2. Ethical and Confidentiality Considerations

Before you embark on an evaluation study with substance abuse treatment clients, you must carefully attend to confidentiality issues that may apply to your clients. These include federal regulations regarding client confidentiality, institutional review board (IRB) approval, informed consent, Health Insurance Portability and Accountability Act (HIPAA) compliance, certificate of confidentiality, and confidentiality and ethical practices when tracking. Each of these topics is covered here.

Federal Regulations Regarding Client Confidentiality

Programs receiving federal funds must protect client confidentiality. Below is a summary on client confidentiality from CSAT's Technical Assistance Publication (TAP) Series 18 ("Checklist for Monitoring Alcohol and Other Drug Confidentiality Compliance," DHHS Publication No. (SMA) 96-3083, 1996, http://www.treatment.org/Taps/TAP18/TAP18.html ):

The Federal regulations [42 CFR Part 2, see note in box below] generally prohibit programs from disclosing "patient-identifying information." "Patient-identifying information" means any information that identifies a patient as ( i ) having applied for or received alcohol or other drug-related services (diagnosis, treatment, counseling, or referral for treatment), or (ii) being an alcohol or other drug (AOD) abuser (§ 2.11, 2.12).

By prohibiting "disclosures," the regulations do not merely refer to explicit statements, such as, " [A specified person] is a patient" or "[A specified person] is an AOD abuser." Rather, the term "disclosure" includes implicit disclosures, such as the following:

allowing a receptionist to confirm that a particular person is a patient, even if the caller or visitor says that he or she is the patient's family member and knows the patient attends the program;
sending a patient a letter in an envelope that suggests that the addressee may be a patient;
faxing a letter on the program's stationery, revealing or suggesting the patient's status to the patient's workplace;
faxing any patient-identifying information about a patient to the wrong fax number;
leaving a telephone message revealing or suggesting patient status with a patient's roommate or on a patient's answering machine, from which another person may hear the message;
disclosing the patient's name and the fact that the patient attended a program to a bill collection agency, attorney, or small claims court;
having a program counselor appear at a patient's workplace or home and revealing his or her relationship with the patient to someone else;
disclosing descriptive or anecdotal material from which a patient's identity may be inferred (e.g., by referring to a patient as "the Mayor's daughter");
producing and identifying a patient when the police arrive at the program with an arrest warrant, but without a valid court order; and
permitting the police to have access to patient records, without first protesting, when the police arrive at the program with a search warrant, but without a valid court order

NOTE: The Code of Federal Regulations (CFR) can be accessed at:
http://www.gpoaccess.gov/cfr/index.html

We recommend using the "browse," rather than the "search" or "retrieve" functions, to find the portions you are interested in. The chapter that governs the confidentiality of alcohol and drug abuse patient records is 42 CFR, Volume 1, Chapter I, Part 2. The chapter that governs the protection of human subjects is 45 CFR, Subtitle A - Department of Health and Human Services, General Administration, Part 46 - Protection of Human Subjects, Subpart A.

Federal regulations do allow the release of information without individual client consent for program evaluation and research purposes. It is up to the program director to determine whether the research merits disclosure of treatment information.

Institutional Review of Study Procedures

We suggest that you seek Institutional Review Board (IRB) approval for your follow-up activities. At the present time, IRB approval is not required by CSAT, but your state or local agency may require it. By gaining IRB approval, you obtain extra protection for your clients by undergoing outside review of your procedures and by making it possible for your evaluation study to receive a federal Certificate of Confidentiality, which protects the evaluation records of your clients from subpoena. For the purposes of gaining IRB approval, your evaluation study is classified as research. If you are in doubt about whether to seek IRB approval, contact the participant protection officer at your funding agency for assistance.

The following summary of the protection of human research participants was derived from information on the National Institutes of Health Web site ( http://cme.cancer.gov/c01/ ).

Research is a systematic investigation (including development, testing, and evaluation) designed to discover or contribute to a body of generalizable knowledge. Protection of research participants is required in a wide range of research types, including research that involves medical records, genetic material, behavioral and/or biomedical assessments, and treatments. Research involving humans is crucial to improving human health through biomedical and behavioral research. At the same time, researchers and the research team have a fundamental responsibility to safeguard the rights and welfare of the people participating in their research activities. Emphasis on enhancing protection is needed to:

Promote the safety and well-being of human participants in research.
Maintain the ethical values and principles underlying research.
Implement scientifically valid research.
Allay concerns of the general public about the responsible conduct of research (NIH, 2002).

The researcher conducting the study has the primary responsibility to ensure that participants in research are fully informed of their rights and properly protected. The researcher is specifically responsible for ensuring that:

The study is properly designed, scientifically sound, and yields valid results.
Participants meet selection and eligibility requirements.
The study is approved by an IRB and conducted according to the approved protocol.
Informed consent is appropriately obtained.
Protocol changes and adverse events are reported to the appropriate boards and authorities.
The rights and welfare of participants are monitored throughout the research intervention.
All members of the research team are qualified and trained in research methods and human participant protections (NIH, 2002).

Before any client recruitment can begin, the evaluator must submit a description of the study procedures and a copy of the Informed Consent Form to the IRB. Most IRBs have templates and sample forms in order to make the submission process easier. In order to approve research, the IRB must ensure that the following requirements are satisfied:

Risks to participants are minimized by using procedures consistent with sound research design that do not unnecessarily expose participants to risk.
Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those that may result from the research, as distinguished from those participants would receive even if not participating in the research.
Selection of participants is equitable. The IRB should consider the purposes of the research and the setting in which the research will be conducted and be particularly mindful of the special problems of research involving vulnerable populations. Participants should share equally in foreseeable benefits and risks.
Informed consent is sought, and will be obtained, from each prospective participant or the participant's legally authorized representative in accordance with, and to the extent required by 45 CFR 46.116.
Informed consent is appropriately documented in accordance with, and to the extent required by 45 CFR 46.117.
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants.
When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.
Additionally, when some or all of the participants are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, or mentally disabled, economically disadvantaged, or educationally disadvantaged persons) additional safeguards are included in the study to protect the rights and welfare of these participants (NIH, 2002).

NOTE: Many IRBs are now requiring that investigators submit certifications showing that they and their study staff have received training on protection of research participants. It is relatively easy to get this training. You simply read the materials, take the test, and receive a certificate. Your institution may have its own training materials. Also, the National Institutes of Health offer a printable training manual and online training at: http://cme.cancer.gov/c01/ . After the training is completed, you can print your certificate.

The IRB reviews the documents submitted by the evaluator and may require changes. At the time of approval, the Informed Consent Form is stamped and given a one-year expiration date. (Approval must be renewed annually for the life of the study.) See the next section for more on the informed consent process.

It is not necessary for your organization to have an in-house IRB. There are several independent IRBs throughout the country that will review study procedures and forms. Initial reviews typically cost $1,000 - $1,400, with yearly continuing reviews costing about $500 - $600. Your local college or university may provide this service without cost. Below is a listing of some independent IRBs. We have not used their services and therefore cannot make particular recommendations.

Biomedical Research Alliance of New York
225 Community Drive, Suite 100
Great Neck, NY 11021
http://www.brany.com/
516-470-6900

Fox Commercial Institutional Review Board, Ltd.
326 North Seventh St, Suite 218
Springfield, IL 62701
http://www.foxirb.com/
217-492-1369

Independent Review Consulting, Inc. (IRC)
San Rafael, CA
http://www.irb-irc.net/
415.485.0717

Internet IRB
(877) 363-7873 x. 401

New England Institutional Review Board (NEIRB)
40 Washington Street, Suite 130
Wellesley, MA 02481
http://www.neirb.com/index.shtml
781-431-7577

Schulman Associates Institutional Review Board, Inc.
4290 Glendale-Milford Road
Cincinnati, Ohio 45242
http://www.sairb.com/
513-761-4100

Sterling Institutional Review Board
6300 Powers Ferry Road, Suite 600-351
Atlanta, GA
http://www.sterlingirb.com/index.html
888-636-1062

NOTICE: The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

A listing of resources regarding protection of research participants is located at:
http://cme.cancer.gov/c01/resources.asp

Informed Consent

Before a client can be enrolled in any evaluation study, the study must be explained in detail. The client must understand the right to full disclosure and the voluntary nature of participation . The client must be provided with written, detailed information about the study, so that he or she can decide whether to participate. The Informed Consent Form should clearly state the following:

Name of the organization conducting and sponsoring the evaluation
Purpose of the evaluation study
Participation is voluntary
All information obtained during the interview remains confidential
Mandated reporting situations (e.g., child abuse) that are exceptions to confidentiality
Benefits or risks, if any, to the client
Topics to be covered in the interview(s) and locator form
Amount of time involved
Time periods that follow-up interview(s) will occur
Procedures for locating clients for follow-up, including databases used
Form of compensation to be used (e.g., money, check, voucher), if any
Specimens to be collected, if any

The Informed Consent Form must be provided to the client, and only after all the client's questions have been answered and he or she has agreed to participate and has signed the Informed Consent Form, can enrollment in the study take place. The client must receive a copy of the Informed Consent Form.

Health Insurance Portability and Accountability Act (HIPAA)

HIPAA was designed to protect the privacy of a medical patient's personal and health information. Examples of protected health information include a person's name, address, birth date, age, phone and fax numbers, e-mail addresses, medical records, billing records, referral authorizations, and research records. This is the type of information that substance abuse treatment programs, evaluators, and researchers have routinely kept confidential. HIPAA now provides nationwide standards for confidentiality and all health care providers were supposed to be HIPAA compliant by April of 2003. Criminal justice and other non-health information is not covered by HIPAA, but may be covered by other privacy laws. For more information on HIPAA and to determine whether your organization is subject to HIPAA requirements, go to: http://www.hhs.gov/ocr/hipaa/ .

HIPAA rules allow disclosure of health information for research purposes. According to the Office of Civil Rights at the U.S. Department of Health and Human Services, provided your client has given consent (i.e., the Informed Consent Form states that you will be obtaining medical information), you may request research-related information from healthcare providers. For more information see: http://www.hhs.gov/ocr/privacysummary.pdf

If your evaluation has been approved by an IRB, and you and your staff are maintaining the confidentiality of your clients' health information, then you are most likely in compliance with HIPAA.

Certificate of Confidentiality

Another very important document to include in any evaluation study is the Certificate of Confidentiality (also known as the Confidentiality Certificate) issued by the U.S. Department of Health and Human Services, under the regulations known as 42 CFR (see note in above Federal Regulations Regarding Client Confidentiality). These certificates protect evaluation study staff and agency staff so that they cannot be compelled to reveal information about study participants in any federal, state, or local civil, criminal, administrative, legislative or other proceedings. The only cases where confidentiality may be breached are cases of suspected or known child abuse or elder abuse, or to protect the client or another person from harm. However, if a client requests that information be released, study information can be released, provided that the client consents in writing to the disclosure. Information and instructions for applying to SAMHSA for a certificate of confidentiality is located in Appendix B.

For more information, contact:

Human Subjects Research/Confidentiality Certificate Coordinator
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism/NIH
Willco Building, Suite 409
6000 Executive Boulevard
Rockville, MD 20852 (Courier address)
Bethesda, MD 20892-7003 (Post Office address)

301-443- 2890 ( Confidentiality Certificate Coordinator)
301-443- 3885 ( Director's Office)

Confidentiality and Ethical Practices when Tracking

Studies that target populations who are engaged in or have formerly engaged in drug use and related activities present unique challenges. Because members of these populations have been involved in activities that are stigmatized by mainstream society, it is difficult to both locate them for evaluation purposes and to secure their consent for an interview. Significant numbers of clients would never consent to being part of a study if they could not be assured that their privacy would be protected. Thus, to protect client privacy, confidentiality safeguards are established and maintained for all tracking and locating activities for the duration of the study, and participants are informed that they will be protected. These safeguards include never specifically describing the study either on the telephone (for both incoming and outgoing calls) or in correspondence; a study can be described as a health study or a study of people's health habits. Only after it is satisfactorily established that the person contacted is the client, should the nature of the study be discussed. The client can be identified by confirming date of birth, social security number, or mother's maiden name (see Appendix C for example of a script used to locate clients).

NOTE: Despite the importance of obtaining a high interview completion rate, ethical and legal bounds are pre-eminent; at no time should a locator/interviewer misrepresent himself or herself or the organization conducting the study. The locator/interviewer declares his/her status as a representative of a study officially sponsored by an organization or government agency. If the organization's or study's name includes the words "drug abuse" or "drug abuse treatment," however, a more neutral name that includes the words "health study" or just "evaluation study" may be used. Field workers and interviewers should introduce themselves as such and explain that they are working on a health study. An exception to the contact procedure is made when contacting a client's employer, in which case confidentiality is protected by providing the interviewer's name only (See Section 4.3, Employer Contact) .

In the course of tracking and locating, it is not unusual to come across other parties, including law enforcement agencies, who may also be searching for a particular client. In these instances, the tracker may be asked to share information about the client. Under no circumstances may any information about the client be revealed. It does not matter whether the individual requesting the information is a family member, a bill collector, a bail bondsman, someone from a social service agency, a process server, or a law enforcement official. The tracker or interviewer may, however, offer to pass information on to the client once he or she is located. If a law enforcement official insists, or produces a subpoena for the information, he or she must be referred to the director of the study. It is of the utmost importance that all personnel be informed about how to respond in these situations. When in doubt, the study director and the appropriate official at the funding agency should be notified. The compromise of a client's confidentiality is unethical and a violation of the law. It could jeopardize a client's employment, family situation, or legal status, and breaking confidentiality may put the entire evaluation study at risk.

The only exceptions to confidentiality constraints are mandated reporting requirements. The federal government, states, and even some municipalities have laws regarding situations (abuse, danger to self or others) requiring that the authorities be notified. Be sure that you and your staff are up-to-date on your local laws and agency procedures and that your informed consent form contains information about what situations you are required to report. For general guidelines for interviewers and trackers who may encounter these situations see Appendix D.

Additionally, the locator/interviewer must not make false promises or claims to learn the whereabouts of a client, or to convince a hesitant client to consent to an interview. The locator/interviewer has access to an array of tracking and locating tools, as well as strategies for convincing hesitant clients to consent to an interview. These tools and strategies have a proven track record of success in previous studies. Questionable methods are not necessary and should not be permitted.