more on ethics and professional conduct

More on Ethics More on Ethics and Professional Conductand Professional Conduct

ConfidentialityConfidentiality Data ManagementData Management Ethanol Challenge Research…specific Ethanol Challenge Research…specific

issuesissues Scientific MisconductScientific Misconduct

Safeguarding Confidentiality (1)Safeguarding Confidentiality (1) PersonnelPersonnel

all staff should be indoctrinated in human subjects all staff should be indoctrinated in human subjects issues on the first day of their project involvementissues on the first day of their project involvement

Staff should have access to confidential information Staff should have access to confidential information on a “need to know” basison a “need to know” basis

violations should be addressed immediately and violations should be addressed immediately and appropriatelyappropriately

Keeping identifying information separate from Keeping identifying information separate from other subject data (not on same machines!!)other subject data (not on same machines!!)

Keeping master lists secure. Some strategies:Keeping master lists secure. Some strategies: Locked (virtual or physical), secure data storage.Locked (virtual or physical), secure data storage. EncryptionEncryption Secure remote connectionsSecure remote connections

Safeguarding Confidentiality (2)Safeguarding Confidentiality (2) Deleting identifying information when no longer Deleting identifying information when no longer

neededneeded

When anonymous data collection is possible, When anonymous data collection is possible, use it!use it!

Be vigilant for “slippage” over timeBe vigilant for “slippage” over time

Underage use and illicit drug use big problemsUnderage use and illicit drug use big problems

Use of Certificate of ConfidentialityUse of Certificate of Confidentiality

NIH ANNOUNCES STATEMENT ON NIH ANNOUNCES STATEMENT ON CERTIFICATES OF CONFIDENTIALITY Release CERTIFICATES OF CONFIDENTIALITY Release

Date: March 15, 2002 NOTICE: NOT-OD-02-037 (1)Date: March 15, 2002 NOTICE: NOT-OD-02-037 (1) National Institutes of Health Certificates of Confidentiality National Institutes of Health Certificates of Confidentiality

are issued by the National Institutes of Health (NIH) to are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced protect identifiable research information from forced disclosure.disclosure.

They allow the investigator and others who have access They allow the investigator and others who have access to research records to refuse to disclose identifying to research records to refuse to disclose identifying information on research participants in any civil, criminal, information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether administrative, legislative, or other proceeding, whether at the federal, state, or local level. at the federal, state, or local level.

Certificates of Confidentiality may be granted for studies Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have collecting information that if disclosed could have adverse consequences for subjects or damage their adverse consequences for subjects or damage their financial standing, employability, insurability, or financial standing, employability, insurability, or reputation. reputation.

NIH ANNOUNCES STATEMENT ON NIH ANNOUNCES STATEMENT ON CERTIFICATES OF CONFIDENTIALITY Release CERTIFICATES OF CONFIDENTIALITY Release

Date: March 15, 2002 NOTICE: NOT-OD-02-037 (2)Date: March 15, 2002 NOTICE: NOT-OD-02-037 (2) By protecting researchers and institutions from being By protecting researchers and institutions from being

compelled to disclose information that would identify compelled to disclose information that would identify research subjects, Certificates of Confidentiality help research subjects, Certificates of Confidentiality help achieve the research objectives and promote achieve the research objectives and promote participation in studies by assuring confidentiality and participation in studies by assuring confidentiality and privacy to participants. Certificates constitute an privacy to participants. Certificates constitute an important tool to protect the privacy of research study important tool to protect the privacy of research study participants. participants.

Thus, NIH would like to encourage their appropriate use. Thus, NIH would like to encourage their appropriate use. NIH is making information widely available to NIH is making information widely available to investigators working on sensitive biomedical, investigators working on sensitive biomedical, behavioral, clinical or other types of research. behavioral, clinical or other types of research.

Extent and Limitations of Coverage of a Extent and Limitations of Coverage of a Certificate of Confidentiality (1)Certificate of Confidentiality (1)

Certificates can be used for biomedical, behavioral, clinical or Certificates can be used for biomedical, behavioral, clinical or other types of research that is sensitive. By sensitive, we other types of research that is sensitive. By sensitive, we mean that disclosure of identifying information could have mean that disclosure of identifying information could have adverse consequences for subjects or damage their financial adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. standing, employability, insurability, or reputation. Examples of sensitive research activities include but are not Examples of sensitive research activities include but are not limited to the following:limited to the following: Collecting genetic informationCollecting genetic information Collecting information on psychological well-being of subjectsCollecting information on psychological well-being of subjects Collecting information on subjects' sexual attitudes, preferences or Collecting information on subjects' sexual attitudes, preferences or

practicespractices Collecting data on substance abuse or other illegal risk behaviorsCollecting data on substance abuse or other illegal risk behaviors Studies where subjects may be involved in litigation related to Studies where subjects may be involved in litigation related to

exposures under study (e.g., breast implants, environmental or exposures under study (e.g., breast implants, environmental or occupational exposures). occupational exposures).


In general, certificates are issued for single, well-defined In general, certificates are issued for single, well-defined research projects rather than groups or classes of research projects rather than groups or classes of projects. projects.

In some instances, they can be issued for cooperative multi-site projects. In some instances, they can be issued for cooperative multi-site projects. A coordinating center or "lead" institution designated by the NIH program A coordinating center or "lead" institution designated by the NIH program officer can apply on behalf of all institutions associated with the multi-site officer can apply on behalf of all institutions associated with the multi-site project. The lead institution must ensure that all participating institutions project. The lead institution must ensure that all participating institutions conform to the application assurances and inform participants conform to the application assurances and inform participants appropriately about the Certificate, its protections, and the circumstances appropriately about the Certificate, its protections, and the circumstances in which voluntary disclosures would be made.in which voluntary disclosures would be made.

A Certificate of Confidentiality protects personally A Certificate of Confidentiality protects personally identifiable information about subjects in the research identifiable information about subjects in the research project while the Certificate is in effect. project while the Certificate is in effect.


Generally, Certificates are effective on the date of issuance or upon Generally, Certificates are effective on the date of issuance or upon commencement of the research project if that occurs after the date of issuance. commencement of the research project if that occurs after the date of issuance. The expiration date should correspond to the completion of the study. The The expiration date should correspond to the completion of the study. The Certificate will state the date upon which it becomes effective and the date upon Certificate will state the date upon which it becomes effective and the date upon which it expires.which it expires.

A Certificate of Confidentiality protects all information identifiable to any individual A Certificate of Confidentiality protects all information identifiable to any individual who participates as a research subject (i.e., about whom the investigator maintains who participates as a research subject (i.e., about whom the investigator maintains identifying information) during any time the Certificate is in effect. An extension of identifying information) during any time the Certificate is in effect. An extension of coverage must be requested if the research extends beyond the expiration date of coverage must be requested if the research extends beyond the expiration date of the original Certificate. the original Certificate.

However, the protection afforded by the Certificate is permanent. All personally However, the protection afforded by the Certificate is permanent. All personally identifiable information maintained about participants in the project while the identifiable information maintained about participants in the project while the Certificate is in effect is protected in perpetuity.Certificate is in effect is protected in perpetuity.

Some projects are ineligible for Some projects are ineligible for a Certificate of Confidentiality a Certificate of Confidentiality

Not eligible for a Certificate are Not eligible for a Certificate are projects that are:projects that are: not research not research not collecting personally identifiable not collecting personally identifiable

informationinformation not reviewed and approved by the IRB not reviewed and approved by the IRB

as required by these guidelines as required by these guidelines collecting information that if disclosed collecting information that if disclosed

would not significantly harm or damage would not significantly harm or damage the participant. the participant.

Limits to Certificates of Confidentiality (1)Limits to Certificates of Confidentiality (1) Investigators should note that research subjects Investigators should note that research subjects

might voluntarily disclose their research data or might voluntarily disclose their research data or information. Subjects may disclose information to information. Subjects may disclose information to physicians or other third parties. physicians or other third parties.

They may also authorize in writing the investigator They may also authorize in writing the investigator to release the information to insurers, employers, to release the information to insurers, employers, or other third parties. In such cases, researchers or other third parties. In such cases, researchers may not use the Certificate to refuse disclosure.may not use the Certificate to refuse disclosure.

Moreover, researchers are not prevented from the Moreover, researchers are not prevented from the

voluntary disclosure of matters such as child abuse, voluntary disclosure of matters such as child abuse, reportable communicable diseases, or subject's reportable communicable diseases, or subject's threatened violence to self or others. However, if threatened violence to self or others. However, if the researcher intends to make any voluntary the researcher intends to make any voluntary disclosures, the consent form must specify such disclosures, the consent form must specify such disclosure.disclosure.

Limits to Certificates of Confidentiality (2)Limits to Certificates of Confidentiality (2) Certificates do not authorize researchers to Certificates do not authorize researchers to

refuse to disclose information about subjects if refuse to disclose information about subjects if authorized DHHS personnel request such authorized DHHS personnel request such information for an audit or program evaluation. information for an audit or program evaluation. Neither can researchers refuse to disclose such Neither can researchers refuse to disclose such information if it is required to be disclosed by the information if it is required to be disclosed by the Federal Food, Drug, and Cosmetic Act. Federal Food, Drug, and Cosmetic Act.

In the informed consent form, investigators In the informed consent form, investigators should tell research subjects that a Certificate is should tell research subjects that a Certificate is in effect. Subjects should be given a fair and clear in effect. Subjects should be given a fair and clear explanation of the protection that it affords, explanation of the protection that it affords, including the limitations and exceptions noted including the limitations and exceptions noted above. above.

Every research project that includes human Every research project that includes human research subjects should explain how identifiable research subjects should explain how identifiable information will be used or disclosed, regardless information will be used or disclosed, regardless of whether or not a Certificate is in effect. of whether or not a Certificate is in effect.

Limits to Certificates of Confidentiality (3)Limits to Certificates of Confidentiality (3)

Certificates of Confidentiality do not take the Certificates of Confidentiality do not take the place of good data security or clear policies and place of good data security or clear policies and procedures for data protection, which are procedures for data protection, which are essential to the protection of research essential to the protection of research participants' privacy. participants' privacy.

Researchers should take appropriate steps to Researchers should take appropriate steps to safeguard research data and findings. safeguard research data and findings.

Unauthorized individuals must not access the Unauthorized individuals must not access the research data or learn the identity of research research data or learn the identity of research participants.participants.

Data Management (1)Data Management (1) Perhaps more important than data analysis, but Perhaps more important than data analysis, but

typically not taughttypically not taught

Need to be attentive to data quality at each Need to be attentive to data quality at each stage of data collection, storage, and stage of data collection, storage, and manipulationmanipulation

Assume the worstAssume the worst Chaos/entropy are persistent threats to the best laid Chaos/entropy are persistent threats to the best laid

plansplans Researchers have a bias and tend not to doubt the Researchers have a bias and tend not to doubt the

validity of their data when it is consistent with validity of their data when it is consistent with expectationexpectation

Data Management (2)Data Management (2) Data Collection IssuesData Collection Issues

Remove ambiguity, confusion, etc. in Remove ambiguity, confusion, etc. in measurement approachesmeasurement approaches

Assess under optimal circumstancesAssess under optimal circumstances Constantly monitor assessors, equipment, etc. Constantly monitor assessors, equipment, etc.

to insure calibration is maintained over the to insure calibration is maintained over the course of the studycourse of the study

Understand equipment, interviews, etc. so you Understand equipment, interviews, etc. so you know what the data should look likeknow what the data should look like

Poorly collected data undermines the value of Poorly collected data undermines the value of the effortthe effort

Data Management (3)Data Management (3)

Data EntryData Entry When data are automatically collected (e.g., When data are automatically collected (e.g.,

via computer)via computer) extensive testing under all possible conditions extensive testing under all possible conditions

should be conducted prior to data collectionshould be conducted prior to data collection Monitoring of data collection quality should be Monitoring of data collection quality should be

ongoingongoing All raw data should be retained for reprocessing if All raw data should be retained for reprocessing if

needed.needed.


When data are entered by handWhen data are entered by hand Smart programs should be usedSmart programs should be used Data should be entered twice and electronically Data should be entered twice and electronically

comparedcompared Different people should be used for the two data Different people should be used for the two data

entriesentries Codes for different types of missingness (e.g., Codes for different types of missingness (e.g.,

refusal, skip out, ran out of time) should be used.refusal, skip out, ran out of time) should be used. Knowledge of formatting for special cases should Knowledge of formatting for special cases should

be taken into account (e.g., date)be taken into account (e.g., date) Rawest level of data should be enteredRawest level of data should be entered


Data EditingData Editing Errors in data entry will often be made or Errors in data entry will often be made or

invalid data points will be discoveredinvalid data points will be discovered It is critical to maintain a paper trail of all It is critical to maintain a paper trail of all

modifications to your data setmodifications to your data set As a general principle, it is best to make all As a general principle, it is best to make all

corrections/changes by program code and not corrections/changes by program code and not by using an editing program to change data by using an editing program to change data points in the raw data filepoints in the raw data file

Issues involving Alcohol Issues involving Alcohol ChallengeChallenge

Trials and Tribulations of Giving Trials and Tribulations of Giving Alcohol Under Controlled ConditionsAlcohol Under Controlled Conditions

National Institute on Alcohol Abuse and Alcoholism

Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation

Prepared by the

National Advisory Council on Alcohol Abuse and Alcoholism

Revised June 1989

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESPublic Health Service

Alcohol, Drug Abuse, and Mental Health Administration

NOTE: The National Advisory Council on Alcohol Abuse and Alcoholism advises the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Secretary of the Department of Health and Human Services (DHHS) on program and policy matters in the field of alcohol abuse and alcoholism. The recommended Council Guidelines represent National Advisory Council recommendations for consideration by research grant applicants, Institutional Review Boards, Initial Review Groups, and others in the alcohol research field. The recommended Council Guidelines are not official Federal NIAAA or DHHS regulation or policy.

PURPOSE OF THE GUIDELINESPURPOSE OF THE GUIDELINES The Council guidelines focus on issues related to experimentation involving alcohol The Council guidelines focus on issues related to experimentation involving alcohol

administration to human subjects in the context of the ethical principles noted above. administration to human subjects in the context of the ethical principles noted above. The Council guidelines are intended to identify potential problematic issues, and to serve The Council guidelines are intended to identify potential problematic issues, and to serve as a guide to help ensure that appropriate consideration is given to relevant issues in the as a guide to help ensure that appropriate consideration is given to relevant issues in the development and review of research protocols involving alcohol administration.development and review of research protocols involving alcohol administration.

The guidelines are not intended to supplant the functions of the IRB, or of OPRR. The The guidelines are not intended to supplant the functions of the IRB, or of OPRR. The guidelines are guidelines are advisoryadvisory to applicants, IRBs, IRGs, and others; they are not codified and to applicants, IRBs, IRGs, and others; they are not codified and do not constitute Federal regulation. Rather, the guidelines are intended to reflect a do not constitute Federal regulation. Rather, the guidelines are intended to reflect a sensitive, ethical approach which is also consistent with current research practices and sensitive, ethical approach which is also consistent with current research practices and experience in the field of alcohol research.experience in the field of alcohol research.

It has been observed that not all IRBs have addressed issues surrounding administration It has been observed that not all IRBs have addressed issues surrounding administration of alcohol uniformly. IRBs, as well as applicant sensitivity to the issues, are often related of alcohol uniformly. IRBs, as well as applicant sensitivity to the issues, are often related to prior experience with similar issues in alcohol or related research. The Council to prior experience with similar issues in alcohol or related research. The Council suggests that IRBs should consider obtaining outside expertise when they do not have suggests that IRBs should consider obtaining outside expertise when they do not have sufficient familiarity with alcohol research issues.sufficient familiarity with alcohol research issues.

The recommendations contained within the guidelines are in no way meant to interfere The recommendations contained within the guidelines are in no way meant to interfere with the recovery for any individual for any disease, including alcoholism. Accordingly, it with the recovery for any individual for any disease, including alcoholism. Accordingly, it is recognized at this time that the accepted and appropriate goal of alcoholism treatment is recognized at this time that the accepted and appropriate goal of alcoholism treatment is abstinence.is abstinence.

GENERAL ISSUESGENERAL ISSUES

Risk/Benefit

Informed Consent

Subject Selection

Confidentiality

Risk/BenefitRisk/Benefit

Risk/BenefitRisk/Benefit A careful appraisal of the risk/benefit ratio is a A careful appraisal of the risk/benefit ratio is a

critical aspect in the assessment of the critical aspect in the assessment of the appropriateness of a research protocol. This need appropriateness of a research protocol. This need derives from the ethical principle of beneficence. derives from the ethical principle of beneficence. in most contexts, the risk pertains to the research subject though, in most contexts, the risk pertains to the research subject though, in some circumstances, it could be broader and encompass the in some circumstances, it could be broader and encompass the

group or society.group or society. benefit must be considered first in the context of the research benefit must be considered first in the context of the research

subject. subject. benefit may also encompass the broader context of other individuals benefit may also encompass the broader context of other individuals

with a similar disease (where applicable) or of humankind. with a similar disease (where applicable) or of humankind. there must be a reasonable balance of risk against potential benefit; there must be a reasonable balance of risk against potential benefit;

without such a reasonable balance, a research protocol cannot be without such a reasonable balance, a research protocol cannot be justified ethically. justified ethically.

the qualifications and experience of the research team must be the qualifications and experience of the research team must be considered in weighing risk/benefit. considered in weighing risk/benefit.

similarly, the site for conduct of the research may influence the similarly, the site for conduct of the research may influence the risk/benefit decision.risk/benefit decision.

Risk/Benefit (continued)Risk/Benefit (continued) The Council recommends consideration of the The Council recommends consideration of the

appropriateness of the qualifications of those who assess appropriateness of the qualifications of those who assess the risk/benefit ratio. Such individuals should be experienced the risk/benefit ratio. Such individuals should be experienced and/or knowledgeable in clinical research issues.and/or knowledgeable in clinical research issues. A particular degree (M.D., Ph.D., etc.) neither qualifies nor disqualifies an A particular degree (M.D., Ph.D., etc.) neither qualifies nor disqualifies an

individual from participation in this assessment process.individual from participation in this assessment process.

The principal responsibility for approval of a research project The principal responsibility for approval of a research project involving human subjects rests with the IRB.involving human subjects rests with the IRB. Both the IRG and Council have a responsibility to consider human subject issues Both the IRG and Council have a responsibility to consider human subject issues It is the local institution, and its IRB, which are most aware of the many subtle It is the local institution, and its IRB, which are most aware of the many subtle

factors involving the research team's qualifications in similar studies, the factors involving the research team's qualifications in similar studies, the suitability of the research site, and local policies and norms affecting the suitability of the research site, and local policies and norms affecting the acceptability of proposed procedures.acceptability of proposed procedures.

Informed ConsentInformed Consent

Informed ConsentInformed Consent The investigator has the responsibility of assuring that the The investigator has the responsibility of assuring that the

informed consent process gives the research subjects all the informed consent process gives the research subjects all the information they need to make a voluntary and informed decision. information they need to make a voluntary and informed decision.

IRBs, as well, should assure that the informed consent documents convey all relevant information in IRBs, as well, should assure that the informed consent documents convey all relevant information in language readily understandable by the research subject or guardian. language readily understandable by the research subject or guardian.

It is appropriate that every informed consent form should indicate that the drug, alcohol, is a toxin and a It is appropriate that every informed consent form should indicate that the drug, alcohol, is a toxin and a reinforcing agent which may cause changes in behavior, including repetitive or excessive consumption. reinforcing agent which may cause changes in behavior, including repetitive or excessive consumption.

Such a statement would appropriately acknowledge that alcohol is not an innocuous substance, and Such a statement would appropriately acknowledge that alcohol is not an innocuous substance, and that everyone who drinks alcohol is at some riskthat everyone who drinks alcohol is at some risk..

Due consideration should be given to the cognitive, physiologic, Due consideration should be given to the cognitive, physiologic, and motivational states of the individuals in terms of their ability to and motivational states of the individuals in terms of their ability to fully understand the context of the informed consent.fully understand the context of the informed consent.

Individuals who are severely intoxicated or in a confusional withdrawal state are unable to give true Individuals who are severely intoxicated or in a confusional withdrawal state are unable to give true informed consent.informed consent.

Alternatively, a blood alcohol concentration (BAC), of zero for the potential subject may not be a Alternatively, a blood alcohol concentration (BAC), of zero for the potential subject may not be a required prerequisite, depending upon cognitive capabilities of the individual at that time. required prerequisite, depending upon cognitive capabilities of the individual at that time.

If there is a question of a potential subject's ability to give meaningful informed consent, an If there is a question of a potential subject's ability to give meaningful informed consent, an independent clinician, ethical consultant, or uninvolved third party with appropriate qualifications may independent clinician, ethical consultant, or uninvolved third party with appropriate qualifications may be asked to evaluate this ability.be asked to evaluate this ability.

Subject SelectionSubject Selection

Subject SelectionSubject Selection

The Council emphasizes the need for care in The Council emphasizes the need for care in subject selection so that appropriate subjects are subject selection so that appropriate subjects are utilized to address the research question and so utilized to address the research question and so that adequate safeguards are followed to prevent that adequate safeguards are followed to prevent unnecessary risk to subjects. unnecessary risk to subjects. need to avoid using subjects merely because of their need to avoid using subjects merely because of their

easy availability, low social or economic status, or easy availability, low social or economic status, or limited capacity to understand the nature of the limited capacity to understand the nature of the research. research.

need to consider the subject's age, sex, familial or need to consider the subject's age, sex, familial or genetic background, prior alcohol use, other drug use, genetic background, prior alcohol use, other drug use, and general medical and psychological condition, and general medical and psychological condition, including, if appropriate, alcoholism recovery status. including, if appropriate, alcoholism recovery status.

ConfidentialityConfidentiality

ConfidentialityConfidentiality

Investigators should be aware that once alcohol Investigators should be aware that once alcohol histories are placed in charts, such charts have to histories are placed in charts, such charts have to be handled with the same confidentiality afforded be handled with the same confidentiality afforded other alcohol records for which requirements other alcohol records for which requirements sometimes go beyond those for many other sometimes go beyond those for many other medical or research records. medical or research records.

Special Federal requirements that apply to Special Federal requirements that apply to certain alcohol records used in research are certain alcohol records used in research are addressed in the Code of Federal Regulations addressed in the Code of Federal Regulations (CFR) under 42 CFR Part 2, "Confidentiality of (CFR) under 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records Alcohol and Drug Abuse Patient Records

Is the investigator assessing whether the Is the investigator assessing whether the potential subjects have a current or prior potential subjects have a current or prior drinking problem, and whether or not the drinking problem, and whether or not the subjects are or have been in treatment?subjects are or have been in treatment?

These types of factors These types of factors mustmust be taken into be taken into consideration when subjects are recruited. consideration when subjects are recruited. Appropriate care should be taken to not Appropriate care should be taken to not unduly place any individual at risk. unduly place any individual at risk.

Will the protocol involve alcoholics (alcohol-Will the protocol involve alcoholics (alcohol-dependent individuals)? (continued)dependent individuals)? (continued)

Experimentation which requires individuals who are alcohol-Experimentation which requires individuals who are alcohol-dependent or alcoholics to be exposed to alcohol clearly warrants dependent or alcoholics to be exposed to alcohol clearly warrants special attention. special attention.

There are a number of extremely important principles which need to There are a number of extremely important principles which need to be addressed by anyone considering or evaluating requests to be addressed by anyone considering or evaluating requests to undertake such research. undertake such research.

It is noted that these issues differ to a degree, depending on where It is noted that these issues differ to a degree, depending on where in the disease/rehabilitative/recovery process the potential subjects in the disease/rehabilitative/recovery process the potential subjects are. are.

Further, it is useful to distinguish between these stages in Further, it is useful to distinguish between these stages in addressing some of the key issues. addressing some of the key issues. For example, the likelihood that a subject would otherwise be For example, the likelihood that a subject would otherwise be

encountering the agent (alcohol) would clearly differ, depending upon encountering the agent (alcohol) would clearly differ, depending upon their disease or recovery status. The risk of the investigator inflicting their disease or recovery status. The risk of the investigator inflicting harm is clearly greater when the probability that the subject would be harm is clearly greater when the probability that the subject would be otherwise exposed to alcohol is lower. otherwise exposed to alcohol is lower.


When potential subjects include alcoholics who are When potential subjects include alcoholics who are current, active drinkers, the screening procedures must current, active drinkers, the screening procedures must clearly include a medical examination to assure the clearly include a medical examination to assure the absence of any medical or mental condition for which absence of any medical or mental condition for which further alcohol exposure at the dose contemplated would further alcohol exposure at the dose contemplated would be contraindicated. be contraindicated.

Further, it is incumbent on the investigator, or his/her Further, it is incumbent on the investigator, or his/her agent, to make a serious and concerted effort to link such agent, to make a serious and concerted effort to link such individuals with treatment. individuals with treatment. This linkage should be active in bringing together the This linkage should be active in bringing together the

subject with alcoholism treatment personnel, and not subject with alcoholism treatment personnel, and not passive as in only providing names of treatment passive as in only providing names of treatment programs and phone numbers to the research subject.programs and phone numbers to the research subject.

Whether or not the subject chooses to remain in the Whether or not the subject chooses to remain in the treatment program, it is incumbent on the investigator treatment program, it is incumbent on the investigator to actively facilitate entry of the research subject into to actively facilitate entry of the research subject into the program.the program.


The use of subjects who have completed the initial The use of subjects who have completed the initial phase of treatment and progressed into rehabilitation or phase of treatment and progressed into rehabilitation or recovery would require an extremely strong scientific recovery would require an extremely strong scientific justification justification and and risk/benefit assessment.risk/benefit assessment. Different factors will need to be considered, including Different factors will need to be considered, including

at what stage they are in the rehabilitation program at what stage they are in the rehabilitation program and the alcohol dose employed. and the alcohol dose employed.

Both the research staff and the treatment personnel Both the research staff and the treatment personnel must consider the potential for untoward effects on must consider the potential for untoward effects on the treatment/recovery process. the treatment/recovery process.

There should be a continuation of treatment after There should be a continuation of treatment after conclusion of research participation for a sufficient conclusion of research participation for a sufficient period to ensure continued recovery.period to ensure continued recovery.


At the present time (1989), it is considered inappropriate to At the present time (1989), it is considered inappropriate to administer alcohol to any recovering alcoholic who is abstinent administer alcohol to any recovering alcoholic who is abstinent and living a sober life in the community. and living a sober life in the community.

The Council believes that the issue of risk for relapse outweighs The Council believes that the issue of risk for relapse outweighs any consideration which may be afforded to the willingness of any consideration which may be afforded to the willingness of the subjects to participate in the project though informed and the subjects to participate in the project though informed and voluntary consent, or the unique requirements within a study to voluntary consent, or the unique requirements within a study to include recovered alcoholics to address the hypothesis posed. include recovered alcoholics to address the hypothesis posed.

This position is derived from an assessment of risk, since the This position is derived from an assessment of risk, since the risk of the exposure eliciting relapse (or other health problems) risk of the exposure eliciting relapse (or other health problems) is considered too great to warrant the recovering alcoholic's is considered too great to warrant the recovering alcoholic's participation.participation.

Is the applicant obtaining a family history in order to Is the applicant obtaining a family history in order to determine individuals who may carry a heightened determine individuals who may carry a heightened

familial or genetic risk to develop alcohol dependency?familial or genetic risk to develop alcohol dependency? Special consideration needs to be given to the Special consideration needs to be given to the

risk/benefit assessment before exposing individuals with risk/benefit assessment before exposing individuals with a family history of alcoholism to alcohol, and even more a family history of alcoholism to alcohol, and even more so when either dosage levels exceed the normal drinking so when either dosage levels exceed the normal drinking practice of the subject, or when the alcohol-naive practice of the subject, or when the alcohol-naive individual is proposed as the subject. individual is proposed as the subject.

It is appropriate to relate both in the assessment of the It is appropriate to relate both in the assessment of the risk/benefit and in the informed consent process that, in risk/benefit and in the informed consent process that, in the context of alcoholism, familial or genetic risks do not the context of alcoholism, familial or genetic risks do not mean predestiny or predetermination. Rather, the risk mean predestiny or predetermination. Rather, the risk translates into vulnerability which should appropriately translates into vulnerability which should appropriately suggest extra caution on the part of any individual with a suggest extra caution on the part of any individual with a family history of alcoholism in the context of any drinking family history of alcoholism in the context of any drinking situation, including, but not limited to, the research study.situation, including, but not limited to, the research study.

Has the age of the subjects been considered?Has the age of the subjects been considered? It is the Council' s opinion that persons who are under the State's legally It is the Council' s opinion that persons who are under the State's legally

set drinking age should normally not be given alcohol in research set drinking age should normally not be given alcohol in research protocols.protocols.

If the hypothesis under test clearly requires the involvement of individuals If the hypothesis under test clearly requires the involvement of individuals from that age group, and the risk/benefit assessment is strongly favorable, from that age group, and the risk/benefit assessment is strongly favorable, investigators must be sure to investigators must be sure to

obtain any underage subject's assent to participate in the research; obtain any underage subject's assent to participate in the research; obtain permission from the parent(s) or guardian for the underage obtain permission from the parent(s) or guardian for the underage

subject to participate in the research; subject to participate in the research; comply with applicable laws of the jurisdiction in which the research is comply with applicable laws of the jurisdiction in which the research is

being conducted being conducted As with all research, investigators and IRBs must adhere to the As with all research, investigators and IRBs must adhere to the

additional requirements for protection of children involved as subjects for additional requirements for protection of children involved as subjects for research, as contained in HHS Regulations for Protection of Human research, as contained in HHS Regulations for Protection of Human Subjects, 45 CFR Part 46, Subpart D.Subjects, 45 CFR Part 46, Subpart D.

The principles for all research with children dictate that the research first The principles for all research with children dictate that the research first begin with animals or adults before involving children. begin with animals or adults before involving children.

In addition, the investigative team should include individuals or the In addition, the investigative team should include individuals or the access to individuals who are sensitive to the needs of children, such access to individuals who are sensitive to the needs of children, such as, as appropriate, social service professionals, pediatricians, oras, as appropriate, social service professionals, pediatricians, or psychologists.psychologists.

Has the need been considered for medical Has the need been considered for medical and psychological evaluation of subjects prior and psychological evaluation of subjects prior

to participation in a study?to participation in a study? Medical and psychological screening may Medical and psychological screening may

be appropriate for given studies, be appropriate for given studies, depending on:depending on: the nature of the studythe nature of the study the maximal doses of alcohol usedthe maximal doses of alcohol used the subject populationthe subject population whether or not they are alcohol-dependent or whether or not they are alcohol-dependent or

using other drugs. using other drugs.

Has the possibility of pregnancy been Has the possibility of pregnancy been assessed for potential female subjects of assessed for potential female subjects of

childbearing age?childbearing age? The possibility of pregnancy should always be The possibility of pregnancy should always be

assessed and a standard hormonal pregnancy assessed and a standard hormonal pregnancy test included. test included.

While menstrual and contraceptive history may While menstrual and contraceptive history may be useful, the assessment of a pregnancy status be useful, the assessment of a pregnancy status should not be made solely by self-reported should not be made solely by self-reported information. information.

At the present time (1989), risk/benefit At the present time (1989), risk/benefit considerations almost always preclude considerations almost always preclude administration of alcohol to pregnant women as administration of alcohol to pregnant women as this may endanger the fetus. this may endanger the fetus.

Has the need for access to medical Has the need for access to medical backup services been considered? backup services been considered?

Depending on dose and subject population, the Depending on dose and subject population, the nature of the medical backup service will vary. nature of the medical backup service will vary.

In minimal circumstances, a nurse or physician In minimal circumstances, a nurse or physician available "on call" may be appropriate. available "on call" may be appropriate.

This may be amplified to require This may be amplified to require the presence of a nurse with a physician available "on the presence of a nurse with a physician available "on

call" orcall" or the requirement of the presence of a physician if higher the requirement of the presence of a physician if higher

doses of alcohol are used or if there are other issues doses of alcohol are used or if there are other issues pertaining to the study population. pertaining to the study population.

Will alcohol-naive individuals be used?Will alcohol-naive individuals be used?

The inclusion of alcohol-naive individuals in a The inclusion of alcohol-naive individuals in a protocol would need to be very strongly justified protocol would need to be very strongly justified within the context of both the requirement that within the context of both the requirement that such individuals be included to answer the such individuals be included to answer the research question posed and a strongly research question posed and a strongly favorable risk/benefit assessment including favorable risk/benefit assessment including consideration of benefits for other individuals consideration of benefits for other individuals with the disease or society as a whole. with the disease or society as a whole.

Will subjects be administered larger amounts Will subjects be administered larger amounts of alcohol than they would normally consume of alcohol than they would normally consume

in their own drinking contexts?in their own drinking contexts?

Such an activity should be justified within the Such an activity should be justified within the context of both the requirements for the scientific context of both the requirements for the scientific questions posed questions posed andand the risk/benefit the risk/benefit assessment. assessment.

Should also consider concentration and time for Should also consider concentration and time for consumption.consumption.

Council only referring to fixed dose and not ad Council only referring to fixed dose and not ad lib drinking here.lib drinking here.

Does the study protocol require an element of Does the study protocol require an element of deception or incomplete disclosure?deception or incomplete disclosure?

Deception or incomplete disclosure of information about Deception or incomplete disclosure of information about the research methods or goals is sometimes requiredthe research methods or goals is sometimes required E.g., in the elucidation of expectancy and placebo effects. E.g., in the elucidation of expectancy and placebo effects.

Research subjects are, however, entitled to a full debriefing Research subjects are, however, entitled to a full debriefing when it was necessary to deceive then.when it was necessary to deceive then.

The consent form should clearly indicate that they may The consent form should clearly indicate that they may receive alcohol and the amount of alcohol they may receive alcohol and the amount of alcohol they may receive. receive.

Information about risks should never be withheld for the Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about answers should always be given to direct questions about the research the research

Are appropriate provisions made to accommodate the Are appropriate provisions made to accommodate the subjects receiving alcohol at the research sites until subjects receiving alcohol at the research sites until the alcohol dose has been effectively eliminated? (1)the alcohol dose has been effectively eliminated? (1)

Providing transportation or escorting a subject back to a place Providing transportation or escorting a subject back to a place of residence (or employment) does not assure that the of residence (or employment) does not assure that the individual will not engage in hazardous activities.individual will not engage in hazardous activities.

In addition to having observable behavior return to normal, it is In addition to having observable behavior return to normal, it is

frequently considered appropriate for the BAC to fall below frequently considered appropriate for the BAC to fall below 0.02 gram percent. 0.02 gram percent.

In environments where the risk of engaging in hazardous In environments where the risk of engaging in hazardous activities is minimal, a level of 0.04 may be considered activities is minimal, a level of 0.04 may be considered acceptable, again, conditioned upon other observable acceptable, again, conditioned upon other observable behavior having attained sufficient normalcy.behavior having attained sufficient normalcy.


It may be prudent to require the subject with other than zero It may be prudent to require the subject with other than zero BAC and no apparent impairment to state in writing that BAC and no apparent impairment to state in writing that he/she will not drive a car or operate other machinery for he/she will not drive a car or operate other machinery for several hours after each experimental session.several hours after each experimental session.

The consent form should address the estimated period of time The consent form should address the estimated period of time

that the subject will likely have to stay at the research facility. that the subject will likely have to stay at the research facility. When dismissed from the laboratory (even with a BAC of When dismissed from the laboratory (even with a BAC of 0.02), subjects should be informed of the estimated time that it 0.02), subjects should be informed of the estimated time that it will take to reach a zero BAC and counseled on the potential will take to reach a zero BAC and counseled on the potential performance impairments to be expected during this period.performance impairments to be expected during this period.

Given the large variability in pharmacokinetic clearance rates, Given the large variability in pharmacokinetic clearance rates, the BAC should be determined with a certified or properly the BAC should be determined with a certified or properly calibrated breathalyser.calibrated breathalyser.


It is recognized that participants in a study, even if encouraged It is recognized that participants in a study, even if encouraged to remain at the testing facility, are free to leave the research to remain at the testing facility, are free to leave the research setting at any time. Should subjects leave prematurely, they setting at any time. Should subjects leave prematurely, they should be escorted back to their residence. should be escorted back to their residence.

Further, the consent form should address this contingency in a Further, the consent form should address this contingency in a statement similar to the following: "If you choose to leave in statement similar to the following: "If you choose to leave in the middle of the session, you will be sent home with care, by the middle of the session, you will be sent home with care, by a conveyance provided by us." a conveyance provided by us."

In some circumstances, consideration may also be given to In some circumstances, consideration may also be given to the use of so-called Ulysses contracts in which subjects agree the use of so-called Ulysses contracts in which subjects agree before the experiment begins to be temporarily restrained (in before the experiment begins to be temporarily restrained (in terms of leaving the facilities) even though they might protest terms of leaving the facilities) even though they might protest the restraint later, when their BAC is above the safe limits.the restraint later, when their BAC is above the safe limits.

Does any aspect of the study dictate the need Does any aspect of the study dictate the need for follow-up of subjects? If so, is this done?for follow-up of subjects? If so, is this done?

Depending on the nature of the study and the subject, it may Depending on the nature of the study and the subject, it may be appropriate to determine if there will be any delayed be appropriate to determine if there will be any delayed reaction from participation in the study. reaction from participation in the study.

This would be appropriate in some circumstances when This would be appropriate in some circumstances when subjects are alcohol-dependent or the offspring (adult or subjects are alcohol-dependent or the offspring (adult or otherwise) of an alcoholic. otherwise) of an alcoholic.

It is recognized that such follow-up may be difficult and/or It is recognized that such follow-up may be difficult and/or unattainable with some subject types. When this is true, unattainable with some subject types. When this is true, however, the applicant should explain why the particular however, the applicant should explain why the particular study population must be used.study population must be used.

Is the proposed payment to Is the proposed payment to participants likely to be coercive?participants likely to be coercive?

Payment to research subjects for their time Payment to research subjects for their time and inconvenience is an acceptable practice and inconvenience is an acceptable practice in alcohol as well as other biomedical in alcohol as well as other biomedical research. research.

Nonetheless, the payment should not be Nonetheless, the payment should not be coercive in the sense of tempting coercive in the sense of tempting individuals to participate.individuals to participate.

Is the method of payment appropriate Is the method of payment appropriate for the subject population?for the subject population?

In those unusual studies where alcohol-In those unusual studies where alcohol-dependent individuals are used as subjects, dependent individuals are used as subjects, immediate cash payments are easily convertible immediate cash payments are easily convertible for the purchase of alcoholic beverages and, for the purchase of alcoholic beverages and, thereby, may not be appropriate. thereby, may not be appropriate.

Therefore, care should be given to the manner Therefore, care should be given to the manner of payment: of payment: Who will get the payment? Who will get the payment? Where and in what form will payment be made? Where and in what form will payment be made? Can payment be made in a form other than moneyCan payment be made in a form other than money to to

avoid purchases of alcoholic beverages?avoid purchases of alcoholic beverages?

Web ReferencesWeb References Belmont ReportBelmont Report

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmhttp://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htmont.htm

Recommended Council Guidelines on Ethyl Recommended Council Guidelines on Ethyl Alcohol Administration in Human Alcohol Administration in Human ExperimentationExperimentation http://www.niaaa.nih.gov/extramural/job22-text.htmhttp://www.niaaa.nih.gov/extramural/job22-text.htm

Certificate of ConfidentialityCertificate of Confidentiality http://grants.nih.gov/grants/policy/coc/http://grants.nih.gov/grants/policy/coc/

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

http://www.niaaa.nih.gov/extramural/job22-text.htm

http://grants.nih.gov/grants/policy/coc/

Journal References on Journal References on Alcohol Challenge IssuesAlcohol Challenge Issues

Wood, M. D., & Sher, K. J. (2000). Risks of Wood, M. D., & Sher, K. J. (2000). Risks of alcohol consumption in laboratory studies alcohol consumption in laboratory studies involving human research participants. involving human research participants. Psychology of Addictive Behaviors, 14Psychology of Addictive Behaviors, 14, , 328-334.328-334.

Scientific MisconductScientific Misconduct(for general discussion)(for general discussion)

Plagiarism and Data Fudging/FraudPlagiarism and Data Fudging/Fraud What are they?What are they? Why do they happen?Why do they happen? What do you do if you become aware of What do you do if you become aware of

it?it? How can you prevent yourself from How can you prevent yourself from

committing scientific misconduct?committing scientific misconduct?

more on ethics and professional conduct

Documents

identifying information

research subjects

confidential information

information separate

research participants

certificate of confidentiality

types of research

research objectives