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THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Social and Behavioral Research (February 2005)

 Brief Overview
 Risk Level Determines Level of CHR Review and Type of Application
    • More Than Minimal Risk Needs Full Committee Review
    • Minimal Risk Needs Expedited Review
    • Research on Educational Strategies, Public Officials, Public Behavior, or De-Identified or Public Data May Be Exempt
Identification and Recruitment of Prospective Subjects
    • Contact Methods
    • Privacy Issues
    • Avoiding Revealing Subject Information to Third Parties
    • Using Medical and Other Health Care Records
    • Minors and Other Vulnerable Populations
    • Intrusive or Repetitive Contact Methods
Consent
    • Waiving Signed Consent
    • Deception and Withholding Information
    • Sample Consent
Risks to Subjects
    • Loss of Confidentiality
    • Legal Risks
           o Mandatory Reporting
           o Subpoenas of Research Information
           o Certificates of Confidentiality
    • Psychological Harms
    • Physical Harms
           o Domestic Violence and Abuse
           o Clinical Procedures
    • Social Pressure
Research Methods and Situations
    • Questionnaires/Surveys
    • Audio and Video Recording
    • Focus Groups
    • Participant Observation
    • Cyberspace
Hints for Obtaining and Maintaining CHR Approval
Resources/Links

Brief Overview

Requirement for CHR Review: At UCSF, all research involving contact with human research subjects or identifiable information about people must be reviewed or formally exempted by the Committee on Human Research. Because almost all social and behavioral research at UCSF involves sensitive information about the research participants’ health or behavior, UCSF does not exempt survey and interview research from the requirement for CHR review (as would be allowed by 45 CFR 46.101.b.ii). The type of review required and the corresponding application form are generally determined by the level of risks for the study participants.

Privacy and Confidentiality: Most CHR concerns that arise about social and behavioral research have to do with issues of privacy and confidentiality.

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The information needed to identify and contact prospective research participants is often information that people consider private. Researchers need to approach prospective participants with sensitivity and respect.

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The most commonly perceived risks of social and behavior research are the consequences of breaches of confidentiality. Research may gather information about research participants that, if it became known to others, could damage the participants’ reputation, employability, or insurability, or could place them in legal jeopardy. The CHR evaluates how well any such risks are managed in proposed research.

Consent: The CHR expects that most studies will be conducted with the fully informed, individual consent of each participant. Usually the consent is documented with a signed consent form that has been prepared according to CHR standards. Exceptions from these expectations need to be explained and justified in the CHR application.

Professional Codes of Ethics: Guidelines for research ethics have been prepared by professional organizations for disciplines like anthropology, psychology, and sociology. These professional guidelines provide more detailed guidance than can be included here. A brief list of resources is provided at the end of this guideline.

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Risk Level Determines Level of CHR Review and Type of Application

Federal regulations categorize level of research in relation to “minimal risk.”

Minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102.i).

More Than Minimal Risk Needs Full Committee Review

Any research involving more than minimal risk to subjects needs to be reviewed by the full CHR and should be submitted using the Full Committee Review Application form. At UCSF the following factors most often contribute to greater-than-minimal risks in social and behavioral studies:

•	Sensitive topics/questions: If researchers record subjects’ identities and if the information gathered in the research could place subjects at legal risk or damage their financial standing, employability, insurability, reputation, or be stigmatizing, then the research should be submitted for full committee review. Topics that frequently require full committee review include sexual activities and preferences, illegal drug use, abusive or self-destructive behavior, and other illegal activities. The exact federal requirement says full committee review is needed if identification of the subjects and/or their response would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. (Categories of Research That May be Reviewed… (see Links/Resources [add link to section at end] for the full reference)) In practice, if sensitive questions are asked and identities are recorded, the research should be submitted for full committee review so that the full CHR has an opportunity to determine whether there are sufficient protections to ensure that risks to subjects are no greater than minimal.
•	Sensitive or Vulnerable Subject Populations: In some otherwise harmless research, subjects may be placed at risk because of their vulnerable situations or conditions. Examples include prisoners; parolees; depressed or distressed persons; minors; battered women, children or elders; people with chronic illness, very debilitating medical conditions, degenerative diseases, or other physical, mental, or emotional disabilities; and the dying. While some research involving vulnerable groups is eligible for expedited review (especially if identities are not collected), often the subjects’ vulnerability raises their risks above the minimal risk standard.
•	Manipulation of Subjects’ Emotions: Research that manipulates subjects’ emotions could place them at risk for psychological harm, especially if the subjects are already vulnerable due to personal situations, conditions, or events. For example, studies applying stress to persons already suffering from post-traumatic stress disorder may carry more than minimal risks. Any study involving more than minimal risk should be submitted for full committee review.

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Minimal Risk Needs Expedited Review

Most social and behavioral research may be submitted for “expedited” review using the Expedited Review Application form. Specifically, federal guidance allows expedited review for “Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies” (See Expedited Review Categories). Most participant observation also can receive expedited review. However,

•	If the research involves more than minimal risk, and especially if it involves sensitive questions and topics (see previous section) full committee review is required.
•	“Expedited” review may not be faster than full committee review. Expedited review means that the study will be reviewed by a subcommittee rather than the full committee. The subcommittee may have as many concerns and may request as many changes as the full committee would.

Research on Educational Strategies, Public Officials, Public Behavior, or Using De-Identified or Public Data May Be Exempt

Some types of human research studies are exempted from the requirement for CHR review.

•	Certification Required: At UCSF, as at most major research institutions, the CHR must formally certify that a study is exempt. Researchers may not make this determination for their own research. Researchers who believe their study is exempt should submit one of the two types of Exempt Certification Application.
•	Categories of Exempt Research: Federal regulations specify what categories of human research are exempt from regular CHR review. Explanation of the categories and UCSF certification procedure can be found at Exempt Certification Application. Because almost all social and behavioral research at UCSF involves sensitive information about the research participants’ health or behavior, UCSF does not exempt survey and interview research from the requirement for CHR review (as would be allowed by 45 CFR 46.101.b.ii). Social and behavioral research that often receives exempt certification at UCSF includes 1. Research in commonly accepted educational settings, on educational methods, techniques, and strategies. 2. Observations of public behavior, as long as no identifiers are recorded. 3. Some survey, interview, or observation studies where the only subjects are elected or appointed public officials or candidates for public office. 4. Study of existing data, documents, and records if the sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

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Identification and Recruitment of Prospective Subjects

Contact Methods: The CHR has developed detailed recommendations for how to identify and approach individuals about participation in research. See UCSF Subject Recruitment Guidelines. A few issues that commonly appear in social and behavioral research are mentioned below.

Privacy Issues: When research is about medical matters or behavior that most people consider private, prospective research participants may be surprised or angry if they learn that unknown researchers have obtained their identity and contact information. Subjects may be particularly upset if researchers have obtained presumably private information about diagnoses like cancer, HIV infections, or mental illness. Prudent researchers will carefully consider how best to approach subjects in such situations. For patients, it may be best to have the first mention of the study come from a care provider already known to the prospective participant.

Avoiding Revealing Subject Information to Third Parties: Researchers should avoid leaving phone messages or sending postcards that may reveal information about a prospective research participant to third parties. Sometimes family members and housemates have not been told details of a prospective subject’s life and diagnoses, and careless phone calls or correspondence may disclose information the subject preferred to keep private. For particularly sensitive topics—for example, the study of abused women or elders—even sealed letters may be opened by others and cause problems for prospective subjects. Researchers have a responsibility to minimize risks from these causes.

Using Medical and Other Health Care Records: Researchers who do not have a clinical relationship with their prospective subjects often wish to obtain names of patients with particular conditions from health care providers. In addition to the subjects’ concerns about privacy, there are legal restrictions on what information can be shared.

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HIPAA Restrictions: Because of the Health Insurance Portability and Accountability Act (HIPAA) health care providers generally are prohibited from providing researchers with identifying information and information about diagnoses and treatments unless (1) patients first authorize the release of the information or (2) a Privacy Board (the CHR at UCSF) approves a waiver of authorization. See UCSF Subject Recruitment Guidelines and HIPAA and Research for additional information.

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Information from Multiple Institutions: Researchers seeking access to patients from multiple institutions must meet the HIPAA requirements of each institution that supplies Protected Health Information. Although HIPAA allows an institution to accept authorization forms and even waivers of authorization from any appropriate constituted Privacy Board (like the CHR), many institutions require review by their own Privacy Board and use of their own forms, as there are financial penalties for inappropriate release of information. See HIPAA and Research for more information.

Minors and Other Vulnerable Populations: Researchers considering enrolling minors, the cognitively impaired, prisoners, or other particularly vulnerable populations should be familiar with CHR guidelines regarding Vulnerable Populations. The guideline on minors in particular includes discussions of enrolling minors in educational and health care settings that are frequently used in social and behavioral research.

Intrusive or Repetitive Contact Methods: Social and behavioral researchers sometimes want to send multiple letters or to make repeated phone calls in order to assure participation by a representative sample of their targeted subject population. Because prospective participants have an absolute right to say no to participation in research, the CHR is reluctant to approve recruitment methods that continue to recontact until the person actively and forcefully refuses participation. For example, the CHR has been reluctant to approve some telephone contact approaches that continued calling after a prospective subject gave a “soft” refusal like saying “I don’t have time for this.” Researchers planning to use contact methods that subjects may consider intrusive should explain why the intrusiveness is necessary and should provide scripts to be used in all contact attempts.

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Consent

The CHR has extensive guidelines regarding informed consent. See Recruitment and Consent Process. A few issues particularly appear in social and behavioral research :

Waiving Signed Consent: In social and behavioral research it is sometimes appropriate to forego obtaining a consenting participant’s signature, although it is almost always required that the participant give verbal consent. A waiver of signed consent can only be approved if certain criteria are met; the CHR applications and the guidelines mentioned above will lead a researcher through those criteria. The following special situations appear frequently in CHR applications:

•	No Need to Record Subject Identities: If subject identities do not need to be recorded for research purposes, and if the main risk to subjects would be from a breach of confidentiality, the CHR can waive obtaining signed consent. Verbal consent should still be obtained. (45 CFR 46.117.c)
•	Participant Observation: Consent is not required for observation of behavior in public situations, as long as no identities are recorded. In situations in which participants reasonably expect their behavior and conversation to be private (as in clinics, classrooms, and meetings that are not open to the public), participant observers usually are expected to make their presence as a researcher known, but signed consent is usually waived with the justifications that it is not practicable to obtain signed consent from all involved and that the risks are minimal. Most studies provide for obtaining signed consent from participants in more formal one-on-one or small group interviews.
•	Telephone Consent: The CHR expects that participants in telephone surveys will be provided the same types of information that are included in written consent forms. Before any substantive survey questions are asked, prospective participants should be asked explicitly whether they are willing to participate. A script for the consent process should be included with the CHR application.

Deception and Withholding Information: The CHR may approve a consent process and a written consent form that withhold some key information about a study or even actively mislead prospective subjects. For example, it may be necessary that subjects not be told the true purpose of a study, because knowing the purpose might change their reactions.

•	Criteria for Approval: The CHR can approve the deception only if the study meets specific criteria laid out in 45 CFR 46.116.d. These are the same criteria as for waiving all consent; see Consent Guidelines for more information. The key criteria are that it must be impracticable to carry out the study without the deception, and the deception must involve minimal risks to participants.
•	Debriefing: The CHR generally requires that participants be debriefed after their participation and be given a full explanation of the reasons for the deception.
•	Prior Disclosure: In some studies it may be possible to explain during the original consent process that some information is being withheld. However, researchers have successfully argued that in many studies even vague references to hidden purposes will affect subjects’ behavior and make the study impracticable.

Sample Consent: A new sample consent form in question/answer format for use in social and behavioral studies is currently being prepared.

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Risks to Subjects

Less experienced researchers may fail to consider all the risks that can arise in social and behavioral research. As discussed above, if the risks are more than minimal, the study must be reviewed by the full CHR, while studies with minimal risks are usually eligible for expedited review. The following risks frequently are found in research reviewed by the CHR. A good application will explain how any such risks will be managed and minimized. These risks also should be described in the consent documents for prospective participants.

•	Loss of Confidentiality: Researchers frequently gather information that, if it became known outside of the study context, could harm participants by damaging their reputations, employability, or insurability. Other information could put subjects in legal jeopardy. Researchers should minimize such risks by asking for the minimal amount of information needed for study purposes and by protecting the information that is gathered.
•	Legal Risks
	o	Mandatory Reporting: Many professionals are subject to legal requirements to report situations like the intent to harm oneself or others. The CHR generally expects that professionals conducting research will comply with their professional reporting requirements; the legal requirements to do so when acting as a researcher may not always be clear, but the CHR usually still sees an ethical obligation. Similarly, if a social or behavioral study includes testing for reportable medical conditions, such as certain sexually transmitted diseases, the medical reporting requirements remain in effect.Consent forms should warn subjects of reporting obligations in any study in which reportable information is likely to be evoked. There is no need to warn subjects about reporting requirements if the study design is not likely to evoke reportable information.
	o	Subpoenas of Research Information: Unlike medical records, research records have no automatic protection against many legal subpoenas. This means that without additional protection, anything a research participant says or otherwise reveals in the course of study participation could potentially be used against the participant in a criminal or civil legal action. Consent forms should warn subjects of the risk of subpoenas in any study which is designed to evoke information that has likely use in legal actions, such as admissions of illegal activities. Researchers receiving a subpoena should consult with legal counsel.
	o	Certificates of Confidentiality: For studies which gather information that might be used against participants in legal actions, the federal government can issue a Certificate of Confidentiality that protects researchers from being compelled by a subpoena to reveal research-related information. The Certificates can be granted regardless of the source of funding for the research. See Consent Process—Certificate of Confidentiality for additional information.
•	Psychological Harms: CHR reviewers frequently express concerns that research participants who are asked about emotional situations or who are deliberately subjected to stress will be harmed emotionally to the extent that they become less functional, need to seek professional help, and even become suicidal. Applications should include plans to handle any such problems that may arise.
•	Physical Harms: Although physical harm seems unlikely in social and behavioral research, the CHR has seen studies with physical risks:
	o	Domestic Violence and Abuse: Participants in studies may be at risk if an abuser learns about their participation. Abusers may feel threatened and increase abuse if they believe study participation involves revealing or discussing abuse. Even contacting a prospective participant by phone, letter, or in person if the abuser is present may raise an abuser’s suspicions.
	o	Clinical Procedures: Social and behavioral research sometimes includes medical aspects, such as blood draws, administration of medications, or physical exercise or stress. The level of review required and the type of application to be submitted should be determined by the most risky procedure being performed.
•	Social Pressure: Various kinds of social pressure can be placed on people who participate or fail to participate in a study. For example, in some communities or classrooms, people who talk to researchers might be considered untrustworthy informers, while in other situations non-participants might be seen as failing to contribute to a potential good for the group.

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Research Methods and Situations

The research methods and situations listed below appear repeatedly in CHR applications. The CHR has developed expectations for how research will be conducted in these situations, and researchers sometimes omit information the CHR needs. The expectations are not rigid requirements, but researchers who need to go against the expectations should take care to explain their reasons.

Questionnaires/Surveys

•	Include with Application: All questionnaires, surveys, lists of topics to be discussed and similar documents should be included in the CHR application, unless they are standard instruments commonly known in the researchers’ field, in which case the instruments need only be identified in the application.
	o	If the questionnaires/surveys are not ready when the CHR application is prepared, the investigator should provide the best draft or outline available and should assure the CHR that the final version will be submitted for approval before it is used.
•	Submit Changes for CHR Approval Before Implementing: No revisions of any documents originally approved by the CHR should be implemented until the revision has been submitted to and approved by the CHR. The criteria for when modifications must receive prior review are much tighter than for grants.
•	Telephone Consent: The CHR expects that participants in telephone surveys will be provided the same types of information that are included in written consent forms. Before any substantive survey questions are asked, prospective participants should be asked explicitly whether they are willing to participate. A script for the consent process should be included with the CHR application.
•	Implied Consent: When a questionnaire has been mailed to prospective participants or is made available in an office or clinic, it may be appropriate to tell subjects that by returning a completed questionnaire they are consenting to be included in the research. Use of such implied consent is particularly appropriate where subjects’ identities are not otherwise recorded. See the discussion of waiving signed consent above. The CHR usually will ask that the questionnaire include an introduction or be accompanied by a separate information sheet or cover letter that contains all the information that would be included in a standard consent form.

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Any recording that will be done should be described in the consent form as one of the study procedures. The consent form should also say how the recordings will be used and how long they will be kept before they are erased or destroyed. It is acceptable to say that the recordings will be kept indefinitely. If research recordings may also be used in teaching, presentations, or for other purposes, researchers should consult the UCSF News Office about obtaining releases for non-research use.

Focus Groups

It is common practice to ask participants in focus groups to use only their first names and to not discuss what was said in the group with other people outside the group. Because these requests cannot guarantee that participants will behave as asked, wording like the following should be included in the consent form’s discussion of confidentiality:

Participant Observation

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Cyberspace

Ethical guidelines for research on the web are still being debated. Researchers should carefully consider ethical issues and explain their thinking in their CHR applications. A few general suggestions have emerged.

•	Protecting Information: Researchers using the internet should be aware of potential security breaches, should provide increased security as they gather increasingly sensitive information, and should use a consent process that frankly warns potential research subjects of the security risks.
•	CHR Review: CHR applications should include printouts of any web pages and documents that will be used in a research study, including pages or messages used to announce a study and obtain consent, and any on-line questionnaires.
•	Revealing the Researcher’s Presence: Just as researchers who observe public behavior are not necessarily expected to announce their presence and obtain informed consent as long as the researchers do not record identities of the persons observed, it may be acceptable for researchers who are merely observing interactions on public websites to refrain from identifying themselves. However, researchers who interact with others on a website, or who observe in situations that might not be considered fully public (such as a chat room that requires registration, has membership criteria, or has rules about research) probably have an obligation to announce their presence, to withdraw from situations in which they are not welcome, and to obtain fully informed consent from anyone with whom they will have extended interaction.

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Hints for Obtaining and Maintaining CHR Approval

Make Creative Use of the Applications’ Categories and Questions

The CHR applications are designed to evoke useful information about a wide variety of studies. Inevitably some of the questions will not be relevant to all studies, and some human subject protection issues that don’t seem to fit anywhere on the application will need to be explained. What is most important is to be sure that all relevant issues are discussed somewhere in the application. For example, activities like completing questionnaires and participating in focus groups should be described as study procedures, even though some people think of a “procedure” as a surgical treatment.

On the other hand, many of the human research protection issues raised by social and behavioral health care research will necessarily be addressed in the course of completing a CHR application. For example, special sections of the applications address use of medical information to identify, contact, and recruit prospective participants.

The application is supported with linked guidance and includes supplements for addressing additional issues.

Use Non-Technical Language in the Application
Social and behavioral researchers applying to the CHR may find it to their advantage to use everyday language to explain their research methods and designs. Many members of the CHR are not familiar with social and behavioral research methods, and nonscientist CHR members must attend every CHR meeting. The CHR most often reviews medical research, and its expertise is weighted toward review of clinical studies. Although every attempt is made to assign reviewers with appropriate expertise, applications presented in non-technical language are more likely to make a favorable impression on all reviewers.

Use Non-Technical Language in the Consent Documents
The professional vocabulary of social and behavioral scientists can be as hard for prospective subjects to understand as medical terminology. Subjects told a study will use an “instrument” may be more likely to think of a sharp, shiny object or guitar than a questionnaire. Likewise, words like “demographics” are not in common use by most prospective subject groups.

Address Any Major Ethical Issues in a Cover Letter
Applicants can build trust with reviewers by addressing potentially controversial issues in a cover letter. For example, if a study proposes aggressive telephone recruitment or enrollment of minors who come to a reproductive health clinic without consulting their parents, acknowledging the potential difficulties and justifying the proposed methods will allow reviewers to efficiently consider the serious issues, rather than discovering the issues here and there in the application and piecing together the researcher’s intention.

Submit Changes for CHR Approval Before Implementing

No revisions of any documents originally approved by the CHR should be implemented until the revision has been submitted to and approved by the CHR. The criteria for when modifications must receive prior review are much tighter than for grants.

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Resources/Links

45 CFR 46: Basic regulation (“Common Rule”) setting out review and consent requirements.

Expedited Review Categories: UCSF guidance on what studies can be reviewed using expedited review procedures.

Categories of Research that May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure: Federal statement.

General Instructions: Exempt Certification Application: UCSF guidance on what studies may be exempt for CHR review, but still require formal certification of exempt status.

American Anthropological Association ethics page: Includes links to other professional associations’ ethics pages.

American Psychological Association Ethics Home Page

American Sociological Association Code of Ethics