Investigator Handbook
Chapter 6: RESEARCH SUBJECTS

Guidelines to Recruitment of Research Subjects

Recruitment and selection of subjects must be equitable within the confines of the study.  The investigator may not arbitrarily exclude participants on the basis of gender, race, national origin, religion, creed, education, or socioeconomic status.

Inclusion of Women and Minorities in Research
Cultural diversity in subject selection is strongly encouraged.  Clinical studies should be inclusionary, designed in such a way that the subject pool is representative in gender, race, ethnicity, and age of the local population affected by the condition being studied.  Exclusion of particular subgroups may be justified in the following cases:

• A specific scientific question is more appropriately addressed with a more targeted group,
• Specific known risks of intervention (or other participation) warrant exclusion of specific groups,
• Gender- or racial-neutrality has been previously demonstrated,
• Redress of gaps in medical knowledge about specific groups,
• Multicenter studies may achieve overall balance by choosing centers with complementary minority representation.

Subject enrollment need not be sufficient to provide high statistical power for calculating effects of gender and minority status on intervention effect in all cases.  Investigators planning phase 3 clinical trials in which prior studies suggest a clinically “significant difference” in effect among subgroups or those in which differential effects are uncertain are encouraged to design the subject pool in sufficient numbers so as to provide a “valid analysis” in each subgroup.

Economically Disadvantaged Subjects
Investigators should consider added costs related to the research that might prevent participation by the economically disadvantaged.  Justification for such cost must be fully explained in the IRB application.

Financial remuneration, reward, reimbursement for expenses, or other inducement for participation should not be so great as to be coercive to potential participants and should constitute reasonable compensation for the inconvenience of participating.

Subject Recruitment
Clinical studies should be advertised to and made accessible to an equitable group of individuals.  In cases in which recruitment and/or retention of women or minority subjects may be difficult, a proactive program may be employed.  Cultural sensitivity in approaching potential subjects is to be encouraged (e.g., respectful of language and custom).  Barriers to participation in underrepresented groups should be anticipated and overcome prospectively (e.g., compensation for child care, lost wages or transportation; waiving of residency requirements; translation of advertising or educational literature and informed consent for non-English speakers).  The extent of compensation will be reviewed critically by CPHS to ensure that it is appropriate to the context of the study and not potentially coercive to vulnerable subgroups.  In order to ensure a diverse study population with sufficient statistical power to examine major gender and ethnic effects, large studies may consider the use of quota systems to manage enrollment.

To overcome lingering distrust of the medical and scientific establishment in minority populations, outreach programs may be used to inform local minority groups about the individual and collective benefits of participation in biomedical research.  Follow-up in these groups with modest advertising of individual projects and discussion of results may be employed.

Recruitment Scripts
Prospective participants often have their first contact with a research coordinator or third party who follows a script to determine basic eligibility for the specific study. The IRB must review these procedures to assure that they adequately protect the rights and welfare of the prospective participants.  The IRB must have assurance that any information collected about prospective participants will be appropriately handled.

Internet Recruitment
All advertisements and recruitment methods must be reviewed and approved by the IRB prior to implementation to assure that the information does not promise or imply a certainty of benefit beyond what is contained in the protocol and the informed consent document.

Students and UT Employees as Subjects
It is acceptable to enroll students in the UT Health Science Center at Houston, provided that:

• The students are not working in the same laboratory as the PI;
• The students do not report directly to the PI;
• The students are not in a class over which the PI has direct responsibility;
• Students, Staff, or Technicians enrolled in the study do not work in a laboratory that is in the sphere of influence of the PI;
• Recruitment does not involve coercion or undue influence.
  

Advertisements
Advertising and Recruitment Are Part of the Informed Consent Process! 
Direct recruiting advertisements are viewed as part of the informed consent and subject selection process.  When direct advertising is to be used, the IRB reviews the information contained in the advertisement and the mode of its communication to determine that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.  This is especially critical when a study may involve participants who are likely to be vulnerable to undue influence. 

The IRB must approve the final copy of all advertisements to include flyers that will be posted on bulletin boards or used as handouts, and broadcast on radio, television or through other venues (e.g., mass email).

Content of Advertisements
Generally, advertisements to recruit participants should be limited to the information that prospective subjects need to determine their eligibility and interest.  When appropriately worded, the following items should be included in advertisements:

• Name and address of the Investigator;
• Purpose of the research;
• Criteria to be used to determine eligibility in a summary form;
• Location of the research (e.g., Medical Center);
• A brief description of the study activities when appropriate;
• Potential benefits, if any; and
• Name and phone number of the person to contact for further information.

Advertisements to be Taped for Broadcast
When advertisements are to be taped for broadcast, the IRB must review the final audio/video tape.  The IRB must review and approve the wording of the advertisement prior to taping to preclude re-taping because of inappropriate content.  The review of a taped message prepared from IRB approved text may be accomplished through expedited review procedures.

New Advertisements Introduced After IRB Approval 
If an investigator decides to begin advertising for participants after the study has received IRB approval, the advertising will be considered as an amendment to the ongoing study.  When such advertisements easily reflect the consent form, the Committee Chairperson can choose to review and approve the advertisement using expedited procedures.  When the comparison is not obvious or other complicating issues are involved, the advertisement may necessitate full Committee review.

Finders Fees

Accepting or paying a "finder's fee" for the referral of patients or subjects into a research study is NOT allowed under Texas law and as such may not be a practice of any UTH employee. Under § 102.001 of the Texas Occupations Code, a state employee is guilty of a third degree felony offense if they pay or accept ANY remuneration for soliciting a patient. Anyone else who violates this section of the Texas Occupations Code may face a civil penalty of up to $10,000 per violation.

This does not mean that patients cannot be referred into an appropriate study. However, you may not offer to pay or agree to accept any payment for such referrals. This includes overt and covert payment as well as payment in kind such as bartered goods or services.

If you are approached with such payments or if there is a question as to whether something constitutes an incentive or bonus payment, please contact the CPHS office at 713-500-7942.

Payments to Subjects

Payments to research subjects for participation in studies is not considered a benefit, nor should it appear to induce a subject to enroll. Rather, it should be considered compensation for time and inconvenience .  The amount and schedule of all payments should be described in the IRB application at the time of initial review, including a summary of both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence.  Procedures for prorating payment should the subject withdraw should also be considered when submitting the IRB application and informed consent documents.

Timing of Payments
Credit for payment should accrue as the study progresses and not be contingent upon the participant completing the entire study.  Unless it creates undue inconvenience or a coercive practice, payments to subjects who withdraw from the study may be paid at the time the study would have been completed had they not withdrawn.  For example, in a study lasting only a few days, it may be permissible to allow a single payment date at the end of the study, even to subjects who withdraw before completion

Completion Bonus
While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion is acceptable, providing that such incentive is not coercive.  The IRB should determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn.

Disclosure of Payments
All information concerning payments, including the amount and schedule of payment(s), should be set forth in the informed consent document.

Advertisement of Payments
Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.

Alterations in Payments
Any alterations in subject payments or liberalization of the payment schedule must be reported to the IRB prior to implementation as an amendment.

Reporting of Payments
The Internal Revenue Service (the IRS) requires that UT Health Science Center at Houston (or whomever is paying the subjects for their participation) report payments in excess of $600 per calendar year on Form 1099-Misc.  The filing of these forms necessitate that the name and social security number of the subject be collected on a Form W-9 and released to the Office of Accounting to process the Form 1099-Misc.  The collection and release of this information must be addressed thoroughly in the informed consent document so that it is clear to the participant that his or her identity will be released for the purpose of payment and reporting.

Vulnerable Populations

As addressed in the Belmont Report, human subjects must be accorded respect as autonomous beings.  However, it also states that there are several categories of persons that have diminished autonomy and must be treated with a more elevated level of protection and a more widely defined relationship between risk and benefit.  If a human subject has diminished capacity for understanding a consent or if they are in a disadvantaged situation and are therefore, easily manipulated, then the protection from risks is a greater priority.  Each case must be treated differently according to its disadvantage.  Some special categories of vulnerable populations include children, pregnant women, neonates, fetuses, and prisoners.  These are not the only vulnerable populations.  Others include cognitively impaired individuals, the elderly, students, employees; any population possibly vulnerable to coercion or undue influence.

Children

There are four classifications of research involving children based on the degree of risk and the benefit to individual participants. For any protocols involving children, PIs should submit the Pediatric Risk Assessment Form in iRIS to indicate the level of risk in their studies (HRP PP IV.10 Review of Research Involving Children/Minors http://www.uth.tmc.edu/orsc/policies/IV.10.htm).  These categories are briefly described below.

Minimal Risk: 

• This protocol does not involve risk (physical or emotional) greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 
• Only one parent need give consent.

Greater than minimal risk and direct benefit: 

• This protocol does involve greater than minimal risk but also presents the prospect of direct benefit to the individual subject.
• Only one parent need give consent.

Greater than minimal risk and no reasonable prospect of direct benefit: 

• This protocol does involve greater than minimal risk and no reasonable prospect of direct benefit to the individual subject but is likely to yield generalizable knowledge about the subject’s disorder or condition.
• Both parents or legally appointed guardians must give consent unless one parent or guardian is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the minor.

Research not otherwise approvable: 

• This research is not otherwise approvable but presents an opportunity to understand, prevent, or alleviate serious problems affecting the health or welfare of children. 
• Requires approval by the Secretary of Health and Human Services
• Requires consent of both parents or guardians.

Parental Permission

The investigator will always be required to obtain parental permission documents and may not approach the child for assent until written permission has been given. Permission of one parent is sufficient if the research involves minimal risk; permission of both parents is necessary if the research involves more than minimal risk.  However, if one parent is deceased, unknown, incompetent or reasonably unavailable, or if one parent has legal responsibility or custody of the child, one parent permission is acceptable.

• The CPHS must determine for each protocol whether the permission of both parents is necessary, and the conditions under which one parent may be considered “not reasonably available”.
• Parental permission may sometimes be insufficient to protect the child’s interests particularly when the interests of one child conflict with those of a sibling or other relation.  In such cases, CPHS may seek  legal guidance to clarify authority.

Children Who are Wards of the State

Children who are wards of the state, an agency, institution, or entity can be included in approved research only if it is either related to their status as wards or the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards.  In this way, if the research is not related to the experience and environment of a ward, their status is made equal with the other non-ward participants. 

However, if the research is approved under 45 CFR §46.409(a) the CPHS must require appointment of an advocate for each child who is a ward.

• The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in the place of a parent.
• One individual may serve as advocate for more than one child.
• The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child during the child’s participation in the research.
• Aside from their duties as an advocate or member of the CPHS, the advocate must not be associated in any way with the research, the investigator, or the guardian organization.
  

Obtaining Assent from a Child

The difference between assent and consent is a child assents without the complete understanding of the purposes of the research and consent happens when there is a complete understanding of risks, benefits, purposes of the research, and their rights as human research subjects.

The investigator must make their best effort to ask the child for permission in order to determine if he/she assents.  In determining this, the investigator takes into account the child’s age, maturity, and psychological state.  This judgment may be made for all children involved in research under a particular research protocol, or for each child.  The child should be given an explanation of the research procedures in a language that is appropriate to the child’s age, experience, maturity, and condition.  This includes a discussion of any discomforts or inconveniences, or if the child will be required to spend time in an unfamiliar place.

For some research activities, the CPHS may require that either a CPHS member, research intermediary or an advocate for the child be present during the assent and permission procedures to verify the child’s understanding and to support the child’s preference.  The CPHS may also require that the parents or a close family member be present during the research, especially if a young child will be exposed to significant discomfort or inconvenience, or if the child will be required to spend time in an unfamiliar place.

Waiver of Assent

Generally, the child’s veto of participation is sufficient to make the child ineligible for inclusion in the study.  However, the parent or guardian, with CPHS and physician approval, may override the veto if the intervention will benefit the child.  The CPHS may determine that the assent of the child is not necessary:

• When the research offers the child the possibility of a direct benefit that is important to the health or well-being of the child and is available only in the context of the research; or
• When research involves the provision of experimental therapies for life-threatening diseases such as cancer.

CPHS should be sensitive to the fact that parents may wish to try anything, even when the likelihood of success is marginal and the probability of extreme discomfort is high.  Should the child not wish to undertake such experimental therapy, difficult decisions may have to be made.  In general, if the child is a mature adolescent and death is imminent, the child’s wishes should be respected.

Texas Law on Consent to Treatment of Children

A child may consent to medical, dental, psychological, and surgical treatment for the child by a licensed physician or dentist under certain limited conditions that include if the child (HRP PP I.04 State and Local Laws Involving Children in Research http://www.uth.tmc.edu/orsc/policies/I.4.htm):

• Is on active duty with the armed services of the United States of America;
• Is legally married;
• Is 16 years of age or older and resides separate and apart from the child’s parents, managing conservator, or guardian and manages his/her own financial affairs regardless of the source of funds;
• Consents to diagnosis/treatment of infectious, contagious, or communicable disease that is required by law or a rule to be reported by the licensed physician or dentist to a local health officer or Texas Department of Health;
• Is unmarried and pregnant and consents to hospital, medical, or surgical treatment, other than abortion, related to the pregnancy;
• Consents to examination and treatment for drug or chemical use; or
• Is unmarried, is the parent of a child, and has actual custody of his or her child and consents to medical, dental, psychological, or surgical treatment for the child.

Pregnant Women, Neonates or Human Fetuses

Research involving women who are or who may become pregnant should receive special attention from investigators because of a woman’s additional health concerns during pregnancy and because of the need to avoid unnecessary risk to the fetus (HRP PP IV.09 Review of Research Involving Pregnant Women, Fetuses, and Neonates http://www.uth.tmc.edu/orsc/policies/IV.9.htm).  Further, in the case of a pregnant woman, the investigator must consider when the informed consent of the father is required.  Procedural protections beyond the basic requirements for protecting human research subjects are prescribed in the Federal regulations for research involving pregnant women.

Pregnant women or fetuses may be involved in research if all of the following conditions are met:

• Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risk to pregnant women and fetuses; and
• The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means; and
• Any risk is the least possible for achieving the objectives of the research; and
• If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions according to regulations; and
• If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with regulations, except that the father’s consent need not be obtained if he is unable to consent because of the unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest; and
• Each individual providing consent under paragraph (D) or (E) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; and
• For children who are pregnant, assent and permission are obtained according to regulations found in the section above; and
• No inducements, monetary or otherwise, will be offered to terminate a pregnancy; and
• Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
• Individuals engaged in the research will have no part in determining the viability of the neonate.
  

Research Involving Neonates

Research involving neonates is allowable if all of the following conditions are met:

• Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates; and
• Each individual providing consent is fully informed regarding the reasonably foreseeable impact of the research on the neonate; and
• Individuals engaged in the research will have no part in determining the viability of a neonate; and
• The following requirements of the paragraphs below have been met as applicable:

Neonates of uncertain viability
Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this section unless the following additional conditions have been met and the CPHS determines that:

• The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or
• The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research.

The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent’s legally authorized representative is obtained in accord with subpart A of 45 CFR §46, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

Nonviable neonates
After delivery nonviable neonates may not be involved in research unless all of the following additional conditions are met:

• Vital functions of the neonate will not be artificially maintained; and
• The research will not terminate the heartbeat or respiration of the neonate; and
• There will be no added risk to the neonate resulting from the research; and
• The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
• the legally effective informed consent of both parents of the neonate is obtained in accord with subpart A of 45 CFR §46, except that the waiver and alteration provisions of 46.116(c) and (d) do not apply.
• However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph 45 CFR §46.205(c)(5) except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest.
• The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this paragraph 45 CFR §46.205(c)(5).

Viable neonates
A neonate after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of subparts A and D of 45 CFR §46. [45 CFR §46.205(d)]

After the Delivery: Using Placenta or Deceased Fetus

Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such activities.

If information associated with material described above is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent parts are applicable.

When your Research Does Not meet the Above Noted CPHS Requirements

If the CPHS does not believe the research protocol meets the requirements detailed in 45 CFR §46.204 or 45 CFR §46.205, the Secretary of the DHHS will conduct or fund the research only if:

• The CPHS finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates.
• The Secretary of DHHS, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either:
•   That the research in fact satisfies the conditions of 45 CFR §46.204 as applicable; OR
•   The following:
• The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates.
• The research will be conducted in accord with sound ethical principles.
• Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this section.

Definitions

Dead fetus - A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.
Delivery - Complete separation of the fetus from the woman by expulsion or extraction or any other means.
Fetus - Product of conception from implantation until delivery
Neonate - A newborn
Nonviable neonate - Neonate after delivery that, although living, is not viable
Pregnancy - Encompasses the period of time from implantation until delivery.  A woman shall be assumed to be pregnant if of reproductive potential and exhibiting any signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery
Viable - As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary of Health and Human services, may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of this subpart.  If a neonate is viable, then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.

Prisoners

The special vulnerability of prisoners makes consideration of involving them as research subjects particularly important (HRP PP IV.08 Review of Research Involving Prisoners http://www.uth.tmc.edu/orsc/policies/IV.8.htm).  Prisoners may be under constraints which because of their incarceration could affect their ability to make a truly voluntary and not coerced decision whether to participate in research.  To safeguard their interests and to protect them from harm, special ethical and regulatory considerations apply for reviewing research involving prisoners.  For this reason, any research that includes prisoners cannot be exempt from review by the CPHS.

The definition of “minimal risk” was used in the Informed Consent chapter of this Handbook, however, this definition has another version when applied to prisoners only. 

Criteria when Enrolling Prisoners in Research

Research involving prisoners will be approved only if the following conditions are met:

• If the research represents
• A study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects; or
• A study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects; or
• Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults); or
• Research on practices, both innovative and accepted, which have the intent and reasonable probability or improving the health or well-being of the subject.
• Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.
• The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers.
• Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners.  * Unless the principal investigator provides to the CPHS justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.
• The information is presented in language which is understandable to the subject population.
• Adequate assurance exists that parole boards will not take into account a prisoner’s participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.
• Where the CPHS finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners’ sentences, and for informing participants of this fact.
• The PI must provide documentation of approval from the detention or correctional facility involved to the CPHS prior to approval.

When a Subject Becomes a Prisoner during the Research

Should a research subject become incarcerated, and the protocol was not originally reviewed and approved for prisoners:
           

• The PI must promptly notify the CPHS of the event.

• CPHS will remind the investigator that all research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease until all of the requirement of Subpart C have been satisfied with respect to the relevant protocol.

Confidential Follow-up Forms

Confidential follow-up forms, or any other linkage between subject codes and identifiers, can be submitted to sponsors only upon assurance from the sponsor that such forms will be submitted to them in sealed envelopes with the notation that they may not be opened without specific permission from this Committee (CPHS).

These sealed envelopes, in addition to the aforementioned information, MUST have the university's name, the PI's name, the protocol number and title, and MUST be marked CONFIDENTIAL.

Should the need arise to notify research subjects of additional information that has come to light about the study drug or device, the CPHS must approve the mechanism for such notification and specifically require that it be channeled through the original PI or the patient's attending physician.

This procedure has been used successfully in the past and preserves the confidentiality of the subject/patient as well as the relationship between the physician/investigator and the subject/patient.

Conducting Genetic Research

The greatest risks to subjects participating in genetic research is the inappropriate release of personal and private information. Therefore, how investigators maintain confidentiality of data and specimens collected during the study is a primary concern to the CPHS.  The protocol and informed consent form should address the following points:

• That all study information is coded and personal identifiers maintained securely;
• That the consent form includes information about who will receive information derived (e.g. the patient, family members, non-participating family members, family physician, other physicians, other investigators);
• To add information as to whether clinically relevant information may be uncovered during the course of the study and give the subjects the opportunity to decline receiving this information;
• If children are to be research subjects, how will consent be obtained; how will data be handled;
• Add the fact that participants may derive no benefit from participation;
• Study data should not be recorded in the patient's medical record; separate research records with controlled access are preferred;
• Will a family pedigree be published or presented? Will there be a possibility of individually identifying subjects?
• Inform subjects of any special risks associated with their participation (e.g. changes in family relationships, risks to privacy, confidentiality, insurability, employability, immigration status, paternity suits);
• Indicate if general study results will be made available to subjects;
• Will genetic counseling be made available? Who will pay for this counseling?
• Indicate if the specimens will be maintained for a limited time or indefinitely, or will be discarded;
• If clinically relevant information is developed over time ask if the patients wish to be re-contacted;
• If you intend to share specimens acquired during the research with other investigators, this information must be included in the consent form and subjects given the choice whether they are willing to permit this or not;
• Should there be a potential commercial value derived from the research, the subject must be informed as to whether they will be asked to waive any rights or control over the tissue so used.
• Subjects must be advised as to which of the items listed above may be declined without impacting participation.