Institutional Review Board (IRB) Guide (Revised July 2009)
Mission: Emmanuel College’s IRB reviews research with human participants. Research is defined as a systematic investigation whose purpose is to contribute to generalizable knowledge. At Emmanuel College, research is not expected to expose participants to any risk of physical danger or psychological distress other than what they would typically encounter as part of daily living.
This Guide incorporates information and language adapted from Department of Health and Human Services (DHSS) documents, the Simmons College IRB Manual, and the Sacred Heart University IRB Guide, and Consent Documents of University of Chicago, Fuller Theological Seminary, and Clemson University. We thank Dr. Diana Stork for founding the IRB at Emmanuel College.
Table of Contents
Pages
Purpose of the IRB
1
Statement of Principles
2
Online Resources
3
Members of the IRB for 2009-2010
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How the IRB Reviews Research Proposals What is the Definition of Research? Assessment of Risk What are the Levels of Review? Levels of Review in Detail Exempt from Review Expedited Review Full Review Decisions
5 5 6 6
When to Submit for Review (2009-2010 schedule)
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What and How to Submit a Research Proposal for Review
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1. Proposal Submission Form (required) 2. Consent Form (depends on project) Purpose Contents Waivers Instructions for Preparation Research with Vulnerable Populations Sample Template of a Consent Form Additional Documentation (depends on project) 3. Research Instruments 4. Recruitment Materials 5. Authorizations
4 4 4
9 14 15 16 17 18 20 24 24 24
Important Additional Considerations Safeguarding Information Changes to the Research Protocol Reporting Adverse Events Renewal of Proposals
24 25 25 25
Student Research in Non-Research and Research Courses and in Research Internships Definitions of Terms
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I. The Purpose of the Institutional Review Board (IRB) of Emmanuel College Emmanuel College is committed to the pursuit of high quality research and applied scholarship to meet the needs and interests of the academy, the College, and the community. At the same time, the College is committed to protecting the welfare of every person who may be involved in research and training projects. Members of the College community, while upholding the highest standards of freedom of inquiry and communication, accept the responsibility this freedom offers: for competence, for objectivity, and for the welfare of every participant in a project. The College has provided a formal guarantee to the U.S. Department of Health and Human Services (DHHS) that it will follow procedures to assure the protection of all human participants involved in research projects. This guarantee applies to all research conducted by anyone on the premises of Emmanuel College and to all research conducted elsewhere by faculty, students, staff, or other representatives of the College. In order to comply with this assurance, the College has established an Institutional Review Board (IRB) or Ethics Review Board competent to review projects that involve human participants in order to ensure that each project complies with the highest ethical standards. In addition to its mandated review functions, the IRB is committed to serving as an educational resource for the Emmanuel College community. The purpose of this document is to assist Emmanuel College investigators in the preparation and submission of research proposals for review by the IRB. The policies and procedures of the IRB are based on the rules and procedures mandated by DHHS Regulations for the Protection of Human Research Participants (45 CFR 46, as amended). http://www.hhs.gov/ohrp/humanparticipants/guidance/45cfr46.htm An excellent book that describes the rules and procedures is Bankert, E. A., & Amdur, R. J. (2006) (Eds.) Institutional review board: Management and function. Boston: Jones and Bartlett which can be obtained in the Emmanuel library. It is the responsibility of the Emmanuel College IRB to protect human subjects and facilitate research conducted by its faculty, staff, and students. When the IRB encounters questions about a proposal, it will attempt to consult with someone knowledgeable in the investigator’s field of study. If no one on the IRB meets this criterion, investigators may request that a particular person who is an expert in the area and who is willing to act as a consultant to the IRB be involved in the review. Although that person will not be able to vote on a proposal, their recommendations will be weighed heavily in the IRB’s decisions. In accordance with the Belmont report, Emmanuel’s IRB research policies and procedures are designed to ensure respect for participants, beneficence, and justice in the conduct of all research. Respect ensures that the dignity of all participants is protected by ensuring their safety and privacy. Likewise, participants are expected to be able to make informed judgments about their desire to participate in a research project, and vulnerable participants are provided with extra protections. Beneficence demands that any costs to individual participants must be outweighed by clear 1
benefits. Third, justice is carried out by ensuring that populations are included or excluded only for reasons directly related to the research project itself. It is the responsibility of all members of the Emmanuel College community to observe these policies and procedures for themselves and on behalf of their students. The College assumes no legal responsibility for individuals who do not conform to the IRB’s regulations and receive IRB approval for all research projects. Furthermore, failure to comply with the IRB’s regulations could impugn the investigator's own name and the reputation of the College and could lead to restrictions on the research activity of the individual and the College. All research projects involving the use of human participants must be reviewed by the IRB. Submission and review procedures are described in this Guide.
II. Statement of Principles of Emmanuel College’s IRB Emmanuel College affirms the value and dignity of the individual person. The value of the person, it is maintained, supersedes and anchors all other values. Persons are never to be treated as mere means but always, at the same time, as ends in themselves. The doctrine of the supreme worth of the person is reflected in American political society in the theory of human rights that underlies the legal system. It is also articulated in such statements as the United Nations' Universal Declaration of Human Rights (1948), the declaration of the Helsinki Agreement (1964), and the Belmont Report (1979). Moral principles not only serve as a basis of social unity but also can provide guidance for individual decision-making. Cases of perplexity arise in various contexts, including that of research involving human participants. Moral principles express ways of resolving perplexities that are well established in scientific and medical practice. An examination of these principles may provide insight into the possibility of making morally sound decisions. A fundamental principle of morality is that of respect for persons, which embodies the conviction that persons are to be treated as autonomous agents. In the context of research involving human participants, respect for persons requires that participants be given the opportunity to determine what shall or shall not happen to them. This opportunity is provided by the requirement of informed consent. Consent is informed when the participant is fully appraised of the risks s/he may undergo in participating in a given research study. Consent is genuine when the participant has the right to refuse participation without recrimination.
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III. Online Resources for IRBs Helpful Human Participants Research resources are listed here. As additional resources are identified, they can be added and posted on the IRB’s FirstClass conference: http://www.hhs.gov/ohrp/ (Office of Human Research Protections; links to other resources) http://www.apa.org/science/rcr/homepage.html (APA research ethics page, links to other resources) http://ori.dhhs.gov/education/products/rcr_humans.shtml (Office of Research Integrity, links to other resources) http://www.ed.gov/about/offices/list/ocfo/humansub.html (Protection of human participants, U.S. Dept of Education) http://www.irbforum.org/ (IRB Forum, with announcements, events, and links to other resources) http://www.msmr.org/IRBResources.html (Mass Society for Medical Research, again good links) http://www.aapor.org/additionalirbresources (American Assoc for Public Opinion Research, again with good links)
IV. Members of Emmanuel College’s IRB for 2008-2009 IRB Administrator: Dr. Frank Scully, Vice-President, Academic Affairs IRB Chair: Prof. Joyce Benenson (Psychology) e-mail: Benensjo@Emmanuel.edu IRB Administrative Assistant: Ms. Diane Bissaro (Dean’s Office, ADM 209) e-mail: Bissardi@Emmanuel.edu IRB Non-Scientists: Ray Devettere (Philosophy), Fr. Tom Leclerc (Religion) IRB Scientists: Gouri Banerjee (Information Technology), Geraldine Chalykoff (Nursing), Christine McKenna (Sociology), Jennifer Nepper Fiebig (Psychology), Kimberly Santucci Sofronas (Education), Bette Weiss (Biology), Todd Williams (Biology) IRB Outside Member: Susan Keane (e-mail: Skeane929@aol.com)
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V. How Emmanuel College’s IRB Reviews Research Proposals A. What is Research with Human Participants? Emmanuel College’s IRB reviews research with human participants. Research is defined as (1) a systematic investigation (2) whose purpose is to contribute to generalizable knowledge (Bankert & Amdur, 2006, p. 101). That is, a systematic attempt in which “the primary goal of the activity must be to develop or contribute to generalizable knowledge” (Bankert & Amdur, 2006, p. 101). Under this definition some demonstration, service, and training projects may be considered to include research activities. A human participant is defined “as a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable, private information” (Bankert & Amdur, 2006, p. 101). Any person proposing to conduct research involving human participants must prepare a project proposal for review by the IRB. The main purpose of the proposal is to describe the research in sufficient detail that the IRB can understand the research purposes, procedures, and protections against risk, including violation of privacy. This will allow the IRB to determine whether adequate protection of the rights and welfare of prospective research participants is provided in accordance with all pertinent laws, regulations, and policies. It is the responsibility of the research investigator to comply with all IRB decisions, conditions, and requirements.
B. Levels of Review An investigator submits a research proposal for one of three levels of review: (1) Exempt from review (2) Expedited review (3) Full review Whether a research proposal is designated to be exempt from IRB review or will receive an expedited or full review very much depends on the risk assessment. Investigators should submit their proposals for the level of review they believe is most appropriate based on the criteria listed below. The Chair of the IRB will make the final decision.
C. Assessment of risk To determine whether the participant will be harmed in any way, the IRB will make a decision based on common sense and sound professional judgment as to whether or not the proposed research places the participant "at risk." A participant is considered to be at risk if s/he may be exposed to the possibility of harm, whether physical, psychological, sociological, or other. The IRB will consider the fact that certain participant populations (e.g., minors, pregnant women, prisoners, mentally hadicapped, workers, culturally or socioeconomically disadvantaged individuals) may be at greater risk than others. Certain risks are inherent in life itself, but the IRB is not concerned with the ordinary risks of public or private living. Risk as applicable to DHHS policy is most obvious in medical and 4
behavioral science research projects involving procedures that may induce a potentially harmful altered physical state or psychological condition. The most obvious examples include surgical procedures, the administration of drugs or radiation, the requirement of strenuous physical exertion and an intervention that precipitates an emotional disturbance. There is also a wide range of medical, social and behavioral procedures and projects in which, although there may be no immediate risk, procedures may be introduced that involve discomfort, anxiety, harassment, invasion of privacy, or that constitute a threat to the participant's dignity. There are also medical and biomedical projects concerned solely with organs, tissues, body fluids and other materials obtained in the routine performance of medical services that obviously involve no element of physical risk to the participant, but their use for certain research, training, and service purposes may present psychological, sociological, or legal risks to the participant or authorized representatives. Finally, the risk element will be examined for those studies dependent upon existing information or stored data that have been obtained for quite different purposes but that, when used in a research context, may present risk to the human participant. Risks in relation to other factors If it is judged that the proposed research project will expose a participant to risk, then the IRB must assure itself that (a) the rights and welfare of the participant are adequately protected, (b) the methods used to obtain informed consent are adequate and appropriate, (c) the risks to the participant are outweighed by the potential benefit to the participant or by the importance of the knowledge to be gained, and (d) risks to participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk.
D. Levels of Review in Detail 1. Exempt from review A research project is exempt from review if it consists of (1) Normal Educational Practices in Typical Educational Settings, (2) Anonymous Educational Tests, Surveys, Interviews, or Observations where participants cannot be identified and no disclosure of participants’ responses could place them at risk civilly, criminally, financially, or damage their financial standing or reputation, (3) Public officials or candidates for public office are involved in #2, (4) Information has been collected already and participants cannot be identified (but see medical-HIPPA and educational-FERPA regulations regarding privacy), (5) Public Department or Agency Heads are examining Public Services, and (6) Taste and Quality Food Studies with wholesome foods and contaminants below minimal acceptable levels (Bankert & Amdur, 2006, pp. 94-95). Because it is difficult to know whether a research project meets these criteria, an investigator must complete a proposal submission form, and the IRB Chair will determine whether further review is warranted. If a submitted proposal is determined by the Chair of the IRB to be exempt from review, the investigator will be notified rapidly. The investigator may begin the study after two hard copies of the appropriate forms have been provided to the IRB office and stamped by the IRB Administrator. If a proposal does not qualify for exemption, the investigator will be notified and advised on the level of review required: expedited or full review. 2. Expedited review due to minimal risk Research activities involving no more than minimal risk may be reviewed by the IRB through the expedited review procedure. Continuing research activities that were approved by the IRB within 5
the past year also may be approved through the expedited review procedure. Expedited review is appropriate for (1) collection of biological specimens through non-invasive means excluding xrays or microwaves but including collection of bodily tissues or fluids, application of physical sensors, physiological/neuroscience tests, moderate exercise and flexibility, (2) research on materials already collected provided privacy is ensured, (3) collection of data from voice, video, digital recordings, or image recordings provided confidentiality is ensured and identification of the participants and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, insurability, reputation, or be stigmatizing, (4) research on group characteristics or behavior as long as the group will not face stigmatization, and (5) continuing review of research previously approved by a full IRB review as long as no new data is collected (Bankert & Amdur, 2006, pp. 99-100). The expedited review procedure may not be used unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. Under an expedited review procedure, the review may be carried out by the Chair of the IRB, with or without consultation with other IRB members. 3. Full Review All proposals that do not qualify for exemption or expedited review, including all research that involves more than “minimal risk,� must be submitted for review by the full IRB. Under a full review procedure, a majority of the members of the IRB will be present, including at least one member whose primary concerns are in non-scientific areas. The investigators may be invited to the meeting to clarify parts of the proposal. In order for research to be approved, it must receive the approval of a majority of those present at the meeting.
E. Decisions If a research proposal is exempt from review, then it is approved and the investigator can begin the study as soon as the paperwork has been submitted. Decisions regarding expedited and full reviews will be assigned to one of four categories: Approved: The investigator may begin the study as soon as the paperwork for the proposal has been submitted to the IRB Administrative Assistant. Approved contingent upon specific modifications: The investigator will be notified in writing as to the nature of the required modifications. The investigator must comply with all required modifications and resubmit a corrected proposal to the Chair of the IRB incorporating the modifications. Once the Chair of the IRB approves the research proposal, the investigator may begin the study as soon as the paperwork for the proposal has been submitted to the IRB Administrative Assistant. Deferred due to serious concerns: Members of the IRB or the full IRB are uncertain whether the investigator can address adequately their concerns. The investigator will be notified in writing as to the nature of their concerns and required modifications. If the investigator believes s/he can 6
comply with all required modifications, the investigator must resubmit a corrected proposal to the Chair of the IRB incorporating the modifications. Once the Chair of the IRB or the full IRB approves the research proposal, the investigator may begin the study as soon as the paperwork for the proposal has been submitted to the IRB Administrative Assistant. Disapproved: The full IRB has decided that the investigator may not proceed with the project. After all decisions, the investigator can contact either the Chair of the IRB or another IRB member designated by the Chair to discuss the proposal.
VI. WHEN TO SUBMIT FOR REVIEW All IRB inquiries and proposals should be submitted on Thursdays before 5pm. Proposals are due one week prior to the scheduled IRB meeting as detailed below. Exempt proposals and addenda are accepted on any Thursday. Adverse effects must be reported immediately to the IRB Administrative Assistant, Ms. Diane Bissaro, who will inform the IRB Chair that day. All questions, revisions, and other relevant information must be sent to the IRB Chair, Dr. Joyce Benenson, at IRB@Emmanuel.edu or to the IRB Administrative Assistant, Ms. Diane Bissaro, at Bissardi@Emmanuel.edu The IRB Chair, Dr. Joyce Benenson, will respond to queries only on Thursdays.
Schedule for 2009 - 2010 academic year Fall 2009 Proposal due September 3, 2009 September 17, 2009 October 1, 2009 October 15, 2009 October 29, 2009 November 12, 2009 December 3, 2009
IRB meeting September 10, 2009* September 24, 2009 October 8, 2009 October 22, 2009* November 5, 2009 November 19, 2009* December 10, 2009*
Spring 2010 Proposal due January 7, 2010 January 21, 2010 February 4, 2010 February 18, 2010 February 25, 2010 March 18, 2010 April 1, 2010 May 6, 2010
IRB meeting January 14, 2010 January 28, 2010* February 11, 2010 February 25, 2010* March 4, 2010 March 25, 2010* April 8, 2010* May 13, 2010*
*Full reviews can be guaranteed only at these meetings. Note: It is critical that professors preparing to submit multiple proposals for research courses take these deadlines into consideration when preparing their courses.
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VII. WHAT AND HOW TO SUBMIT FOR IRB REVIEW 1. Proposal Submission Form
All Levels of Review
2. Consent, Permission, or Assent Forms
If used, include for all Levels of Review
3. Instruments for Data Collection
If used, include for all Levels of Review
4. Recruitment Materials
If used, include for all Levels of Review
5. Authorization(s) from cooperating institutions, organizations, or agencies, as needed.
If used, include for all Levels of Review
6. CITI forms must be completed.
All Levels of Review
The IRB proposal form is available online at http://www.emmanuel.edu/Academics/Academic_Resources/Institutional_Review_ Board.html The form must be downloaded and sent electronically, along with relevant documents, in one attachment to IRB@Emmanuel.edu After the IRB has approved a project, two hard copies of the IRB proposal plus all forms related to the project with the investigators’ signatures must be brought to Ms. Diane Bissaro in the Dean’s Office (ADM 334A). Both copies must be stamped by Ms. Bissaro. One will be filed in the IRB office and the investigators must retain the second. A project cannot begin without the proper forms being filed. Investigators with questions concerning the development, submission, or status of their proposal should contact either the IRB Chair, Dr. Joyce Benenson, at IRB@Emmanuel.edu or the IRB Administrative Assistant, Ms. Diane Bissaro, at Bissardi@Emmanuel.edu.
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Office Use Only PROPOSAL CODE
IRB Proposal Submission Form
Submission Date:
Click here to enter a date.
Principal Investigator:
Click here to enter text.
E-mail:
Click here to enter text.
Position of Principal Investigator
Choose an item.
Faculty Advisor (if student):
Click here to enter text.
Anticipated Start Date:
Click here to enter a date.
Anticipated End Date:
Click here to enter a date.
Anticipated Level of Review:
Choose an item
If more than one Investigator, names of other Investigators and their positions: Click here to enter text.
1. Proposal Title: Click here to enter text.
2. Briefly describe the questions/hypotheses you will address: Click here to enter text.
3. In two or three paragraphs, briefly provide a rationale for your research project based on prior literature. Write so non-specialists will comprehend your project: Click here to enter text.
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4. Describe in detail the design of your project, or how you will analyze your data: Click here to enter text
5. Describe in detail all methods including the procedures and measures you will employ. Please attach appendices with the precise instruments, if applicable. Click here to enter text 6. Are you planning to use deception in your study? If so, justify its use: Note:The IRB discourages the use of active deception in research. Click here to enter text
7. Are you planning to include a debriefing session at the conclusion of your study? If so, provide a rationale for using a debriefing and a precise description of the debriefing. Choose an item 8. Describe in detail all demographic information (age, gender, ethnicity, etc.) that you will collect: Click here to enter text. 9. Describe the population that you will include in your research proposal and why you chose that population. Indicate whether you have any special knowledge of or experience with this sample population: Click here to enter text. 10. Estimate the approximate number of participants you expect to include: Click here to enter text.
11. Describe in detail how you will recruit your participants. Participating Emmanuel students must be 18 years of age or older. Describe the process you will use to ensure this age restriction is met. Indicate if you are using students in the Psychology Department Participant Pool. Please write verbatim the information you will post to recruit your participants: Note: If you are recruiting participants from another institution, you may need to get approval from that institution’s IRB, as well as from the Emmanuel College IRB. If the institution does not require its own IRB review, you may be asked to provide written documentation of the institution’s support for your project. In most circumstances it is inappropriate for an investigator to use their own students as participants because of the possibility of coercion. Exceptions may be allowed, but the investigator would have to substantiate the need to use their own students as participants and propose an acceptable plan in accordance with IRB requirements and policies.
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12. Please describe how you will obtain participants' approval. If you are obtaining consent or permission, please use our template on page 20-21 and attach the form(s) as appendices. The IRB is federally mandated to ensure that the consent process is free of coercion or undue influence. For research involving permission and assent, a complete description of the process must be included. Important Note: The consent/permission form should be written at the level of an 8th grader. Please see the consent form template and sample consent form provided at the back of the guidebook. Click here to enter text. 13. If you believe the IRB should waive the requirement of a signed consent form and you are not going to collect the form, please justify your decision here. If you are not going to distribute consent forms at all, please justify your decision here: Click here to enter text. 14. Please describe any foreseeable risks that your research project could pose and assess their likelihood and seriousness. Note: Risk is a very broad concept for which Principal Investigators should seek counsel from the IRB, if there are any questions. The IRB will examine the project to ensure that a wide range of risk issues are addressed- from the risk of information and identity disclosure to feelings of discomfort generated by questions on a survey to physiological discomfort or danger. There are other risks, but the preceding is intended to underscore the breadth of the concept.
Click here to enter text. 15. If risks are involved, describe procedures for protecting against or minimizing any potential risks identified above and assessment of likely effectiveness and seriousness: Click here to enter text. 16. Describe any benefits that will accrue to participants themselves or to society: Click here to enter text. 17. Will you be recording or collecting any identifiable, private information about individual participants that would allow an individual to be identified (for instance unusual ethnicity, birthdate, etc.)? Choose an item 17.1 Will you be collecting audiotapes, videotapes, or still photography in your research? Choose an item. 17.2 If you answered yes to either question, describe a.)which media will be used and b.) how you will protect the privacy of your participants and maintain confidentiality, including provisions for secure storage of data after the completion of your research. (On the consent/permission form, you will need to inform participants or guardians of your intent to record, and you will need to describe what will happen to these records). Click here to enter text. 11
17.3 If you answered yes, please read and sign below: I understand that I am obligated to protect and keep confidential any identifiable, private information gathered about individual participants through the conduct of my research. I agree to keep such information confidential, unless I obtain the participant’s express written permission to do otherwise or unless I am legally compelled to provide the information. Signed: ___________________________________ Date:________________________ 17.4 If you answered no, you will need to ensure that you protect the privacy of your participants and maintain confidentiality, including provisions for secure storage of data. Please describe how you will accomplish this: Click here to enter text. 17.5. Does this proposal involve any of the following populations: Choose an item. 18. Is this project being reviewed by any other review board? If yes, provide name and location of other institution. Choose an item. 19. Are you going to collaborate with any Emmanuel department or external agency or organization. If yes, please attach a letter of approval from the Emmanuel department or external agency. Choose an item.
After the IRB has approved a project, two hard copies of all forms related to the project with the investigators’ signatures must be brought to Ms. Diane Bissaro in the Dean’s Office (ADM 209). Both copies must be stamped by Ms. Bissaro. One will be filed in the IRB office and the investigators must retain the second. Note: All correspondence must be deposited in the IRB Administrative Assistant’s files. A study cannot begin until this correspondence has been filed. Investigators with questions concerning the development, submission, or status of their proposal should contact Prof. Joyce Benenson, IRB Chair or Ms. Diane Bissaro, Administrative Assistant.
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Assurances: If a Consent Form is used, it is understood that it must be kept on file for three years. Participants must be given a copy of the consent Form. The IRB may request copies of signed Consent Forms for all participants participating in this research. It is understood that Emmanuel College students should be initially recruited as participants by public announcement and not by personal solicitation. If any project exceeds a period of one year in duration, it must be reviewed and receive IRB approval before the beginning of the second and any successive years of the project. It is understood that Investigators must comply with the federally mandated educational training requirement. This is done by taking the online “Course in the Protection of Human Research Participants,� which is found at https://citiprogram.org. There are CITI modules for Biomedical researchers, Social/Behavior/Educational researchers, and a module for student researchers and their research advisor. It is understood that any required financial disclosure documents must be signed before the project is approved. In signing this statement, I certify that I have already completed the CITI training. I also certify to the accuracy of the information provided in this document and in any attachments or other supporting documents, and I reassert my intention to abide by the College’s policies and procedures governing research involving human participants. Signature: ___________________________________________________ Date: _________________ Signature: ___________________________________________________ Date: _________________ Signature: ___________________________________________________ Date: _________________ Signatures of all project investigators are required. ------------------------------------------------------------------------
(for IRB use only)
___ Proposal Submission Form ___ Consent/Permission/Assent Form ___ Research Instruments ___ Recruitment Materials ___ Authorizations Signature of IRB Chair: ________________________________________ Date: __________________ Joyce F. Benenson, Ph. D. e-mail: benensjo@emmanuel.edu Recorded at IRB Full Meeting on Date: ____________________________ 13
2. Informed Consent and Consent Forms A. The Purpose of Obtaining Informed consent The informed consent of the individual is a vital element in the protection of human participants. Before a person participates in an investigation involving risk or the likelihood of substantial stress or discomfort, the nature of these hazards and the procedures to be followed are to be carefully explained and participant consent obtained. The IRB will carefully review the consent process to ensure that participants are adequately informed and free to make a decision about participation. The IRB will review the consent form to determine if it contains all appropriate elements of informed consent. Three types of acquiescence to participate in a research project can occur. First, those participants who are over 18 years can consent to participate in research themselves as long as they understand the research project and can voluntarily choose whether to participate. Second, in cases in which a participant is under 18 or cannot be expected to understand the research proposal or cannot voluntarily choose whether to participate (typically a minor or cognitively impaired person), a legal guardian can provide permission for that person to participate. Third, in the case when a legal guardian provides permission for a participant to partake in the research project, the investigator generally should attempt to obtain the actual participant’s assent which may occur verbally. This generally requires a simplified description of the research proposal. Because this is a critical component of the respect for the dignity of participants, the IRB will carefully review the process and documents for consent, permission, and assent forms. Consent is a process, not a form. Whether a form is used or not, there must be a process that provides potential participants with enough information for them to make an informed decision and does so in a way that is free from pressure and undue influence. Although there are regulations that require the participant or the participant's legally authorized representative to give consent prior to the participant's participation in a study, the principal reason for informing participants about a study is that they have a moral and ethical right to know what is to be done to them and what consequences this might entail before they give their consent. An experiment or other forms of research entail something that is done to the participant, and, therefore, differs from the usual clinical practice where something is done for the person. The use of human participants is a privilege (a favor) granted to the investigator, not a right. Investigators should seek consent under circumstances that provide the prospective participant or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. An individual does not abdicate any rights by consenting to be a research participant. A participant has the right to withdraw from a research project at any time or to refuse to participate without loss of benefits to which the participant would otherwise be entitled. Further, a participant has the right to receive appropriate professional care, to enjoy privacy and confidentiality in the use of personal information and to be free from undue embarrassment, discomfort, anxiety, and harassment. It is recommended that, whenever possible, the principal investigator obtain informed consent from the participants themselves. The investigator must seek consent under circumstances that 14
provide the prospective participant sufficient opportunity to consider whether or not to participate (i.e., participation in projects must be voluntary). Unless the IRB issues a specific waiver of consent or of documentation of consent (see below), documented written informed consent of participants (through the use of a consent form) is required for all research projects where there is any risk to the human participants. If a participant is not legally or physically capable of giving informed consent, a legally authorized representative may give permission for the participant to partake in the research. Careful consideration will be given to the representative's depth of interest in and concern for the participant's rights and welfare.
B. The Contents of the Consent/Permission Form Consent form should convey all of the following information, at a minimum. It should also be simply written and easily understood. (APPENDIX D contains detailed information/advice about the preparation of the consent form and includes a Consent Form Template.) •
A statement that the study involves research, a readily understood explanation of the purposes of the research and the expected duration of the participant’s participation, a description of the procedures to be followed, including identification of any procedures which are experimental
•
A description of how data will be handled (who will have access for what purposes)
•
A description of how and to whom data and results will be disseminated (intentions to present or publish, share with colleagues, and at what level of aggregation, etc)
•
A description of any reasonably foreseeable risks or discomforts to the participant
•
A description of any benefits to the participant or to others which may reasonably be expected from the research and/or findings (if no direct benefit, this should be stated)
•
A statement describing the extent, if any, to which confidentiality of records that identify the participant will be maintained. (If signed Informed consent forms are used, regulations require they must be kept for 3 years.)
•
An explanation of whom to contact for answers to pertinent questions about the research and research participants’ rights, and whom to contact in the event of a research-related problem or injury to the participant
•
For research involving more than minimal risk, an explanation as to whether any medical or psychological treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
•
A statement that participation is voluntary, that deciding not to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled
•
A statement concerning costs or compensation to the participant, if any 15
•
A statement similar to this in the consent document: If you have questions or concerns about the research, you may contact [name and contact information of investigator and/or the Chair of the Institutional Review Board at 617-735-9921. Students should also include name of and contact information for their research advisor or course instructor.
The IRB may require additional information to be included in the consent process and/or included in the Consent Form. What to do with the Consent Form Research investigators must insure that anyone signing a written Consent Form is given a copy of that form before they participate in the project. Research investigators are responsible for safeguarding the consent documents signed by human research participants for at least three years following the termination of the project. Faculty supervisors must maintain the consent documents for student investigators.
C. Waiving the Consent Form Requirement (Bankert & Amdur, 2006, p. 220) The IRB may waive the requirement for the investigator to obtain a signed Consent Form for some or all participants if it finds that: (1) The research involves no more than minimal risk to the subjects. (2) The waiver or alteration will not adversely affect the rights and welfare of the subjects. (3) The research could not practicably be carried out without the waiver or alteration. (4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation (Bankert & Amdur, 2006, p. 217). Waiving the Documentation of Consent Requirement (Bankert & Amdur, 2006, p. 221) The IRB may waive the requirement that the investigator document who signed Consent Forms if it finds that: (1) The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant must be asked whether s/he wants to be linked with the research OR (2) The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context OR
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(3) The participant never signed a consent form, because the consent form requirement was waived. In that case, the investigator should provide participants with a written description of the project before initiating the project. For example, if the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, the consent form could be provided, but not returned (not documented by the investigator). The research must present no more than minimal risk of harm to participants and not involve procedures for which written consent is normally required outside of the research context. Reasons to waive use of a signed consent form should be given in the Proposal Submission Form. When the documentation requirement is waived or altered, the IRB may still require an informed consent process – providing participants with a written or oral description of the research and making sure they are freely choosing to participate.
D. Instructions for Preparing the Consent Form Stationery: The consent form must be written on official Emmanuel College stationery and must have an approval stamp from the IRB. (Printing on EC stationery will occur after the IRB has approved the project and the consent form.) Language, style and level: The consent form should be written in the second person. When combined with conditional language and the invitation to participate, use of the second person communicates that the investigator believes there is a choice to be made by the prospective participant. Use of the first person may be interpreted as presumption of participant consent before consent has been legally obtained. The information that is given to the participant or the representative shall be in language understandable to the participant or the representative. Keep in mind that terms commonly used by members of a profession are a part of the professional's language, a language many people outside that profession do not understand. If there is any doubt that a term may not be understood, a definition should be added. If some of the anticipated participant population does not understand English, appropriate translation should be provided. Researchers are commonly advised to write consent materials for about an 8th grade reading level. The consent form must not contain any exculpatory language through which the participant or the participant's representative is made to waive or appear to waive any of the participant's legal rights, or through which s/he releases or appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence. Length: The consent form should be long enough to explain consent factors adequately but not so long or detailed as to lose the attention of the participant or to cause confusion. If a separate project description is given to participants, the actual consent form will not need to exceed one page. 17
Submission to the IRB: Investigators must include copies of any proposed consent form(s) with the proposal. Investigators must also submit copies of any written or verbal explanation of the project that will be given to participants. The approved Consent Form is valid for a maximum of one year. In cases where a project is continuing beyond one year, permission to continue use of the Consent Form must be applied for at least 45 days in advance of the one-year anniversary date. Such permission is granted in conjunction with the application for Continuing Review. Note: If your research study will include individuals with linguistic backgrounds other than English, the IRB will generally require that you translate the Informed Consent Form into the appropriate other language. It must be submitted with the other materials you are sending in your application. An English “back translation” of the Form should be submitted, as well. In cases where an individual may be unable to read—whether it be English or another language—or has impaired vision, appropriate arrangements must be made to orally convey the contents of the Informed Consent Form. Arrangements must also be made for the individual to give or withhold their willingness to participate in the research project. Consent Form Template The template shown on the following two pages is designed to help Emmanuel College Faculty, Staff, and Students as they design the consent process and prepare a consent form. All researchers are required to make use of this template. If this template is not appropriate for a particular study or if you have any consent questions, contact IRB Chair. Remember that what is included here relates to consent, designed for adults. For children, assent needs to be obtained as well as permission from parent or guardian. For the IRB, assent should be a few simple paragraphs that you include as a separate document in your submission (outlining what you will tell each child before they take part in your study. It should explain everything you will be asking them to do and that they can stop at any time. You are expected to get their personal permission to participate (assent) before you use them as participants. If they are able, they can assent in writing, as well as verbally. When working with young children, you must describe how on-going assent will be assessed – what behavioral or verbal cues will be used to determine whether continuing is appropriate or not.
E. Research with Vulnerable Populations For research with children, the elderly, the disabled, and other vulnerable populations, additional protections are required. Permission must be obtained from parents/guardians for all vulnerable participants as well as assent from participants themselves. No participant can provide consent unless they are over 18 years of age. If participants are under 18 years, they will require a family member/guardian to provide permission for them to participate. Emmanuel students under 18 years cannot participate without parental permission. Pregnant women and prisoners also are considered vulnerable populations, so special considerations apply. Investigators should review the material in the CITI training modules and consult with the IRB for further details. Assent and Permission: Be sure to include copies of materials to be sent home to families/guardians and the Permission Forms they would sign. Be sure that procedures for gaining and maintaining Assent are clear. For example, teenagers under 18 require parental permission, 18
but they themselves must also provide Assent. This can be accomplished by having them read and sign something. For younger children, the elderly or disabled, ongoing assent must be obtained before the research commences, then continually determined verbally and behaviorally. You will need to make it clear how this will be done. For research in institutions (schools, nursing homes, hospitals, prisons): Investigators will need to provide written documentation to the IRB Administrative Assistant that the institution approves of your research project before you begin to collect data. Investigators may also include this information as an Appendix if they have contacted an institution before submitting to the IRB. However, the IRB makes the final decisions regarding all procedures and instruments, so it is reasonable to obtain formal IRB approval before obtaining approval from an institution.
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F. Template for Consent/Permission Form Emmanuel College Department of [ ] [Names of Researchers] Consent/Permission Document [Title of Study] [Date] Dear X: You are invited to participate in a research study entitled (name of study) conducted by (insert the Principal Investigator’s name here; with student research, insert both the student name and the faculty sponsor’s name).
A. Purpose and Procedures The purpose of this research is (explain the purpose of the study in easily understood language). In this study, you will (describe the procedures to be followed in easily understood language; describe the tasks that the participant will be engaging in. If you will be asking any personal or sensitive questions, state as much here. This study will take place (specify location). The time to complete this study is approximately (add expected time; indicate how time is divided – e.g. two sessions, a week apart). The number of people who will participate is approximately (add expected number). (If participants will be compensated, state the amount and terms of compensation. If payments will be prorated if a participant withdraws from the study, state the terms. Course credit for participation is considered compensation and must be described, along with the reminder that an alternative way to earn credit is available.)
B. Risks and discomforts There are no known risks to participating in this study. OR There may be some risks or discomforts if you participate such as (describe any reasonably foreseeable risks or discomforts to the participant. You should also describe the measures you will take to minimize these risks and discomforts. When appropriate, be sure to include specific information regarding referral(s) to professional consultation if your project has potential for causing strong feelings in participants (i.e.: questions regarding sexual orientation, physical abuse, drug use, suicidal thoughts, etc.). [For studies involving more than minimal risk, add the following statement: If this study causes you any discomfort, you may contact {name/service} at {telephone number and e-mail address}. This person/institution provides services to people like you who have experienced this type of situation.]
C. Potential benefits There are no direct benefits to you from participating in this research. (If appropriate, you can add: This research may help us to understand…(limit to a brief statement). OR (Describe any benefits to the participant and to others that may reasonably be expected from the research.)
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D. Protection of confidentiality/anonymity Your name or other identifiers will not be attached to your answers so that your confidentiality can be maintained. Your privacy will be ensured in that all data resulting from this study will be analyzed, written, and published in summary form. (State conditions for exactly how you will protect the confidentiality of data here.) OR This study is anonymous. Your name (and other personal information about you) will not be recorded. (If the study is anonymous, then this should be stated here. Indicate how anonymity will be preserved.)
E. Voluntary participation Your participation in this research study is voluntary; you may choose not to participate. You also have the right to stop participating at any time for any reason. You will not be penalized in any way should you decide not to participate or if you withdraw from this study.
F. Contact information 1. If you have any questions or concerns about this research, please contact (list researcher’s contact information, including name, mailing address, telephone number, and email address; include a faculty contact on student research). 2. If you have any questions about your rights as a participant in this research or if problems arise, please contact Dr. Joyce Benenson, Chair of the Emmanuel College Institutional Review Board (IRB) at 617-7359707 (e-mail: IRB@Emmanuel.edu) or Ms. Diane Bissaro, Administrative Assistant of Emmanuel’s IRB at 617-735-9713 (e-mail: Bissardi@Emmanuel.edu). The IRB is a group of people who review research proposals and may also review study records to ensure that research is designed and conducted in an ethical and safe way.
G. Consent (choose one of the following endings) By completing the (questionnaire/interview/focus group participation --- select appropriate method), you are agreeing to participate in this study. You may want to keep a copy of this document for future reference. OR I have read this consent document and have been given the opportunity to ask questions. I have been given a copy of this document for future reference. I agree to participate in this study. Participant’s signature: ____________________________________
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Date: ________________
G. Example of Actual Consent Form Emmanuel College Department of Sociology Ms. Jane Doe Consent/ Document
College Students’ Ideas about Marriage November 2009 Dear Student: You are invited to participate in a research study entitled “College Students’ Ideas about Marriage” conducted by Jane Doe, a student in Dr. Chris McGuire’s Sociology class.
A. Purpose and Procedure The purpose of this research is to learn what college students today think about marriage. In this study, I will ask you questions about married couples you know, about your views on the pros and cons of marriage, and what you picture for yourself in the future. I will take notes during our meeting and record the interview on audiotape. The interview should take about 45 minutes to an hour. I will interview between 10 and 12 people. You may receive course credit for participating in this study.
B. Risks and discomforts The only risk for you to participating is that you might feel uncomfortable, shy, or sad when talking about the marriages of people you know or what you hope for yourself. If you do feel distressed, you can visit Dr. Linda Jurgela at Emmanuel College’s Counseling Center or call them at 617-735-9150 to arrange an appointment.
C. Potential benefits There are no direct benefits to you from participating in this study. However, you might find the interview interesting, and your comments will help me learn more about college students’ views of marriage.
D. Protection of confidentiality/anonymity I will keep your first name in my files so that I can keep track of who I interviewed already. In all the reports or articles that I write and presentations that I give, I will not use your name or any other description that would let people figure out who you are. I will keep my notes and the list of names of students who participated on my password-protected laptop computer until the end of the semester, after which I will delete the file. Your name or other identifiers will not be attached to your answers so that your confidentiality can be maintained. Your privacy will be ensured in that all data resulting from this study will be analyzed, written, and published in summary form.
E. Voluntary participation Your participation in this research study is voluntary; you may choose not to participate. You also can stop participating at any time for any reason, and you can skip any questions you don’t want to answer. Nothing negative will happen if you decide not to participate at any time.
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F. Contact information If you have any questions or concerns about this research, please contact me (Jane Doe e-mail DoeJane@yahoo.com) or my faculty supervisor, Dr. Chris McGuire at 617-555-5555 or McGuireChris@emmanuel.edu. If you have any questions about your rights as a participant in this study or if problems arise, please contact Dr. Joyce Benenson, Chair of the Emmanuel College Institutional Review Board (IRB) at 617-735-9707 (e-mail: IRB@Emmanuel.edu) or Ms. Diane Bissaro, Administrative Assistant of Emmanuel’s IRB at 617-735-9713 (e-mail: Bissardi@Emmanuel.edu). The IRB is a group of people who review research proposals and may also review study records to ensure that research is designed and conducted in an ethical and safe way.
G. Consent I have read this consent document and have been given the opportunity to ask questions. I have been given a copy of this document for future reference. I agree to participate in this study. Participant’s signature: ____________________________________
Date: ________________
Keep one copy for yourself, and give one copy to Jane Doe. Thank you for your help!
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3. Research Instruments Research instruments include, but are not limited to the following: surveys, interview guides, observation tools, psychometric tests, or any data collection tool. Submit copies of your research instrument(s) if possible. If not, describe them in detail.
4. Recruitment Materials Flyers, recruitment advertisements on the Psychology Subject Pool website, survey monkey descriptions, and other recruitment materials must be submitted.
5. Authorization(s) from cooperating institutions, organizations, or agencies Investigators cannot begin to collect data until appropriate authorizations are filed with the IRB Administrative Assistant.
VII. Important Additional Considerations A. Safeguarding Information Safeguarding information about an individual that has been obtained in the course of investigation is a primary obligation of the investigator. When the investigator is a student, responsibility for the conduct of the research and the supervision of human participants lies with the faculty sponsor. Such information shall not be communicated to others unless explicit permission for the release of identifying data is provided by the individual. Information about individuals may be discussed only for professional purposes and only with persons clearly concerned with the project. Written and oral reports should present only data germane to the purposes of the project, and every effort should be made to avoid invasion of privacy. Provisions must also be made for the maintenance of confidentiality in the preservation and ultimate disposition of any data collected. Adequate security measures must be described to the IRB and carried out by the principal investigator until the records are destroyed. Records containing personal information shall be destroyed as soon as possible in keeping with the longrange goals of the project. Signed copies of informed consent forms must be maintained by the principal investigator and be stored in a secure manner. Unless otherwise specified by Federal and/or state regulations, retention shall be for a period of at least three years beyond the termination of the study. If the investigator 24
resigns from the College before the end of the designated period, the informed consent forms must be submitted to the IRB unless otherwise specified. The one exception to provisions of confidentiality however concerns the federal government. Unless the investigator files a form with the federal government requesting confidentiality before data is collected, federal officials concerned with protection of participants are allowed to request data collected by an investigator.
B. Changes to the Protocol If a research procedure changes in after a research project has been approved, the investigator must not proceed with the proposed changes without written approval of the IRB. In cases where an investigator is seeking approval for a project essentially identical to a project previously approved by the IRB, renewed approval should be obtained generally through an expedited review. Full reviews are required where an investigators submits a previously approved proposal to other funding agencies.
C. Adverse Effects on Participants It is the researcher’s responsibility to notify the IRB in writing of any adverse effects to research participants within one week of such event(s). If a researcher should encounter any unexpected and serious adverse effects on human participants, research should be immediately discontinued and the IRB must be notified.
D. Renewed Approval Any project which exceeds a period of one year in duration must be reviewed and receive IRB approval prior to the beginning of the second and any successive years of the research project. Renewed Approval must be sought at least one month prior to the anniversary date of approval for the research study. The Consent Form is also valid for a maximum of one year after its approval. In cases where a project is continuing beyond one year, permission to continue use of the Informed Consent Form must be applied for at least one month in advance of the one-year anniversary date. Such permission is granted in conjunction with the application for Continuing Review.
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VIII. Student Research in Non-Research and Research Courses and in Research Internships All research conducted at Emmanuel College must be evaluated for its ethical implications and approved. This can be accomplished in a variety of ways. Approval can be provided by the professor of a course, by another institution’s IRB, or by Emmanuel College’s IRB. Personal, legal protection is provided however only when Emmanuel College’s IRB approves the project (or accepts the approval of another institution’s IRB). In some cases however, a professor may assume legal responsibility under the conditions described below. The following descriptions outline the different means by which ethical approval may be obtained at Emmanuel College. •
Collection of data within the confines of an Emmanuel course- If a professor obtains consent from all members of a course to collect data as part of the course, then the professor may collect data only on the students in the course. For example, the professor may demonstrate how to create and distribute questionnaires, give interviews, collect observations, or run an experiment by having the students in the course serve as participants for one another. The data collection must pose no risk to the students or participants; participants must have the right to refuse to participate without penalty; confidentiality must be maintained to the greatest extent possible; extra precautions must be taken with vulnerable populations (such as gender or ethnic minorities); and the data may not be published. The professor of the course however assumes legal liability and will not be protected by the college should a legal complaint arise. If a professor is uncertain whether a project is ethically sound, then the project should be submitted to Emmanuel College’s IRB.
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Collection of data within a non-research course- If a professor wishes students in a course to collect data as part of the course with participants from outside the course, the data collection must pose no risk to either the students or participants, involve only a few participants, and cannot meet the formal definition of research (which is defined as interaction with human participants in a systematic fashion designed to further knowledge). For example, observing a few individuals in public places, interviewing several individuals, holding a focus group, conducting a completely physically and psychologically harmless experiment, or providing a harmless intervention within a service learning course with a few individuals all are acceptable. The data collection must pose no risk to the students or participants; participants must have the right to refuse to participate without penalty; confidentiality must be maintained to the greatest extent possible; extra precautions must be taken with vulnerable populations; and the data may not be published. The professor of the course however assumes legal liability and will not be protected by the college should a legal complaint arise. If a professor is uncertain whether a project is ethically sound, then the project should be submitted to Emmanuel College’s IRB.
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Collection of data within a research course- All research courses in which students are expected to conduct a formal research project require approval from Emmanuel’s IRB. The professor may bundle all students’ research projects into a single submission or students in the course may submit individual or small-group proposals to the IRB.
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Individual Research Projects by Students at Emmanuel College(including research internships, senior research projects, individual student research projects)- Any student 26
conducting an individual research project for credit at Emmanuel College whether at Emmanuel College or at any other institution (for example, another college, a university, or a hospital) must submit the project to Emmanuel College’s IRB for approval. If the project has been approved already by another institution’s IRB, then the student must submit documentation of approval from that institution to Emmanuel College’s IRB along with brief descriptions of the project and the student’s specific role in the project. The documentation may consist of the approval letter from the other institution’s IRB or of a signature by the principal investigator of the project on which the student is working indicating that the principal investigator has received IRB approval from the institution. The name of the institution, the principal investigator, the student’s name, and the date the IRB approval was obtained must be included. The IRB Chair then may either waive the requirement that the student submit to Emmanuel’s IRB or require that the student also submit the proposal to Emmanuel College’s IRB. As long as the project complies with Emmanuel College’s policies, other institution’s IRB decisions will be respected. This information may be submitted by hard copy or electronically to the IRB Chair. The IRB reserves the right to disapprove of a student’s research.
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Definitions of Terms Research: systematic investigation designed to develop or contribute to generalizable knowledge. Under this definition some demonstration, service and training projects may be considered to include research activities. Investigator: either a person affiliated with Emmanuel College (faculty, staff, or student) conducting human participants research on or off campus, or a person unaffiliated with the University who wishes to conduct research involving human participants on campus Human Participant: a living individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the individual or b) identifiable, private information Intervention: both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes Interaction: communication or interpersonal contact between investigator and participant Private information: information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants. Minimal risk: risks of harm anticipated in the proposed research that are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests Legally Authorized Representative: an individual or other body authorized under applicable law to consent on behalf of a prospective participant to the participant's participation in the research procedure(s) Institutional Review Board: the committee at Emmanuel College given the authority to approve or disapprove research projects involving human participants.
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