Contents

  1. What is research?
  2. What is a human subject?
  3. What is an IRB?
  4. What is CPHS?
  5. What is OPHS?
  6. What is OHRP?
  7. What regulations do CPHS and OPHS follow when reviewing human subjects research?
  8. What is a clinical trial?
  9. What is informed consent?
  10. I was not asked to give informed consent and found out later that I was part of a research study conducted by a UCB researcher. How is this possible?
  11. I’ve been approached to participate in a research project at UC Berkeley. How do I know the study has received CPHS approval?
  12. How do I decide whether or not to participate in a research project?
  13. What questions should I ask the researcher?
  14. What are my rights as a research subject?
  15. Can I change my mind after I’ve agreed to participate?
  16. Will other people know about my participation in the research study?
  17. What if I have questions about the study after I’ve agreed to participate?
  18. What if I have questions or concerns about my treatment as a research subject?
  19. Where can I find more information on research participation?

1. What is research?

You’re probably already familiar with the term “research.”  Webster’s dictionary defines research as a “careful study that is done to find and report new knowledge about something.”

Research in the context of human subjects research (HSR), however, has a very specific definition. Federal regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic investigation means a study or examination involving a methodical procedure or plan.

Generalizable knowledge means conclusions, facts, or principles derived from particulars (individual subjects, medical records, etc.) that are applicable to or affect a whole category (members of a class, kind, or group, a field of knowledge, etc.) and enhance scientific or academic understanding.

Design refers to the purpose of the investigation.

Some investigations are exploratory or are intended to train students and are not designed to produce generalizable knowledge. These activities do not require review by an IRB.


2. What is a human subject?

Human Subject means a living individual about whom a researcher conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (e.g., exposing a subject to a stimulus in order to influence the subject’s response to another stimulus).

Interaction includes communication or interpersonal contact between investigator and subject (e.g., an interview).

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which 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).


3. What is an IRB?

An Institutional Review Board (IRB) is a committee charged with reviewing and approving the ethical involvement of human subjects in all research projects related to that institution, to ensure that the safety and welfare of the subjects are protected. The IRB also serves as an institutional compliance committee and is responsible for reviewing reported instances of regulatory noncompliance related to human subjects in research.


4. What is CPHS?

At UC Berkeley, the IRB (see above) is called Committee for Protection of Human Subjects (CPHS). UC Berkeley has two IRB panels, CPHS-1 and CPHS-2. Both are comprised of faculty, staff, and community members with expertise in areas of research related to the projects they review.


5. What is OPHS?

The Office for Protection of Human Subjects (OPHS) is the administrative office at UCB that supports the Committee for Protection of Human Subjects (CPHS) by coordinating the review of research, keeping abreast of changing policies, rules and regulations, and working with CPHS and researchers to address research protocol and compliance issues.


6. What is OHRP?

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well-being of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.


7. What regulations do CPHS/OPHS follow when reviewing human subjects research?

Federal HHS regulations 45 CFR 46 and Food and Drug Administration regulations 21 CFR 50 govern human subjects research.


8. What is a clinical trial?

A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions, usually involving a drug or device and possibly including a placebo or other control, to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Clinical trials as defined by the Food and Drug Administration (FDA) must be posted on clinicaltrials.gov.

Note that, with no medical school at UC Berkeley, a very small number of clinical trials occur here.


9. What is informed consent?

Informed consent is defined as a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. When researchers obtain informed consent, subjects should not be asked to waive any of their legal rights or release researchers from liability for negligence.

If you have been approached to participate in a research project, you will likely be asked to provide informed consent to participate. You should be given a copy of the consent form to take with you in case you have questions later. In certain circumstances, informed consent may be waived as allowed by federal regulations (see FAQ #10 below).

Generally, informed consent should include a description of the following:

  • The purpose of the research.
  • Study procedures, including duration of each procedure and total participation time.
  • Risks involved in participating and the steps taken to minimize these risks.
  • Potential benefits to you and/or to society as a whole.
  • The extent to which confidentiality of your research records will be maintained.
  • Whether or not you will be compensated for your time.
  • Whom to contact should you have questions about the research or about your rights as a participant.
  • The voluntary nature of participation (i.e., your freedom to decline without any negative consequences).
  • Request for your signature. Investigators often have the option of waiving this requirement. In this case, you may be asked for verbal consent or electronic consent.

Note that there are different levels of IRB review based on level of potential risk from categories listed in the regulations. Full board and expedited applications undergo CPHS/OPHS review and approval. Studies that qualify for exempt review undergo an exempt determination review. Informed consent and recruitment materials are not reviewed by CPHS/OPHS at the exempt level.


10. I was not asked to give informed consent and found out later that I was part of a research study conducted by a UCB researcher. How is this possible?

Informed consent may be waived by CPHS/OPHS under certain circumstances. In these circumstances, subjects do not receive an informed consent document. A researcher must demonstrate that their research meets specific criteria (allowed by 45 CFR 46) in order to waive informed consent.

It is possible that the study you participated in qualified for a waiver of consent. Please contact OPHS to determine whether or not the study you participated in had CPHS approval (see FAQ #11 below).


11. I’ve been approached to participate in a research project at UC Berkeley. How do I know the study has received CPHS approval?

All research reviewed by CPHS must be submitted through UC Berkeley’s online submission system, eProtocol. If a project has been reviewed by CPHS/OPHS, a “CPHS #” should appear in the lower left footer or at the top of the informed consent document. In addition, CPHS/OPHS contact information should be referenced in the body of the consent form.

In addition, you can ask the researcher if the project has received CPHS approval, or contact OPHS directly to be sure the research has been reviewed and approved:

Office for Protection of Human Subjects
University of California, Berkeley
Telephone: (510) 642-7461
Email: subjects@berkeley.edu


12. How do I decide whether or not to participate in a research project?

Participation is a personal decision. As a potential subject, you are encouraged to weigh the risks and benefits of participation and to ask the researcher any questions you may have about the study. Please keep in mind that research participation is always voluntary and never required. As a potential research subject, you should never feel pressured to participate.


13. What questions should I ask the researcher?

While the informed consent document should include information such as a description of study procedures, duration of participation, confidentiality measures, etc., there may be some information not included that you would find helpful. These questions might include the following:

  1. Who has reviewed and approved the study?
  2. If I change my mind, how do I end my participation in the study?
  3. What will happen to me at the end of the study?
  4. Will I be told the results of the study?
  5. Will I be reimbursed for any expenses?

If any aspect of the research is unclear or confusing, be sure to ask the researcher for clarification. Keep in mind,there are no “stupid” questions! As the research participant, you should feel fully informed and comfortable with your decision to participate.


14. What are my rights as a research subject?

Participation in a research study is always completely voluntary. You are free to decline to participate for any reason. You may also stop participating at any time. Even after consenting to participate, you can stop. Should you decide to decline or stop participating, this decision should in no way influence any services or benefits to which you are otherwise entitled. If you are taking medication as part of the research, please discuss any adverse effects of early discontinuation with the researchers. You should never feel pressured to participate in research and if you do, please contact OPHS at 510-642-7461 or at subjects@berkeley.edu.

If you are participating in a biomedical study, you should also refer to the Medical Research Subjects’ Bill of Rights.


15. Can I change my mind after I’ve agreed to participate?

Of course! You can decide to stop participating at any time without penalty or loss of benefits to which you are otherwise entitled.


16. Will other people know about my participation in the research study?

The informed consent document should include a section on confidentiality. This section should describe who will have access to your data and how your data will be used in the future. Identifiable data should not be released unless the researcher has asked for specific permission for this. If audio and/or video-recording will be done, you may be asked to fill out and sign a Media Records Release form which asks for specific permission regarding various uses of these recordings. Individually identifiable information should not be released to third parties without your consent.

If you have any questions about the study’s confidentiality measures and/or how your data will be used, please ask the researcher directly.


17. What if I have questions about the study after I’ve agreed to participate?

At the start of the study, you should be given the researcher’s contact information. This information is generally included in the informed consent document. If you are not able to get a hold of the researcher, have misplaced the researcher’s contact information, or did not receive the researcher’s contact information at the start of the study, please contact OPHS.

If you have questions or concerns about your treatment as a research subject, please see FAQ #18 below.


18. What if I have questions or concerns about my treatment as a research subject?

If you have any questions or concerns about your rights and treatment as a research subject, you are welcome to contact the office of UC Berkeley’s Committee for the Protection of Human Subjects, at 510-642-7461 or subjects@berkeley.edu. We are happy to help!


19. Where can I find more information on research participation?

Go to the OHRP About Research Participation website to watch videos, view questions to ask researchers, and find additional resources related to research participation