potential participants, they are not always as representative or appropriate to the research as other subject pools. Attention should be given to whether they are being solicited solely for convenience.
For research proposals utilizing recruitment of students by the teacher/researcher, the HSC may require contacting the Department Chair for approval of the proposed subject population and recruitment method.
Research conducted in grade schools may require school district approval, principal of school approval, or district IRB or review board approval, depending on the requirements of a particular school district. Depending on the nature or design of the research, teacher consent may also be required. Note that parental permission and child assent must always be obtained, unless the UCSB HSC has granted a waiver. All such school approvals shall be submitted to the HSC for inclusion in the protocol file. The HSC may require district approval as a condition of UCSB approval, or may permit the researcher to obtain district approval at a later time, as long as proof of school approval is submitted as required by the HSC.
California’s Child Abuse and Neglect Reporting Act (“CANRA”) requires employers, including the University, to identify “Mandated Reporters” (individuals required to report observed or suspected child abuse or neglect to designated law enforcement or social service agencies) and secure, as a condition of employment, acknowledgement of their status and reporting obligations. Visit the UCSB Human Resources webpage for more information on mandated reporting.
Employees of the university that have been identified in their official university capacity as a mandated reporter are also considered mandated reporters of child abuse on research protocols. Typically, student researchers (who are not also employees) are not considered mandated reporters.
In situations where conditions of child abuse or neglect might be revealed to UCSB researchers, mandated reporters are required to make themselves known as such to participants. This can be accomplished through the informed consent process.
In situations where conditions of suspected child abuse or neglect might be revealed to UCSB researchers and the researchers have not been identified as mandated reporters by the University, the IRB may require that the informed consent process include a statement or warning about the researcher’s ethical responsibility to report suspected or known incidents of child abuse or neglect to the appropriate authorities, including law enforcement.
Separate from CANRA, the California Penal Code requires any person who reasonably believes he or she has observed murder, rape, or certain lewd or lascivious acts where the victim is a child under the age of 14 years to notify a peace officer of the potential crime. This reporting mandate applies whether or not the witness is a mandated reported and regardless of his or her affiliation with the University.
The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records.
FERPA gives parents certain rights with respect to their children's education records. These rights transfer to the student when they reach the age of 18 or attend a school beyond the high school level. Students to whom the rights have transferred are "eligible students."
Generally, schools must have written permission from the parent or eligible student in order to release any information from a student's education record. The IRB cannot waive consent or permission to release student educational records, unless the research qualifies for an exception under FERPA.
FERPA allows schools to disclose those records, without consent, to the following parties or under the following conditions (34 CFR § 99.31):
a) School officials with legitimate educational interest;
b) Other schools to which a student is transferring;
c) Specified officials for audit or evaluation purposes;
d) Appropriate parties in connection with financial aid to a student;
e) Organizations conducting certain studies for or on behalf of the school;
f) Accrediting organizations;
g) To comply with a judicial order or lawfully issued subpoena;
h) Appropriate officials in cases of health and safety emergencies; and
i) State and local authorities, within a juvenile justice system, pursuant to specific State law.
Unless one of the above applies to your research, if you are collecting, obtaining, using, or otherwise analyzing student records that fall under FERPA laws, you must obtain a release form signed by the student, which must include the following information:
a) Printed Student Name;
b) Perm # , and DOB ;
c) Exact records to be released;
d) Name of person or entity receiving records and IRB protocol number;
e) Specific description of the records to be released, include a date/time frame if applicable (e.g., 2019- 2020 academic year);
f) Students signature and date
Submit a copy of the FERPA release form in the Attachments Tab of the ORahs protocol application for IRB review. A description of the records being requested should also be included in the Consent Form.
For specific questions regarding FERPA and human subjects research, please contact email@example.com.
Under federal law, research involving deceased persons generally is not human subjects research and does not require review IRB review and approval.
However, there are three exceptions:
- If the data or samples contain personal identifiers, the research is subject to HIPAA. In this case, IRB approval of the research is not required, but the investigator must obtain authorization from the deceased individual’s legally authorized representative and should contact the UCSB campus privacy officer.
- If the information collected from a cadaver will result in an investigator obtaining information about the cadaver’s living relatives (e.g., genetic studies) IRB approval is required. These activities meet the definition of human subjects research because the researcher will collect private, identifiable information about third parties.
- If the research involves State of California-produced death data files containing personal identifying information then IRB approval may be required. State of California-produced death data files which require IRB approval include:
- All files that can be linked to other death files using the certificate number (e.g., Death Address Files, Multiple Cause of Death Files); and
- All files that are provided with personal identifiers (e.g., Death Statistical Master Files, Merged Death Files, Fetal Death Statistical Master Files).
Research involving State of California-produced death data files that do not contain personal identifying information does not need to be approved by an IRB.
Note: Access to State of California-produced death data files that include personal identifying information also requires review by the State of California Committee for the Protection of Human Subjects (CPHS). Researchers apply for CPHS review when ordering the data from the State of California. The State of California requires that researchers have a “valid scientific interest” in order for the IRB to approve such a study.