If your program intends to conduct a needs assessment or program evaluation, you must be aware of federal regulations that protect the privacy and confidentiality of persons involved in research (i.e., human subjects). This guide provides basic information about these federal regulations and explains how they pertain to your needs assessment or program evaluation.

For more information on conducting needs assessments or program evaluations, see Guide to Conducting a Needs Assessment and Guide to Performance Measurement and Program Evaluation.

About This Series

OVC's series of four technical assistance guides are tools for victim service providers and allied professionals, like you, who want or need to conduct program evaluations or needs assessments. The guides will help you make critical decisions and ensure that you make the best use of your funds to promote the goals and purposes of your program. These four guides were originally developed for OVC and the grantees who received funding to serve victims of human trafficking. The guides have since been adapted for use by other grantees and organizations that provide programs for victims of any type of crime.

Guide to Performance Measurement and Program Evaluation

Prepare goals and objectives, identify performance measures and program outcomes, identify evaluation questions, create a program planning or logic model, select evaluation design, decide on data collection methods, analyze and present data, use evaluation data

Guide to Conducting a Needs Assessment

Design your needs assessment, determine data collection methods, analyze and present data, use the needs assessment results for planning

Guide to Hiring a Local Evaluator

Find a local evaluator, determine questions to ask and what to look for, decide on what to include in job descriptions, find out how to work effectively with evaluators

Guide to Protecting Human Subjects

Read about the law related to protecting human subjects, learn about key issues you need to address when conducting research that involves human subjects, learn about Institutional Review Boards and how to involve them in your research

About This Guide

Overview

This guide addresses four main questions:

1. Why do human subjects need to be protected and what federal regulations are in place to protect them?
2. What activities constitute research that may be subject to federal law?
3. What is an Institutional Review Board and how does it work?
4. What forms can be used to protect the privacy and confidentiality of human subjects?

This guide concludes with a discussion of other important considerations to keep in mind when conducting research activities that involve human subjects. It also includes a resources section with a list of additional resources available to assist you in this endeavor and a glossary of key terms and appendixes that include sample documents.

How To Use the Guide

You may use this guide along with the other guides in this series to help you develop and conduct a needs assessment or program evaluation:

• Guide to Performance Measurement and Program Evaluation
• Guide to Conducting a Needs Assessment
• Guide to Hiring a Local Evaluator
  
  

Why Protect Human Subjects?

In social science research, a human subject is a person from whom or about whom you collect information during your assessment or evaluation. For example, a human subject could be a person who fills out a questionnaire or survey, participates in a focus group, or whom you interview. These persons could be service providers, clients, community members, or government representatives.

Research activities involving human subjects raise ethical concerns that should be carefully considered. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addresses these concerns in the Belmont Report, published in 1979. This report lays out the basic ethical principles of research activities involving human subjects:

• Respect for persons. Individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
• Beneficence. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm but also by making efforts to secure their well-being to maximize possible benefits and minimize possible harms that may occur.
• Justice. The selection of research subjects needs to be scrutinized to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability rather than for reasons directly related to the problem being studied.

Federal regulations regarding the protection of human subjects in research activities are based on these guiding principles. For the U.S. Department of Justice, these regulations can be found in Title 28 of the Code of Federal Regulations (CFR) in Part 46, “Protection of Human Subjects.” The Office of Justice Programs also has regulations related to privacy and confidentiality of private information, which can be found in Title 28 of the CFR in Part 22, “Protection of Confidentiality of Identifiable Research.” Copies of these regulations are included in appendix A (PDF 92.1 KB). In brief—

• Part 46, “Protection of Human Subjects,” states in part that human subjects of federally supported research and statistical activities must be protected against undue and unnecessary risks. These regulations, among other things, govern the establishment and operation of Institutional Review Boards (IRBs) to review research designs that involve human subjects. In general, federal funds cannot be used for research involving human subjects unless the research team first seeks IRB approval. However, the regulations include some categories of research that are exempt from this requirement.
• Part 22, “Protection of Confidentiality of Identifiable Research,” states in part that, if research activities involve the collection, analysis, or use of information identifiable to a private person, these research activities must maintain the confidentiality of this information. Identifiable information can only be used, disclosed, or revealed as authorized.
  
  Identifiable information is information that is labeled by either a name or other personal identifiers or that can be reasonably interpreted, by virtue of sample size or other factors, as referring to a particular person. This could include Social Security numbers and the names of service providers and clients.

Which Activities Are Affected?

Today, most federal and private granting institutions require certain activities that may constitute research and are subject to federal law. For instance, programs that do not have any expertise in research and evaluation, such as those that provide direct services, may wonder if the activities in which they are participating constitute research.

Two common types of activities that programs may conduct and that may be considered research are needs assessments and program evaluations:

• Needs assessment. A systematic effort to gather information from various sources that will help identify the needs of victims and the resources that are available to help them. For more information on conducting a needs assessment, please refer to the Guide to Conducting a Needs Assessment included in this series.
• Program evaluation. The systematic process of obtaining credible information to be used to assess and improve a program. Additional information on program evaluation can be found in the Guide to Performance Measurement and Program Evaluation included in this series.

Conducting a needs assessment or program evaluation is not always research, but may at times be considered research and may be subject to federal laws protecting human subjects. To determine whether your project activities constitute research, consult with an expert in program evaluation or review Title 48 of the CFR, “Federal Acquisition Regulations System.”

If you determine that your activities constitute research and involve human subjects who need to be protected, then you most likely will need to go through the Institutional Review Board (IRB) process. The remainder of this guide acquaints you with the general workings of the IRB and the forms that are commonly used to ensure that subjects’ privacy and confidentiality are protected.

Who Approves Affected Activities?

If you determine that your research activities involve human subjects who need to be protected, you may have to seek approval of these activities from a reviewing board known as an Institutional Review Board (IRB). An IRB is an administrative body established pursuant to federal regulations to review research activities involving human subjects. An IRB consists of at least five members with diverse backgrounds, expertise, and experience. It has the authority to approve, require modifications to, or disapprove research activities involving human subjects that fall within its jurisdiction.

The role of an IRB is to ensure that—

• Risks to subjects are minimized.
• Risks to subjects are reasonable in relation to anticipated benefits and the importance of knowledge.
• There is proper informed consent and documentation of informed consent.
• The research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
• Additional safeguards have been included in the study to protect the rights and welfare of any subjects likely to be vulnerable to coercion or undue influence.

This section reviews—

• How To Find an IRB
• IRB Application
• IRB Review
• Possible Outcomes of an IRB Review

How To Find an IRB

IRBs may be found within public entities such as hospitals and universities or may be run by private companies within your community. If you decide to hire a local evaluator to assist with your project, the evaluator may be affiliated with a local IRB. You may also find a list of registered IRBs (http://ohrp.cit.nih.gov/search) online. Some IRBs offer their services at no charge, but others charge for their time at varying rates. You should build the cost of an IRB review into your evaluation budget.

IRB Application

In general, you will submit an application that includes sufficient information regarding the research study to an appropriate IRB for review. Each IRB has its own tailored application form, and you are advised to contact the relevant IRB about the review process and the forms you will need to complete.

For example, an IRB application may include the following types of forms:

• Request for IRB Action Form. By submitting this form, you are formally requesting a date for the research review. It is your responsibility to request a review date that allows sufficient time for review and approval before you conduct research involving human subjects. Check with your IRB for its submission deadlines.
• Protocol Review Form. This form provides the IRB with relevant information such as the objectives of the research study, procedures for obtaining consent, procedures for maintaining confidentiality, and the potential risk to human subjects. Make sure you submit supporting documentation with the form, including consent forms; relevant sections from grant applications or contract proposals; letters, advertisements, and other materials used to recruit potential subjects; information packets about the research that are distributed to its subjects; and full protocols, questionnaires, and other data collection forms.

The forms included in appendix B (PDF 101 KB) are samples only. Obtain the forms and supporting documentation that you will need to include in your application from your IRB.

IRB Review

Upon initial review of your research project, the IRB may make one of the following determinations about how the review process will be handled:

• Exemption From IRB Review. Your project activities meet the criteria for exempt research as established in the regulations. Examples of exempt research are outlined in appendix A (PDF 92.1 KB). (See 28 CFR 46.101(b).)
• Expedited IRB Review. Your research activities present no more than minimal risk to the human subjects involved and meet the criteria for an expedited IRB review as established in the regulations. Information about the procedures for expedited IRB review is outlined in appendix A (PDF 92.1 KB). (See 28 CFR 46.110.)
• Full IRB Review. Your research activities involve minimal risk or greater than a minimal risk to the human subjects involved and your project must receive a full IRB review. Generally, when research activities are subject to a full IRB review, members of the IRB read the IRB application and the research protocols prior to the IRB meeting. At the meeting, a quorum of the IRB members must be present for review and approval of the research project and the protocols to take place.

Research activities, such as conducting a needs assessment or program evaluation, may require a full IRB review if they involve interviewing or surveying victims who are vulnerable to potential risks in connection with their participation in these evaluations, or if the research involves sensitive questions that participants are likely to find stressful or confusing. A full IRB review can take several months before approval is granted, so plan your evaluation timeline accordingly.

Possible Outcomes of an IRB Review

After the IRB reviews the research activities, it can render one of three decisions:

• Approve the research involving human subjects without revisions.
• Conditionally approve the research involving human subjects pending revisions.
• Disapprove the research involving human subjects.

If your study is approved, you will receive documentation that IRB approval has been given. Keep the original documentation on file, as well as copies of the original, in case funders or other interested parties request it.

Forms and Written Statements

This section discusses the forms that an IRB application usually includes, such as consent forms and written statements and confidentiality statements. You may adapt the sample consent form included in appendix B (PDF 101 KB) for your use.

Consent Forms and Written Statements

Federal regulations require that certain information be provided to ensure that prospective human subjects understand the nature of the research activities and can knowledgeably and voluntarily decide whether to participate in a study. Ensuring that human subjects make a free and informed choice whether or not to participate in research activities protects not only the human subjects but also the program conducting the research.

Obtaining informed consent from human subjects is a process; it is not just having them complete a form. You should consider the type of information to be communicated and the situation under which the consent process will take place (e.g., approach, timing, personnel involved). The onus is on the program to ensure that prospective human subjects fully understand the research activities they will participate in.

Some important issues to keep in mind include the following:

• Obtain consent either in writing or through verbal communication.
• Use laymen’s language.
• Do not use exculpatory language.
• Consider carefully what your research entails.
• Consider modifying existing language to suit your needs.

Obtain consent either in writing or through verbal communication.
Keep in mind that you may obtain informed consent from subjects either in writing or through verbal communication. For example, you may have the subject sign a document, generally called a consent form, or have the subject read a written statement that you’ve prepared and then have the subject verbally consent.

Written consent may be an issue for victims who have serious security concerns. In this event, the IRB may still require that you give subjects a written statement regarding the research. These statements should provide the same information as consent forms but not include a signature line. Instead of a signature, you will be required to obtain verbal consent.

Use laymen’s language.
Consent forms should be written in laymen’s language. Consider the age, reading level, and comprehension skills of potential human subjects. These considerations are especially important for victims who may have very limited English speaking skills and little education in their native country. Therefore, use simple and succinct language in consent forms and translate forms into the victims’ native language when appropriate. It also is a good idea to include copies of translated documents in your IRB application. Sample consent forms are included in appendix B (PDF 101 KB).

Do not use exculpatory language.
Consent forms should not contain any exculpatory language. In other words, you cannot ask participants to waive their legal rights or release the program from liability or negligence (e.g., “I waive any possibility of compensation for injuries that I may receive as a result of participation in this research”). Federal regulations further require that consent forms include the information listed in exhibit 1 and found in 28 CFR 46.116(a).

Consider carefully what your research entails.
Consider carefully what your research activities will entail and include in the consent form any additional information that subjects or the IRB may need. Relevant additional information could include the following:

• Approximate number of human subjects involved in the study.
• A statement asserting that any significant new findings developed during the research activities that may affect the human subject’s willingness to continue participation will be provided to the human subject.
• Any additional costs to the human subject that may result from participating in the research activities.

Consider modifying existing language to suit your needs.
Here is a list of some suggested language that you may want to use in consent forms and written statements:

• “Because this is a group meeting, it is important that each of you agree to respect and protect each other’s privacy, just as we are obligated to respect and protect your privacy. By verbally consenting to participate in this group, you agree to protect the confidentiality of all other group participants and to keep any information you hear or learn today in the strictest of confidence, including the names of others in this group. This means you will not disclose or discuss anything you hear or learn today with anyone outside of this group. Please be aware that we cannot guarantee that other participants will uphold this pledge of confidentiality, and that your participation is voluntary.”
• “If you understand all of the information that we have provided to you about the project and would like to participate in the group discussion, please raise your hand.”
• “You have given permission for the discussion to be audiotaped and further understand that the transcripts will be used only for research or statistical purposes and that your name will not be associated with your transcript or audiotape.”
• “Your participation is completely voluntary. You do not have to answer any questions that you do not want to answer. Your participation, or any decision not to participate, will not affect your immigration status or any other services to which you are entitled.”

You may modify this language as appropriate for your needs. In addition, you may decide to use some of this language in informational materials you use to recruit potential human subjects, and in introductory scripts and text for data collection protocols (e.g., interview guides, focus group guides, and surveys).

Confidentiality Statements

All individuals working as research team members who have access to data in identifiable form should be provided with a copy of 28 CFR, Part 22, “Protection of Confidentiality of Identifiable Research” (PDF 92.1 KB). This includes the project director, program staff, independent consultants, and local evaluators. Having read these regulations, research team members should sign a confidentiality statement agreeing to comply with these regulations and all policies and procedures adopted in accordance with regulatory requirements. The local evaluator should also sign these statements and keep them within his or her own files. A sample confidentiality statement is included in appendix B (PDF 101 KB).

Conclusion

Protecting human subjects is an extremely important aspect of all research activities. As your program provides services to and for victims of crime, ethical concerns regarding the protection of human subjects bear even more significantly on your research activities. In light of these concerns, you may decide it is in your best interest to hire a local evaluator with the appropriate experience to conduct the evaluation. For more information, see the Guide to Hiring a Local Evaluator, included in this series. Should you choose not to hire a local evaluator, you should make one person in your initiative responsible for handling the evaluation. Advise the evaluator and research staff to use this guide as a general reference for how to protect the human subjects in your research activities.

Resources

U.S. Department of Health and Human Services, Office for Human Research Protections (http://www.hhs.gov/ohrp)

The Office for Human Research Protections (OHRP) provides leadership regarding protections for human subjects of research and implements a program of compliance oversight to protect the human subjects used by institutions engaged in human subject research conducted or supported by the U.S. Department of Health and Human Services. OHRP provides clarification and guidance on involving humans in research; develops and implements educational programs and resource materials; and promotes the development of approaches to enhance protections for human subjects.

National Institutes of Health Certificates of Confidentiality Kiosk (http://grants.nih.gov/grants/policy/coc/index.htm)

The National Institutes of Health’s (NIH) online Certificates of Confidentiality Kiosk provides information to investigators working on sensitive biomedical, behavioral, clinical, or other types of research. Investigators will find background information on certificates of confidentiality, frequently asked questions, a slide presentation, and much more. Please note that the sample privacy certificate provided on the NIH Web site is different from the privacy certificate used by OVC grantees.

Glossary

Activities are the products and services your program provides to help solve the conditions identified.

Evaluation plan provides the framework for conducting the evaluation.

Evaluator is an individual trained and experienced in designing and conducting evaluations.

Focus group is a small-group discussion guided by a trained facilitator for gathering data on a designated topic.

Goals are measurable statements of the desired long-term, global impact of the program. Goals generally address change.

Human subject is defined as "living individual(s) about whom an evaluator conducting research obtains data. . . ." This includes service providers, clients, and any individuals asked to complete a survey or questionnaire.

Identifiable information is defined as "information that either is labeled by name or other personal identifiers; or can by other factors be reasonably interpreted as referring to a particular private person." This could include Social Security numbers and the names of service providers or clients.

Institutional Review Board is an administrative body established to protect the rights and welfare of human subjects participating in a research study, with authority to approve, require modifications to, or disapprove research activities that fall within its purview.

Needs assessment is a systematic effort to gather information from various sources that helps to identify the needs of victims and the resources that are available to help them.

Objectives are specific, measurable statements of the desired immediate or direct outcomes of the program that support the accomplishment of a goal.

Program evaluation is a systematic process of obtaining credible information to be used for program assessment and improvement.

Appendixes

• Appendix A: Title 28 Code of Federal Regulations (PDF 92.1 KB)
• Appendix B: Sample Forms (PDF 101 KB)