BINGHAMTON UNIVERSITY
HUMAN SUBJECTS RESEARCH REVIEW OFFICE
INVESTIGATORS GUIDELINES
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BINGHAMTON UNIVERSITY INVESTIGATORS GUIDELINES |
Download Investigators Guidelines PDF The purpose of this manual is to assist investigators planning to conduct research involving human subjects in designing their research and submitting it for approval. Investigators are urged to read this manual carefully in order to avoid unnecessary delay in obtaining approval for their research. |
ISSUES OF SPECIAL CONCERN
OBTAINING INFORMED CONSENT PROCEDURES FOR OBTAINING CONSENT VULNERABLE POPULATIONS Research Involving Prisoners Research Involving Minors |
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WHAT is human subjects
research? A living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information [45 CFR 46.102(f)] The Food and drug Administration (FDA) defines human subjects as: Human who participate in research either as a recipient of the test article or as a control. A healthy human or a patient. (21 CFR 50.3(g) and 56.102(e)). Subject is an individual on whom or on whose specimen an investigational device is used. (21 CFR part 812) WHY must it be reviewed? WHO reviews It? WHO must submit it? HOW is it submitted? WHEN does it have to be
submitted? HOW will it be reviewed? WHERE can I get assistance?
When an investigator plans to conduct research involving human subjects, he/she would be advised to read through the Investigators Guidelines and contact the Human Subjects Research Review Committee (HSRRC) Office at (607) 777-3818 or hsrrc@binghamton.edu if you have any additional questions. Aspects of the project that may be problematic can be discussed and alternative procedures suggested. At this point, the research often can be designed in a way that will facilitate approval.
ALL investigators, research personnel, faculty supervisors, and all other individuals involved in human participants research must complete a Federal Mandated Human Subjects Research Training Program. Investigators submitting new protocols, as well as those who may be continuing previously HSRRC approved research, must complete the course. The course can be found on our website: http://humansubjects.binghamton.edu The training program should be completed prior to the submission of your protocol. Re-certification is required every three years.
Determining Human Subjects Involvement Principal Investigators should contact the Human Subjects Research Review Office if they are unsure if their research actually involves "Human Subjects". All research projects involving human subjects conducted by University faculty, staff and students or done under the sponsorship or auspices of the institution must be reviewed and approved by the Human Subjects Research Review Committee (HSRRC). This includes research involving subjects from outside the university and research which is not funded. This includes the following types of research, (this is not an exhausted list)
Once it has been determined that an activity is to be considered human subjects research, it will be reviewed under one of three categories: Exempt, Expedited or Full Board Review. The review procedures for each of these are described below.Final authority for making this determination rests with the HSRRC.
Research that is not defined as “minimal risk - means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” And which can place the Human Subjects at risk, must be reviewed by the Full Board Committee. In order to approve research the committee must find all elements listed in 45CFR 46.111. This may include:
§46.111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116. (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
The HSRRC has developed Human Subjects Research Review Forms for submitting proposals. The forms can be found on-line at http://humansubjects.binghamton.edu/Forms.htm The form must be typed or neatly written and all documentation must be included. Ineligible forms will be returned to investigators without being reviewed. Students submitting materials should ask their faculty sponsor to e-mail the HSRRC confirming that they have read the materials submitted and are ready to sign off on the application. This e-mail needs to include the student investigator's name, title of the project and faculty sponsor's name and position. Student submittals will not be reviewed until this e-mail is received.
The following items, where appropriate, must be included with the Human Subjects Research Review Form
Protocol Evaluation
Under EXEMPT and EXPEDITED REVIEW, The proposal must be submitted, as an e-mail attachment, to hsrrc@binghamton.edu or by mail: Diane Bulizak, HSRRC, ITC Alpha Bldg. Room 2219. The review is then carried out by the Chair, or an authorized designee. The designee may approve the project, request additional information or submit the proposal to the full HSRRC for review and approval. The HSRRC may require a full review to reconsider any proposal approved under expedited review. The investigator is notified if a full review is required. If the investigator questions any determination made under expedited review, he/she has the option of requesting a full review by the HSRRC, which will make the final determination. Under FULL REVIEW, The proposal must be submitted, as an e-mail attachment, to hsrrc@binghamton.edu or by mail: Diane Bulizak, HSRRC, ITC Alpha Bldg. Room 2219. The review is generally conducted at the next convened meeting of the HSRRC. The HSRRC meets regularly during the academic year and as needed during the summer. A proposal must be received by the dates listed on the main webpage. Investigators are welcome to attend the meeting and answer questions or provide additional information regarding their projects. All student investigators must have a University supervisor who is responsible for ensuring compliance of all procedures of the approval. The faculty supervisor must sign the proposal, or forward an e-mail to hsrrc@binghamton, certifying that the project is under his/her supervision. Class projects may be reviewed as one proposal, at the discretion of the instructor. If the entire class is not using the same procedure, each student or group of students using a different procedure must submit the required information, but the class project will still be considered one proposal. In general, it is advisable for students to select research projects which are eligible for "exempt" or "expedited" review. In this way, approval for the projects will take very little time. Students are not, however, prohibited from conducting research that requires Full Board review, but additional time may be required to obtain approval from the full HSRRC. In all cases, it is the responsibility of the instructor to ensure that students use only approved procedures. To further expedite the approval of class projects, the instructor can obtain approval before the semester begins under two circumstances; 1) if all of the students are using the same procedures (e.g., a class survey) and the instructor has established the procedures before the class starts, or 2) the instructor submits a list of alternative procedures for approval and the students are to choose one from the list. For more information on Student Class Projects, informartion sheet and an application can be found on our website: http://humansubjects.binghamton.edu/Forms.htm A. Students: Under the SUNY Board of Trustees policy students may not be required to participate in any research project as a subject as a course requirement or required by faculty member to serve as a subject for pilot testing research instruments. Courses that involve a research requirement must make clear that participation in research, as a subject is one of several options to fulfill the research requirement. A written explanation of all research alternatives is strongly urged. The informed consent for projects proposing to recruit student participants must make clear the voluntary nature of their participation. B. Recruiting Subjects Over the Internet. The use of the Internet to recruit subjects presents similar issues as with any other recruiting tool. The HSRR Office needs to review information to be presented to subjects. Not only does the HSRR Office need to review the text of the recruitment, but it also has to examine the context in which the recruitment takes place (e.g., posting a message on a newsgroup or creating a web site to recruit subjects). When the Web is used to recruit subjects, the HSRR Office must see an example of what the prospective subjects will see (i.e., a "screen shot"). The Binghamton University HSRRC requries that all recruitment on the internet be limited to:
C. Advertising: Binghamton University considers direct advertising for study subjects to be the start of the informed consent and subject selection process. Advertisement should be reviewed and approved by the HSRR Office as part of the package for initial review. However, when the clinical investigator decides at a later date to advertise for subjects, the advertising may be considered an amendment to the ongoing study. When such advertisements are easily compared to the approved consent document, the HSRRC chair, or other designated HSRRC member, may review and approve by expedited means, as provided by 21 CRF 56.110 (b)(2). When the HSRRC reviewer has doubts or other complicating issues are involved, the advertising should be reviewed at a convened meeting of the HSRRC.
Although regulations require that all human subjects' research records be retained for three years following the completion of the research, we recommend that records be maintained in the investigator's files for an indefinite period following completion of the study. Approval of a project by the HSRRC applies only to the procedures submitted in the proposal. No form of recruitment, or any other aspect of the research, may commence until HSRRC approval has been issued. The investigator must secure prior approval from the HSRR Office for any changes in the procedures that will affect the use of human subjects. The investigator must also report to the HSRR Office any problems that arise in connection with the use of human subjects. Approval for projects is valid for no more than one year. See below for the procedures for obtaining a continuation of approval.
The HSRRC is required to continue to reevaluate research projects at intervals appropriate to the degree of risk but not less than once a year. For research involving no more than minimal risk, the approval period is generally one year. For research involving greater than minimal risk, the HSRRC will determine the appropriate approval period. For research with a one-year approval period, investigators must request a continuation for the approval yearly if the activity lasts more than one year. Four (4) continuations will be granted for a given project. After 5 years, the project must be resubmitted. The Continuing Review form requires the investigators to provide the following information:
Continuing review must occur on or before the one-year anniversary date of the previous HSRRC review, even though the research activity may not begin until some time after the HSRRC has given approval. As a result, the HSRR Office must receive the request for continuation sufficiently in advance of the anniversary date to allow it to conduct its review. Reminders will be sent out several weeks before the anniversary date. In the event that a continuing review is not received before the expired date, the protocol has expired and all recruitment and research activities must stop. You will be notified of these actions and a non-compliance form will be created and presented to you and for full board review. The full board review committee will assess the incidient and determine an action. If this is a continuous problem, the HSRRC may terminate the research approval. NOTE: IF APPROVAL FOR THE PROJECT LAPSES, CONDUCTING THE RESEARCH IS A VIOLATION OF UNIVERSITY POLICY AS WELL AS STATE AND FEDERAL REGULATIONS.
Modifications to Approved Research Changes or amendments to an approved research project cannot commence until reviewed and approved by the HSRRC. The PI will submit a modification form which outlines in detail the revisions, along with any other documentation required. When a full board reviewed protocol requires a modification, these modifications will be re-reviewed by the full board, unless the Chair or his designee has determined that the modification fits the Office of Human Rights and Protection criteria: 45 CFR 46.110(b) An IRB may use the expedited review procedure to review either or both of the following:
When a modification is requested from a previously exempt or expedited protocol and the proposed change is major and affects the risk to the participants, then the full board must review the revisions during a convened meeting. In rare circumstances when the change is necessary to eliminate immediate hazards to the research subject, the HSRRC should be informed of the changes following the implementation as soon as possible and should review the changes to determine that it is consistent with the protection of human subjects. Revised consent forms will be re-stamped showing the date of the approved modification. This action does not change the expiration date for the yearly review.
Unanticipated Problems/Adverse Events/Complaints According to Federal Guidelines 45 CFR 46(103)(b)(5) and 21 CFR 56.108(b), written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval. Federal regulations (45 CFR Part 46, Subpart A) require written procedures and policies for ensuring reporting of "unanticipated problems" involving risk to participants to the HSRRC, appropriate institutional officials, and the Department Head. An adverse event is an occurrence or situation during the course of a research project that includes, any serious or adverse events associated with the study procedures, and /or problems involving the conduct of the study which may occur during the course of his or her own research projects. Which Events Require a Report? Any problems involving the conduct of the study or patient participation. For example, social and behavioral interviews may deal with sensitive issues - occasionally, research subjects will become upset because of the nature of the questions, this requires reporting. Any problems involving the recruitment and/or consent processes require reporting. For example, if a person who is contacted, either in writing or in person, about participating in a study becomes upset about the recruitment process, this should be reported. Any deviations from the approved protocol should be reported in writing. Examples of a more serious nature include incidents of a person being enrolled in a study before signed consent has been obtained. How are Reports
Reviewed? What is the Effect of Failure to Report? Failure to report is a breach of the conditions under which HSRRC approval is given, and could result in suspension or revocation of approval. Suspension or revocation of approval could result in loss of support by funding agencies and loss of right to publish. The HSRRC will monitor performance of specific compliance issues and any non-compliance issues brought to the HSRR Office or the Office of Compliance and Risk Management (OCRM) attention. When investigator non-compliance issues are identified, The Human Subjects Research office has instituted the following procedures:
Allegations of serious non-compliance will be reported immediately to the HSRRC Chair, to the Director of OCRM and to the Institutional Official All unanticipated problems/adverse events/complaints must be reported promptly.
ISSUES OF SPECIAL CONCERN Audio/Video/Photographic Recordings Recording the voice and/or image of an individual creates a type of record that requires unique handling and storage, particularly is the content may be considered sensitive. Research subjects must be informed that such recordings will occur, and be provided with information about the storage, confidentiality, and future use of the recordings.
Conflict of Interest HSRRC members will not review, participate in the discussion of, or vote upon any research protocol for which they have a conflict of interest. No HSRRC member can take part in the initial or continuing review of a protocol in which they have a conflict of interest other than to provide requested information. Principal Investigators must fully disclose to all human subject participants, through the informed consent, any financial affiliation or any other monetary influence that the Principal Investigator may have with the research protocol. Principal Investigators must also include with the initial protocol application the following Conflict of Interest Form: http://humansubjects.binghamton.edu/Forms/Forms/Conflict%20of%20Interest%20Declaration52.rtf Binghamton University abides by the following Federal Guidelines conflict of interest requirements: Code of Federal Regulations, Title 42 Part 50 Subpart F. http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm Title 21, Chapter 1 – Food and Drug Administration, DHHS, Part 54 – Financial Disclosure by Clinical Investigators. Updated April 5, 1999. Access date April 25, 2001. Electronic Code of Federal Regulations: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr54_main_02.tpl
Deception
The debriefing should:
If having incomplete or erroneous information is not likely to be harmful to subjects, the HSRR Office will consider delaying the debriefing until all subjects have completed their participation. Care should be taken in debriefing to protect the well being of the subjects. All debriefings must be submitted as a written text document to the HSRR Office. The debriefing should always be a dialogue. Those conducting the debriefing should be trained to elicit and respond to subject concerns. Information should not be provided that might damage subjects' self-esteem or hurt their feelings. The use of highly evaluative terms (e.g. `We tricked you." Or `We lied to you.") should be avoided in explaining deceptions to the subjects.
All genetic research must be reviewed by the full HSRRC. Genetic research is constantly evolving and more personal information is being obtained. This information can have dire consequences on the human subjects and can affect the subject’s insurability and employment opportunities. Genetic studies that generate information about subjects’ personal health risks can provoke anxiety and confusion The following Binghamton University procedures and NYS laws must be taken into Informed Consent NY Civil Rights Law Section 79-1 For the researchers convenience we provide an informed consent template that addresses all of the issues concerning genetic research: http://humansubjects.binghamton.edu/Samples/DNA%20Informed%20consent%20sample.doc Archived specimen repository and bank requirements
The Archive will require regular inspection (2 times per year) by Environmental Health & Safety Staff. This inspection includes the standard EH&S audit. While scheduling this, you may request that your Biosafety Committee audit is conducted at the same time. The laboratory directors will be required to forward all audit reports and compliance approvals from EH&S and the Biosafety Committee to the Human Subjects Research Review Office. To schedule a lab inspection, EH&S can be contacted at hazwaste@binghamton.edu OR X 7-2211.
The Archive must be sufficiently secure to prevent theft, loss or destruction of valuable information. The laboratory director should be aware of all individuals with access to archive. Archive rooms should be locked and accessibly to laboratory personnel with key access. We recommend, if not already in place, that the archive be equipped with key-card access via a BU ID, so that there is an electronic time-stamped recording of personnel entering the lab.
The protocol must include a detailed description of what type of data has been collected and how all data records are stored and kept secure. All data should be protected and backed-up (on other computers or in file cabinets, etc). All data must be kept in a secure and defined location.
In order to function as human biological repository and specimen bank, the Archive will be required to establish an official material transfer and data use agreement for those researchers interested in obtaining samples. The Office of Technology Transfer and Innovative Partnership in the Division of Research will oversee this process. The laboratory directors will be required to forward all MTAs to the Human Subjects Research Review Office.
If the specimens in the Archive are identifiable and belong to living subjects it is a requirement to obtain a Certificate of Confidentiality before sharing information. This certificate can be obtained through the National Institutes of Health. However, if data has been de-identified this may not be required, although advisable. Please complete the DNA Archive Specimen and Data Storage application for committee review
Research in foreign countries also presents special concerns regarding the rights and welfare of human subjects. In general, the HSRRC accepts the standards of the location in which the research is taking place, unless those standards grossly violate the basic principles of ethical human subjects’ research. In addition, the following issues apply to international human subjects’ research:
Permission to Conduct Research (Social Behavioral)
It is clear that the Internet will be used more and more in conducting human subjects research. Research on the Internet presents new concerns to the traditional human subjects issues: risk, consent, participation by minors, and confidentiality. Investigators are going to have to provide technical information on how they will deal with these issues. The HSRR Office may require additional information on internet-based research issues. The National Institute of Mental Health has proposed suggestions for addressing such risks: http://humansubjects.binghamton.edu/internet-based-rsch-interventions-chart-may2007.pdf Internet-Based Issues may include:
Risk. There are two sources of potential harm to subjects from research: harm resulting from participation in the research (e.g., acute emotional reactions to certain questions), and harm resulting from breach of confidentiality. Since there is generally no direct contact with subjects participating in research over the Internet, it may be difficult or impossible to deal with individual subject reactions. As a result, some sensitive research may not be appropriate for the Internet. Breach of confidentiality is the primary source of harm in most Internet research and is dealt with below. Consent. Since it is currently not possible to get a signed consent form over the Internet. Investigators can have subjects submit a signed consent form and send them a password to gain access to the research pages. In any event, investigators must indicate to the HSRRC how they plan to get consent from subjects. Confidentiality. Since it is impossible to guarantee absolute data security over the Internet, sensitive research may not be appropriate for the Internet. Investigators need to address how they intend to assure confidentiality, keeping in mind that the degree of concern over confidentiality is directly related to the sensitivity of the data. Data transmitted via e-mail cannot be anonymous without the use of additional steps. Almost all forms of e-mail contain the sender's e-mail address. In order to maintain anonymity the research must use an "anonymizer" - a third party site which strips off the sender's e-mail address. (Form more information on Anonmizer(s) visit: www.anonymizer.com; www.rewebber.com; wwww.mutemail.com) Data submitted over the Web can only be anonymous if software is used to store the information directly in a database without identifiers; otherwise identifiers are attached to the data. Web servers automatically store a great deal of personal information about visitors to a web site and that information can be accessed by others. For more information on ethical internet based research, please visit the Association of Internet Researchers: The Association of Internet Researchers is an academic association dedicated to the advancement of the cross-disciplinary field of Internet studies. It is a member-based support network promoting critical and scholarly Internet research independent from traditional disciplines and existing across academic borders. The association is international in scope. http://www.aoir.org/reports/ethics.pdf Types of Research on the Internet. There are three types of research conducted on the Internet:
Recruiting Subjects Over the Internet. The use of the Internet to recruit subjects presents similar issues as with any other recruiting tool. The HSRRC needs to review information to be presented to subjects. Not only does the HSRRC need to review the text of the recruitment, but it also has to examine the context in which the recruitment takes place (e.g., posting a message on a newsgroup or creating a web site to recruit subjects). When the Web is used to recruit subjects, the HSRRC must see an example of what the prospective subjects will see (i.e., a "screen shot"). Observation of Internet Activity. Observation of Internet activity usually involves such activities as gathering information about the use of the Internet and/or recording user information or users' comments. Examples include: participant observation of an on-line discussion group, using "cookies" to track web sites visited, or asking visitors to a web site to provide demographic information. The human subjects issues involved in this type of research generally involve consent/disclosure issues. Investigators need to indicate to the HSRRC how they intend to obtain the subjects' consent to use this information for research. As with other types of participant observation, investigators generally must disclose their role as researchers to the group participants. The HSRRC must see an example of what the prospective subjects will see (i.e., a "screen shot"). Collecting data over the Internet. This type of research generally involves having subjects submit data, e.g., survey data, over the Internet and presents the most serious human subjects concerns. As in the other types of Internet research, the investigator needs to indicate how subjects' consent will be obtained and their confidentiality protected. Of particular concern with this type of research is the participation by minors and investigators must address this issue in their HSRRC protocols. The HSRRC must see an example of what the prospective subjects will see (i.e., a "screen shot").
Investigational New Devices (IND) All device studies require full board review. The Principal Investigator will supply the following information: a description of the device, reports of prior investigations with the device, the proposed investigational plan, a description of patient selection criteria and monitoring procedures, as well as any other information that the HSRRC deems necessary to make its decision. The application must include information that describes the type of device study: Significant Risk (SR), Non-significant Risk (NSR), and exempt studies. Sponsors are responsible for making this initial determination. SR studies must fully comply with FDA regulations 21 CFR 812, and NSR studies must comply with the abbreviated requirements 21 CFR 812.2(b). : For more information please refer to the following links:Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, US Department of Health and Human Services, FDA Center for Devices and Radiological Health (CDRH), January 2006 ..\Education\Articles Guidelines\SR vs NSR Studies_2006.pdf FDA Code of Federal Regulations Website http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm Principal Investigators (Researchers) conducting studies in which an investigational device will be used must ensure adequate control of the device. Adequate control and handling off investigational devices include all of the following:
All research that is conducted by Binghamton University’s Faculty, Staff or Administrators that works in collaboration with another institution must obtain an IRB approval from the collaborating institution, or, if an IRB does not exist a letter of collaboration or permission must be obtained from the appropriate official. All modifications, revisions, continuing reviews, adverse events, unanticipated problems, complaints and any other correspondence that is received from the collaborating institution must be forwarded to the HSRR Office. Often social scientists conduct research on organizations rather than individuals. Since the information gathered in this research is not about individuals, there is often a great deal of confusion about compliance with human subjects requirements. "Organizational research" is defined as research obtaining information only about organizations, not about the individuals in or served by the organizations. Any research which gathers information about individuals (whether identified or not) must meet the human subjects requirements described in this Guidebook. The human subjects requirements for organizational research depends on the source and nature of the information obtained. There are three categories of organizational research:
Please consult the HSRR Office for information concerning organizational research categorization.
Payment to subjects must be allocated as outlined by the FDA guidance listed below: Food and Drug Administration Information sheets: Guidance for Institutional Review Boards and Clinical Investigators: 1998 Update: Sponsor-Investigator-IRB Interrelationship “…Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date. While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive. The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.”
The Office has a complete list of all questionnaires that were previously reviewed and approved and also notes the Human Subjects audience that was involved in the research. For a complete list of pre-approved questionnaires, please review this site: Questionnaires Questionnaires are the most common research method used in human subjects research at the University. As a result, researchers often overlook some of the human subjects concerns that can hold up approval of a questionnaire study, such as consent and confidentiality. Consent: Although most questionnaire studies do not require a written consent form, researchers must still ensure that subjects are giving informed consent to participating in the study. All questionnaires must include some form of cover sheet or instructions to subjects which provides subjects with the same information that would be included in a consent form. In particular, subjects need to be informed:
Confidentiality: In even the most innocuous questionnaire research, all research information must be kept strictly confidential. Complete anonymity is the best protection from breaches of confidentiality. Researchers must be aware that demographic information, in some circumstances, can be an identifier. Anything that allows an individual subject to be identified is an identifier and this information must be protected. The degree of protection depends on the sensitivity of the information. Another point that is often overlooked is the collection of completed questionnaires. In some circumstances, the individuals collecting the questionnaires can identify who turned in which form. For sensitive information, it would be best if forms were returned in sealed envelopes.
In addition to the basic requirements for conducting human subjects research specific research topics present additional concerns relating to the rights and welfare of research subjects. The HSRRC has often delayed or disapproved protocols in these topics until additional information or a Certificate of Confidentiality has been issued According to the Office for Human Research Protection, Institutional Review Board Guidebook, Chapter 3, Section D. Privacy and Confidentiality, the policy states:
Risks In this kind of research, risks often include:
In some research (e.g., about fetal alcohol syndrome), the people at risk include not only the subjects of the research, but third parties (e.g., the mothers) as well. Confidentiality. One of the most important risks in socially sensitive research is the effect of a breach of confidentiality. The researcher must make every effort to try to ensure confidentiality; we suggest relying on anonymity whenever possible. Anonymity means that no one, not even the investigator, can identify an individual subject. Simply eliminating names and other obvious identifiers does not guarantee anonymity; demographics can sometimes identify subjects as well. Any information or pattern of information that can uniquely identify an individual eliminates anonymity. When anonymity is not feasible, then the researcher must demonstrate to the HSRRC how confidentiality can be assured. Depending on the sensitivity of the subject matter, extra care should be taken to ensure that subjects cannot be identified. With some research topics, such as sexuality or criminality research, not only is the information sensitive, but the subjects' presence in the study can be a sensitive piece of information. Social Risks. If the research concerns illegal behavior, (e.g., a study of HIV and risk factors among prostitutes), the researcher may need to have the cooperation of local legal authorities or a federal Certificate of Confidentiality (see section on Certificates of Confidentiality). If there is a risk of triggering retribution by others, such as violence by abusing partners, the researcher must ensure that nothing given can identify a person as a respondent. Risk to the community must be minimized, often by researchers and community agreeing about publication, (e.g., whether to identify the community). Benefits. Researchers should also maximize benefits of the research to each volunteer and community. They must ensure availability of services to the volunteers. For a survey of fetal alcohol syndrome, for instance, researchers should link to established, or help establish, real services of prevention and treatment. At the very minimum, subjects should be provided with sources of help and support available in the community. Coercion. Research involving emotionally vulnerable subjects should avoid coercion by caregivers. Many patients who are dependent on caregivers' help may feel that refusing to take part in research will lead to loss of the care they need, in spite of the written "non-coercion disclaimer" in consent forms. One way to avoid the problem is to emphasize repeatedly the freedom to refuse. Another is to have at least the consent, and sometimes the research as well, done by people other than the caregivers. Mandatory Child Abuse Reporting All research that involves children and/or individuals who may divulge acts of abuse must be fully informed that NYS requires mandatory reporting of abuse by those individuals listed below. According to Section 413 of the Social Services Law, the following persons are mandated child abuse reporters in New York State:
Situations In Which Reports Are Required Whenever a mandated reporter suspects child abuse or maltreatment while acting in his/her professional capacity as a staff member of a medical or other public or private institution, school, facility, or agency, he or she shall immediately notify the person in charge of that school, facility, institution or his/her designated agent, who will then (also) become responsible for reporting or causing a child abuse report to be made to the county Child Protective Services agency. It should be noted that Section 413.1 of the Social Services Law does not require more than one report from the institution, school, facility, or agency on any one incident of suspected abuse or maltreatment. However, the mandated reporter's obligation is not discharged unless the report is made.
One method commonly used to protect confidentiality is to use subject codes rather than names or other identifiers. Care must be taken, however, to ensure that the code cannot be used as an identifier. For example, a frequently used code is the last four digits of the subject's social security number. Unless an extremely large number of subjects are being used, this number can still be used to identify an individual subject. Arbitrary or random codes are much better at protecting confidentiality. On the other hand, when different sets of data for a single subject must be linked, an arbitrary code is usually unsuitable because subjects will forget them. In these cases, the best method is to provide subjects with a formula that they can use to generate a unique code and which will generally result in the same code number each time the subject uses it. The following is an example of a workable formula:
FOR EXAMPLE: If your mother's name was Sally and your father's name was George and you were born on May 1st, you would enter: SA GE 05 01
OBTAINING INFORMED CONSENT Informed consent is not a single event or just a form to be signed -- rather; it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include full disclosure of the nature of the research and the subject's participation, adequate comprehension on the part of the potential subjects, and the subject's voluntary choice to participate.
Definition of Informed Consent Informed consent is one of the primary ethical principles governing human subjects research; it assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. "Informed consent" means the knowing consent of an individual, or his/her legally authorized representative, who is able to exercise free power of choice without undue inducement or any form of force, fraud, deceit, duress or other form of constraint or coercion.
State and Federal Informed Consent Requirements New York State: defines “Voluntary informed consent” (NY Public Health Law, Article 24-A; Section 2442; March 1998) as the legally effective knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion….The basic elements are information, understanding and voluntary agreement. Information includes:
Federal Regulations 45 CFR 46.116(a) details the following elements of information that must be provided to each subject:
Federal Regulations 45 CFR 46.116 (b) When appropriate, one or more of the following elements of information shall also be provided to each subject:
Informed consent is not valid unless the consentor understands the information that has been provided. While no one can guarantee that another person has understood the information presented, it is the responsibility of the investigator to do what he/she can to enhance each prospective subject's comprehension of the information. To determine the appropriate way to present the information, the investigator must consider:
Factors such as age, education level, cognitive ability, and language fluency directly affect subject comprehension of information. The manner of presentation, including the specific wording of the information, must be tailored to facilitate comprehension by each individual subject.
The investigator should be aware that, even if the HSRRC has approved a consent procedure, it is his/her responsibility to ensure that each potential subject understands the information and to take whatever steps are necessary to gain that comprehension. Individuals may not be used as research subjects unless they understand the information that has been provided.
Consent is a legal concept and only legally competent adults can give consent.
In order to be valid, consent must be freely given. That means that it is free from all forms of coercion. In addition to overt coercion, the investigator needs to be sensitive to more subtle forms of coercion, such as social pressure, requests from authority figures, and undue incentive for participation. Since coercion exists when it is perceived by the subject, the investigator must attempt to view the consent process from the subject's perspective. For example, a teacher asks her class to participate in research. Even if she tells the class that participation will not affect their grades, most students will assume that they will somehow be penalized for not participating. The potential subjects perceive a coercive |