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FREQUENTLY ASKED QUESTIONS

GENERAL TOPICS
Local Review and international research
Internet Research
Audio or video recording
Incentives & payment
Students as subjects
Research in schools
WHEN TO OBTAIN APPROVAL
Definition of human subjects research
Exempt research
Use of existing data
Oral histories
Approval process
Conducting research at another institution
Using ORahs
ORAHS PROTOCOL TIPS
Page one
Subjects
Location
Procedures
Risk
Consent
Consent forms
Progress
Attachments
GENERAL TOPICS
Local Review and international research
If research is being conducted outside of the United States, local ethical review needs to be sought to ensure research is appropriate for its locale. The review should assess whether the project is culturally insensitive or offensive and whether participation could place the subjects at risk. The reviewer should be from the country or area targeted.  The reviewer should also be able to understand the research. They should be independent of the research.
This would also include Internet surveys if subjects outside of the U.S. were being recruited.
A certification that the local reviews will be submitted to HSC before research begins needs to be included in the locations section of the ORahs protocol.
For additional information, please see the following guidance from OHRP: http://www.hhs.gov/ohrp/policy/local.html
Internet research
“Internet research” is a broad term that includes both the Internet as a tool for research and as a research location. Internet-based research is popularly 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 become complicated when research is conducted online. UC Berkeley has developed guidance on a variety of issues surrounding internet-based research and to help investigators design studies that are in line with 45 CFR 46.  Additionally, OHRP is developing their own guidance for researchers.
Audio or video recording
Audio and video recordings are considered to be potentially identifiable private information.  Informed consent must be obtained prior to audio or video recording subjects, and it is important to disclose how the recordings will be used, who will have access to them, and when or if they will be destroyed.  The subject should be given the opportunity to withdraw from the study after the recordings have been made.
Incentives & payment
Payment for participation in a study is not considered to be a benefit for research participants. Rather, it should be considered compensation for time and inconvenience or a recruitment incentive. The amount and schedule of all payments should be described in the ORahs protocol at the time of initial review, including a summary of both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence. Procedures for prorating payment should the participant withdraw should be included in the ORahs protocol application and informed consent document(s).
When offering course credit, a non-research alternative must be offered that provides the same amount of course credit for similar time & effort.  Care must be taken to ensure that the credit offered would not negatively affect students who do not participate in the research study.
Students 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 teacher, students may feel compelled to participate, believing that failure to do so will negatively affect their grades and the attitude of the teacher (and perhaps other students) toward them. For this reason, the HSC will not, in general, permit a teacher to use his/her own students as subjects in the teacher's research project. The HSC will review whether 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 concerns regarding this type of research.  However, consent should be obtained before research data is used.
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.
Research in schools
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.
WHEN TO OBTAIN APPROVAL
Definition of human subjects research
Find definitions and more information on our Regulations, Policies, and Guidance webpage:  http://www.research.ucsb.edu/compliance/human-subjects/regulations-policies-and-guidance/
Exempt research
There are six categories of research that may be exempt from the reguirements of the Federal Policy for the Protection of Human Subjects (45 CFR 46).  If research is found to be exempt, you must still submit a protocol application through ORahs.  Although research that qualifies for exempt status is not subject to the federal regulations for human subjects research, investigators still have a responsibility to protect the rights and welfare of their subjects.
Use of existing data
Projects that use an existing data set, which includes identifiable data gathered in earlier research projects, may require a new IRB protocol for review. Secondary analysis of existing data may include the review of medical records, student records, data collected from previous studies, audio/video recordings, etc. that were initially collected for another purpose. In order to be existing, the information must be "on the shelf" (i.e., it has already been collected) at the time that the current research is proposed.
Though such projects do not involve interactions or interventions with humans, they may still require IRB review, since the definition of "human subject" at 45 CFR 46.102(f) includes living individuals about whom an investigator obtains identifiable private information for research purposes.
In addition to being identifiable, the existing data must include "private information" in order to constitute research involving human subjects. Private information is defined as information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical or school record). Information that contains identifiers and can be accessed freely by the public (without special permission or application) is not "private" and the research therefore does not therefore involve human subjects. For example, a study involving only analysis of the published salaries and benefits of public university presidents would not need IRB review since this information is not private.
Data analysis activities that meet the definition of research with human subjects may qualify for an exemption or require expedited or even full committee review. Any such project must receive IRB approval or a determination of exemption before the investigator accesses the data.
Oral histories
The UCLA Office for Protection of Research Subjects (OPRS) contacted Dr. Michael Carome, HHS-OHRP Associate Director for Regulatory Affairs, to seek his guidance concerning the matter of whether qualitative research utilizing open-ended interviews, especially activities performed by oral historians and other social scientists, would require IRB review. The full outline of this discussion is available here.
In short, Dr. Carome clarified that the decision concerning whether activities that consist of open-ended qualitative type interviews (such as oral history projects or ethnographies) require IRB review hinges upon whether the activity meets the above definition of research—specifically, whether the activity is “designed to contribute to generalizable knowledge.” The purpose of these activities is often to create a record of specific historical events and, as such, is not to generalize findings to a broader population or group. However, activities involving similar characteristics may be “designed to contribute to generalizable knowledge.” Below are examples of qualitative interviews that are considered to be research and examples of qualitative interviews that are not considered to be research.
Examples:
An oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape is not intended to prove a hypothesis, inform policy, or draw conclusions. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories. Open-ended interviews that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings would not constitute research.
Open-ended interviews are conducted with surviving Gulf War veterans to document their experiences in order to draw conclusions about those experiences, inform policy, and generalize findings. This would constitute research.
Open-ended interviews are conducted with surviving Negro Baseball League players in order to create an archive for others to analyze and generalize findings in the future. Since the intent of the archive is to create a repository of information for others to use in research, the creation of such an archive would constitute research.
Approval process
See our Approval Process webpage: http://www.research.ucsb.edu/compliance/human-subjects/approval-process/
Conducting research at another institution
1. What if I will be engaged in human subjects research at another UC campus?
PIs conducting human subjects research at another UC campus must either get HSC approval from UCSB or have an active reliance (formerly NOITR or Notice of Intent to Rely on One UC IRB) under the UC MOU. Please visit our information page on the UC MOU and the UC Reliance Registry.
2. What if I will be engaged in human subjects research at a non-UC institution?
PIs conducting human subjects research at a non-UC institution must either get HSC approval from UCSB or enter into an Inter-Institutional Agreement (IIA), which allows UCSB to rely on the other institution’s IRB review. Please visit our information page on Inter-Institutional Agreements.
3. What if I am an unaffiliated researcher wanting to recruit subjects from the UCSB community?
If you are a non-UCSB researcher who wishes to recruit from the UCSB community but are not collaborating with a UCSB PI, then UCSB is not engaged in the research and no IRB review is needed. The non-UCSB researcher is responsible for abiding by the policies of his/her home institution’s IRB and for obtaining appropriate permission to recruit from UCSB groups and organizations.
4. What if I am collaborating on human subjects research at UCSB?
Non-UCSB researchers who wish to collaborate on research at UCSB must have an eligible UCSB principal investigator to serve as the sponsor who will submit a protocol to UCSB’s IRB for approval. Non-UCSB researchers are responsible for obtaining IRB approval from their home institutions.
Using ORahs
See our ORahs Tutorial webpage: http://www.research.ucsb.edu/compliance/human-subjects/orahs-tutorials/
ORAHS PROTOCOL TIPS

General Topics and Protocol Process Questions

SPECIAL TOPICS

WHEN TO OBTAIN APPROVAL

ORAHS PROTOCOL TIPS

GENERAL TOPICS

Local Review and international research

Human research conducted outside the United States must conform to the same ethical and regulatory standards to which research conducted in the United States is held, and must conform to applicable local laws and norms of the host country. International human research must be conducted in accordance with applicable UCSB policies for the conduct and review of human research, including those concerning informed consent and participation of vulnerable populations. All human research conducted outside the United States must receive approval from the UCSB Human Subjects Committee (HSC) and, where available, from the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) used by the international site.

If IRB review is not available at the international site, then local ethical review needs to be sought to ensure research is appropriate for its locale. The review should assess whether the project is culturally insensitive or offensive and whether participation could place the subjects at risk. The reviewer should be from the country or area targeted. The reviewer should also be able to understand the research. They should be independent of the research.

If an international institution or site is considered to be "engaged" in research supported by UCSB or federal funding, the international institution must obtain and maintain compliance with a Federal-wide Assurance (FWA) from the US Department of Health and Human Services (DHHS). The site also must receive approval for the research from an IRB familiar with the local context and registered with the Office of Human Research Protections of DHHS, or obtain DHHS approval as an equivalent host country entity.

For specific details regarding international human subjects review requirements, go to the DHHS International Compilation of Human Research Standards webpage. Click the link to access a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations.

A certification that the local reviews will be submitted to HSC before research begins needs to be included in the locations section of the ORahs protocol. See the UCSB SOP on International Research for additional information that should be included in your submission.

 

Internet research

“Internet research” is a broad term that includes both the Internet as a tool for research and as a research location. Internet-based research is popularly 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 become complicated when research is conducted online. UC Berkeley has developed guidance on a variety of issues surrounding internet-based research and to help investigators design studies that are in line with 45 CFR 46.  Additionally, OHRP is developing their own guidance for researchers.

Special considerations for survey researchers

In ORahs, investigators are required to stipulate Terms of Use, Privacy, etc associated with acceptable recruitment and survey provider sites. For sites not listed above, additional information must be included to fully describe the data safeguards, storage, ownership, etc associated with the collection of human subjects research data.

Audio or video recording

Audio and video recordings are considered to be potentially identifiable private information.  Informed consent must be obtained prior to audio or video recording subjects, and it is important to disclose how the recordings will be used, who will have access to them, and when or if they will be destroyed.  The subject should be given the opportunity to withdraw from the study after the recordings have been made.

Subject compensation

Payment for participation in a study is not considered to be a benefit for research participants. Rather, it is considered compensation for time, travel, and inconvenience. The amount and schedule of all payments must be described in the ORahs protocol and informed consent document(s) at the time of initial review, including a summary of both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence. Procedures for prorating payment should the participant withdraw must also be described in the ORahs protocol application and informed consent document(s).

When offering course credit, a non-research alternative must be offered that provides the same amount of course credit for similar time & effort.  Care must be taken to ensure that the credit offered would not negatively affect students who do not participate in the research study.

Investigators must adhere to university reporting requirements including, but not limited to, provision of subjects' social security numbers (SSN) or other identifiers.

Use of SSNs for Subject Reimbursement

If social security numbers are required to process payments to research subjects, this should be explained in the application for HSC review and the following safeguards should be implemented:

· Records containing SSNs should be stored securely and separately from research records, should not be copied unnecessarily and should be destroyed as soon as is feasible.

· Subjects should be informed of this limitation to the confidentiality of their information. The consent form should indicate that subjects will be asked for their SSNs, why SSNs will be collected, and how this information will be protected. The subject should be informed that (s)he has the right to renounce any research payment and consequently would not be required to disclose the SSN in order to participate in the research study.

· When completing check requests or other paperwork using SSNs, staff should take care not to include extraneous but potentially damaging information such as the study title, the nature of the research or the names of procedures undergone.

LOTTERY/RAFFLE CONSIDERATIONS

• Participants must be 18 years or older
• Payment/lottery chance cannot be withheld until the completion of the study. They must be prorated in some manner if the subject withdraws.
• Approximate odds of winning lottery need to be included in the Consent form. For example, if a researchers would like to have 30-50 subjects and each gets one entry, then simply 1 in 30-50 chances is fine. If multiple entries, estimate the low & high and include in the consent form
• The timing of the lottery can certainly be after the study has been completed. An entry cannot be withheld into the lottery until the subject completes the study. This can be done several different ways. For example, some researchers provide multiple entries into the lottery, 1 for starting the study, another for every X days they participate, 1 for completing the study; alternatively the researcher may just give everyone who joins 1 entry whether they withdraw or not.
• Online survey: Keeping the email name participants may enter into the survey separate from their data: Create a second survey asking for participants' email address if they want to be entered into the lottery (this question will *not* be located in the first survey).This will redirect respondents from the first survey to this survey.
• If participants quit an internet study by closing out of their browser, it is not possible to direct them to the final page (due to closed internet browser). However, researchers can update the information sheet (consent form) so that participants are told the following prior to providing consent to participate: "If you choose to withdraw from the survey before you complete it, you may contact investigator XXX at XXX@XXX.ucsb.edu to be entered into the lottery and/or if you would like more information about the purpose of the study."

Students 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 teacher, students may feel compelled to participate, believing that failure to do so will negatively affect their grades and the attitude of the teacher (and perhaps other students) toward them. For this reason, the HSC will not, in general, permit a teacher to use his/her own students as subjects in the teacher's research project. The HSC will review whether 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 concerns regarding this type of research.  However, consent should be obtained before research data is used.

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 Coordinator highly recommends contacting the Department Chair for approval of the proposed subject population and recruitment method.

Research in schools

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.

WHEN TO OBTAIN APPROVAL

Definition of human subjects research

Click here for definitions.

Exempt research

There are six categories of research that may be exempt from the reguirements of the Federal Policy for the Protection of Human Subjects (45 CFR 46).  If research is found to be exempt, you must still submit a protocol application through ORahs.  Although research that qualifies for exempt status is not subject to the federal regulations for human subjects research, investigators still have a responsibility to protect the rights and welfare of their subjects.

Use of existing data

Projects that use an existing data set, which includes identifiable data gathered in earlier research projects, may require a new IRB protocol for review. Secondary analysis of existing data may include the review of medical records, student records, data collected from previous studies, audio/video recordings, etc. that were initially collected for another purpose. In order to be existing, the information must be "on the shelf" (i.e., it has already been collected) at the time that the current research is proposed.

Though such projects do not involve interactions or interventions with humans, they may still require IRB review, since the definition of "human subject" at 45 CFR 46.102(f) includes living individuals about whom an investigator obtains identifiable private information for research purposes.

In addition to being identifiable, the existing data must include "private information" in order to constitute research involving human subjects. Private information is defined as information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical or school record). Information that contains identifiers and can be accessed freely by the public (without special permission or application) is not "private" and the research therefore does not therefore involve human subjects. For example, a study involving only analysis of the published salaries and benefits of public university presidents would not need IRB review since this information is not private.

Data analysis activities that meet the definition of research with human subjects may qualify for an exemption or require expedited or even full committee review. Any such project must receive IRB approval or a determination of exemption before the investigator accesses the data.

Oral histories

The UCLA Office for Protection of Research Subjects (OPRS) contacted Dr. Michael Carome, HHS-OHRP Associate Director for Regulatory Affairs, to seek his guidance concerning the matter of whether qualitative research utilizing open-ended interviews, especially activities performed by oral historians and other social scientists, would require IRB review. The full outline of this discussion is available here.

In short, Dr. Carome clarified that the decision concerning whether activities that consist of open-ended qualitative type interviews (such as oral history projects or ethnographies) require IRB review hinges upon whether the activity meets the above definition of research—specifically, whether the activity is an "investigation" and “designed to contribute to generalizable knowledge.” The purpose of these activities is often to create a record of specific historical events and, as such, is not to generalize findings to a broader population or group. However, activities involving similar characteristics may be “designed to contribute to generalizable knowledge.” Below are examples of qualitative interviews that are considered to be research and examples of qualitative interviews that are not considered to be research.

Examples:

An oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape is not intended to prove a hypothesis, inform policy, or draw conclusions. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories. Open-ended interviews that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings would not constitute research.

Open-ended interviews are conducted with surviving Gulf War veterans to document their experiences in order to draw conclusions about those experiences, inform policy, and generalize findings. This would constitute research.

Open-ended interviews are conducted with surviving Negro Baseball League players in order to create an archive for others to analyze and generalize findings in the future. Since the intent of the archive is to create a repository of information for others to use in research, the creation of such an archive would constitute research.

Approval process

See our Review Process webpage.

Conducting research at another institution

1. What if I will be engaged in human subjects research at another UC campus?

PIs conducting human subjects research at another UC campus must either get HSC approval from UCSB or have an active reliance (formerly NOITR or Notice of Intent to Rely on One UC IRB) under the UC MOU. Please visit our information page on the UC MOU and the UC Reliance Registry.

2. What if I will be engaged in human subjects research at a non-UC institution?

PIs conducting human subjects research at a non-UC institution must either get HSC approval from UCSB or enter into an Institutional Authorization Agreement (IAA), which allows UCSB to rely on the other institution’s IRB review. Please contact HSC@research.ucsb.edu for additional information.

3. What if I am an unaffiliated researcher wanting to recruit subjects from the UCSB community?

If you are a non-UCSB researcher who wishes to recruit from the UCSB community but are not collaborating with a UCSB PI, then UCSB is not engaged in the research and no IRB review is needed. The non-UCSB researcher is responsible for abiding by the policies of his/her home institution’s IRB and for obtaining appropriate permission to recruit from UCSB groups and organizations.

4. What if I am collaborating on human subjects research at UCSB?

Non-UCSB researchers who wish to collaborate on research at UCSB must have an eligible UCSB principal investigator to serve as the sponsor who will submit a protocol to UCSB’s IRB for approval. Non-UCSB researchers are responsible for obtaining IRB approval from their home institutions.

Obtaining documentation that research does not include human subjects research

If your proposed research does not meet the requirements for human subjects research and you would like to receive documentation for your files, email your request for confirmation to the HSC Coordinator at hsc@research.ucsb.edu with a brief description of your research purpose, procedures, and data collection processes.

ORAHS PROTOCOL TIPS

Using ORahs

Go to the ORahs Tutorial webpage to access how-to instructions and the Orahs User Manual on the ORahs e-submission portal.

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