IRB GUIDEBOOK
9|29|12
I. Intro
A. the history of the human subjects protection system
*'the voluntary consent of the human subject is absolutely essential'
--> 1| capacity to consent
2| freedom from coercion
3| comprehension of the risks + benefits involved
+ a| minimization of risk + harm
b| a favorable risk|benefit ratio
c| qualified investigators using appropriate research designs
d| freedom of the subject to withdraw @ any time.
B. the Belmont Report: Ethical Principles + Guidelines for the protection of human subjects of research (1978)
1| respect for persons:
- the need to obtain informed consent
--> involves a recognition of the personal dignity + autonomy of individuals, + special protection of those persons w| diminished autonomy
2| beneficence:
- the need to engage in a risk|benefit analysis + to minimize risk
--> entails an obligation to protect persons from harm by maximizing anticipated benefits + maximizing possible risks of harm
3| justice:
- subjects must be fairly selected
--> requires that the benefits + burdens of research be distributed fairly
[practice vs. research]
(therapy)
'informed consent' =
1| sufficient information
+ on which whether or not to participate --> including:
1| the research procedures
2| their purposes, risks + anticipated benefits
3| alternative procedures (where therapy is involved)
4| a statement offering the subject the opportunity to ask questions + to withdraw @ any time from the research
2| comprehension:
--> subjects must be able to comprehend the information that is given to them + the presentation of info must be adapted to the subject's capacity to understand it.
+ each class of persons should be considered on its own terms (e.g. minors, ppl w| impaired mental capacities)
Points the IRB will consider:
1| does the principal investigator have the appropriate qualifications, experience + facilities to ensure that all aspects of the project + follow:up will be conducted rigorously + w| due regard for the safety + well-being of the subjects?
2| are there adequate procedures in place through which the research will monitor the project + report problems to the IRB?
3| what is the investigator's past record w| regard to approved research?
(basic IRB review)
A. Risk|Benefit Analysis
- 'benefit': a value or desired outcome; an advantage
- 'minimal risk': a risk is minimal where the probability + magnitude of harm or discomfort anticipated in the proposed research are not greater, in + of themselves, than those ordinarily encountered in daily life or during the performance of physical or psychological examinations or tests.
- 'risk': the probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study. both the probability + magnitude of possible harm vary from minimal to significant.
1| identify the risks associated w| the research, as distinguished from the risk of therapies the subjects would receive even if not participating in the research;
- embarrassment|shame
- job loss
- racial discrimination
2| determine that the risks will be minimized to the extent possible;
- protect participant identity whenever possible
- seek to represent all participants in an honest and yet positive light
- check in w| participants as the process goes along
- send participants text from the script + have it approved before January rehearsals
3| identify the probable benefits to be derived from the research;
- a true examination of what occurred
- informing audience members of Black history + an providing a contextual understanding (case-study) of the 2008 financial crisis
- further evaluation of public schools Yonkers, New York (+ localities throughout the U.S.) w| regard equality + accessibility
- my father being respected for the honorary man that he is
- to tell a great story; one that is mine as much as it is his
4| determine that the risks are reasonable in relation to be benefits to subjects, if any + the importance of the knowledge to be gained;
- participants are already experiencing embarrassment|shame, job loss + racial discrimination
- if anything the production of this play would work to systematically reduce the above symptoms
5| assure that potential subject will be provided w| an accurate + fair description of the discomforts + anticipated benefits;
- i will personally meet + discuss (of the record) the discomforts + anticipated benefits of the project
- i will include a clause in the informed consent waiver that acknowledges that said conversation has taken place + that the participant(s) understand the discomforts + anticipated benefits of the project
6| determine intervals of periodic review, + where appropriate, determine the adequacy of the provisions in place for monitoring the data collected;
- i will check in w| participants on a monthly basis
- i will keep track of participant approval of interview text in the final performance
7| determine the adequacy of the provisions to protect the privacy of subjects + to maintain the confidentiality of the data +, where the subjects are likely to be members of a vulnerable population (e.g. mentally disabled), determine that the appropriate additional safeguards are in place to protect the rights + welfare of those subjects.
- i will sign a waiver ensuring the privacy of subjects + disclose which participants wish to remain anonymous
- i will not share the data w| anyone without the permission of the participant(s)
- additional safeguards are in place to protect the rights + welfare of the subjects; who are all members of a vulnerable population as a result of their involvement in the NAACP case
*(1) is the invasion of privacy involved acceptable in light of the subjects' reasonable expectations of privacy in the situation under study?
- Yes. The invasion of privacy involved is acceptable in light of the subjects' reasonable expectations of privacy in the situation under study.
(2) is the research question of significant importance to justify the intrusion?
- Yes. My research seeks to test the following hypothesis: 'Is there a connection between physical action and the struggle for an actively anti-racist world? And if so, what is it and how can you foster it?' This question is of significant importance to justify the intrusion because it is a story about people - about what's been lost. It seeks to abide by the essence of why this was done and its impact on real people through an interdisciplinary approach that engages the study of culture and human development, economics + socio-political theory and the philosophy of education.
(3) can the research design be modified so that the study can be conducted without invading the privacy of the subjects?
- Yes. If necessary I can base my studies solely in primary research such as newspaper archives + court records, but the current research design invades the privacy of the subjects to a very minimal degree.
*Social+Economic Harms
--> Some invasion of privacy + breaches of confidentiality may result in embarrassment within one's business or social group, loss of employment, or criminal prosecution. - a researcher's plans to contact such individuals for follow:up studies should be reviewed w| care.
NOTE: IRBs should obtain complete information regarding experimental design + the scientific rationale (incl. the results of previous animal + human studies) underlying the proposed research + the statistical basis for the structure of investigation
*Are the investigators competent in the area being studied, + are they serving dual roles (e.g. teacher, or employer in addition to researcher) that might complicate their interactions w| subjects?
- identify any potential conflicts of interest;
1| i am telling my own story as well as the story of my father
2| i will maintain an unbiased approach to the process + stay as true to the facts as possible; whilst continually checking-in w| subjects in order to protect the privacy + minimize the risk of those involved
3| i will get both sides of the story
*will the research design yield useful data?
- consult biostatistician|statistician?
--> incorporating adequate safeguards into research design is a useful method of minimizing risk.
a| frequent monitoring
b| the presence of trained personnel who can respond to emergencies
c| coding data to protect confidentiality
d| debriefing subjects after participation
--> often suggested in behavioral research involving deception or incomplete disclosure, esp. if the research may induce psychological distress, guilt or embarrassment.
--> gives the investigator an opportunity to explain any deception involved + to help the subjects deal w| any distress occasioned by the research.
*I will use good judgement + evaluate potential risks on a case-by-case basis.
*Assessment of Anticipated Benefits
1| benefits to subjects
2| benefits to society
- how to determine whether or not risks are reasonable in relation to anticipated benefits?
Points to Consider
1| are both risks + anticipated benefits accurately identified, evaluated + described?
- Yes.
2| Are the risks greater than minimal risk? Have you taken into account any special vulnerabilities among prospective subjects that might be relevant to evaluating the risk of participations?
- The risk are not greater than minimal risk. I have taken into account all vulnerabilities among prospective subjects that might be relevant to evaluating the risk of participants.
3| If the research involves the evaluation of a therapeutic procedure, have the risks + benefits of the research interventions been evaluated separately from those of the therapeutic interventions?
- The research does not involve the evaluation of a therapeutic procedure. In the event that I choose to evaluate the research as a therapeutic produces during the debriefing process, I will evaluate the risks + benefits of the research interventions separately from those of therapeutic interventions.
4| Has due care been used to minimize risk + maximize the likelihood of benefits?
- Yes. Due care has been used to minimize risk + maximize the likelihood of benefits.
5| Are there adequate provisions for a continuing reassessment of the balance between risks + benefits? Should there be a data + safety monitoring committee?
Yes, there are adequate provisions for a continuing reassessment of the balance between risks + benefits. There will not be a data + safety monitoring committee.
the Nuremberg code - developed by the int'l military tribunal that tried Nazi physicians for the 'experiments' they performed on unconsenting inmates of concentration camps.
--> subject should be made known of the nature, duration + purpose of the experiment; the method + means by which it is to be conducted; all inconveniences + hazards reasonably to be expected + the effects upon his health or persona which may possibly come from participation.
*Federal regulations require the following info to be provided to each subject:
(1) a statement that involves research, an explanation of the purposes of the research + the expected duration of the subject's participation, a description of the procedures to be follows + identification of any procedures which are experimental.
American cities operated under systems of oppression rooted in slavery until the Brown VS. Board of Education Supreme Court decision of the 1960s found segregated educational facilities to be inherently unequal when two parties don't have equal power. The Civil Rights movement that rose soon-thereafter foresaw the case's pertinence and sought to enforce it on a national-level. In the aftermath of this 1960s quest for social justice; the city of Yonkers, New York remained chock-full of people of color who held heart-wrenching grievances regarding housing discrimination and segregation within the public school system. The subsequent NAACP VS. The City of Yonkers decision of the 1980s and 1990s found the city guilty of violating the freshly amended United States Constitutional standards for racial equality.
This project crosses disciplinary boundaries for two reasons. One is that in order to truly understand a historical moment it is necessary to take an interdisciplinary approach. Mine has consisted of classes in economics and economic development, social and political theory, childhood and education, critical race theory, cultural and media studies, business and social entrepreneurship, gender studies and labor history. Another way that this project crosses disciplinary boundaries is that this final production will incorporate several of the interdisciplinary arts including text, movement, video and sound. Additionally I will be working with Childhood, Youth and Learning and Hampshire Youth Connect to cast First Generation [a Springfield-based youth performing arts troupe that makes performance about oppression and liberation] in my final production.
I feel adequately prepared to embark on this ambitious project because of my experience working with First Generation and the Paul Robeson Freedom School. During January-term 2012 I raised money for my current internship with First Generation through ticket-sales for Let the Body Speak: An Arts and Performance Project. Additionally I taught at the recently-founded Paul Robeson Freedom School in Brooklyn, New York. The school, recently opened by activists from the Yes Men, Occupy Wall Street and Occupy the Hood emphasizes a radical education that provides youth with an understanding of the true history of our nation as well as the tools necessary to compete against and function within a complex industrialized world. At the Paul Robeson Freedom School, I taught classes on Dance and the History of Social Movements (my Division II Concentration) that incorporated both physical movement and lessons in radical history.
(2) a description of any reasonable foreseeable risks of discomforts to the subject;
- When my father resigned from the bar in 2004, the Klu Klux Klan's national website posted a GIF of two beer mugs clinking together above text that read, "Buddington lost his law license!" and his picture made the front page of the Yonkers Journal News. Did my father make the cover because of his attempts to make peace? Or was it a search warrant distributed to perpetuate the sinister forces that created these conditions?
- I need to have full accountability of all participants because of the danger. My father has asked that my Division III research be under the radar. Until he is reinstated to the bar in 8-10 months it is necessary that I discuss details of the case quietly.
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
- (see above)
- As an advanced learning activity: I am going to teach an EPEC course that the cast + crew will be required to take during January-term 2013. The class [open to community members as well] will cover a wide-range of skills necessary for the production, including: authentic movement, contact improvisation, and performance in detonated language [voice for actors]. In order to adequately prepare the cast for the context of the play, the course will also review the history of Black radicalism.
4| A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5| A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
6| for research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs + if so, what they consist of, or where further info may be obtained;
7| an explanation of whom to contact for answers to pertinent questions about the research + research subjects' rights + whom to contact in the event of research-related injury to the subject;
- I can be reached by phone at 914.374.8391 or by email at formingamovement@gmail.com
8| a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, + the subject may discontinue participation @ any time without penalty or loss of benefits to which the subject is otherwise entitled;
- 'Participation in 'forming a movement' is voluntary. Refusal to participate will involve no penalty or loss of benefits to which the I am otherwise entitled, and I may discontinue participation at any time without penalty or loss of benefits to which I am otherwise entitled.'
+ (additional info):
a| a statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable;
- 'I understand that the procedure of 'forming a movement' may involve risks to me which are currently unforeseeable.'
b| anticipated circumstances under which the subjects' participation may be terminated by the investigator without regard to the subjects' consent;
- 'In the event of unanticipated circumstances, the investigator may terminate my participation without my consent.'
c| any additional costs to the subject that may result from participation in the research;
- 'I will communicate any additional costs to me that result from participation in the research to the production manager [Jack Spagnola] of 'forming a movement'.'
d| the consequences of a subject's decision to withdraw from the research + procedures for orderly termination of participation by the subject;
- There will be no consequences in the event that a subject decides to withdraw from the research.
- Orderly termination of participation by the subject will be orchestrated by the assistant director [Sassy Oriana Blum Jensen] and Stage Manager [Rebekah Merck] in dialogue with the director [Idalia Buddington]
e| a statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; +
- 'Significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.'
f| the approximate number of subjects involved in the study;
- There will be approximately 10-20 subjects involved in the study.
*don't think of informed consent as a form that must be signed, but as an educational process.
- the nature of the proposed subject population:
'My methodology will involve conducting an ethnography of the NAACP VS. The City of Yonkers case. In addition to interviewing activists who were directly involved in the case; I will interview local residents who have been inadvertently impacted by the city's racist housing system and educational structure. Simultaneously I will review primary research from court records and newspaper archives.
- the type of information being conveyed:
'forming a movement' is an ethnographic dance-theater event about a segregated America; it seeks to contextualize the NAACP VS. The City of Yonkers case as but one microcosm of a centuries-long citizen's revolt against America as an inherently segregated superstructure.
- the circumstances under which the consent process will take place (e.g. manner, timing, place, personnel involved)
Points to Consider
1| do the investigators plan to involve a particularly vulnerable population?
- Yes, I plan to involve a particularly vulnerable population.
2| do the proposed explanations of the research provide an accurate assessment of its risks + anticipated benefits? is the possibility (or improbability) of direct benefit to the subjects fairly + clearly described?
- Yes. The proposed explanations of the research provide an accurate assessment of its risks + anticipated benefits, and the possibility (or improbability) of direct benefit to the subjects is fairly + clearly described.
3| Is the language + presentation of the information to be conveyed appropriate to the subject population? (Consider the level of complexity + the need for translation into a language other than English)?
- Yes. The language and presentation of the information to be conveyed is appropriate to the subject population. If necessary, I will consider the level of complexity and the need for translation into a language other than English.
4| Are the timing of + setting for the explanation of the research conducive to good decision-making? Can anything more be done to enhance the prospective subjects' comprehension of the info + their ability to make a choice?
- [Post-mortem|Debriefing] Questionnaire: 'Was the timing of + setting for the explanation of the research conducive to good decision-making? Could anything more have been done to enhance your comprehension of the information and your ability to make a choice?'
5| Who will be explaining the research to potential subjects? Should someone in addition to + other than the investigator be present?
- I will be explaining the research to potential subjects. No one other than me will be present.
6| Should subjects be reeducated + their consent required periodically?
- I will periodically require consent from subjects.
7| Should the IRB monitor incoming data to determine whether new information to be conveyed to participating subjects? How often should this occur? Who is responsible for bringing new information to the attention of the IRB between scheduled reviews?
- The IRB need not monitor incoming data to determine whether new information to be conveyed to participating subjects. I will check in with the IRB on a monthly-basis. I am responsible for bringing new information to the attention to the IRB between schedules reviews.
8| If a waiver of some or all of the consent requirements is requested, does the importance of the research justify such a waiver? Is more than minimal risk involved? Can the research design be modified to eliminate the need for deception or incomplete disclosure? Will subjects be given more information after completing their participation? Would the information to be withheld be something prospective subjects might reasonably want to know in making their decision about participation?
- The importance of the research does not justify the waiver of some or all of the consent requirements. More than minimal risk is involved, and the research design has been modified to eliminate the need for deception or incomplete disclosure. Subjects will be given more information after completing their participation, and will be given gratuitous tickets to final performances. I will not withhold information that prospective subjects might reasonably want to know in making their decision about participation.
No comments:
Post a Comment